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Jun 15, 2005 (Vol. 25, No. 12)

FDA Needs to Balance Risks and Benefits for Patients

Why the Proposed Drug Safety Oversight Board Is a Good Idea

  • The Food and Drug Administration, considered to be the most trusted federal agency, is under attack for trying to do what it does bestprotect the publics health by approving therapeutics that are both safe and effective.

    Unlike the generic drug scandal at the end of the 1980s, the latest attacks challenge the FDAs credibility as a regulatory agency. They include a hesitancy to take action over cardiac risks of COX-2 inhibitor pain-killers like Vioxx, Celebrex, and Bextra, and a delay in identifying possible suicide risks for teenagers taking antidepressants such as Zoloft, Paxil, and Prozac.

    The pressure has led the FDA to propose a new oversight and openness group within the Office of Drug Safety, a subunit of the Office of New Drugs. Together with concerns about the 2002 renewal of the 1992 Prescription Drug User Fee Act, this combination has led some critics, most notably Iowa Senator Charles Grassley, to label the FDA as simply too cozy with drugmakers. These critics suggest that the Office of Drug Safety should be an independent body.

    I strongly disagree with Senator Grassley and believe, based on more than 20 years in the pharmaceutical and biotechnology field, that the FDA is prudent in its regulatory decisions, which are based on a strategy that science and safety, not politics, drive its decisions.

    That is why I believe the Office of Drug Safety, with its new Drug Safety Oversight Board, should remain within the FDA. It would be comprised of FDA officials and medical experts from other federal agencies with outside medical experts and consumer representatives serving as consultants.

    Who else is better at understanding both drug safety and efficacy issues?

    The new oversight board can also respond to critics who claim that the current Office of Drug Safety is unlikely to get officials who approve therapeutics to admit that they might have made a mistake in approving a product.

    The proposed board, and other possible FDA reforms, will be debated at IBCs Drug Discovery Technology and Development World Congress, to be held August 811, in Boston, featuring Acting FDA Commissioner Lester Crawford.

  • Internal Steps

    The FDA is taking the appropriate internal steps starting with the newly proposed independent oversight board, which will oversee the management of drug safety issues and provide emerging information about the benefits and safety risks of approved medicines to health providers and patients.

    The board will resolve disagreements over approaches to drug safety issues and oversee the implementation of drug safety policies. The safety initiative will also include a Drug Watch website to find emerging information about possible serious side effects for approved drugs.

    But separating safety from efficacy, a goal of some FDA critics, is not the answer. Regulatory decisions and communications need to be based on sound science and reflect sound judgments of both benefit and risk. Moreover, risk-benefit analyses need to be integrated with the drug safety functiona rather different conclusion than the shrill assertions by some members in Congress who say that safety and review functions must be distinct and separate.

    Of course, outsiders who read newspaper headlines may easily conclude that since a regulator and an industry depend on each other, they have to be close. Some observers may scratch their collective heads over how an FDA advisory panel unanimously concluded that Celebrex and its COX-2 inhibitor cousins, Bextra and Vioxx, significantly raised the risk of heart attack and stroke and yet recommended that the drugs still be sold.

    They may also wonder about the agencys ability to handle the increased suicidal risks among teenagers who take antidepressants, following concerns that several other drugs were dangerous as labeled.

    But a closer look reveals that the FDA, widely respected as a cautious and conservative body, has been making organizational progress in drug safety reforms. Its drug review process remains a worldwide gold standard. In response to advances in medical science, the FDA approves drugs after they are studied in many more patients and have undergone more detailed safety evaluation than ever before.

    And the FDA has a keen understanding of the risk-versus-reward or risk-versus-benefit equation for approving drugs. Last year, FDA advisory committees were fairly conservative and turned down 6 of the 10 new drugs or indications brought to them for approval. Moreover, only 20% of the new drugs approved in 2004 received advisory committee reviewsa figure that disproves the FDA is in bed with the pharmaceutical and biotechnology industries.

  • Adverse Effects

    However, no amount of study before marketing will ever reveal all the information about effectiveness or all the risks of a new drug once it is widely available.

    Adverse effects not seen during clinical trials are identified after approval through post-marketing clinical trials along with observational studies on more widespread use of approved products.

    These processes, which traditionally rely on drug companies and physicians to report issues of drug safety, are also a key reason why there is a severe shortage of data and will change for the better under the FDAs proposed expanded Office of Drug Safety.

    Still, the issue of how to detect and limit adverse reactions will be challenging. Weighing the impact of these side effects against the benefits of the therapeutics for individual patients and the public health is a complex question that requires a better understanding of both public health and scientific issues.

    No doubt the COX-2 experience will leave a lasting mark on the agency and make it more cautious about approving chronic treatments and imposing extensive post-marketing surveillance requirements on chronic drugs. We can expect the FDA to be far more active in communicating emerging safety signs to the public and to maintain high drug review standards.

    This transparency should rectify concerns that the FDA is too close to the pharmaceutical and biotech industries and instead shine a spotlight on how the nations premier regulatory agency is working harder to protect the public it serves.



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