Tuesday, July 29, 2014
PhRMA counsel calls for criminalization of Americans personally importing authentic meds
(PART 2 OF OUR SERIES ON WHY SECTION 708 VIOLATES DUE PROCESS OF AMERICAN CITIZENS)
In what may be most blatant example of the complete disregard of the health—and rights--of American citizens, the Associate Counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA) has urged the U.S. Food and Drug Administration (FDA) to invoke criminal penalties against citizens who purchase safe, affordable brand-name prescription medicines from licensed, registered pharmacies in Tier One Countries by personal importation.
The call for prosecution was made in the trade group’s submission of comments regarding Section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA) that would create a spectacle of the FDA destroying safe authentic medicines for such arcane reasons as ‘labeling’ even if the labels meet the requirements of the country of origin-- countries that have standards of oversight and efficacy that meet or exceed those of the U.S., as evidenced by the FDA’s own actions in reciprocal agreements with agencies in those countries to provide oversight of ingredient manufacture, as well as Pharma’s establishment of production facilities in countries other than the U.S.
In the PhRMA submission, Sarah A.Spurgeon, Assistant General Counsel of PhRMA, notes that the FDA has traditionally allowed a degree of discretion for personal importation, following a long-standing policy of ‘decriminalizing’ such importation, or allowing the personal importation under provisions of existing law that if a drug is unavailable in the U.S.to an American citizen, and therapy was begun in a country other than the U.S., it may be imported into the U.S. for therapeutic reasons,
Then she urges the FDA take action by requiring that “... the patient provides evidence that the product is intended for the continuation of treatment begun in a foreign country...” and that the FDA “...restate this sentiment in the preamble to this final rule and state that, absent meeting the criteria set forth in the PIP, FDA may take action against individuals importing drugs in violation of the law, including use of its new destruction authority once FDA has finalized this proposed rule. (Emphasis mine).
This is clearly beyond the boundaries of the Rules Promulgation Process. It is a reflection of the real motive of Pharma interests to make the U.S. a Safe Haven for the Highest Prescription prescription medicine prices in the world.Ms. Spurgeon’s appeal reflects what many critics have long known about the coziness of the relationship of Pharma and its front groups such as PhRMA, the Center for Safe Internet Pharmacies, the Partnership for Safe Medication, with the FDA—a relationship that has evolved to the possible destruction of authentic vital medicines that are a lifeline to millions of Americans, at a time when as many as 50 million Americans forego the health benefits of access to a regimen of adherence to needed prescriptions because of cost.