Overhauling the Food and Drug Administration (FDA)

The Wall Street Journal reports that Sen. Charles Grassley and Rep.
John Dingell are taking the lead in calling for revamping the FDA which is
recognized as being “too cozy with the companies they regulate.”

“The lawmakers say an FDA restructuring should build a much taller wall
between the agency and the industry it regulates. The FDA would gain
authority to recall drugs, which it can’t do today, and to impose
significant fines on drug companies for safety violations. The lawmakers
also want the FDA to inspect generic-drug makers before approving a new
product. Perhaps most importantly, they want the next president to appoint a
tough FDA commissioner completely independent from the industry.”

An indication that there is a groundswell of support for major reform of the
agency:
Sen. Arlen Specter (R., Pa.), usually sympathetic to the agency, called the
FDA “a joke.”
Senate Appropriations Chair Herb Kohl (D., Wis.) upbraided Dr. von
Eschenbach after he had to be dragged to join DHHS secretary in a night time
news conference to announce a request to Congress for additional funds for
overseas inspections after the disastrous Chinese heparin blood scandal.

And, even Billy Tauzin, president of the drug industry’s lobby, PhRMA
(Pharmaceutical Research and Manufacturers of America) acknowledged that he
has warned members about what may lie ahead in the way of tighter
regulations.

“It’s an accumulation of things some companies did over the years. Now it’s
death by a thousand cuts,” he said in an interview. “We gotta stop the
bleeding.”

Indeed, as the St. Petersburg Times reported in May, 2007:

Between 1989–1991: 1.56 Percent of newly approved drugs pulled from market;

Between 1997-2000: 5.34 Percent of newly approved drugs pulled from market;

In 1998, the number of complaints to the FDA about clinical drug trial
irregularities = 10;

In 2006, the number of complaints to the FDA about clinical drug trial
irregularities = 350.

See:
http://www.sptimes.com/2007/05/27/Worldandnation/Drug_s_chilling__path.shtml

AHRP believes that no meaningful reforms are possible until FDA officials
who have been “cozy with companies”– are replaced with independent
professionals the public can trust. The current FDA top brass has lost
public trust–they cannot, therefore, remain in their positions of
authority.

Source: Atypical_Antipsychotics Yahoo Group

Thank you Vera for your contribution!

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