More power (and money) for FDA, docs say

Doctors are getting in on the improve-the-FDA act. The American College of Physicians has issued a policy paper calling for new powers and new funding for the agency. "The FDA is critical in assuring the prescription drugs available in this country are safe and effective," Dr. Joseph W. Stubbs, president of ACP, said in a statement. "Unfortunately they have not historically been given the support and structure necessary to be optimally effective."

Even FDA Commissioner Margaret Hamburg would agree with him on that. Whether she'd agree on the association's specific proposals is another question. Besides recommending increased funding for the agency, ACP also recommends that the FDA:

• Increase regulation of drugs made outside the U.S., [1]using funding from the feds and from user fees.
• Get expanded authority over the design of pre-approval clinical trials and other studies.
• Prohibit drug-bundling that limits marketability and availability of meds.
• Improve the adverse-events reporting system [2].
• Have the authority to require new drugs to be labeled with a special symbol indicating they are new.
• Have the power to limit DTC ads for two years after a drug's approval.

Watch those last two recommendations, they're doozies. As you know, there's an ongoing debate about marketing of new drugs; consumer advocates say that it should be limited, because new meds are tested on pre-selected subjects, who are often in better overall health than many potential patients. Once on the market, those drugs go to a much broader and more diverse group--and safety problems can obviously ensue.

These proposals are rooted, in part, in a 2005 study by the Institute of Medicine. The FDA asked IOM to assess the drug safety system and make recommendations for improvement. "Since the report was issued, the agency has taken steps to improve; however, problems still remain," ACP contends. Would you agree? What do you think of ACP's ideas?

- see the ACP statement
[3]- read the article [4] in the Los Angeles Times

Related Articles:
GAO: FDA regulators can't track adverse event reviews [2]
FDA reform advocates want trial, data transparency [5]
Obama wants to boost FDA budget 19% [6]
GAO calls FDA a 'high-risk' problem [7]
FDA reforms lack cash backup [8]