St. Louis, MO, July 30, 2014—A stance by the Pharmaceutical Research and Manufacturers of America (PhRMA) for the U.S. Food and Drug Administration to take action against individuals who personally import prescription medicines should be an issue in the 2014 Congressional elections says the publisher of the RxforAmericanHealth blog.
Daniel Hines, publisher of RxforAmericanHealth and TodaysSeniorsNetwork says that the submission from a PhRMA associate counsel to the FDA regarding rules promulgation for Section 708 of the Food and Drug Administration Affordability and Innovation Act (FDASIA) is yet another indication of PhRMA’s goal to ensure that the U.S. remains a “safe haven for the highest prescription medicine prices in the world.”
“This is perhaps the most blatant example of the complete disregard of the health—and rights—of American citizens,” Hines says.
Section 708—which Hines describes as a flawed piece of legislation—is designed to permit the seizure and destruction of personally imported prescription medicines from outside the U.S. valued at $2500 or less.
“The safety and authenticity of prescription medicines is something all Americans should support,” Hines continues. “But, Section 708 will create a spectacle of the FDA destroying safe authentic brand-name medicines for such arcane reasons as ‘labeling’ even if the labels meet the requirements of the country of origin-- including Tier One 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.”
“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.
“PhRMA would make criminals of American citizens simply exercising their right to good health that would otherwise be denied them, and for whom personally imported medicines offer a safe, sensible solution.
“It is time to finally and clearly present one, undeniable fact—a medicine that is unaffordable is unavailable—and it is time, in this Election Year of 2016 to demand answers from political candidates as to where they stand on this issue.”
