FDA - panel proposes "conditional approval" of new meds

A panel of five experts who provided drug safety advice to the FDA published a critique of the agency yesterday, calling into question its ability to protect the public from unsafe drugs.

The experts were all former or current members of the FDA's Drug Safety and Risk Management Advisory Committee.

The group said the agency's safety studies missed serious problems with drugs both before and after approval, and wrote that the FDA lacks the authority to pull unsafe drugs off the market or change drug labels to reflect possible dangerous side effects.

The experts, whose critique was published in yesterday's Archives of Internal Medicine said the agency was incapable of properly sanctioning drug companies that failed to adequately monitor the safety of their drugs. The group also charged that the FDA lacks the structure and finances to protect against the influence of the pharmaceutical industry.

"The FDA has for the past decade been aware of these problems; they've done very little to fix them," said panel member Curt D. Forberg, professor of medicine at Wake Forest University.

The panel's findings follow a report issued last month by the Institute of Medicine, which found the agency's system of drug approval and regulation to be in poor condition.

The IOM report was conducted at the request of the FDA, which has drawn criticism over the past two years after it was slow to withdraw Merck's prescription painkiller Vioxx in 2004, when it was found to increase the risk of heart attack.

Both the IOM report and the report from the expert panel, which includes current panelists Robyn S. Shapiro and Arthur A. Levin, as well as former members Peter A. Gross and Brian L. Strom, recommend banning direct-to-consumer drug advertisements until drugs have been on the market long enough for problems to emerge. Both panels also call for the agency to be granted new powers to fine drug firms that fail to conduct safety studies, as well as limit conflicts of interest on expert drug safety panels.

The panel went beyond the IOM report in also recommending an additional drug safety monitoring agency, as well as increased funding for monitoring. The experts also recommended "conditional approval" for certain drugs, which would require drug makers to prove a drug's safety or have it pulled from the market.

Several of the recommendations would require Congressional action, though some members of Congress have already pushed for change within the FDA. Senate Finance Committee Chairman Charles E. Grassley, R-Iowa, has sponsored legislation that would increase the agency's drug safety monitoring authority and "...end the agency's too-cozy relationship with drug companies," Grassley said.

Source: Jessica Fraser at News Target