Seizures of prescriptions represent broken promise of Obama Administration to support of personal importation of prescription medicines

A rash of seizures by the Food and Drug Administration of vital medicines from licensed, registered pharmacies in Tier One Countries is threatening the health of Americans by denying them their right to purchase safe, affordable medicines that are identical to those sold in the U.S., but at prices as much as 60 percent lower.

The FDA action breaks the promise made during the 2008 Presidential campaign by then-candidate Obama to provide access through personal importation of these medicines as a part a strategy of lowering prescription drug costs in the U.S.

When Obama was seeking the votes of America’s Seniors, their caregivers and families, he and others spoke frequently and with great conviction about their support of the right of individuals to purchase safe, affordable medicines from sources outside the U.S.

But, in September 2008, Dora Hughes of the Obama Campaign Staff sent up the first signals that the support was not as strong as Candidate Obama would have people believe when she was quoted as saying that there were problems with what is called reimportation.

(The term reimportation is misleading. Personal importation is more accurate as it best describes American citizens exercising their right to purchase the very same medicines that are priced at as much as 60 percent more in the U.S. than from pharmacies in Tier One Countries that meet or exceed standards of oversight of those in this country.)

Since then, the Obama Administration has engaged in a series of actions that indicate that it not only has no intention of carrying out its campaign pledge, but has even made arrangements and deals with the pharmaceutical industry that have helped boost the cost of medicines to such an extent that a growing number of Americans are finding drug prices to be a deterrent to their being able to buy and take their prescriptions.

· The deal with PhRMA in which the drug industry ‘agreed’ to lower prescription drug prices for drugs in the dreaded Doughnut Hole of Medicare Part D, only to raise prices at rates far exceeding inflation during the year before the price drop was to take place, is the prime example of the willingness of the Administration to sacrifice principle for process. Actually, PhRMA limited its ‘financial hit’ to $80 billion over ten years, a ‘hit’ that will almost certainly be outstripped by the industry’s price increases. The price increases are already eating up the $250 stipend paid to Seniors in the Doughnut Hole. In return, PhRMA pledged not to oppose the President’s signature legislation, the Patient Protection and Affordable Care Act.

· As a part of what many consider the quid pro quo for PhRMA’s pledge, the Administration kicked ‘reimportation’ of prescription medicines—and its primary supporter for many years, Senator Byron Dorgan (D-ND)—under the bus when FDA Commissioner Margaret A. Hamburg, in a letter to the Senate, warned that her agency was not able to guarantee that drug imports would not be counterfeited or contaminated. The Administration was silent about Commissioner Hamburg’s statement.

· There was speculation that the Administration had also pledged to continue to oppose personal importation as a part of the PhRMA deal. The stepped-up seizures and the Administration's coziness with a PhRMA-backed group, the Partnership for Safe Medicines (PSM), lends credibility to that concern. Consider this timeline:

05/2009: PSM opposes Reimportation... 09/18/2009: PSM says Search Engines promote illicit drugs...12/08//2009 : Commission Hamburg says ‘difficulties exist’ for safe reimportation , Dorgan Amendment fails...02/10/2010 : PSM applauds Google position on stopping Internet pay per click for Canadian pharmacies...06/22/: PSM applauds Administration position on ‘protection’ of intellectual property rights including drug manufacture...06/2010 : Commissioner Hamburg restates position about ‘difficulties’ with reimportation...06/2010: Senator Dorgan announces plans to introduce reimportation amendment to food safety legislation...07/29/2010: National Association of Chain Stores sends letter objecting to Dorgan amendment...09/14/2010: Generic group joins PSM...09/2010: PSM announces that Commissioner Hamburg to speak at Inaugural Conference on Counterfeit Medicines , sponsored by PSM...SEIZURES ACTIVITY PICKS UP IN AUGUST

PSM, which purports to seek an end to the danger of counterfeit medicines, a goal which we all share, is the proverbial sheep in wolf’s clothing—a PhRMA- backed organization with interlinking relationships to PhRMA among its Board members. Consider these links of the Board members:

Marvin D. Shepherd, Ph.D , Director, Center for Pharmacoeconomic Studies, College of Pharmacy, University of Texas-Austin , long-time record of opposition to personal importation, PhRMA links covered in previous blogs. http://rxforamericanhealth.blogspot.com/2009/07/time-for-critics-of-importation-to-look.html

Bryan A. Liang, Ph.D, M.D., J.D. , Executive Director, Institute of Health Law Studies, California Western School of Law Co-Director, San Diego Center for Patient Safety. See linkage to James N. Class, below

James N. Class, Ph.D Director, Global Public Policy, Merck & Co, Inc , Class is a member of the Institute of Health Law Studies at Case Western headed by Liang

Thomas T. Kubic , President and CEO, Pharmaceutical Security Institute, Composed of the security directors from 26 pharmaceutical manufacturers with business operations in more than 160 countries.

Scott A. LaGanga , Senior Director, Pharmaceutical Research and Manufacturers of America,

· While the latest round of seizures reflect a lesson learned by the FDA as it ‘softens’ its approach by posturing as the ‘protector’ of the patient that has ordered the medicine , it apparently doesn’t know much about formularies as one of the primary drugs seized is Lipitor, manufactured by Pfizer in Ireland for distribution and sale world-wide. But the highest-selling drug in the world is, according to the FDA, apparently a new drug with its safety and effectiveness in question (an excerpt from the FDA letter follows);

o ”According to the FDA’s ‘Procedures for Human Pharmaceutical Products Shipped through International Mail Facilities, it is a new drug because it is not generally recognized as safe and effective by experts and requires a prescription. It is an unapproved drug because there is no FDA approval of a new drug application on file for the product…” (emphasis mine)

· There is, of course, a prescription for the seized medicine. The FDA has admitted that it does not test the seized medications. The new letter says that the agency is not accusing the patient of a crime. What then is the basis of the seizure? The claim of acting as a protective measure simply dissipates in the light of the fact that by its action, the FDA is actually endangering the finances of the patient at best by denying them the right to purchase safe, affordable medicines.

At worst, by the denial of a vital medicine designed to protect the health of the patient, the FDA is endangering the health and well-being of the patient—this by an agency that is supposed to serve the public good. The Obama Administration should act on its election pledge to lower the prices of prescription medicines with a number of strategies, including the right of personal importation, and direct its appointees to act to stop the possible health-threatening seizures of vital medicines.

Commissioner Hamburg is widely recognized as a talented, intelligent professional with high standing in the medical community. Surely she can apply some of those talents to addressing what she perceives as ‘difficulties’ and work to deal with a problem that affects the very heart of our health care system—the highest drug prices in the world.