Proposal calls for sweeping changes at US Food and Drug Administration

WINSTON-SALEM, N.C. -- Five current or former members of the Drug Safety and Risk Management Advisory Committee to the U.S. Food and Drug Administration (FDA) called today for Congress to make sweeping changes to deal with a large number of longstanding problems at the agency.

"The current FDA system of regulating drug safety has serious limitations and is in need of changes," they say in Archives of Internal Medicine, released today. Since Congress is ultimately responsible, "it is up to Congress to take the steps necessary to reinvigorate the FDA's ability to assure the public that approved medical products are safe."

Curt D. Furberg, M.D., Ph.D., professor of public health sciences at Wake Forest University School of Medicine and the lead author, said the five decided to write the analysis after becoming discouraged by the FDA's inability to fix its own problems.

"Congress has not provided adequate funding and authority to the FDA," he said.

The group cites eight major problems impacting FDA performance, including:

  • The system of initial approval of drugs often fails to detect serious adverse drug reactions.
  • The same FDA center that approves drugs also has the responsibility of taking safety actions, creating a conflict-of-interest situation.
  • The FDA is overly dependant on user fees from drug companies.
  • The FDA is short on expertise in drug safety and public health.

"The key features of today's media stories about questionable drug safety are the same as with previous drug tragedies," Furberg said. "New drugs are introduced on the market with inadequate safety documentation; serious adverse drug reactions are later reported from the marketplace, and a large number of patients are unnecessarily injured before the drugs are withdrawn or better managed. The only difference is the name of the culprit drug."

Furberg and his colleagues recommend that Congress make five changes:


Contact: Robert Conn
Wake Forest University Baptist Medical Center

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