FDA's Drug-Approval Rate for 2011 on Pace to Exceed 2010

By JENNIFER CORBETT DOOREN

WASHINGTON—The Food and Drug Administration has approved 20 new drugs so far this year, just one short of the total for all of 2010, according to a top agency official.

The pace likely puts the FDA on track to approve more new types of drugs in 2011 than the previous few years.

In testimony before the House Energy and Commerce's health subcommittee, Janet Woodcock, the head of the FDA's drug division, responded to some lawmakers concerns that a tougher safety stance taken by the agency was slowing down the pace of drug approvals and hurting the pharmaceutical and biotech industry.

FDA's drug approval figures involve drugs or biologics—which are made from living cells—that are considered new types of products. They don't include approvals granted for new formulations or new uses of existing drugs as well as vaccines.

Ms. Woodcock explained the agency meets more than 90% of deadlines that are part of the drug-review process. She also said so-called first cycle approvals are at a 20-year high with and said more than two-thirds of new drugs being approved within the six-to-10-month time frames given to new drug applications. In other cases companies are asked to submit more information, which prompts additional reviews, or drugs are rejected.

Some of the notable approvals to date include two new hepatitis C drugs from Merck & Co. and Vertex Pharmaceuticals Inc. as well as the melanoma treatment Yervoy from Bristol-Myers Squibb Co.

However, the new drug-approval list includes some products that were initially delayed such as the lupus drug Benlysta from Human Genome Sciences Inc. and GlaxoSmithKline PLC. Last week the FDA approved a new drug, Xarelto, to prevent blood clots that was co-developed by Johnson & Johnson and Bayer AG. That approval was delayed for about two years as the FDA sought more information from the companies.

In written testimony, Jonathan Leff, a managing director at Warburg Pincus LLC, a private-equity and venture-capital firm, said the FDA's tougher focus on drug safety since the 2004 market withdrawal of the painkiller Vioxx has hurt the biotech industry and is a major contributor to the rising cost and length of drug development.

"At a time when medical research is exploding with potential, many promising scientific discoveries are not being developed into new treatments for disease due to lack of investment capital," he said. He cited figures showing venture investment in the U.S. life sciences industry declined by $2 billion from 2008 to 2010.

Ms. Woodcock defended the FDA's role, saying challenges being faced by the biotech and pharmaceutical industry are related to high failure rates of drugs in the development process rather than FDA regulations.

The House panel hearing was held Thursday to discuss the reauthorization of legislation that allows the FDA to charge drug companies user fees. Current law expires next year. Lawmakers are expected to renew the law as it traditionally enjoys broad support from both parties.

Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com

via online.wsj.com

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