Publisher of RxforAmericanHealth urges President to Stand up to Pharma, take a stand for American Patients’ Health

President Trump urged to end opportunity for Pharma to extend control of drug prices, prescription medicine policy in US 

 ST. LOUIS, MO, USA, June 19, 2017 /EINPresswire.com/ -- The publisher of the TodaysSeniorsNetwork chain of advocacy websites, including TodaysSeniorsNetwork, RxforAmericanHealth and AmericanRxBillofRights, has urged President Donald Trump to “stand up for Americans’ health by standing up to Pharma” with the issuance of his plans to issue an executive order to lower drug prices.

Daniel Hines says that the President should implement such policies as personal importation of brand-name medicines form licensed registered pharmacies in Tier One countries whose standards of safety and efficacy meet or exceed those of the U.S., price negotiation for Medicare, reciprocal agreements with regulatory agencies in Tier One Countries to ensure medicines meet standards of safety, and rules to ensure pricing transparency by Pharma.

“During the election, and since taking office, the President has, on the one hand, attacked the predatory pricing practices of Pharma, while continuing to meet with pharmaceutical representatives, making appointments of key policy makers such as Healthy and Human Services Secretary Tom Price, and FDA Commission Scott Gottlieb, both of whom disdain such readily available relief from high prices as price negotiation and personal importation of medicines,” says Daniel Hines.

“That is why, after the initial rush of optimism about the President’s decision to issue executive orders to lower drug prices, news stories that the President’s actions would favor Pharma are troubling and would, if factual, continue to deny patients access to the vital lifeline of maintenance medicines that help ensure the continued health and well-being of Americans, leading to even more serious health issues that can only be addressed by catastrophically priced drugs and treatments that are beyond the reach of the overwhelming majority of Americans.”

In a blog on RxforAmericanHealth, Hines offers insights into a ‘chain of events’ that has allowed Pharma to “thumb its collective nose” to the American public and the U.S. Congress, explaining that:

“For more than a quarter-century, Americans have been victims of the predatory pricing practices of Pharma.
• Americans pay the highest prescription prices in the industrial world
• This is based upon a national policy of allowing the industry to ‘charge what the traffic will bear’
• The Pharmaceutical Industry has created alliances, influenced governmental policy, colluded with regulatory agencies designed to ensure prices are unaffordable, and literally ‘bought’ the U.S. Congress with the most contributions of any industry segment in the U.S.

• Result #1—A denial for an estimated 55 million Americans to be able to exercise their right to the health benefit made possible from access to a regimen of vital life-line medicines, simply because they are unaffordable;
• Result # 2—The ‘hoped-for’ answer to the scourge of unaffordable medicines—generic medicines—has seen price spikes that have made many of them equally unavailable to American patients;
• Result # 3—Literally millions of Americans suffer from diseases—many of them life-threatening—raising the question of a possible link to the cause-effect impact of unaffordable but vital maintenance medicines that could have benefitted patients and deterred the harmful effects of their disease;
• Result # 4—Pharma raises prices on specialty medicines to thousands of dollars for treatments, even though many of the costly medicines are older, lower-cost medicines, and manufacturers are simply taking advantage of the illness of Americans;
• Result # 5—Congress becomes indignant, holds hearings, witness testify, advocacy groups coalesce to ‘address’ price challenges, but prices remain high, Congress continues with more hearings…and Americans continue to pay the highest prices in the world…WHY?
• RESULT #6--Because Pharma and its allies in the House of Representatives and the U.S. Senate who are the beneficiaries of Pharma’s extensive contributions have controlled the discussion on how to lower prescription and health care costs while Pharma continues to rake in obscene profits, and American patients continue to be denied their medicines.

“This is more than unfortunate, it is tragic because it illustrates what can only be considered the politicization of an important American healthcare issues, e.g., the beneficial impact upon the health and well-being of American patients from access to adherence to a regimen of authentic prescription medicines,” Hines explains.

He notes that the estimates vary, but the undeniable fact is that millions of American patients forego such adherence simply because the medicines themselves are so high-priced that they are unaffordable, making them, in and of themselves, unavailable.
“We are faced with the spectacle of an ineffective response from Congress, which continues to offer narrowly defined proposals ranging from personal importation to transparency to more generics to penalties for Pharma price gouging, and conducting time-consuming hearings that result in nothing, while Pharma continues to thumb its collective nose to the American people and sets prices beyond the reach of patients,” Hines continues.

“At the same time, a score of group and organizations issue periodic statements, collective letters and develop positions that address the costs and availability of medicines that cost thousands of dollars, all the while ignoring the fact that these commendable efforts are not mutually exclusive from the inclusion as part of recognition of the harmful impact of lack of access to any medicine, and that an unaffordable maintenance medicine is just as unavailable to untold numbers of patients as a medicine that costs $120,000 a year.

“It is time for a change! American patients can’t wait any longer!,” Hines says. “It is incumbent upon President Trump to take decisive actions that will stand up to Pharma and for the American patient.”

Daniel Hines
TodaysSeniorsNetwork
636-399-2849 email us here

Congressional request to President Obama offers chance for cooperative effort by Obama-Trump to lower prescription drug prices via personally imported medicines

In an interview upon his selection as TIME Magazine’s  ‘Person of the Year,’ President-elect Donald Trump said that his intent remains to “lower prescription drug costs” although he admitted that he still hadn’t decided upon just how to do it.

The President-elect has also repeatedly expressed his ‘admiration’ for President Obama, admitting that he was surprised at the good, even friendly, relationship that is emerging between them.

This is ironic since during the Campaign, Candidate-Trump vowed to rescind every Executive Order issued by President Obama.  Since then, President-Elect Trump has softened his stance, saying he would only rescind those that he considered ‘illegal.’

Therein lies what may be the key to opening the door to allow President-elect Trump to achieve his goal to lower prescription drug costs, thanks to his new-found friendly relationship with President Obama.

And, in yet another twist in this strangest of Presidential elections, he may actually offer President Obama a chance at establishing what could be a part of the Obama legacy—a role in which both men can exhibit the type of bi-partisanship that would reflect favorably upon them, all the while offering millions of Americans price relief from the abusive pricing practices of Pharma, i.e., a recognition of the rights of American patients to have access to safe, affordable and authentic personally imported medicines.

The opportunity is actually created by an October 2016 letter from 33 Democrat Congressmen to President Obama requesting him to use executive action on a number of fronts to lower prescription drug costs, and to prevent further outrageous unmerited price increases by Pharma.

It has become increasingly apparent that personal importation of prescription medicines is the only readily available and most immediate relief to Pharma pricing practices as evidenced by the Representatives’ request to “…  encourage your administration to explore implementing drug importation rules that are already part of U.S. law. Under authority from the Medicare Prescription Drug Improvement and Modernization Act of 2003, the Secretary of Health and Human Services can certify the importation of prescription drugs from other countries under specific qualifications. This regulatory action would pose no risk to public health and safety and could result in a significant reduction in the cost of prescription drugs to American families.”

It is significant that the letter indicates the complete lack of adherence by both the Bush II and Obama Administrations to the intent of Congress by allowing the Secretary of Health and Human Services (HHS) to ignore the specific letter of the law.

That is why we urge the President and the President-elect to take the actions necessary to compel the Secretary to act , and to do so in a fair and partial manner that reflects that personally imported authentic medicines at potential savings of up to 60 percent are being denied to Americans, or for those who do engage in personal importation of their medicines, their medicines are subject to potential seizure and destruction only because of labeling differences that are required by the countries of origin of the imported medicine.  The seizures can take place irrespective of the authenticity of the medicines.

By issuing the executive order requested by the Congressional letter, President Obama will  act on behalf of millions of Americans who simply cannot afford their medicines.  An unaffordable medicine is unavailable in and of itself because of the price, and a medicine that is not taken because it is unavailable is of no value.

For the President-elect, cite your campaign pledge to support personal importation, let President Obama know of your support of his issuance of an Executive Order to ensure that unelected bureaucrats are subject to the clearly expressed intent of Congress, not the whims of a particular industry segment, that there will be attempts to set-aside such an Executive Order by your administration.

In 2008, then-Candidate Obama pledged to support the personal importation of safe, affordable brand-name prescription medicines from licensed-registered pharmacies in Tier One Countries whose standards of safety and efficacy meet or exceed those of the U.S.

It seemed at the time that personal importation, which had long been practiced by millions of Americans seeking the health benefits made possible by access to their maintenance medicines was finally about to be a part of a policy to lower prescription drug costs.

Senator Claire McCaskill (D-MO), a long-time supporter of Personal Importation, told me, after a hearing she was holding in St. Louis on Medicare Advantage plan abuses,  that legislation allowing personal importation of medicines would be one of the first pieces of legislation that the newly elected President Obama would sign, and it would be on his desk within 48 hours of his inauguration.

That never happened.

Instead, President Obama Administration, faced with challenges on a number of fronts, and acting in the belief that his legacy would be based upon passage and implementation of a sweeping health care bill,  engaged in secret, behind-closed-doors meetings with the very forces of Pharma who agreed to not launch ‘Harry-Louise’ type of campaign that derailed ‘Hillarycare’, in return for shaping many provisions of the law that were favorable to it.

For President-Elect Trump, cooperation and support of such an Executive Order will illustrate that you are concerned about the health and well-being of Americans, and that you recognize that lack of access to affordable medicines is the wind that reaps the whirlwind of Pharma pricing abuses, and consequences of costly, even possibly life-threatening health conditions that could have been avoided.

The full Subtitle of the Medicare Prescription Drug Improvement and Modernization Act of 2003 follows:

Subtitle C: Importation of Prescription Drugs - (Sec. 1121) Directs the Secretary to promulgate regulations permitting pharmacists and wholesalers to import prescription drugs from Canada into the United States. Sets forth specified provisions respecting: (1) importer and foreign seller recordkeeping and information requirements; (2) qualified laboratory drug testing; (3) registration with the Secretary of Canadian sellers; and (4) approved labeling.

BLUMENTHAL, GRASSLEY, KLOBUCHAR CALL FOR DEPARTMENT OF JUSTICE TO CONSIDER INVESTIGATING MYLAN

Mylan may have knowingly misclassified the EpiPen in order to reap huge profits at the expense of states and taxpayers

WASHINGTON, D.C., September 30, 2016 – U.S. Senators Richard Blumenthal (D-CT), member of the Judiciary Committee, Chuck Grassley (R-IA), chairman of the Judiciary Committee, and Amy Klobuchar (D-MN), ranking member of the Judiciary Subcommittee on Antitrust, Competition Policy, and Consumer Rights, have called on the Department of Justice (DOJ) to consider investigating whether Mylan Pharmaceuticals violated the law when it apparently misclassified its EpiPen product in order to pay a lower rebate to states and reap huge profits at the expense of taxpayers.

“The American people have been rightly outraged as Mylan engaged in substantial price increases that resulted in billions of dollars paid by U.S. consumers,” the Senators wrote. “They deserve to know whether the company also violated the False Claims Act and diverted millions of dollars from U.S. taxpayers.”

More than ten years ago, Mylan classified EpiPen as a “Non-Innovator Multiple Source Drug,” or generic drug, for purposes of the Medicaid Drug Rebate Program. In order to protect states from high pharmaceutical prices, the Medicaid Drug Rebate Program requires drug companies to pay a percentage of their revenues to states in the form of rebates. Under this program, companies like Mylan are required to pay a higher rebate for brand-name drugs than for generic drugs. In a letter to the DOJ today, the Senators cited evidence that Mylan may have knowingly misclassified EpiPens, potentially in violation of the False Claims Act and other statutes. 

                                                                                   

The text of the letter is available here and below.

Dear Attorney General Lynch:

We write to inquire whether the Department of Justice has considered an investigation into whether Mylan Pharmaceuticals violated the law when it apparently misclassified its EpiPen product for purposes of the Medicaid Drug Rebate Program.

Congress created the Medicaid Drug Rebate Program to protect states from high pharmaceutical prices by requiring drug companies to pay a percentage of their revenues to states in the form of rebates. Crucially, the Medicaid Drug Rebate Program distinguishes between “innovator drugs”—new products that are generally insulated from generic competition by patents—and “non-innovator multiple source” (NIMS) drugs—older products that are available from multiple sellers. Companies pay a rebate of 13 percent of the price of non-innovator drugs. For innovator drugs, sellers pay a minimum rebate of 23.1 percent, but they can pay far more for drugs that experience large price hikes.

Pharmaceutical companies are responsible for determining whether their products are innovator or NIMS drugs. Companies can reap huge profits, at the expense of the states and taxpayers, by misclassifying innovator drugs as NIMS drugs. In the past, the Department has secured settlements against drug companies under the False Claims Act for such practices—including against Mylan Pharmaceuticals.^[1]

Mylan has classified the EpiPen as a NIMS drug since acquiring the product license in 2007. According to press reports, however, the Center for Medicare and Medicaid Services (CMS) has stated publicly that this is incorrect.^[2]

The first indicator that the EpiPen should not be classified as a NIMS drug is the plain text of the relevant statute. Under section 1927(k)(7)(A) of the Social Security Act, for a drug to be classified as a NIMS there must be “at least 1 other drug product which . . . is rated as therapeutically equivalent.^[3]” In other words, the NIMS drug must face an FDA-approved competitor. The EpiPen faces no such competitor, and it has not since Mylan began selling the product.

The second indicator comes from Mylan’s own behavior. The Medicaid Drug Rebate Program imposes a higher rebate on innovator drugs because innovator drugs are generally protected by patents. Shortly after Mylan began marketing the EpiPen, it sued Teva Pharmaceuticals for patent infringement, leading to a settlement that kept Teva out of the EpiPen market until late 2015.^[4] During this timeframe, Mylan increased its prices dramatically, including a rise from $265 to $609 in the last three years.^[5]

Senators Decry Mylan’s EpiPen Price-Lowering Tactics As ‘Complex Shell Game’

 Kaiser Health News 

August 31, 2016--In a show of force, 20 Democrats send a letter to the allergy drug maker, demanding answers. They say that the generic price that will be offered by Mylan “is still three times higher than the cost of the branded EpiPen in 2007.”

The Associated Press: 20 Democratic Senators Blast Steep Price Hike For EpiPens
In a sign of growing concern in Congress, 20 Democratic senators are demanding answers about steep price hikes for the life-saving EpiPen injector device. The senators said in a letter Tuesday that price hikes of more than 500 percent have jeopardized access to emergency allergy shots for many Americans. The letter was addressed to Heather Bresch, CEO of the pharmaceutical company that makes the devices, Mylan N.V. Bresch is the daughter of Sen. Joe Manchin, D-W.Va. Manchin did not sign the letter. (Daly, 8/30)

The Wall Street Journal: Senators See ‘Shell Game’ In EpiPen Maker Mylan’s Bid To Ease Access To Allergy Drug
A group of 20 senators called the recent price-lowering overtures from the company that makes the EpiPen emergency auto-injector a “well-defined industry tactic to keep costs high through a complex shell game.” The sheer number of senators – 19 Democrats plus independent Sen. Bernie Sanders – represents a ratcheting-up of the stakes over the dramatic price increases of the emergency epinephrine product from Mylan NV. Mylan has sought recently to quell criticism by announcing discount programs and, on Monday, other plans soon to offer a generic version at half price. (Burton, 8/30)

Morning Consult: Senate Democrats Blast Mylan’s Affordability Moves
The senators, 19 Democrats and independent Sen. Bernie Sanders of Vermont, wrote that the company’s decision to offer a generic version of EpiPens and offer a discount coupon for patients paying the full list price out-of-pocket still results in high costs for patients through insurance premiums. (McIntire, 8/30)

The Star Tribune: Franken Joins Mounting Criticism Of EpiPen Manufacturer 
U.S. Sen. Al Franken of Minnesota has added his voice to the congressional outcry against price increases Mylan pharmaceutical company made to its epinephrine auto-injector that treats potentially deadly allergic reactions. Last week, Sen. Amy Klobuchar of Minnesota called for a Senate Judiciary Committee hearing and asked the Federal Trade Commission to investigate possible antitrust violations by Mylan, which raised the price of a two-pack of its EpiPen product from $100 in 2008 to $500 to $600 in 2016. (Spencer, 8/30)

Los Angeles Times: State Senator Introduces Resolution To Condemn EpiPen Price Hikes
State Sen. Ed Hernandez's attempt to push through a drug pricing transparency bill sputtered this year, but the West Covina Democrat still wants his colleagues to weigh in on the latest controversy in the cost of prescription drugs: the surging price of EpiPens. Hernandez is introducing a resolution that excoriates the anti-allergy device's manufacturer, Mylan, joining a chorus of federal lawmakers who have accused the company of price-gouging. (Mason, 8/30)

St. Louis Public Radio: Epi Pen Price Spike Leaves St. Louisans With Few Options 
So far, [Maureen] Walkenbach’s meticulous monitoring of her son’s food intake has kept her from having to use an EpiPen. But the injectors expire every year, and have to be re-purchased. The Walkenbachs have health insurance, but recently switched to a high-deductible plan. Even with a patient assistance coupon from Mylan, Walkenbach was on the hook for more than $500 for one EpiPen set — a cost she said she’s willing to pay, because going without it would be unthinkable. Instead of three pairs of EpiPens, Walkenbach said the price is forcing her to make do with two — switching one from her kitchen cabinet to her purse whenever she leaves the house. When she forgets it, as she did on a recent trip to the grocery store, she rushes home in a panic.  (Bouscaren, 8/30)

Government-Protected ‘Monopolies’ Drive Drug Prices Higher, Study Says

 Scientific research that leads to new drugs is usually funded by the National Institutes of Health via federal grants, the researchers found. (Heidi de Marco/KHN)

By Sydney Lupkin Kaiser Health News.

August 23, 2016--The “most important factor” that drives prescription drug prices higher in the United States than anywhere else in the world is the existence of government-protected “monopoly” rights for drug manufacturers, researchers at Harvard Medical School report today.

The researchers reviewed thousands of studies published from January 2005 through July 2016 in an attempt to simplify and explain what has caused America’s drug price crisis and how to solve it.

They found that the problem has deep and complicated roots and published their findings in JAMA, the journal of the American Medical Association. The study was funded by the Laura and John Arnold Foundation with additional support provided by the Engelberg Foundation.

“I continue to be impressed at what a complex and nuanced problem it is and how there are no easy solutions either,” said lead study author Dr. Aaron Kesselheim, a professor who runs the Program on Regulation, Therapeutics and Law at Harvard Medical School and Brigham and Women’s Hospital.

“As I was writing, the enormity of the problem continued to shine through.”

Five key findings in the JAMA review:

1. Drug manufacturers in the U.S. set their own prices, and that’s not the norm elsewhere in the world.

Countries with national health programs have government entities that either negotiate drug prices or decide not to cover drugs whose prices they deem excessive. No similar negotiating happens in the U.S.

When a Republican-majority Congress created the Medicare drug benefit in 2003, they barred the program that now covers 40 million Americans from negotiating drug prices. Medicaid, on the other hand, must cover all drugs approved by the Food and Drug Administration, regardless of whether a cheaper, equally or more effective drug is available.

And private insurers rarely negotiate prices because the third party pharmacy benefits managers that administer prescription drugs, such as Express Scripts and CVS Health, often receive payments from drug companies to shift market share in their favor, according to the study.

2. We allow “government-protected monopolies” for certain drugs, preventing generics from coming to market to reduce prices.

In an effort to promote innovation, the U.S. has a patent system that allows drug manufacturers to remain the sole manufacturer of drugs they’ve patented for 20 years or more. The FDA also gives drug manufacturers exclusivity for certain products, including those that treat people with rare diseases.

But sometimes, drug companies deploy questionable strategies to maintain their monopolies, the study says. The tactics vary, but they include slightly tweaking the nontherapeutic parts of drugs, such as pill coatings, to game the patent system and paying large “pay for delay” settlements to generics manufacturers who sue them over these patents.

And this is a serious problem, the study concludes, because drug prices decline to 55 percent of their original brand name cost once there are two generics on the market and to 33 percent of original cost with five generics.

3. The FDA takes a long time to approve generic drugs.

Application backlogs at the FDA have led to delays of three or four years before generic manufacturers can win approval to make drugs not protected by patents, the study says.

4. Sometimes, state laws and other “well-intentioned” federal policies limit generics’ abilities to keep costs down.

Pharmacists in 26 states are required by law to get patient consent before switching to a generic drug, the authors wrote. This reportedly cost Medicaid $19.8 million dollars in 2006 for just one drug: a statin called simvastatin whose brand name is Zocor. Costs ran higher because pharmacists didn’t get patient consent and Medicaid had to pay for the costlier brand name drug even though a cheaper product was available.

5. Drug prices aren’t really justified by R&D.

Although drug manufacturers often cite research and development costs when defending high prescription prices, the connection isn’t exactly true, Kesselheim and his team found, citing several studies. Most of the time, scientific research that leads to new drugs is funded by the National Institutes of Health via federal grants. If not, it’s often funded by venture capital. For example, sofosbuvir, a drug that treats hepatitis C, was acquired by Gilead after the original research occurred in academic labs.

“Arguments in defense of maintaining high drug prices to protect the strength of the drug industry misstate its vulnerability,” the authors wrote, adding that companies only spend 10 percent to 20 percent of their revenue on research and development.

“The biotechnology and pharmaceutical sectors have for years been among the very best-performing sectors in the U.S. economy.”

Instead, the price tags are based on what the market will bear, they wrote

In general, fixing America’s drug price problems won’t be easy, the study authors concluded. Congressional gridlock and the power of the pharmaceutical lobby make allowing Medicare to negotiate Part D prices an unlikely possibility. And leaving that aside, policymakers must find a way to tighten rules and strengthen oversight surrounding patent protections and exclusivity without chilling innovation, Kesselheim said.

Those not involved in the study said the fact that it was published in JAMA is meaningful because the authors are able to speak directly to doctors.

“I think the most significant thing about this is not necessarily what he’s saying but who he’s saying it to,” said Kenneth Kaitin, who directs the Tufts Center for the Study of Drug Development.

“In part, the concern over rising drug prices is something that physicians have been more aware of lately…They’ve still been for the most part on the sidelines of these issues.”

Kaitin said the exception has been the American Society of Clinical Oncology and the physicians at Memorial Sloan Kettering Cancer Center.

Dr. Joshua Sharfstein, the Associate Dean for Public Health Practice and Training at the Johns Hopkins Bloomberg School of Public Health, said Kesselheim’s study provides a “bird’s eye view” of how the U.S. became an outlier when it comes to drug prices, without getting lost in the weeds.

“It also illustrates that there is not a single policy that is going to address the range of challenges that our health system faces around drug pricing,” Sharfstein said.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

How will prescription medicine prices be determined in the Future? Time for Congress to step up in the interest of the American people!

(Publisher’s Note:  This is Part One of a two-part series examining how Pharma is using Congress’ failure to enact comprehensive legislation to lower prescription medicine prices as an opportunity to advance Pharma’s model of ‘the value of medicines’ as adding to life-spans as the basis for prescription drug pricing with Pharma itself being the ‘determinator’ of the value and cost of medicines.)

There are significant national events taking shape in this country, and not just the Presidential Election.

As important as the elections are to the American future, the moves by Pharma and its front groups to ensure that it will be the ‘determinator’ of how prices for virtually all medicines will be established should spur Congress to step-up and develop a policy based on consensus that can lead to a clearly defined policy that will finally end the predatory pricing practices of Pharma.

Admittedly, the issue of the cost of vital prescription medicines has received ‘extraordinary attention’ from Congress, drawing the ‘wrath’ of Senators and Representatives with hearings, statements of outrage, and the introduction of a number of stand-alone bills to address one or another of many strategies that could and should be a part of a comprehensive approach to lower prescription drug prices.

Unfortunately, the many bills themselves ultimately hinder the chance of lowering prescription drug prices through legislation. 

As important as it is that individual Senators and Representatives take a stance on lowering prescription drug prices, it is time for Congress to develop a consensus that incorporates the key, workable elements of each proposal to create a synergy that could lead to legislation to lower prices. This includes:

1.               Price negotiation based on recognition that a medicine that is unaffordable is, in and of itself, unavailable;

2.              A ‘stakeholder’ role for the American public that supports so much of Pharma R&D, by an increased presence of consumer advocates and private citizen in policy development, hearings, and opportunities for public comment;

3.              A revised patent policy that ensures the public investment in R&D is protected in legislation that will provide penalties if Pharma is abusive in its pricing practices;

4.              Reciprocal Memorandums of Understanding between regulatory agencies of Tier One Countries as validation of the safety and efficacy of the oversight of personally imported medicines from those countries;

5.              Criminal penalties for abuse of pricing practices based on a ‘what the traffic will bear’ philosophy;

6.              Greater transparency in Pharma pricing practices;

7.              An end to direct to consumer advertising for prescription medicines.

Without such Congressional action, even though we have witnessed a tremendous public outcry (finally) over the predatory pricing practices in which Pharma thumbs its nose at patients, policy-makers, and the American public generally with prices that are based on ‘what the traffic will bear’, there will continue to be virtually not even the slightest chance to actually lower prescription drug prices.

This has opened the door for Pharma to launch a public relations and lobbying campaign to establish its stance that medicines should be priced as a function of the ‘value added’ from the medicine itself, with Pharma itself determining the ‘value’ and, therefore, the price of the medicine.

The million-dollar campaign features one ad showing an infant with a voice-over reminding the viewer (the campaign is targeted towards Congress) that “Time is Precious” and that new medicines give us “hope.”

It would, of course, be wonderful if Pharma truly believes that its primary mission is to offer ‘hope’ through the improved health of the American public.  

But when it uses ‘hope’ as a vehicle to continue to price its medicines at unaffordable prices, it is nothing less than a cruel facade played out at the expense of patients. (to be continued)

(In Part Two, we will examine the claims about the ‘flaws’ that have been unfairly attributed to legislative efforts both past and current to lower prescription medicine prices, )

Experts: High Drug Price Trend Has “Infected” Generics

 Authors Highlight Concern That Pharmaceutical Companies Use Strategies to Delay Patient Access to Affordable Generic Drugs

Newswise, January 29, 2016 – An article published online today in Blood, the Journal of the American Society of Hematology (ASH), suggests that pharmaceutical companies use several strategies to keep affordable generic drugs from the market, illustrating an emerging trend that authors say is becoming as harmful to consumers as high-cost brand-name drugs.

The market price of pharmaceuticals, some costing patients more than $100,000 per year, increases public health spending and sometimes forces patients to make life-or-death decisions when they cannot afford their medications. The authors write that approximately one in five Americans admit they do not fill their prescriptions because of cost. 

From an economic standpoint, in 2013 the United States spent nearly 40 percent more per capita on pharmaceuticals than the second highest spender, Canada.

Generic drugs, which by law may enter the market once the patent on a brand-name drug expires, are intended to offer an affordable option for patients without sacrificing the efficacy and safety of the original formula. 

From 2004-2013, generic drugs saved the U.S. health system nearly $1.5 trillion, according to the authors. However, for many patients generic drugs are inaccessible.

“The timely availability of affordable generic drugs is the difference between life or death for patients with cancer and other diseases who cannot afford brand-name pharmaceuticals, the majority of which are priced at monopoly levels and protected by 20-year patents,” said lead author Hagop Kantarjian, MD, of The University of Texas MD Anderson Cancer Center. 

“Unfortunately, these sorely needed generics are increasingly out of reach. As we sought to understand what keeps these affordable drugs from the market, we identified several specific strategies that pharmaceutical companies use to extend their patents and eliminate competition.”

In this Blood Forum article, a feature of the journal designed to present well-documented opinions on issues important to the science and practice of hematology, Dr. Kantarjian and colleagues assert that pharmaceutical companies use a variety of strategies to delay, prevent, and suppress the timely availability of affordable generic drugs. 

Among them, the authors detail "pay-for-delay," in which the company that owns the patent pays a generic company to delay entry into the market. The Federal Trade Commission estimates that the pay-for-delay settlements cost taxpayers, insurance companies, and consumers approximately $3.5 billion per year. In other cases detailed in the article, the patent-holder deters competition by creating its own version of drugs at generic prices. 

While this practice may reduce costs for consumers by 4-8 percent in the short-term, the authors suggest that companies often use the authorized generics as a bargaining chip in pay-for-delay deals, pledging not to release their own drugs in return for the true generic company promising to delay market entry.

Other strategies the authors discuss include investing heavily in advertising the brand-name drug (often spending more on marketing than on research and development) and lobbying for laws that prevent patients from importing cheaper generics from other countries, which the authors write can cost as little as 20-50 percent of U.S. prices. 

The authors also highlight some drug companies that they allege buy out competitors and then increase the price of a newly acquired generic drug by several fold overnight.

In addition, the authors also describe a strategy they call “product hopping,” which involves switching the market for a drug to a reformulated “new and improved” version with a slightly different tablet or capsule dose that offers no therapeutic advantage over the original but has a later-expiring patent. 

The company then heavily advertises the new brand-name drug in an effort to convince patients and physicians to switch. As a result, when the generic version of the original becomes available, pharmacists cannot substitute it for the new branded version because state laws allow substitution only if certain characteristics, such as dosing, remain the same.

In recognition of the harm and expense that the authors suggest these strategies impart on both patients and the economy, they propose several solutions that would support timely access to affordable generic drugs, including allowing Medicare to negotiate drug prices, monitoring and penalizing pay-for-delay deals, allowing transportation of pharmaceuticals across borders for individual use, and challenging weak patents.

“Each day in my clinic I see leukemia patients who are harmed because they cannot afford their treatment, some risking death because they cannot pay for the medicine keeping them alive,” said Dr. Kantarjian. “Overall, these strategies demonstrate that the trend of high brand-name drug prices has recently infected generic drugs, as companies value profit at the expense of long-term utility to society. We must be vigilant in recognizing these strategies and advocating for solutions that will allow companies to accomplish their dual mission: make reasonable profits and help save and/or improve patients’ lives.”

Blood (www.bloodjournal.org), the most cited peer-reviewed publication in the field of hematology, is available weekly in print and online and has been serving the hematology community for 70 years. Blood is the official journal of the American Society of Hematology (ASH) (www.hematology.org), the world’s largest professional society concerned with the causes and treatment of blood disorders.

ASH’s mission is to further the understanding, diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems by promoting research, clinical care, education, training, and advocacy in hematology.

blood® is a registered trademark of the American Society of Hematology. Follow @BloodJournal on Twitter.

Why High Drug Prices require an Rx Bill of Rights for Americans

Senator Bernie Sanders (I-VT) is the first Presidential candidate to announce that, if elected, he will introduce legislation that will reduce prescription medicine prices.  

One leg of his three-legged stool deals with the rights of Americans to have access to safe, affordable brand-name prescription medicines from licensed, registered pharmacies in Tier One countries of whose standards of safety and efficacy meet or exceed those of the USA.  The other two legs of the platform deal with abuses of the regulatory process by Pharma, acting in collusion with FDA.  

We applaud Senator Sanders for his leadership.  He has been a long-standing advocate of the detrimental impact upon the health care system of the US created by the comfortable relationship between Pharma and the FDA, and the predatory pricing practices of Pharma that have made the US a 'safe haven' for its charging what the traffic will bear for medicines. 

It is time for an American Rx Bill of Rights that confers the right of participation in vital health decisions for Americans. Following are the first six articles of such an Rx Bill of Rights, based upon the most pertinent issues affecting prescription drug costs. 

Article One (A Basic Right to Good Health)

The impact of millions of Americans being denied the health benefits of access to a regimen of safe, affordable medicines because of cost is a national health issue that has yet-to-be-recognized consequences.  

(That is why the ability of American Citizens to make health care decisions in concert with their physicians such as the purchase of personally imported safe, affordable prescription medicines should not be hampered by any actions by government or private entities as a policy to restrict Americans' access to  authentic medicines. )

Article  Two (An Unaffordable Medicine is Unavailable)

A prescription medicine that is unaffordable is unavailable, thereby meeting the 'rules' of the FDA that such a medicine that is otherwise unavailable is indeed eligible to be personally imported by an American patient, 

(Arbitrary denial by the FDA to such access is detrimental to the health of the patient  by denying him or her access to vital maintenance medicines.This is a violation of the purpose of the FDA which is ostensibly designed to protect the health and well-being of American citizens.)

Article Three (Citizens as Stakeholders)

It is incumbent upon Congress that it act to ensure that ordinary American citizens whose health and finances are adversely affected by Pharma pricing practices, advocacy groups other than those of Pharma, are given a 'stakeholder'status equal to that of Pharma.

(The relationship between the FDA, elected officials, and Pharma has led to numerous abuses, access by Pharma to legislators and other elected officials based on the contribution of millions of dollars, favored status for Pharma representatives and their front groups as the primary representative at public hearings to determine the health care policy for Federal, State and Local Governments, thereby skewering the decision-making process.)

Article Four (Due Process)

Americans who purchase safe, affordable medicines from licensed, registered pharmacies in Tier One Countries whose standards meet or exceed those of the U.S., are the legitimate owners of their authentic medicines and are entitled to exercise their due process rights to have their personal property free from undue and unjustified seizure oar destruction by any governmental agency unless the seizing authority can demonstrate via established judicial processes and to courts that such seizures are of bogus, counterfeit or unsafe prescription medicines.

Article Five (Public Interest)

Americans are significant contributors to the development of research and development costs of new medicines through their tax dollars in support of grants to the National Institutes of Health (NIH), and, as such, should be protected from unfair or questionable patent protection granted to Pharma that fails to recognize the rights of American citizens. 

(Abuses in pricing, illegal business activities, or undue influence upon policy-making by the FDA or elected officials should result in a reduction of the patent protection afforded Pharma to the detriment of untold numbers of Americans who must be able to pay what Pharma believes the traffic will bear.)

Article Six (Reciprocity)

The FDA should extend reciprocity to other Tier One countries in the interests of the health of American citizens. 

(The majority of brand name prescription medicines sold to Americans is manufactured at plants outside the U.S., under FDA supervision, or at plants licensed by Pharma members to produce medicines under a license granted by a particular company, a validation that medicines produced outside the U.S. and sold in this country are indeed capable of being safe.  Also, the FDA has entered into agreements with regulatory agencies in many countries to assume the task of overseeing ingredients manufacture of ingredients for brand name medicines.  Added to that is that many countries (excluding the U.S and the FDA) have reciprocal agreements (Memorandums of Understanding) that one country will accept the medications produced in another country as safe and authentic.)

New Study: Proposed Medicare Part D Rule Would Increase Medicare Costs $24 Billion, Hike Senior Premiums

  

WASHINGTON, March 11, 2014 /PRNewswire-USNewswire/ -- A new actuarial study released by The Pharmaceutical Care Management Association (PCMA) examining the impact proposed changes to the Medicare prescription drug program finds that eliminating preferred pharmacy networks in Part D would increase premiums by approximately $63 annually for over 75 percent of Part D enrollees and raise overall program costs by an estimated $24 billion over the next ten years.

"CMS' proposal to eliminate preferred pharmacy networks will make it harder and more expensive for seniors to access prescription drugs," said PCMA President and CEO Mark Merritt.

The study examines the sections of CMS' proposed rule on preferred pharmacy networks. Currently, more than 75 percent of Part D beneficiaries are enrolled in plans that feature preferred pharmacy networks.

Key findings from the study, which was sponsored by PCMA and prepared by Oliver Wyman, include:

• As of February 2014, more than 75% of prescription drug plans (PDP) enrollees are in plans with preferred pharmacy networks and these enrollees could be adversely affected by the elimination of plans utilizing preferred pharmacy networks.

• The preferred pharmacy networks provision would increase premiums for the affected population by an average of approximately $63 per year for the 2015 plan year.

• The rule could increase cost sharing among PDP enrollees by an average of $80 to $100 per year.

• Since the rule would inflate the national average benchmark for Part D plans, CMS would pay an estimated additional $64 in direct subsidies per beneficiary per year in 2015, for a total increased payment of nearly $1.5 billion in 2015 across all PDP enrollees, based on Part D enrollment of approximately 23 million beneficiaries.

• Over a 10-year period, the increased cost of eliminating preferred pharmacy networks is estimated to be approximately $990 per affected enrollee, and the cost would be approximately $24 billion to CMS in the form of higher direct subsidy payments.

Oliver Wyman's findings are generally consistent with a separate Milliman analysis that found the entirety of the proposed rule will increase Part D costs by up to $1.6 billion in 2015.

In addition, a recent poll found that seniors in plans with preferred pharmacy networks are overwhelmingly satisfied, citing lower costs, convenient access to pharmacies and other benefits, according to a survey from Hart Research Associates. The survey found that 85 percent of seniors surveyed are satisfied with their preferred network plan. In addition, the survey found that four in five seniors would be disappointed if their preferred network plan is eliminated.

The Medicare Payment Advisory Committee has warned CMS that the proposed changes to preferred pharmacy networks could lead to disruptions in beneficiaries' access to medicines.

PCMA represents the nation's pharmacy benefit managers (PBMs), which improve affordability and quality of care through the use of electronic prescribing (e-prescribing), generic alternatives, mail-service pharmacies, and other innovative tools for 216 million Americans.

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Prescription drug personal importation bill fails in Senate. 'Do no Harm' to personal importation should be goal of policy-makers

Watching the ‘debate’ regarding the amendment by Senator John McCain (R-AZ) in support of his amendment to the Food and Drug Administration funding bill to establish astructure for personal importation of prescription medicines by individuals,one had to have a feeling of de javu.

There were so many  familiar faces.  Senator  McCain  showing his irritation and frustration at the continued success of Pharma in derailing any importation legislation…Senator Charles Grassley (R-IA) once again exhibiting the Midwestern Common Sense that has made him a favorite with Iowa voters…Senator Olympia Snowe (R-ME) in a last hurrah before retiring after this term, showing the passion and leadership that has made her name synonymous with personal importation through the bills that bore her and former Senator Byron Dorgan’s(D-ND) names. 

She even used the Lipitor example of the former Senator Dorgan and one could only wonder if Senator Dorgan, who retired from the Senate after his last valiant effort topass legislation favorable to personal importation—a failure which he laid at the doorstep of the White House, accusing the Obama Administration ofdeal-making with Pharma--would appear on the Floor and lend her his favorite prop, a bottle of Lipitor, the most profitable medicine ever developed. 

At the same time, one had to wonder why Senator Snowe used the Lipitor example since the drug no longer has its patent protection, and a flood of generics is expected to erode the market Lipitor enjoyed when it had such protection.

There were many of the same Pharma supporters of past debates, who pooh-poohed Senator McCain’s charges about Pharma influence, which is so obvious that to deny it is and of itself a self-proving action. 

But while the amendment went down in flames with 43 yeas, 54 nays (60 votes needed toadoption), there were other reasons that it failed, none of which has anything to do with the merits, benefits and record of personal importation.

Not the least of these was an old problem continues to be troublesome for  importation legislation and is an indication that since there likely will be no form of legislation passed, the goal should be to protect the right to personal importation.  Although the amendment has passed in the Senate many times, it has always had a challenge in even being called up for a vote.

Former Senate Majority Leader Bill Frist (R-TN), who has since returned to private medical practice, reneged on his commitment to bring the proposal up for a vote during the administration of George W. Bush.  This led to a running discussion throughout  that session of Congress and succeeding sessions of what strategy would be employed to identify a ‘vehicle’ to which to attach the legislation.

The problems continued with the election of President Barrack Obama. 

Supporters all believed Candidate Obama to be a proponent of personal importation, until an aide, Dora Hughes, said in September 2008 that Candidate Obama was not as strong a supporter of personal importation as had been presumed. 

Still, while at a hearing in St. Louis by Senator Claire McCaskill, when I asked the Senator   about the Obama position, she assured me that it would be the first bill he signed into law.

Alas, we were soon to discover when President Obama made a closed-door, back-room deal with Pharma to not support personal importation in return for a Pharma guarantee of not doing a ‘Harry and Louise-type attack’  upon the President’s healthcare proposal, that,alas, Ms. Hughes’  insights were better than Senator McCaskill’s.  And,  as noted earlier, Senator Dorgan  bemoaned the lack of leadership from the Obama Administration when his final effort also fell short of the 60-vote threshold,citing the deals made by Pharma with the Administration.

The simple truth:  The President early on determined that Healthcare Legislation was to be his legacy.  The economy and joblessness were set aside, as was prescription medicine importation .

Part of the closed-door negotiations including blocking personal importation was to strike a deal that supposedly was to reduce the costs of medicines for Seniors in the Doughnut Hole by $80 billion (but which because of the delay of enacting the cuts, and prescription price increases, has been one of the best investments Pharma ever made—even more lucrative than the multi-million investment in former Representative Billy Tauzin (D-LA) who engineered the passage of Part D,  and then resigned his post to immediatelybecame head of PhRMA, the industry’s trade association).

If anyone wonders why Senator McCain was so upset during the most recent claims by Pharma's Senators that healthcare policy is not/has not/and will not be influenced by Pharma—which Senator McCain described as the very type of thing that has eroded public confidence in Congres-- may I suggest it was not ‘anger’ or temper, it was righteous indignation.

Still, the amendment he offered and 41 other Senators supported was defined by situations that reflected the same, albeit , valid arguments made since Seniors were the first Americans to turn to personal importation of prescription medicines at the turn of the Century 12 years ago via bus trips to Canada to order their medicines at tremendous savings of as much as 60 percent.

Their actions were to give rise to a vigorous new industry—the establishment of certified, licensed, and registered pharmacies dispensing medications via the Internet, thereby allowing more than just the Americans located on the Northern US Border to have access to safe, affordable brand-name medicines at tremendous savings.

It also spurred many local groups, governments and others individual Americans to realize that they could attain fiscal relief through personal importation , all the while providing the  health benefits of  access to safe, affordable brand-name medicines.

Lower costs…improved health…fiscal savings…safety…a competitive alternative to the highest prescription medicine prices in the world…those are the drivers that make personal importation still the most viable option available to lowering US prescription medicine prices.

Personal importation validates that Americans can use their Common Sense in exercising their right and ability to make responsible healthcare decisions.  That native Common Sense is absent from the US Congress that has failed in developing solutions to the challenge of high prescription medicine prices that before the widespread use of personal importation forced millionsof citizens to do either without their vital medicines or without other  life-supporting services such as food andshelter.

And therein, I submit, lies the root of the ‘solution’ to the challenge of presentation and support of any legislation that might be presented in the future in support of personal importation—namely, illustrating how personal importation reflects the inherent Common Sense of the American people, similar to Rep. Ron Paul's (R-TX) proposal (HR 147) to basically, 'just do it,' which we have supported for sometime.

The McCain amendment was self-defeating with its emphasis upon restrictions of sourcing that limited personal importation to only medicines from Canadian internet-based pharmacies because the language had ambiguities that would have made the amendment ineffective.  Example: the medicines would by my reading have to be dispensed specifically by a Canadian Internet pharmacy,  restricting the ability to have medicines dispensed from licensed, registered pharmacies in other countries whose standards of oversight and efficacy meet or exceed  those of pharmacies in Canada or the U.S.

The legislation also called for the Secretary of Health and Human Services to ‘certify’ the involved pharmacies, although they have been approved by the appropriate provincial licensing authority in Canada.  In a touch of irony, previous forms of personal importation legislation that have passed the Senate have been turned aside by opponents of personal importation by the introduction of ‘poison pill’ amendments requiring ‘certification’ by the Secretary of Health and Human Services that any imported medicine is safe.

 It’s a ridiculous position, one that was first introduced at the same time that Ford F150’s were crashing and burning, causing me to suggest to then-Senator James Talent’s (R-MO) staff, that the ‘certification’ of the safety of ALL vehicles, tires, engines, etc.,  should be demanded of  the Secretary of Transportation, requiring that he or she ‘certify’ that there would be no recalls nor safety problems with the Ford vehicles at that time, or other situations that could affect the safety of a vehicle.

What will be next? 

Perhaps the Online Pharmacy Safety Act, introduced by Senator Diane Feinstein (D-CA) and Senator Jeff Sessions (R-AL)  that would empower the Secretary of HHS to utilize the VIPPS Certification Program of the NationalAssociation of Pharmacy Boards to ‘certify’ online pharmacies in the US, an authority it denies certification services such as PharmacyChecker.com andPharmacy Accreditation Services, designed specifically to provide oversight services for Internet pharmacies.

Senator Snowe described the McCain Amendment as a ‘first step.’  Actually, the first step was taken years ago by millions of Seniors  , followed by untold numbers of other Americans for whom personal importation of brand-name medicines has provided a lifeline to vital medicines that have contributed to their health, finances, and well-being.

By continuing the comparisons of price differences alone, without a greater emphasis upon the beneficial contribution and proven record of personal importation to providing fair and equitable pricing for vital medicines, and improved health, the proponents of personal importation, of whom I am one, continue to allow opponents to trot out the same old tired saws about rogue pharmacies, the claimed 'dangers ' of the Internet from even legitimate safe pharmacies, and the claimed negative impact upon R&D of new medicines.

Even after  Pharma’s stunning defeat in the Stop Online Pharmacy Act,  the latest vote is indicative that Senator McCain’s lament about the influence of Pharma inside the Beltway is ‘on spot.'

It is time for proponents of personal importation to shape their message and quit dribbling the basketball at Pharma’s 50-yard line and come forth with the proven merits and benefits already made possible by personal importation.   By developing such a message of what the past and future benefits will be, not merely for the purpose of passing legislation but to ensure Congress acts to block Pharma's continuing effort to scare the American people in such a way as to keep them using their Common Sense to continue exercising their right--and capability--to make responsible healthcare decisions, and to distinguish facts from Pharma-driven-fiction--the continued beneficial contribution of personal importation shall be ensured.