Personal Importation: It is time for Congress and the Administration to act

Recently, Senators Amy Klobuchar (D-MN), Charles Grassley (R-IA) and John McCain wrote a letter to Health and Human Services(HHS) Secretary Tom Price asking him to utilize legislation crafted 14 years ago to exercise his authority to ‘enable’ personal importation of prescription medicines under provisions of the Medicare Prescription Drug Improvement and Modernization Act of 2003.

That such a request to the Secretary is necessary is a reflection of the failure of Congress to overcome the opposition of Pharma, which views personal importation as a threat to its ability to impose the highest prescription drug prices in the world upon American patients.

The Senators are not alone in making such a request. A group of 33 Democrat members of the House of Representatives sent a similar appeal to President Obama, asking him to issue an executive order shortly before the end of his Presidency. 

Also, throughout the last 14 years, advocates for personal importation have challenged previous HHS Secretaries to act on specific portions of the legislation, namely, requiring that …’The Secretary, in consultation with appropriate government agencies, shall conduct a study on the importation of drugs into the United States pursuant to section 804 of the Federal Food, Drug, and Cosmetic Act (as added by section 1121 of this Act). Not later than 12 months after the date of the enactment of this Act, the Secretary shall submit to the appropriate committees of the Congress a report providing the findings of such study”; and, “…In particular, the Secretary shall by regulation grant individuals a waiver to permit individuals to import into the United States a prescription drug that— ‘‘(A) is imported from a licensed pharmacy for personal use by an individual, not for resale, in quantities that do not exceed a 90-day supply; ‘‘(B) is accompanied by a copy of a valid prescription; ‘‘(C) is imported from Canada, from a seller registered with the Secretary; ‘‘(D) is a prescription drug approved by the Secretary under chapter V; Regulations...”.

These provisions are an early indication of the fact that there was—and remains today—a realization by Congress that even in 2003, relief was needed for the millions of Americans who were then—and today—denied access to 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.

Significantly, although the HHS Secretaries over the years chose to not act on the legislation, American patients acted on their own initiative, and by so doing have provided a de facto validation of the authenticity and validity of personal importation of brand-name medicines from Tier One Countries of which Canada is one.

But, rather than relying upon 14-year old legislation, it is now time for Congress to act to deal with the current state of and continuing needs of American patients to incorporate personal importation into effective legislation as reflected in the AmericanRxBillofRights which was submitted to the platform committees of the Democrat and Republican Platform Committees of the 2016 conventions.

The need for a new approach is because there exists the potential for one provision of the 2003 Act to be not only unnecessary but actually harmful to personal importation.

The provision in the 2003 act would empower the HHS Secretary to establish wholesale operations within the U.S., solely for the importation of medicines from Canada to be resold in the U.S., as well as allowing specific pharmacies to engage in personal importation.

This was opposed by many proponents of personal importation when it was first presented in the 2003 legislation.

There are several reasons for concern about this segment of the 14-year-old bill:

·       One of the debates that arose about personal importation from Canada in 2003, was a reaction from some Canadian officials being fearful that Canada would become ‘America’s drugstore’ which can be directly linked to the wholesaling provision;

·       Equally pertinent, many American advocates of personal importation believed then, and continue to do so today, that to grant such blanket authority to wholesalers and individual pharmacies would defeat the very purpose of personal importation, i.e., individual American patients’ access to safe, affordable brand-name medicines;

·       That is because we must be concerned about U.S. wholesalers gaining control over large supplies or sources of lower-cost medicines, giving them a capability to control prices in a manner similar to the abusive practices of Pharma, and crippling the ability of Americans to make purchases of their meds from any source other than the wholesalers and pharmacists.

It is time, therefore, for Congress, especially those erstwhile supporters of personal importation to come together to form a consensus on comprehensive legislation for personal importation of prescription medicines as the only readily available avenue with which to ensure that no American is denied their access to vital lifeline medicines because they are unaffordable.

This calls for consensus building in which Representatives and Senators of both parties who support personal importation instruct their staffs to come together to identify what opportunities—and obstacles—face enactment of new, current legislation to lower prescription drug prices via personal importation;  address such  problems caused by the one in ten Americans not being able to afford their medicines; to restrain the Food and Drug Administration from the seizure and destruction of medicines which can easily be identified as authentic, safe medicines.

By acting in such a manner to meet their obligations to the American public, Congress can develop legislation in which personal importation will have a major role and will reflect the realities of the needs of Americans patients today, rather than simply appealing for the HHS Secretary to carry the water on this issue.

Publisher Lauds Committee for Mylan investigation, says time for Congress to pass legislation cutting Drug Prices

It is time for the American voter to hold Congress accountable and demand the end to Pharma pricing abuses as exemplified--this time--by Mylan

ST. LOUIS, MISSOURI, USA, September 29, 2016 /EINPresswire.com/ -- The publisher of TodaysSeniorsNetwork, which includes RxforAmericanHealth and the AmericanRxBillofRights, has lauded the members of the House of Representatives Oversight Committee for its vigorous questioning of both Mylan Chief Executive Officer Heather Bresch and Dr. Douglas Throckmorton, Deputy Center Director for Regulatory Programs of the Food and Drug Administration, in recent hearings about the continuing EpiPen price scandal, but says Congress must ask itself about its failure to end Pharma pricing abuses.

“It is gratifying to see bi-partisan consensus on the dramatic, undesirable consequences affecting the health and well-being of American citizens because of the predatory pricing practices of Pharma,” Daniel Hines said in a letter to Committee members.

“Hopefully the expressions of outrage and indignation by the members are a prelude to Congressional action to end Pharma’s charging not just what the traffic will bear but what it determines to be necessary to inflated profits despite the harmful consequences to patients that simply cannot afford their medicines.”

But, Hines notes, there are questions that remain unanswered, and must be directed to not Pharma but to Congress.
“The questions should be asked by voters across the country as Congress prepares to recess before the elections,” he says. "It's in the voters' hands."

The questions include, When will Congress act? What will it take to make it act? Why has it not acted before, choosing instead to hold what seem to be endless ‘investigations? How does the FDA ignore previous Congressional Direction? What penalties are there other than fines for Pharma’s errant actions and misleading Congress? What is the harmful effect of unaffordable maintenance medicines that are a vital lifeline to patient? Why has Congress not implemented allowed personal importation of brand-name medicines from Tier One Countries to ensure that Americans have access to such a vital life-line?

In his letter to Committee members, Hines asked the following questions:
1. Throughout the hearing, Committee members noted that ‘they had been here before’, charges were leveled against Ms. Bresch’s statements calling them ‘rope-a-dope,’ ‘a shell game,’ and suggesting that perhaps this will be the impetus that will finally lead to Congressional action. But, If this latest example of Pharma abuse does not lead to Congressional action, what will it take? When will Congress act? Why is there a delay?
2. The testimony of Dr. Throckmorton, M.D., and his non-responsive answers to requests from the Committee, were appalling. His refusal to share information with the Chair of the Committee was particularly troublesome, and is indicative of the FDA, an agency ostensibly designed to protect the health and well-being of Americans, claiming equal status with Congress. Another example of such a blatant rejection of Congressional oversight is its refusal to implement ‘march in’ rights for more than 35 years, even in light of a recent bi-partisan Congressional request from 51 members of Congress. ‘Why does Congress allow the FDA to act in such an authoritative manner, refusing to acknowledge Congressional oversight?’ Also, why did the FDA reportedly deny the application of Teva for a competitive product to EpiPen on the basis of patent exclusivity of the design of the Mylan product?
3. The Wall Street Journal and others report that Ms. Bresch “underreported” Mylan profits by 60 percent, manipulating tax payment claims that, according to the WSJ did not apply to Mylan. Senators Amy Klobuchar (D-MN), Chuck Grassley (R-IA) and Richard Blumenthal (D-CT) have asked the Department of Justice to investigate whether Mylan has committed fraud. Will this claim be investigated further by Congress or DOJ? If the charge is found to be true, what will be the result?
4. There was a consensus on the Committee that a medicine that is unaffordable is, in and of itself, unavailable. You can’t buy what you can’t afford. But, millions of Americans have for years been denied the health benefits of access to a regimen of their prescribed medicines. It is virtually impossible to estimate the adverse impact to the health of individuals and society that have occurred simply because they can’t afford their medicines, due to Pharma and the FDA ignoring previously adopted directives to the FDA and HHS to explore and facilitate what is a readily available, affordable and safe resolution to the fact that Americans pay the highest prescription prices in the world—i.e., 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.
5. Congress has introduced legislation that would allow personal importation many times over the past 15 years. Millions of Americans have personally imported their medicines for years despite by FDA and Pharma opposition. Both current Presidential candidates support some form of personal importation of prescriptions from Canada and Tier One Countries as a means to lower prescription costs. There are bi-partisan bills for personal importation that have been introduced in the current Congress. But the FDA claims it cannot verify the safety and efficacy of drugs produced outside this country and that are personally imported , although it works with Pharma to provide oversight of the more that 80 percent of the prescription ingredients that are produced outside the U.S., and has stated that it is seeking greater cooperation with counterpart oversight agencies outside the U.S. Added to this is that while millions of Americans have been denied access to affordable medicine because of Pharma pricing practices, millions more have turned to personal importation of safe, affordable medicines for years, leading to the question, why does Congress fail to enact enabling legislation for personal importation?

Hines concludes, “One can only hope that the Mylan hearings will lead to a consensus-building initiative that will result in comprehensive legislation as outlined in the American Rx Bill of Rights and finally ending the ‘be damned’ attitude of Pharma.

Daniel Hines
TodaysSeniorsNetwork
636-399-2849
email us here

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.

RxforAmericanHealth publisher supports Task Force on Lowering prices, calls for additional Congressional leadership

Publisher's note:  The following is a copy of a letter sent today (January 12, 2016) by RxforAmericanHelath Publisher Daniel Hines to members of the Democrat Task Force designed to lower prescription drug prices.  In the letter, we support the intent of the Task Force, but urge them to expand their scope from the spike in generic drug prices to more comprehensive, bi-partisan legislation that will address the 'public (and Congress) be damned attitude of Pharma as it continues to charge whatever it wishes for medicines. This is the launch of what we believe will be a 'watershed year' that could finally end the pricing abuse of pharma,  with Congressional action that recognizes that a medicine that is unaffordable is, in and of itself, unavailable.  As many have noted, a medicine that is denied is of no health benefit. The letter follows:

I am writing in my capacity as publisher of the TodaysSeniorsNetwork group of nationally followed and read blogs,  including RxforAmericanHealth, to support your of  Congressional efforts with the formation of the Affordable Drug Pricing Task Force to lower prescription medicine prices for Americans.

It is time for Congress to pass comprehensive, bi-partisan legislation that will direct the Food and Drug Administration to act in a manner to facilitate access to safe, affordable medicines for Americans and to end the pricing abuses we continue to witness from Pharma in complete disregard of criticism from policy-makers the media and, yes, even Congress. This is a leading issue of the 2016 elections , and can be expected to grow in importance, as increasing numbers of Americans face the reality that a medicine that is unaffordable is, in and of itself, unavailable. 

I am a supporter of 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.  However, I, and a growing number of Americans, realize that rather than a reliance upon a single solution, what is needed is a comprehensive approach to lowering prescription medicine prices.  This includes:

1.  Price negotiation;

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.

I am including links to three articles I hope you and your staff will find helpful.  I am sending this to your office via fax so you shall have a ‘hard copy’ for your consideration,.  I am also emailing it to your healthcare legislative aide. 

1. RxforAmericanHealth publisher calls for bi-partisan Consensus, Coalition legislation in Congress To lower prescription costs...The publisher of Rx for American Health is calling for a coalition of Senators and Representatives and their staffs to reach consensus on a single comprehensive bill incorporating major points of a number of disparate legislative proposals to lower prescription medicine prices, and to be prepared to offer their bill immediately with the reconvening of the  114th Congress in January 2016…

2    Why High Drug Prices require an Rx Bill of Rights for Americans…The publisher of RxforAmericanHealth has called for both the Democrats and Republicans to address the issue the impact of rising prescription drug costs by incorporating into their Party platforms an American Rx Bill of Rights…(continue) Time for A Congressional Caucus to support Congress moves on Personal Importation…

3.  The publisher of RxforAmericanHealth says that it is time for Congress to form a Congressional Caucus to support recently introduced legislative proposals on behalf of the personal importation of safe, affordable prescription medicines, and to act as a watchdog to prevent the potential of abuse by the Food and Drug Administration of Section 708 of the Food and Drug Administration Safety Innovation Act (FDASIA) with the unwarranted destruction of valid, safe medicines personally imported by Americans…(continue)

Thank you for taking the time to review these materials.  I shall look forward to your response.  If you have any questions, please feel free to contact me at the contact information listed at the top of this letter.
Daniel Hines

Report: Rapid Rise in Cost of Specialty Drugs Exceeds Median Family Income

November 23, 2015/PRNewswire-USNewswire/ -- Retail prices for over one hundred widely used specialty prescription drugs surged skyward by nearly 11 percent in 2013, surpassing the median income of an American family, according to a new AARP Public Policy Institute (PPI) report issued today.

The average annual cost of a specialty medication used on a chronic basis exceeded $53,000 in 2013. This cost was greater than the median U.S. household income of $52,250, more than twice the median income of $23,500 for people on Medicare, and almost three-and-a-half times higher than the average Social Security retirement benefit of $15,526 over the same time period.

"Specialty drugs are among the most expensive on the market, and are expected to be the fastest growing group of drugs over the next decade," said Debra Whitman, PhD, AARP's Chief Public Policy Officer.

"These exorbitant prices and price increases can be financially disastrous, especially for people on fixed incomes. Americans cannot continue to absorb the astronomical costs associated with these products indefinitely."

The AARP PPI report also found that specialty drug prices are considerably higher than other drug prices. In 2013, the average annual cost for specialty prescription drugs was 18 times higher than the cost of brand name prescription drugs and 189 times higher than the cost of generic prescription drugs.

Specialty drugs generally include drugs used to treat complex, chronic health conditions.

They often require special care in how they are administered to patients, as well as in how they are handled and stored. Many specialty drugs treat conditions that are common among older people, including rheumatoid arthritis, multiple sclerosis, and cancer.

The new report, the third in a series of reports on prescription drug prices, examined the retail prices of 115 specialty prescription drugs most widely used by older Americans.

The analysis included 47 different drug manufacturers and covered 30 different therapeutic categories. The vast majority (85%) of the 115 specialty drugs studied are used to treat chronic health conditions.

Highlights of the Rx Price Watch Report
Based on the retail prices of 115 widely used specialty prescription drugs in 2013:

• Average annual cost for one specialty medication used on a chronic basis: $53,384
• Average annual cost was 18 times higher than the cost for brand name drugs: $53,384 vs. $2,960
• Average annual cost was 189 times higher than the cost for generic drugs: $53,384 vs. $283
• Average annual price increase was more than 7 times higher than inflation: 10.6% vs. 1.5%
•  

"We know that nearly two-thirds of older Americans use three or more prescription drugs on a regular basis," saidLeigh Purvis, MPA, PPI Director of Health Services Research and co-author of the new report.

"The average price of just one specialty drug now outstrips what many families earn in a year. These high drug prices can make it extremely difficult for patients to afford the treatment they need to stay healthy."

According to the AARP PPI report, policy makers interested in reducing the impact of high drug prices should focus on solutions that balance the need for pharmaceutical innovation with the need for improved health and the financial security of consumers and taxpayer-funded programs like Medicare and Medicaid.

"Rx Price Watch Report: Trends in Retail Prices of Specialty Prescription Drugs Widely Used by Older Americans, 2006 to 2013" Methodology

AARP's Public Policy Institute, in collaboration with the PRIME Institute at the University of Minnesota, developed a group of 115 specialty prescription drug products most widely used by older Americans. Using data from the Truven Health MarketScan® Research Databases, the report analyzed retail price changes between 2006 and 2013 for these 115 specialty drugs.

Additional Resources

• Rx Price Watch Report: Trends in Retail Prices of Generic Prescription Drugs Widely Used by Older Americans, 2006-2014
• Rx Price Watch Report: Trends in Retail Prices of Brand Name Prescription Drugs Widely Used by Older Americans, 2006 to 2013
• AARP Drug Compare Tool – Learn the difference and similarities between any two Rx or over-the-counter medications.
• AARP Bulletin article, "Feeling the Pain of Costly Prescription Drugs" (Jan/Feb 2015)

Call for Congressional Coalition effort to draft consensus, comprehensive legislation combining elements of proposals, for 2016 conventing of Congress

 In what may be one of the biggest news stories of 2015, and one with the potential for long-range health and financial benefits for untold numbers of Americans is that the harmful effects of Pharma pricing strategies has seemingly become an issue of primary importance to the U.S. Congress.

But, after the many hearings are held, after the Forums are over, after the Task Forces disband, after Pharma and its front groups launch their counterattack using the vast financial support of literally dozens of members of Congress and the army of lobbyists that will be turned loose on Capitol Hill, the question remains: 

Will this be, as Henry A. McKinnell,, the then-chairman of Pfizer scolded then-Governor Tim Pawlenty of Minnesota in a press conference following a shareholders’ meeting in St. Louis, the seeming outrage would be nothing more than a ‘Prairie Fire that comes along every four years as a product of the elections and then ‘burns itself out.’

That is why it is crucial that Congress acts to ensure that the U.S. joins the rest of the industrialized world to ensure that our citizens have access to affordable, safe, and innovative medicines that will enhance the health and well-being of all Americans.

As a long-time supporter and advocate for personal importation of brand name medicines, acting as a consultant on personal importation issues, I have previously expressed my support for a Congressional Caucus of Congressional supporters of personally imported brand name medications.

Now, the furor over the Pharma practice of ‘charging what the traffic will bear’ has led to a number of Senators and members of the House of Representatives of both political parties supporting legislation on behalf of a range of issues such as ‘pay to delay’; personal importation; patent rights of U.S. citizens as ‘stakeholders’ because of their dual role as patients and as major providers of the fiscal support of Research and Development costs of developing new medicines; and, measures to allow negotiation of prices for Medicare and Medicaid, a practice already in place for the Veterans’ Administration.

While all of these initiatives are encouraging, we believe it is time for a coalition of Senators and Representatives and their staffs to come together to reach consensus on a single comprehensive bill incorporating all of the points listed above, and to be prepared to offer their bill immediately  with the reconvening of the  114^th Congress in January 2015.

By so doing, Congress will assume its rightful role as the determinant of policies affecting prescription medicine safety, cost and availability with a bill that will favorably provide physical and fiscal benefits to untold numbers of Americans.  It will also end the ‘Safe Haven’ that Pharma has created in the U.S. for its predatory pricing practices. 

It was in August 2014 that I wrote how Pharma was developing ‘The Perfect Storm” to advance its agenda employing a number of techniques to ensure that America remained its ‘Safe Haven’.

An exploration of the many aspects of Pharma’s strategy led us to “…The conclusion is that whereas previous Pharma efforts had been characterized as admittedly potentially harmful, they were ‘individual’ in nature and lacked what can be determined in the present circumstance to be ‘cumulative’…”

We noted that “The current Pharma effort on a number of fronts reflects a comprehensive, coordinated strategy that by its breadth threatens the health and fiscal interests of the American patient/client…”

We cited the strong support of Pharma’s agenda by members of Congress who received millions of dollars of contributions from Pharma, noting that there existed  “…An attitude inside the Beltway by elected Senators and Representatives who are beneficiaries of huge donations from Pharma interests that is described as a ‘By Invitation Only’ (BIO) attitude.  The BIO-approach limits the opportunity for advocates of personal importation to testify before Congressional hearings on issues that affect the role of personal importation while including only Pharma interest spokespersons.”

The situation was bleak, but at the same time, I observed to colleagues that there were always certain things that we could count on from Pharma. 

The first was the arrogance of the industry which had led over many years and instances to a hubris that exposed Pharma’s primary motive, i.e. to charge the highest prices possible and whatever ‘the traffic will bear’.

I followed that with the observation that perhaps Pharma was not as smart as we gave them credit for being, noting the comment of a Pharma lawyer during the submission of comments on Section 708 of the Food and Drug Administration Safety Innovation Act (FDASIA) in which she called for the criminalization of individuals who were personally importing their authentic medicines from Tier One Countries, a policy move that was contrary to all previous FDA actions.

I have always hoped that the public, policy makers and media would someday recognize the merits of the mantra published so many times in these blogs:  A medicine that is unaffordable is equally unavailable, and, by extension, a medicine that is unavailable is equally incapable of providing any health benefit.

Now, that day has come, and it is Pharma that is attempting a pushback to overcome the wrath of the public and policy makers by claims that treatments that cost $80,000 to $100,000 are ‘worth it’ when compared to the alternative of dying.

But the highly expensive, overly priced specialty medicines were only the tip of the iceberg.  One need to only consider the spike in Generic prices in the last year.

There is finally a recognition of the problem of the predatory pricing policies at a national level as the two Democrat candidates for President have offered comprehensive legislation that for the first time combines all the elements that have contributed to Pharma abuse in proposed legislation.

The proposals include dealing with ‘pay to delay’ tactics that keep lower-cost medications from being introduced; a recognition of the ‘stakeholder’ role of U.S. citizens and taxpayers who provide much of the funding for Pharmaceutical research in the U.S. through their support of the National Institute of Health; a call for changes in the prosecution of criminal activity by Pharma members that would hold not merely the companies liable, but would subject the offending officers of the firms to criminal action; and, a strategy that would allow the ending of patent protections with the ‘ownership’ of the patents ‘returning’ to American citizens; finally, there are many bi-partisan bills in the U.S. Congress dealing with one or another aspect of Pharma practices including ‘pay to delay’, personal importation of Brand Name medicines from Tier One Countries, promotion of the broader use of generics,

The result is that whereas a year ago, Pharma was creating ‘The Perfect Storm’, it today is in an unprecedented situation in which it is not the determiner of the debate, but is instead is engaged in the middle of the storm with lightning bolts directed at them by hospitals, insurance companies, patients, Presidential candidates, and Congressional investigations.

This creates a climate of opportunity for long-suffering Americans who have paid steadily increasing prices for their medications. It creates a climate of opportunity to end Pharma actions that create costly—and too often unaffordable medicines—that are a major driver of health care costs.  It creates a climate of opportunity to recognize the role of the American patient, caregiver, family member as having ‘stakeholder’ rights that merit a seat at the table in the form of ordinary citizens and/or their advocates. 

Most importantly, it creates a climate in which the totality of the harmful  effects of Pharma pricing  strategies has been exposed.  

The challenge: Will Congress exercise leadership to take the steps that will ensure success, or, will we witness another Prairie Fire burning out?