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September 15, 2011 (Vol. 31, No. 16)

FDA Thumps Industry, Patients Feel the Pain

As the Agency's Demands Escalate, Fewer Drugs and Devices Will Make It to Market

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    Henry I. Miller, M.D.

    Complaining about the unpredictability of the FDA three years ago, Fred Hassan, then CEO of Schering-Plough, said, “What will it take to get new drugs approved? The point is, we don’t know.” Such an admission from the head of a major drug company was a shocking revelation, but it reflected the arbitrary and capricious nature of FDA oversight and the level of frustration of drug developers.

    Since then, things haven’t improved: According to a June 3 Reuters story, “Orexigen Therapeutics, the maker of a weight-loss drug once seen as a potential blockbuster, said it was scrapping its bid for approval in the United States because of ‘unprecedented’ demands by regulators on safety trials. Orexigen said that it would focus on developing the drug, Contrave, and another [obesity] drug candidate, Empatic, in markets outside the United States until there was a clear pathway to approval in the United States.”

    Drug development statistics are daunting. Bringing a new drug to market now requires on average 12 to 15 years, and costs more than $1.4 billion—in no small part because the average length of a clinical trial increased 70% between 1999 and 2006. During 1996–1999, FDA approved 176 new medicines; during 2007–2010, the number fell to 88, a decline of 50%. That trend will continue because in 2010 the number of applications for approval of new drugs was the lowest in decades.

    Perhaps the most ominous statistic of all is that drug manufacturers recoup their R&D costs for only one in five approved drugs. This fraction is likely to decrease further as FDA demands ever-larger, ever-more expensive clinical trials to accumulate data on the safety of drugs in development, particularly for certain indications such as obesity and type 2 diabetes.

    John Freund, who runs a venture capital firm specializing in biopharmaceutical drug and medical device companies, lamented that “the industry is increasingly turning away from developing drugs to treat diseases that millions of Americans have, such as diabetes, obesity, and cardiovascular disease—at a modest cost per patient—because it has become nearly impossible to get them approved in the U.S. The FDA recently tightened the requirements to get new antibiotics approved, and the result will be that fewer drugs to treat deadly resistant bacteria will be developed in the future.”

    The primary reasons for these catastrophic trends are excessive demands from FDA, bureaucrats’ escalating risk-aversion and their constantly moving goalposts during clinical testing, and the absence of constructive congressional oversight.

    Instead of concentrating on getting more drugs through the pipeline to patients, FDA has focused on the kinds of compliance actions that punish drug companies and their executives but please activists and congressional critics while offering little if any benefit to patients.

    A February 28 Wall Street Journal editorial described the FDA’s obstructionism toward potentially important cancer medicines, an apparent example of bureaucrats’ breast-beating at the expense of desperate patients. During a February hearing, the FDA made it plain to drug companies that it considers the “accelerated approval” route to be too lenient.

    Introduced almost two decades ago, accelerated approval permits the FDA to issue what amounts to a limited, or conditional, approval of a new drug that is intended for a “serious or life-threatening disease” and for which there is an “unmet medical need.” It has worked well and has saved countless lives.

Posted 9/15/2011 by P. Driscoll

The FDA needs revamped processes to ensure the timely review of potentially life-saving medical products, but also with an eye to recognizing the inherent risk in accelerated reviews for drugs and 510(k) process for devices.  The tone of Dr. Miller's commentary would have one believe that advocates for simply eliminating the FDA.  A little more candid recognition of the FDA's challenge would lend more credibility to the drug and device industries' concerns.


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