Medicare Rights President Joe Baker Testifies at Congressional Hearing in Support of Part B Drug Payment Model

Washington, DC. May 25, 2016—Medicare Rights Center President Joe Baker testified in support of the Centers for Medicare & Medicaid Services (CMS) proposal to test new ways to pay for prescription drugs covered under Medicare Part B, at a hearing held by the Subcommittee on Health of the U.S. House Committee on Energy and Commerce. “Calls to withdraw the Part B Drug Payment Model fail to acknowledge the very real and unrelenting beneficiary access challenges that exist under the current payment system—not merely hypothetical ones. We applaud CMS for proposing to test solutions that have the potential to alleviate calamitous cost burdens, which cause too many older adults and people with disabilities to forgo necessary care,” said Joe Baker in his testimony. “We urge members of Congress to support and strengthen the proposal by recommending improvements that put patients at the center of the payment model.” The Medicare Rights Center’s support for the CMS proposal is informed by the organization’s experience working with people with Medicare and their families for more than two decades. Medicare Rights answers nearly 17,000 questions on its national helpline and provides educational tools and resources to over two million beneficiaries, family caregivers, and professionals annually. Challenges affording needed health care are a common theme heard on the helpline, affecting nearly one in five callers.   Sky-high cost sharing for Part B prescription drugs is a notable concern, most often for cancer and immunosuppressant medications. “People with Medicare and taxpayers deserve a Medicare program that pays for high-value, innovative health care. The Part B Drug Payment Model presents an important opportunity to ensure that the Medicare program meets this high bar,” said Baker.   The Medicare Rights Center also submitted comments in support of the CMS proposed Part B Drug Payment Model during the public comment period that ended on May 9. To read Joe Baker’s testimony from the hearing, visit the Medicare Rights Center’s website.

Promise of Nearly a Year of Life on Targeted Drug Not Reality for All Liver Cancer Patients, Study Finds

Drug can have serious side effects and significant out-of-pocket costs for advanced liver cancer patients

Newswise , May 25, 2016- For advanced liver cancer, there’s a single approved drug shown to offer patients a chance at longer life. 

But a new study by University of North Carolina Lineberger Comprehensive Cancer Center researchers found that this drug was notably less effective in a group of Medicare patients who likely had more extensive cancer and serious liver disease than patients included in clinical trials.

In the journal The Oncologist, researchers report today that the median survival for a group of Medicare patients on the drug sorafenib was three months, which was significantly lower than the median survival of nearly 11 months for patients treated with the drug during a phase III clinical trial. 

As the drug comes with significant side effects and a cost to patients and insurers of more than $10,000 a month, researchers are questioning the value of the drug for all patients.

“No drug that results in a three-month survival can be thought to be offering a meaningful life expectancy,” said Hanna K. Sanoff, MD, MPH, a UNC Lineberger member and an associate professor and section chief of the UNC School of Medicine Gastrointestinal Medical Oncology Program. 

“This doesn’t mean that we shouldn’t prescribe it, but we should be mindful that the broader population of liver cancer patients is sicker than the patients in the landmark trial. Our patients deserve to know that the promise of nearly a year of life may not be their reality.”

The U.S. Food and Drug Administration approved sorafenib -- known commercially as Nexavar – for the treatment of advanced hepatocellular carcinoma in 2007. In a phase III clinical trial, patients with advanced liver cancer had a median survival of 10.7 months on the drug, which was 2.8 months more than patients who didn’t get the treatment. 

But patients in that study also were in good physical condition and their level of cirrhosis, which nearly universally accompanies liver cancer, was well controlled, Sanoff said.

“This drug was tested in a clinical trial with patients with mild cirrhosis who were pretty fit,” Sanoff said. 

“Because of concurrent cirrhosis, it may be that the gap between the trial population and the average liver cancer patient may be greater than in some other cancers.”

In the new study, the researchers analyzed survival data for a group of patients insured by Medicare, a government health insurance program for people aged 65 years and older or with disabilities, and who were diagnosed between 2008 and 2011. 

Of the 27 percent of 1,532 patients given sorafenib, median survival from the first prescription was three months, which was not statistically longer than survival of untreated patients.

They concluded that lower survival in the Medicare population was likely due to a generally sicker population. Further analysis suggested that patients in the study with earlier stage disease might be more likely to benefit from taking the drug.

The researchers pointed to issues of cost – both financial and in terms of side effects – as factors that patients and doctors should consider when deciding on a course of treatment.

“We need to question who we prescribe this to, not only because of the cost of the drugs from a side effect perspective, but also the actual financial cost,” Sanoff said.

In previous studies, researchers have found that the median monthly price for the drug across all available Medicare part D plans in 2014 was $10,811 per month, said study co-author Stacie Dusetzina, PhD, a UNC Lineberger member and assistant professor in the UNC Eshelman School of Pharmacy and UNC Gillings School of Global Public Health.

That price tag can mean thousands of dollars in out-of-pocket costs for patients, Dusetzina said, as most plans require cost sharing of at least 25 percent when filling the drug’s prescription. 

Even for patients who have reached the catastrophic spending level in Medicare Part D – when the amount they are expected to pay out-of-pocket decreases - they would still pay $540 per prescription fill each month.

“This is obviously going to present financial challenges for many patients,” Dusetzina said. 

“This underscores the fact that establishing effectiveness of therapies outside of trial settings is complicated but important, if we want to really understand the value of cancer therapies. Translating the benefits of treatments into a ‘real world’ setting isn’t always easy.”

Patient data was drawn from the National Cancer Institute’s Surveillance, Epidemiology and End Results Program Medicare linkage.

This work was supported by grants from the National Cancer Institute, NIH Building Interdisciplinary Research Careers in Women’s Health K12 Program, and the North Carolina Translational and Clinical Sciences Institute. 

Additional support was provided by the Integrated Cancer Information and Surveillance System (ICISS), and from the UNC Lineberger Comprehensive Cancer Center with funding provided by the University Cancer Research Fund.

Conflicts of interest: Sanoff has received research grant funding from Bayer and Novartis. Another co-author Bert H. O’Neil of the Indiana University Simon Cancer Center has consulted for Bayer.

In addition to Dusetzina, O’Neil and Sanoff, other authors include YunKyung Chang, PhD, of UNC Lineberger; and Jennifer L. Lund, PhD, of UNC Lineberger and the UNC Gillings School of Global Public Health Department of Epidemiology.

AMERICAN RX BILL OF RIGHTS SITE LAUNCHED; URGES PUBLIC TO ASK SENATORS, REPS WHERE THEY STAND ON RX PRICES, POLICIES

Election 2016 offers once-in-lifetime opportunity to elect Congress to support comprehensive legislation to lower prices

ST. LOUIS, MISSOURI, USA, May 13, 2016 /EINPresswire.com/ -- The newly launched American Rx Bill of Rights(http://americanrxbillofrights.blogspot.com) is urging Americans to ask their Senators and Representatives to take a position on the need for comprehensive, bi-partisan legislation that will guarantee access for Americans to safe, affordable prescription medicines.

Daniel Hines, publisher of the TodaysSeniorsNetwork group of blogs, and Rx for American Health, says the new site is directly aimed at “making a difference” in the 2016 Elections.

“The ‘Articles’ of the Rx Bill of Rights include proposals that can make an immediate impact upon the health and well-being of millions of Americans by ensuring that they are able to afford their vital medicines,” he explains.

“The elections of 2016 offer what may a once-in-a-lifetime opportunity to ensure that millions of Americans are no longer denied the health benefits made possible by access to vital medicines simply because of the predatory pricing practices of Pharma,” he continues. “ Simply put, a medicine that is unaffordable is, in and of itself unavailable, thereby putting the health and well-being of Americans at risk, contributing to rising health costs caused by complications that could have likely been avoided by access to safe, affordable medicines.”

The Articles of the American Rx Bill of Rights are: Article One—A Basic Right to Good Health; Article Two--An Unaffordable Medicine is Unavailable; Article Three--Citizens as Stakeholders in Rx Policy Development; Article Four—Due Process to Protect Unfair Confiscation of Authentic Medicines
Article Five—The Public Interest of an Rx Bill of Rights; Article Six—Reciprocity Agreements to Facilitate Personal Importation of and Access to Safe, Valid Medications

An explanation of the Articles follows:
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): 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. That why it is incumbent upon Congress that it acts 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.

Article Four (Due Process): Americans who purchase safe, affordable brand-name 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.

Overpriced drugs hurting seniors

by Sen. Al Franken, D-Minnesota

April 12,  2016--Many budget-strapped seniors are being forced to choose between buying doctor-prescribed medications and paying for other basic necessities

• Companies should not be allowed to delay generic drugs from hitting market

At a recent meeting in St. Cloud, some older Minnesotans shared stories that they should never have to tell.

Like millions of other Americans, these seniors feel powerless as their health and financial well-being is often jeopardized by ever-rising prescription drug prices. Recent double-digit increases – far beyond the U.S. inflation rate – are putting essential, even life-saving, medicines out of reach for too many people.

In short, many budget-strapped seniors are being forced to choose between buying doctor-prescribed medications and paying for other basic necessities like food, rent or gas. For some, it means cutting their pills in half to make them last longer, or even taking the risk of forgoing medications altogether.

At the St. Cloud meeting, a local woman shared the price of just one of her husband’s many medications has increased by $100 per month since January. 

Now, to save money, he no longer takes it each day as recommended by his doctor, but is spreading each dose over two or three days.

Her story was gathered as part a “Prescription Drug Cost Listening Tour” my office conducted throughout the state to hear about the impact of skyrocketing drug prices.  

As a member of the Senate Health Committee, I plan to share stories like hers with my congressional colleagues so they can hear firsthand about the urgent need to address this problem.

Real problem

Rising prescription drug costs are a very real and growing problem for many nationwide. Lack of competition has allowed drug companies to hike prices exorbitantly – even on generics. 

And a number of new specialty drugs come with staggering prices that are being passed on from insurers to everyone else.

Last fall, Americans were enraged when Turing Pharmaceuticals hiked the price of one life-saving drug by more than 5,500 percent  – from $13.50 to $750 per pill. 

The company was able to game the system because there is little or no competition. As outrageous and excessive as this was, it’s not the only example of an exorbitant price increase. In short, it showed millions of Americans – especially vulnerable seniors – can be devastated by sudden spikes in drug prices.

And with Americans spending hundreds of billions each year on prescription drugs, the problem of isn’t going away soon. Since January, Pfizer raised the prices of 60 brand name drugs by an average of 10 percent. 

Eight of those drugs went up by at least 20 percent. With treatments for some diseases like cancer costing more than $100,000 annually, out-of-pocket costs can quickly cripple the financial well-being of elderly Americans, even those with comprehensive insurance. Such increases are also driving up insurance premiums for everyone else.

Top of Form

Bottom of Form

My solutions

We have to fight back. That’s why I’m taking several steps to slow the advance of drug costs.

First, I am pressing legislation to “pay-for-delay,” where brand-name drug manufacturers pay generic drug makers to delay bringing cheaper, generic alternatives to market. 

By eliminating generic-drug competitors, big drug companies can reap large profits by keeping brand-name prices high. My bill would help millions of Americans by stopping these deals and bringing affordable medications to the market sooner.

I also plan to re-introduce a measure to cut drug prices and save taxpayers up to $24 billion by allowing the federal Medicare program to negotiate lower prices for drugs used by older Americans. 

Unlike other federal health programs like Medicaid and those run by the Veterans Administration, Medicare officials are banned by law from negotiating lower prices with drug manufacturers.

Most industrialized countries use their buying power to negotiate lower prices for their citizens. In fact, many drugs developed and manufactured in the United States cost much less in other countries. 

That’s why we need to lower barriers to importing lower-cost drugs from countries like Canada, so seniors can save money and import their medications safely and legally.

In March, I introduced a measure to end a tax break that allows drug companies to write off the billions of dollars they spend on television, magazine and Internet advertisements to sell more expensive brand-name drugs, even when cheaper, equally effective drugs are on the market. 

The United States is one of only two countries that allows these “direct-to-consumer” ads, which ultimately drive up health care costs. American taxpayers spend too much to fund this tax break – that’s money that can be put to better use.

We have to do more to bring down prescription drug prices that disproportionately hit seniors. 

That’s why I’m working in Washington to enact common sense measures to cut the cost of the prescriptions that Minnesotans need.  And it’s why I’ve been listening to them in communities across Minnesota and sharing their stories in Washington.

Sugar Shock: Insulin Costs Tripled in 10 Years, Study Finds

Both yearly spending by people with diabetes, and cost per milliliter, up sharply – outpacing costs for other blood sugar medications

Newswise, April 7, 2016 — People with diabetes who rely on insulin have seen the cost of that drug triple in just a decade -- even as doctors have prescribed higher doses to drive down their blood sugar levels.

Meanwhile, the cost of other diabetes drugs has stayed about the same or even gone down.

The rise in insulin costs was so large that since 2010, the per-person spending on insulin has been higher than per-person spending on all other diabetes drugs combined.

Published today in the Journal of the American Medical Association, the findings estimate in constant dollars what patients and their insurance plans paid from 2002 to 2013 for all antihyperglycemics, or medicines that reduce blood sugar levels.

The authors of the study say the rise in insulin compared with other therapies means it’s time to look again at the effect, and the cost-effectiveness, of non-insulin therapies. 

They also note that the price of insulin is not likely to drop because of competition from generic forms, because of the way it is regulated.

The research was done by a team from the University of Melbourne in Australia and the University of Michigan, using data from the federal Medical Expenditure Panel Survey that asks patients and insurers about care and costs.

“In the United States, the more than 3-fold increase in the cost of insulin over the past decade is alarming. It is a burden to both patients and payers and may deny some people access to a lifesaving therapy,” says William Herman, M.D., MPH, the Michigan co-author and a longtime diabetes care researcher. 

“Although the newer, more expensive insulin analogs appear to have incremental benefits compared to older, less expensive insulin preparations, their premium price requires us to ask whether they are really necessary, and if so, for whom?”

Herman, a professor of internal medicine at the Medical School and of epidemiology at the School of Public Health, is a member of the U-M Institute for Healthcare Policy and Innovation.

“What our study shows is how quickly things can change and why there is a need to focus on the costs as well as the benefits when deciding treatment options for people with diabetes,” says Philip Clarke, Ph.D., the study’s senior author and a professor in Melbourne’s School of Population and Global Health and Centre for Health Policy.

Rising prices & doses

Insulin injections keep people with Type 1 diabetes alive, and they take multiple daily injections often starting in childhood. 

In adults with advanced Type 2 diabetes, doctors prescribe it to control blood sugar and stave off devastating damage throughout the body – usually after diet and exercise, and other medications, have failed to reduce blood sugar levels enough.

In the time period studied, the total cost of insulin more than tripled, from $231 a year to $736 a year for each patient, in 2013 dollars. The cost per milliliter of insulin nearly tripled in that same time, from $4.34 to $12.92.

And in the same period, the average annual usage went from 171 mL to 206 mL, as prescribed doses went up. This likely happened due to increasing overweight and obesity, which increase the amount of insulin needed by a person, as well as new national recommendations that stress lower sugar levels for all people with diabetes.

Meanwhile, the per-person spending on all other blood sugar medications was $502 in 2013, down from about $600 in 2002 in constant dollars. The cost of these medications combined dropped over the first nine years, bottomed out in 2011 and rose slightly since then.

The cost of metformin, which is available as a generic drug, plummeted from $1.24 per tablet in 2002 to just 31 cents in 2013. Even the newer class of drugs known as DPP4 inhibitors only got 34 percent more expensive since they hit the market in 2006.

The researchers analyzed data from nearly 28,000 people who received treatment for diabetes in the 11-year period, a time when diabetes was rising steadily. The average age was around 60.

About one in four of the participants used insulin to control their blood sugar, and two-thirds were taking an oral medication. In the latter part of the study period, a small percentage began taking new injectable drugs designed to complement oral drug use.

More study needed

The researchers could not separate out users of synthetic human insulin, the least expensive form currently available, from those who use the more recently introduced “analog” forms that act more slowly or quickly in the body depending on the desired effect. 

They also didn’t have data on what insulin users spent on the needles and other devices used to inject insulin, except when that cost was included in drug costs, such as for pre-filled insulin pens.

And, they didn’t have information on which oral medication users took generic forms, which are less expensive. 

But they note that prices of oral medications are likely to drop over time as generics become available, while the fact that insulin is regulated as a biologic medication by the Food and Drug Administration means that prices won’t likely drop as generic competitors enter the market and encounter the strict rules governing biologics.

Further research using data that includes these details could further enhance understanding of how costs have changed for people with diabetes over the years.

In addition to Clarke and Herman, the research team included three Melbourne researchers: first author Xinyang Hua, M.Sc., Natalie Carvalho, PhD, and Michelle Tew, MPH; and Elbert S. Huang, MD of the University of Chicago. The study was supported by grants from the U.S. National Institutes of Health (DK090435) and the Australian National Health and Medical Research Council (1028335 and 1079621). Reference: JAMA, doi:10.1001/jama.2016.0126

Big Pharma Settlements Highlight the Need for Tougher Enforcement

Public Citizen Report Catalogues 25 Years of Pharmaceutical Industry Lawbreaking; Sharp Decline in Settlements, Penalties in 2014-2015

WASHINGTON, April 5, 2016 - Stronger enforcement is needed to deter pharmaceutical manufacturers from continuing to break the law and defraud federal and state health programs, according to a Public Citizen report released today.

The report – an update to a previous study released in 2012 with additional data through 2015 – catalogues all major financial settlements and court judgments between pharmaceutical companies and federal and state governments from 1991 through 2015, which totaled $35.7 billion.

Of the 373 settlements over those 25 years, 140 were federal settlements totaling $31.9 billion, and 233 were state settlements totaling $3.8 billion. GlaxoSmithKline and Pfizer reached the most settlements and paid the most in financial penalties – $7.9 billion and $3.9 billion, respectively.

From 1991 through 2015, 31 companies entered into repeat settlements with the federal government. The violation resulting in the most federal penalties was unlawful promotion, usually off-label marketing.

Twenty-nine states and the District of Columbia reached at least one single-state settlement with a pharmaceutical company during the 25-year period studied. The most common violation was drug-pricing fraud against state Medicaid programs.

Hawaii recovered the most money as a proportion of Medicaid drug expenditures; South Carolina recuperated the most money per enforcement dollar spent; Louisiana claimed the most single-state settlements; and Texas finalized by far the most whistleblower-initiated settlements.

Another key finding is that both the number and size of settlements decreased significantly in 2014 and 2015. Just $2.4 billion in federal financial penalties were recovered in 2014-2015, less than one-third of the $8.7 billion in 2012-2013 and the lowest two-year total since 2004-2005.

Moreover, there were just 20 state settlements in 2014-2015, the lowest two-year total since 2006-2007. This reflected a dramatic decrease in federal financial penalties for unlawful drug promotion and a similarly sharp decline in the number of single-state settlements stemming from overcharging government health programs.

The report explores several possible reasons for this drop in settlement activity. The possibilities include a decline in federal enforcement; a shift in the focus of federal prosecutions away from off-label marketing and toward other forms of illegal activity, asalluded to (PDF) by U.S. Department of Justice officials in 2012; changes in state Medicaid pharmaceutical reimbursement strategies; and shifts in industry marketing strategies.

“We don’t yet know why there were fewer and smaller settlements in the 2014 to 2015 period,” said Dr. Sammy Almashat, researcher with Public Citizen’s Health Research Group and lead author of the report.

“But we do know that, in addition to the rarity of executive accountability, previous penalties never have been large enough to deter the most common types of pharmaceutical fraud. So it would be surprising if the industry suddenly decided, of its own accord, to comply with laws it has routinely violated for decades.”

The pharmaceutical industry’s $711 billion in global net profits from just one decade (2003-2012) dwarf the $35.7 billion in penalties recovered over the last quarter century.

The largest settlement announced since Public Citizen’s last report – and the third-largest health fraud settlement in history – demonstrates the stark imbalance between the penalties for and the profits made on implicated products.

In 2013, Johnson & Johnson paid $2 billion after pleading guilty to off-label promotion of its antipsychotic Risperdal for use in elderly patients with dementia.

Risperdal brought in $11.7 billion in sales for the company in just the first 12 years after its approval (1994-2005), nearly six times the total settlement amount.

“Breaking the law shouldn’t be profitable, especially not when patients’ health and lives are on the line,” said Dr. Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group.

“The recently reduced settlement activity is still indicative of ongoing, systematic wrongdoing, which is costing American consumers and taxpayers enormous sums and endangering patients. Larger financial penalties, especially for repeat offenders, and jail time for executives implicated in criminal activity might actually change the calculus, so that the consequences of lawbreaking are no longer just a cost of doing business for Big Pharma.”

The report’s authors conclude that federal and state governments need to ramp up enforcement and discuss several more effective strategies to deter future fraud.

Legislation introduced by U.S. Sen. Bernie Sanders (I-Vt.) and U.S. Rep. Elijah Cummings(D-Md.) in September 2015 would terminate any remaining marketing exclusivities, granted by the U.S. Food and Drug Administration, for drugs implicated in illegal activity.

“Time and time again, drug companies defraud American taxpayers while making billions off government-granted monopolies,” Sanders said in response to Public Citizen’s report.

“Enough is enough. The greed of the pharmaceutical industry must end. I urge my colleagues to stand up to the pharmaceutical industry and pass legislation to send a clear message that crime will no longer pay.”

HHS and NIH must act to define standards for ‘march-in’ implementation to help lower drug prices as part of comprehensive national policy

The publisher of RxforAmericanHealth says that the Department of Human and Health Services (HHS) and National Institute of Health (NIH) must act to define standards for implementation of ‘march-in’ rights to help lower prescription medicine prices.  

In an open letter to Secretary Sylvia Burwell posted on RxforAmericanHealth, Daniel Hines says such action coupled with other initiatives including price negotiation for medicines, 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, criminal penalties for abuse of pricing practices based on a ‘what the traffic will bear’ philosophy, greater transparency in Pharma pricing practices, and an end to direct-to- consumer advertising for prescription medicines, will ensure a ‘stakeholder’ role for the American public that supports so much of Pharma R&D, by an increased presence of consumers,  advocates and private citizens in policy development and hearings.

He notes that HHS Secretary Burwell recently denied a request from 50 members of Congress to implement march-in provisions leading to a number of Senators joining in support of the request aimed at cost increases of the Cancer drug Xtandi.

“While this issue has surfaced again as a request for similar action from even more Congressmen and advocacy groups regarding the Xtandi patent, it is the failure of HHS and NIH to face up to their responsibilities to take action in the public interest that is the greater concern,” Hines explains.

He says the “requests themselves are an exercise of the authority of Congress, as they are based upon long-standing (30 years) existing legislation that makes it evident that it is incumbent upon the agencies to take action when Congress believes it is appropriate.” 

He cites a number of reasons in support of his contention:

·       The function of the Health and Human Services is to ostensibly protect the health and well-being of Americans, while the National Institute of Health is the primary agency of the United States government responsible for biomedical and health-related research.

·       A major responsibility of each is that is must address not only the safety and efficacy of medicines, but their availability as well since if a medicine is unavailable for any reason it creates a health care crisis for those patients who are derived of the potential benefit of the denied medicine;

·       As the Congressional letter notes: ‘march-in rights’ should be asserted under 35 U.S.C. § (203) (a)(2) “when action is necessary to alleviate health and safety needs are not being reasonably satisfied” or “benefits of a patented product are not available to the public on reasonable terms”;

·       The current pricing crisis of vital medicines clearly not only do not ‘reasonably’ alleviate health and safety needs of Americans, but are actually contributing to endangering the health of patients who are denied the benefits of access to the benefits to be derived from a regimen of vital medicines;

·       Likewise, this means that the “benefits” of a patented medicine are not available to the public since a product that is unaffordable is, in and of itself, unavailable and is “not available to the public on reasonable terms”;

·       The linchpin for implementation of ‘march in’ action is the definition of ‘extraordinary circumstances’.  Webster’s defines extraordinary as unusual or different from the usual.  We can only hope that so many Americans being denied access to unaffordable medicines, the disastrous burden upon individual health, outrageous price increases over the past few years, and Direct-to-Consumer advertising of medicines that exceeds pharmaceutical industry research and development, are not considered to be usual, and that, instead, an ‘extraordinary’ situation does indeed exist.

“This places the responsibility upon HHS and NIH not to decide whether a circumstance is ‘extraordinary’ based upon personal whim and observation, devoid of any factual studies that represent standards,” Hines says.

“With that in mind, we urge steps be taken to clearly define standards that would constitute an ‘extraordinary’ situation, not only for higher-priced specialty medicines but for vital lower-priced maintenance prescriptions that have been priced beyond the reach of untold numbers of Americans leading to adverse health complications.”