Physicians’ Group Calls for Changes at FDA

The American College of Physicians has called for broader authority and increased funding for the U.S. Food & Drug Administration (FDA). According to a press release from the college, chronic underfunding and other problems have hindered the agency’s ability to regulate the safety and effectiveness of <"">new and approved drugs.

“The FDA is critical in assuring the prescription drugs available in this country are safe and effective,” said Joseph W. Stubbs, MD, FACP, president of ACP said in the statement. “Unfortunately they have not historically been given the support and structure necessary to be optimally effective.”

The changes sought by the America College of Physicians are detailed in a policy paper entitled ‘Improving FDA Regulation of Prescription Drugs.” The paper offers a half-dozen recommendations about how to improve the agency’s ability to approve and monitor new drugs.

The paper recommends that the FDA:

* be given increased funding;

* increase their capacity to regulate drugs manufactured outside the U.S. through appropriations and user fees;

* be given expanded authority to exercise in the design of preapproval trials and studies;

* prohibit the bundling of drugs that limits marketability and availability;

* improve the adverse events reporting system; and,

* be given the authority to require new drugs be labeled with a symbol that indicates it is a new drug and that direct-to-consumer advertising be limited for the first two years after a drug’s approval.

According to the college’s press release, in 2005 the FDA requested that the Institute of Medicine put together a committee to assess the current state of the U.S. drug safety system and to make recommendations to improve that system. The committee found that FDA’s ability to approve and monitor drug safety had been compromised by a lack of regulatory authority, long-standing underfunding, organizational problems, and a lack of postmarketing data on the effectiveness and safety of drugs. Since the report was issued the agency has taken steps to improve, however problems still remain, the press release said.

The American College of Physicians is the largest medical specialty organization and the second-largest physician group in the United States.

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