• Defective Drug Side Effects

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A Republican lawmaker who has remained neutral for weeks, Sen. Michael B. Enzi, said Thursday that recent internal reforms by the Food and Drug Administration did not do enough to protect patients from drugs with potentially deadly side effects.

Enzi is the chairman of the Health, Education, Labor and Pensions Committee that has jurisdiction over the agency and said he would look into options for bipartisan legislation with Massachusetts Sen. Edward M. Kennedy, the ranking Democrat on the committee.

Enzi said he recently met with Sen. Charles E. Grassley, a very vocal critic of the FDA, to discuss possible legislation because “doing nothing to address the current controversies is not an option.” Grassley, who chairs the Finance Committee, had requested the right to testify before the FDA advisory committee convened to deicide the risk of cardiovascular problems among COX-2 drugs Vioxx, Celebrex and Bextra, but was turned down by Enzi, which is unusual considering Grassley’s power in the Senate.

Grassley allied with Dodd to introduce a bill that is expected to be introduced in the next two weeks, to create an independent safety group to replace the existing Office of Drug Safety, which has already been met with heavy resistance from the pharmaceutical lobby.

The FDA Deputy Commissioner Janet Woodcock testified before Enzi’s committee, saying the agency had learned its lesson from the Vioxx recall and the agency plans on putting future safety information out to the public in a “timely manner”. While Woodcock said the agency was more focused on drug safety than any other time in history, with changes underway that should prevent recurring problems, Enzi said he was considering several suggestions for further changes.

The FDA is considering internal reforms, including creating a drug safety board, setting up a process to fully consider dissenting opinions from its own experts and brining an outside group from the Institute of Medicine, which is part of the National Academy of Sciences, to evaluate its safety program.

The congressional battle over the safety of America’s prescription drug has garnered a lot of attention and is expected only to grow when legislation is introduced in the upcoming weeks.