Settlement reflects vulnerability of Personal Importation safety critics as example of 'people who live in glass houses'

Publisher's Note:  The beneficial contribution of personal importation of safe, authentic brand-name medicines from Tier One Pharmacies has long been a target of the National Association of Boards of Pharmacy (NABP) on the grounds that there was no efficient oversight provided that could 'guarantee' the safety of the medicines nor the operations of the dispensing pharmacies although the medicines would be dispensed from licensed, registered pharmacies in Tier One Countries whose standards of safety and efficacy meet or exceed those of the U.S. 

Settlements such as this one as part of an earlier $1.6 billion settlement that Abbott Laboratories for making false claims about its anti-epileptic drug Depakote indicates that the criticisms of the NABP are those of people living in glass houses, and that their industry and that of Pharma are often, in and of themselves, in violation of U.S. law, leading to questions of the efficacy of NABP , as well as the oversight it offers on the ethics of Pharma and too many pharmacies.

This, in turn, demands additional oversight into the potential for negative impact upon the health and well-being of untold numbers of Americans, especially those among the most vulnerable as America's Aging population.

The news release below, illustrates this potential for abuse by Pharma and in this instance, PharMerica Corp.  Add to this the failed oversight provided by a state's Board of Pharmacy in allowing the continued manufacture of unsafe compounded medicines, and we believe the vulnerability of the NABP opposition to personal importation of brand-name prescription medicines from registered pharmacies in Tier One Countries is self-apprent:

WASHINGTON, October 11, 2015 /PRNewswire/ -- Long Term Care Pharmacy – PharMerica Corp.- has agreed to pay$9.25 million to settle allegations that it violated the federal false claims act and similar state false claims acts by receiving kickbacks from Abbott Laboratories to promote the anti-epileptic drug, Depakote.

The settlement resolves claims that were part of a 2007 lawsuit filed by false claims act whistleblower, Meredith McCoyd. Claims made initially by McCoyd against Abbott were resolved as part of a $1.6 billion settlement in 2012.

The case is entitled, U.S. ex rel. McCoyd v. Abbott Labs. et al., No. 1:07-cv-00081 (W.D. Va.). 

Reuben Guttman and Traci Buschner of Guttman, Buschner & Brooks PLLC (GBB) in Washington, D.C. have been lead counsel for Ms. McCoyd throughout the litigation, including the initial $1.6 billion settlement.  Firm senior counsel and medical director, Caroline Poplin, M.D., was also part of the GBB team representing McCoyd.

"This case highlights mismanagement of medical care for the nation's elderly," said Reuben Guttman. "It is really a case about paying to put drugs in the bodies of patients who were without the ability to engage in informed consent."

"Congressional oversight of the nursing home industry is in order," said Traci Buschner.

Guttman, Buschner & Brooks PLLC is a leading firm representing whistleblowers. http://gbblegal.com/

Attorneys from the firm have represented whistleblowers in the following cases:  U.S. ex rel. Doghramji et al. v. Community Health Services, Inc. et al. (M.D. Tenn.)($97 million government recovery in 2014); U.S. ex rel. Sandler and Paris v. Wyeth Pharmaceuticals et al (W.D. Okla.)($257 million civil government recovery in 2013); U.S. ex rel. Graydon v. GlaxoSmithKline (D. Mass)($1.04 billion dollar government recovery in 2012); U.S. ex rel. Demott v. Pfizer (D. Mass)($2.3 billion government recovery in 2009); U.S. ex rel. Szymoniak v. Bank of America et al, (D.S.C./W.D.N.C.) ($95 million government recovery in 2012); U.S. ex rel. Kurnik v. Amgen et al., (D.S.C.)($24.9 million government recovery in 2013.)

Sanders, Cummings Introduce Comprehensive Legislation to Lower Soaring Drug Prices

WASHINGTON, Sept. 10 – Sen. Bernie Sanders (I-Vt.) and House Oversight and Government Reform Committee Ranking Member Elijah Cummings (D-Md.) today introduced legislation to address skyrocketing increases in prescription drug prices.  

Americans, who already pay the highest prices for prescription drugs in the world, saw prices jump more than 12 percent last year, according to the Centers for Medicare and Medicaid Services. 

That increase was more than double the rise in overall medical costs. Nearly one in five Americans did not fill a prescription last year because they could not afford it.

“Americans should not have to live in fear that they will go bankrupt if they get sick. People should not have to go without the medication they need just because their elected officials aren’t willing to challenge the drug and health care industry lobby,” Sanders said. 

The pharmaceutical industry spent nearly $230 million on lobbying last year, some $65 million more than any other industry, and employed over 1,400 registered lobbyists. 

 “In light of 1,000 percent price increases – and more – American families are fed up with trying to afford their medications as they watch drug companies rake in record profits,” Ranking Member Cummings said. 

“This commonsense and comprehensive bill will reverse this alarming trend, help put people before profits, and make lifesaving drugs more affordable and accessible to millions of Americans families.” 

The Prescription Drug Affordability Act of 2015 authorizes the Secretary of Health and Human Services to negotiate drug prices with pharmaceutical companies to bring down costs for Medicare drug benefits. 

The bill also includes tougher penalties for drug companies that commit fraud and bans the practice of brand name drugmakers paying competitors to keep lower-priced generic substitutes off the market. The bill also lowers barriers to the importation of lower-cost drugs from Canada.

“We should use our buying power to get better deals for the American people. Other countries do it and so should we,” Sanders said.

The Senate bill is cosponsored by Sen. Al Franken (D-Minn.). The legislation is supported by the Alliance for Retired Americans, Social Security Works, the National Committee to Preserve Social Security and Medicare, National Center for Health Research, Public Citizen, Association of Clinicians for the Underserved, and RxRights, representing the voices of millions of Americans.

Click here to read the bill.
Click here to read the fact sheet on the bill.
Click here to read Sen. Sanders’ prepared remarks. 

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.)

Missouri Congresswoman displays courage, insight, leadership in comments about onerous Section 805 ‘power grab’ by Pharma, Health Human Services and Homeland Security

 There is legislation in Congress that is considered ‘must pass.’  These are bills of such vital importance that there is virtually total agreement on their importance to protecting the safety of the American public.

That is why it was not surprising that recently first the U.S. Senate , and within a week later the House of Representatives overwhelmingly passed the Prescription Drug UserFee Act (PDUFA), which generates the vast majority of the federal government’s budget for the Food and Drug Administration’s (FDA) reviewing new medications.

This is one of the legitimate and valuable functions of the FDA.  The other is to provide the oversight to ensure a safe food supply forAmericans.

But, Washington being Washington, nothing is as simple as it seems. 

Lobbyists,staffers with a particular political agenda, and special interests of Congressional Representatives  and Senators have too often created a synergy that betrays the very purpose of agencies such asthe FDA by making it a surrogate for implementing policies that benefitthe particular and limited goals of those who would stand to profit, rather than doing what is best for Americans.

This occurs because special interests are able to co-opt the intent of the legislativeprocess by having Congressmen and Senators insert onerous elements in thebills, elements skillfully crafted to seem to be in accordance with the purposeof the legislation.

No lobby is better at this than the Pharmaceutical industry and its trade group PhRMA. 

For many years, we have published blogs detailing the network of the many front groups that PhRMA has created under the guise of ‘protecting’ the safety of prescription medicines sold in the United States, but which are actually meant to make the US a ‘safe haven’ for the highest prescription medicine prices in the world.

For more than 12 years, PhRMA and its members have used their vast army of lobbyists and their seemingly unlimited financial resources to deny the right of Americans to have access to safe,affordable brand-name medicines from licensed, registered pharmacies in Tier One countries, whose standards of safety and oversight meet or exceed those of the US.

They have had some successes, primary by inserting ‘poison pill’ amendments to legislationpassed by the Senate (many times) requiring the Secretary of Health and HumanServices (HHS)  to ‘certify’ the safety of each and every prescription medicine personally imported, effectively killing the legislation.

But, a distinguishing characteristic is that they never seem to give up.  However, even with their vast expenditures, Pharma is not invincible. But, it is persistent, as the following record of creating mischief illustrates:

Over the years, working in collusion with the supportive staff of the FDA, opponents of personally imported medicines have attempted a number of tactics:

• ·         Random and ill-founded seizures of legitimate prescription medicines by Customs Inspectors, extending even to intimidation of the Elderly persons, who were denied their vital medicines by the seizures,  by demanding that they sign letters prepared by Customs in which the Seniors purchasing the medicine  ‘admitted’ to being ‘guilty’ of importing ‘illegal’ medicines.

o   When Congress learned of the practices of Customs, it quickly passed legislationforbidding the seizures and ending the Customs involvement.

• ·         Attemptsto deter personal importation by attempting to lump prescription medicines fromoutside the US as ‘bogus’ and potentially dangerous to the health of Americans.

o   Fortunately, the common sense of the American public has prevailed, and the record is clear regarding the safety and efficacy of imported medicines from reputable sources.  This has been validated by independent studies, as well as Americans demonstrating that they do indeed have the ability to make responsible decisions and the ability to distinguish between legitimate sources for safe, affordable medicines.

o   Ironically, the case can be made that if Pharma were to expend the same amount of energy towards reciprocity with Tier One countries, as it and the FDA have now done regarding inspections of ingredients for the manufacture of pharmaceuticals,  such action could be beneficial in attacking the challenge of bogus pharmacies.

o   In what was a blatant betrayal of Candidate Obama’s pledge of support for personal importation, the Obama Administration engaged in ‘secret’ deal-making with Pharma in which the Administration pledged to drop support for personal importation in return for PhRMA’s pledge not to engage a ‘Harry and Louise’ type campaign (which deterred President Bill Clinton’s Administration in its attempts at healthcare reform) against what the President hoped to be his ‘legacy’ legislative accomplishment. Recently released emails between PhRMA and the White House should be ‘must reading’for anyone with indignation over the influence of powerful lobbying groups.  Ironically, the lack of transparency might be responsible for the many flaws in Obamacare--flaws that could have been avoided if there had been more opportunity for citizen input with open sessions, and which might be responsible for the legislation's constitutionality being decided by the US Supreme Court.  The outcome could affect a number of situations, including, if it is overturned, the possibility of PhRMA declaring that all deals are void.

o    http://rxforamericanhealth.blogspot.com/2011/11/stop-online-piracy-act-endangers-health.html  in which it attempted to use language that would have given legislative sanction to Pharma’s battle against personal importation.  The law of unintendedconsequences was exemplified by a ‘blackout’ and disruption of the Internet, the coming together of seniors’ groups with technical interest groups, resulting in more than 100,000 letters and emails sent by America’s elderly to Congress and the Senate.

However, the thrill of victory was short-lived as Pharma turned its attention to PDUFA, which because of its ‘must-pass’ quality, has problematic language in both the Senate and House bill.

The Senate bill contains a provision from Senator Tom Harkin (D-IA) that might be open to interpretation of the FDA that pharmacies in other countries involved in personal importation must register with the FDA.  

In conversations with the Senator's office and designees, we have been assured that the Senator continues to 'support' personal importation, and had worked with the FDA to assure that no action is taken against personal importation, but significantly when the contact with the Majority Office, the staff member said that the Conference Committee will not add language similar to that of previous bills to specifically exempt personally imported prescription medicines, because there is 'no intent' that pharmacies are included in the registration requirement.  We were told that the language is intended for ingredients manufacturers in other countries. 

We have, however, been told that the presumed members of the Conference Committee are reportedly meeting informally and in secret, causing us to wonder if they will ever learn,even after hobbling together the Rube Goldberg healthcare proposal now being considered by the Supreme Court.  

But, it in the House of Representatives when the most onerous language can be found.  Section 805 would authorize the Secretaries of HHS and Homeland Security to seize and immediately destroy and medicine that they deem to be potentially harmful to Americans' health OR (my emphasis) with a value of less than $2000. 

That is why it is gratifying to see the courage of Rep. Joanne Emerson (R-MO 8)in making the record on what advocates believe is the latest subterfuge of PhRMA to attempt to co-opt legislation for its own purposes and to open a new front on its continuing battle against personal importation--this time with the sanction of the legislative process.

Rep. Emerson's statement follows:

"MR. SPEAKER, I want to express my support for the reauthorization of the Food and Drug Administration (FDA) under consideration today.  The FDA provides essential safeguards for patients in America and around the world, while making possible new treatments and therapies for diseases and conditions which affect millions.  This bill supports greater speed of generic medications to market and assures much needed drugs to treat cancer will get to the patients who need them.

"However, one provision (Section 805) in this legislation causes me special concern.  The section includes the new authority for the Secretary of Health and Human Services to consult with the Department of Homeland Security to cause the destruction of any drug "that has reasonable probability of causing serious adverse health consequences or death. or that is valued at an amount that is $2,000 or less."  This section poses a serious concern to hundreds of thousands of Americans who receive their drugs by mail from licensed and regulated pharmacies in Canada and other foreign countries.

"For these patients, these American consumers, there is often only one choice beyond a Canadian pharmacy, and that is to not purchase the medicines they need at all.

Patients expecting receipt of legitimate prescriptions, written by their doctor and filled by a licensed pharmacy in Canada, could have their shipment of medication destroyed without receiving any notification either before or after the federal government takes that action.  A bus full of senior citizens which crosses the border into Canada to visit a pharmacy where they can fill their prescriptions for one-third the price of the same medications in Canada could have their pill bottles seized at the border, their meager budget for their monthly health care expenses already exhausted.  This is not good policy, nor is it what Americans expect from a free market.

"This language threatens a critical, cost-effective supply of medications and pharmaceuticals.  These drugs are exactly the same as their counterparts sold in America.  I urge further discussion of this critical issue in conference and a full examination of the consequences of passing this provision into law."

With her statement, Rep. Emerson, a long-time supporter of personal importation and the co-founder of the Affordable Medicine Caucus with Rep. Peter Welch (D-VT-At Large) has put Pharma on notice to not attempt to misinterpret the 'intent' of Section 805,  and she has made the record on behalf of and support for personal importation.

Rep. Emerson's example should be an example for other legislators.

Attempts by PhRMA to co-opt legislation in the same manner that it dealt with a White House so desperate to enact a legacy bill that it violated the positions and principles that the American public embraced in Candidate Obama in 2008, must be opposed by the American public, who hopefully  will rally in opposition to continued efforts at power grabs by unelected bureaucrats claiming the right to interpret implementation of legislation that could drastically affect the personal health and  well-being of untold numbers of Americans.

Let's hope their legislators heed the sentiments of American citizens and not those of PhRMA.  

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