FDA tightens its grip on drug regulation

BMJ 2007; 334 doi: https://doi.org/10.1136/bmj.39119.546181.59 (Published 08 February 2007) Cite this as: BMJ 2007;334:290
  1. Rebecca Coombes, journalist, London (rcoombes{at}bmjgroup.com)

    Criticised for being too close to the drug industry, the US drug regulator is trying to fix its image as the guardian of drug safety

    What's happened?

    Dogged by controversy in recent years, the US Food and Drug Administration has announced moves to tighten up regulations on the safety of drugs—including reviewing the safety of new drugs after 18 months on the market.

    The FDA has a growing reputation for weakness, and in particular it faced flak over the withdrawal in 2004 of the painkiller rofecoxib (Vioxx). Two months after Merck withdrew the previously approved drug when it was shown that the drug increased the risk of heart attack, a member of the agency's drug safety team told the US Senate that the agency was “virtually defenceless” against another “tragedy and a profound regulatory failure” like that concerning rofecoxib.

    In September 2006 the Institute of Medicine issued a report decrying the big imbalance between pre-marketing and post-marketing drug surveillance. The report made 25 recommendations for strengthening the agency.

    Last week the FDA finally announced several initiatives designed to improve the safety of prescription drugs, including more monitoring of adverse events after drugs have been approved and put on the market. It will pilot a programme to publish a “report card” on two or three new drugs, 18 months after they reach the market. The reports will review side effects, use, and the latest research.

    It will also collaborate with the Department of Veterans Affairs, the Medicare and Medicaid programmes, and other groups to track drugs in use. It will publish results on its website. The agency also announced the creation of a database of genetic codes associated with bad drug outcomes, the development of a computer model to identify patients who are most likely to suffer liver injury, and the design of screening tests that would identify patients most at risk of general drug problems. “This new science of safety will help us make products safer from the get-go,” Janet Woodcock, the agency's deputy commissioner for operations, told the Washington Post.

    How was the announcement received?

    This is the latest effort to fix the agency after a series of mis-steps, said the New York Times in an editorial. The agency's prior reliance on the drug approval process to determine whether a drug was safe and effective had not been rigorous enough, it said. “Unfortunately, by that time a drug has typically been tested in only a few hundred or a few thousand patients—too few for many kinds of adverse effects to become apparent. Once a drug is used by millions, the agency has limited powers to halt sales that begin to look risky.

    “Even so, Congress needs to give the agency more money and more teeth: including explicit powers to impose conditions on drugs that begin to look risky, to require additional testing, and even to yank drugs from the market.”

    However, activists say that, without laws, drug companies will continue to leave important information on safety and side effects unpublished.

    The watchdog Consumers Union said that the proposals fall “dramatically short of the changes needed to overhaul the nation's drug safety system.”

    In the Wall Street Journal Senator Edward Kennedy said, “Only legislation can give the Food and Drug Administration the tools it needs to ensure it is the gold standard for safety.”

    Senator Kennedy, chairman of the Senate's health panel, and fellow Capitol Hill law maker Mike Enzi introduced a drug safety bill last week that would require companies to release most of their clinical trial studies and would create stricter rules for drug advertising. The bill will also give the agency explicit powers to alter drug labels.

    A similar bill by Kennedy and Enzi was launched last year and failed. But, said the Wall Street Journal, this year it has a far better chance of passing, because of the Democrats' takeover in Congress. It said, “Democrats aren't reluctant to give expanded authority to federal regulators and see the drug industry as a tempting target because of its tenuous popularity with consumers and its traditional ties to Republicans. And they're getting support from some Republicans upset by Vioxx.”

    A related bill sponsored by the vocal critic of the drug industry Senator Charles Grassley was also introduced last week, its key aim to create a drug safety centre at FDA to oversee drugs after they enter the market.

    Not all of the Institute of Medicine's recommendations have been taken up. In USA Today, the FDA's commissioner, Andrew von Eschenbach, said that the institute's report was not a “rigid blueprint.”

    Unsurprisingly, the drug industry is opposing the moves. Alan Goldhammer, deputy vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, the industry's main lobbying group, told the New York Times: “The agency has made substantive and significant progress in improving and enhancing the drug safety system in the US. One thing we don't want to see happen is if patients get concerned and they decide to stop therapy and don't talk to their doctors.”

    What next?

    The FDA is unlikely to make its first report on the proposal on post-marketing surveillance of drugs for another two and a half years.

    Meanwhile, the drug safety bills introduced this week may be included in upcoming legislation authorising fees that fund many of the FDA's operations. The drug industry is set to pay the FDA just under $400m (£200m; €310m) in fees in the next financial year. The deal has fuelled criticism that the agency is too cosy with drug companies. One of the strings attached to the drug companies' funding was that the FDA could spend only a small amount on tracking the safety of drugs. The deal between the agency and industry expires this year, and new legislation will be necessary to renew it. Whether the money should be coming from drug makers at all is subject to fierce debate.

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