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Report: Drug Oversight Needs Work

By's Jennifer Hoar

It's been a busy few days on the drug safety circuit.

On Saturday, a Texas judge ordered pharmaceutical company Merck to pay $32 million to the family of a 71-year-old who died within a month of taking Vioxx, the company's highly-touted anti-inflammatory drug.

Then, today, citing "recent controversy about drug safety," the government issued a 67-page report illuminating the weaknesses of the Federal Drug Administration in monitoring the safety of drugs once they've gone on the market.

The report stated that the FDA "lacks a clear and effective process for making decisions about, and providing management oversight of, postmarket drug safety issues."

Drafted by the Government Accountability Office at the request of Senator Charles Grassley, R-Iowa, and Congressman Joe Barton, R-Tex, the report comes almost two years after congressional hearings in which the FDA was criticized for its handling of worrisome information about Vioxx and antidepressant medications for children.

In March 2004, Grassley had said that the FDA's Office of Drug Safety "may have attempted to hold back information" linking the antidepressant drug use among children and increased suicidal tendencies. Meanwhile, a November 2004 hearing revealed that the FDA had not acted promptly on 2001 information that Vioxx might pose risks to cardiovascular health.

Today's GAO report highlighted the communication problems existing between the two offices that handle postmarket drug safety concerns.

The report observes that "insufficient communication" between the Office of Drug Safety and the Office of New Drugs "has hindered the decision-making process."

"Specifically, ODS management does not always know how OND has responded to ODS's safety analyses and recommendations," the report observed.

Reacting to the GAO assessment, Pharmaceutical Research and Manufacturers of America (PhRMA) senior vice president Caroline Loew said in a statement that "we agree with the GAO that it is vitally important for the Office of Drug Safety and the Office of New Drugs to collaborate effectively with one another on drug safety issues."

Loew went on to praise pharmaceutical companies for making safety a priority, as demonstrated by "the fact that less than 3 percent of prescription medicines have been withdrawn from the market in the past 20 years."

As for steps for improvement, the GAO suggested that Congress expand the FDA's authority to allow it to require drug manufacturers to monitor the safety of their drugs after putting them on the market.

Ted Mayer, legal counsel for Merck, said the pharmaceutical company had done just that with Vioxx.

"We continued to study and monitor the medicine after it was approved for market," Mayer explained. Plus, "we reported our findings to regulatory agencies."

Jennifer Hoar