Eleven Food and Drug Administration
Commissioners -- who have served Presidents from Johnson to Clinton -- have
written to members of Congress that the reimportation of prescription drugs
poses grave risks for American patients.
The letters, from consecutive former commissioners and acting
commissioners dating back to 1969, warn that removing the protections in
current law regarding reimportation of drugs could expose U.S. patients to
dangerous, counterfeit or adulterated medicines.
The reimportation issue is at the forefront of the news because there is
legislation pending before a House/Senate conference committee that would
overturn a consumer protection law enacted in 1988. The pending legislation
would lower safety standards for imported prescription medicines. The
conference committee is expected to act quickly in reconciling the House and
Senate versions of reimportation legislation. A vote could come in early
Michael A. Friedman, M.D., Acting Commissioner in the Clinton
Administration (1997-1998), wrote to Senator Orrin Hatch that "the Jeffords
amendment adopted in the Senate and the Coburn, Crowley and Gutknecht
amendments adopted in the House to the Agriculture appropriations bill would
lower safety standards for prescription medicines imported or re-imported into
the U.S. ... (T)hese measures would significantly increase risks to patients
on prescription medicines because their drugs might be adulterated,
counterfeit or sub-potent."
Donald Kennedy, Ph.D., FDA Commissioner under President Carter and current
Editor-in-Chief of Science, wrote to Senator Trent Lott, "At a time when
science is making new discoveries and consumers are demanding more and better
medicines, we should be focusing on efforts to decrease, rather than increase,
health and safety risks. The entire thrust of the Jeffords amendment is to
relax the standards for medicines imported or re-imported into the U.S. below
those applied today by the FDA under the Federal Food, Drug and Cosmetic Act
... If we lowered the safety standards for prescription medicines now,
precisely when the use of medicines continues to rise and be more pivotal to
health care, the effects on patient health and safety could be 'devastating'
Arthur Hull Hayes, Jr., M.D., FDA Commissioner under President Reagan,
wrote to House Minority Leader Richard Gephardt, "After my review of the
proposed (Crowley, Coburn and Jeffords amendments) legislation, I am amazed
that the Congress would consider emasculating provisions of the Food, Drug &
Cosmetic Act and The Prescription Drug Marketing Act. Both these laws were
adopted to protect those living in the U.S. from ineffective or unsafe drugs
Alan F. Holmer, President of the Pharmaceutical Research and Manufacturers
of America (PhRMA), said that these warnings from former FDA Commissioners
should act as a red flag to members of Congress.
"Congress should heed these warnings from people who know the dangers of
counterfeit and adulterated drugs and stop this legislation before it can harm
American patients," he said.
Other commissioners writing letters to warn of reimportation dangers are:
David Kessler, M.D. (Bush, Clinton), James Benson (Bush), Frank Young, M.D.,
Ph.D. (Reagan, Bush), Mark Novitch, M.D. (Reagan), Jere Goyan, Ph.D. (Carter),
Sherwin Gardner (Nixon, Ford, Carter), Charles Edwards, M.D. (Nixon), James
Goddard, M.D. (Johnson).
Copies of the letters can be downloaded at the following sites http://www.phrma.org .