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.
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