US officials move toward drug safety independence

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U.S. lawmakers and health officials are moving to give more independence to an office that reviews drug safety, but some experts say ensuring medicines are studied after they hit the market is more important than the bureaucratic pecking order.

Health and Human Services Secretary Tommy Thompson is expected to announce changes as early as next week to give the U.S. Food and Drug Administration’s Office of Drug Safety more autonomy from the Office of New Drugs, which approves new therapies.

"I’m working on how I’m going to set that up,” Thompson told reporters Wednesday, adding that a review group outside the FDA was a consideration.

Plans to give drug safety a distinct voice come after mounting concerns over the agency’s handling of suicidal behavior in youths taking antidepressants and Merck & Co. Inc.’s withdrawn painkiller Vioxx, which led to scathing testimony from a veteran FDA scientist at a recent congressional hearing.

Sen. Charles Grassley, head of the Senate Finance Committee that held the Nov. 18 hearing, said he plans to introduce legislation early next year to give the Office of Drug Safety more independence within the FDA.

“The office that reviews the safety of drugs that are already on the market should not in any way be under the thumb of the office that put the drugs on the market in the first place,” Grassley, an Iowa Republican, told Reuters.

But some say the biggest problem Congress needs to address is the agency’s lack of money and clout to follow drugs once they hit the market. The FDA often asks companies to conduct follow-up studies as a condition of product approval but lacks the resources to enforce the request.

Experts differ on the best way to monitor medicines once they are on the market, with some advocating the function be removed from the FDA altogether.

“This (new) agency should be given full authority to ensure compliance with regulations and sufficient funding to establish an effective national active surveillance system,” the Journal of the American Medical Association said this month.

Harvard Medical School professor Jerry Avorn said extra funding for the drug safety office would be best. “It matters less where the rectangle sits on a table of government organization,” said Avorn, author of “Powerful Medicines.”

The FDA could contract with major health insurers to review patients for possible safety red flags, Avorn said, estimating such data mining would cost about $500,000 per drug.

Lawmakers should also give the FDA more power to force companies to complete post-marketing studies, said Arthur Levin, head of the Center for Medical Consumers. The FDA should be able to levy large fines and other penalties against firms that don’t comply, said Levin, who also sits on the FDA’s drug safety advisory committee.

Others want a panel of outside experts similar to the National Transportation Safety Board (NTSB), which advises on transport safety and is independently funded and staffed.

Like the NTSB, such a group could advocate for changes at companies, the FDA, universities and others involved in drug development, said Raymond Woosley, vice president for health sciences at the University of Arizona.

The independent body would not approve or market drugs “so they’re not going to have a stake,” Woosley said.

Acting FDA Commissioner Lester Crawford last month asked the Institutes of Medicine (IOM) to review the way the agency monitors safety risks but the independent scientific group is not expected to report for months.

The drug industry is waiting for the IOM report but has few complaints about current FDA safety structure. “The system is working quite well,” said Alan Goldhammer, head of regulatory affairs for the Pharmaceutical Research and Manufacturers of America. 

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