By James DeGiulio --
The Food and Drug Administration has been the subject of recent criticism from drugmaker advocates who allege that the FDA's tougher safety standards have slowed down the pace of drug approvals and have hurt the drug industry. However, despite these allegedly repressive safety standards, the head of the FDA's drug division, Dr. Janet Woodcock, speculated in May that the FDA would approve more drugs in 2011 than the number of new drugs approved in 2010 ("FDA official sees drug approvals rising"). Barring some unforeseen event, it appears likely that this year, the FDA will easily surpass the number drug approvals for 2010. The FDA has already approved 20 new drugs so far, excluding approvals granted for vaccines or new formulations or uses of existing drugs, almost matching the 21 drugs approved in 2010, according to a recent article in the Wall Street Journal ("FDA's Drug-Approval Rate for 2011 on Pace to Exceed 2010"; subscription required for full access).
These numbers should quiet critics of the safety standards for the time being. Industry advocates and some lawmakers have criticized the FDA for instituting higher burdens on drugmakers to win approval. The FDA has tightened safety regulations since the 2004 market withdrawal of the painkiller Vioxx. After the Vioxx withdrawal, the FDA was criticized by the public for lack of vigilance, and the agency responded by re-evaluating its practices.
Last week, The House Energy and Commerce's health subcommittee held a panel hearing to discuss the reauthorization of legislation that allows the FDA to charge drug companies user fees (which is expected to be renewed, as it is supported by both parties). However, during the panel, Jonathan Leff, a managing director at Warburg Pincus LLC, a private-equity and venture-capital firm, provided written testimony asserting that the FDA's tougher focus on drug safety has hurt the drug industry and is a major contributor to the rising cost and length of drug development. Mr. Leff stated that despite potential for producing a marketable and beneficial therapeutic, many promising scientific discoveries are not being developed into new treatments for disease due to lack of investment capital. He cited figures showing venture investment in the U.S. life sciences industry declined by $2 billion from 2008 to 2010.
In response, Dr. Woodcock (at left) defended the FDA, insisting that the FDA has changed its requirements only because the new science required it. She pointed instead to the high failure rates of drugs in the development stage, rather than the FDA approval stage, as presenting the main contributor to the rising cost and length of drug development. Dr. Woodcock explained the agency meets more than 90 percent of deadlines that are part of the drug-review process. She also said first cycle approvals are at a 20-year high, and more than two-thirds of new drugs are approved within the 6-to-10-month time frame given to new drug applications. Dr. Woodcock admitted that there are certain cases where companies are asked to submit more information, which prompts additional reviews, and in other cases drugs are rejected. She did note that expert advisory panels, which generally make determinations on new drugs, have been more difficult to assemble. In 2007, the FDA tightened guidelines to minimize drugmaker industry ties that could sway a panelist's view. Since many of the individuals with the most expertise are affiliated with drugmakers, they are ineligible to sit on these advisory panels due to conflicts. Rather than relying on advisory panels for specific experimental drugs, Dr. Woodcock said she would prefer to see more panel discussions of general policy issues, such as approval standards for a specific area.
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