Washington Editor

WASHINGTON - According to a recently released document, the FDA approved 32 new molecular entities last year, a downturn from 2005's 38 approvals that continues a trend of fewer new product clearances in recent years.

The agency's Center for Drug Evaluation and Research (CDER) cleared the majority of the new products, including 18 new drug applications and four biologic license applications. Ten were priority products approved in six months, on average, and 12 were standard reviews approved in the median time of 13.7 months.

The FDA's Center for Biologics Evaluation and Research (CBER) approved 10 new BLAs. Three received priority reviews and were cleared within 6.4 months, on average, and the remainder were approved in an average standard time frame of 13 months.

Among products approved last year were a few antibodies, including Lucentis (ranibizumab, Genentech Inc.) for wet age-related macular degeneration, Sprycel (dasatinib, Bristol-Myers Squibb Co.) for several types of leukemia and Sutent (sunitinib malate, Pfizer Inc.) for gastrointestinal tumors and advanced kidney cancer. New enzyme replacement therapies include Myozyme (alglucosidase alfa, from Genzyme Corp.) for Pompe disease and Elaprase (idursulfase, from Shire plc) for Hunter Syndrome. New vaccines include FluLaval (GlaxoSmithKline plc) for influenza and Gardasil (Merck & Co. Inc.), a vaccine against human papillomavirus to prevent cervical cancer. In addition, the angina drug Ranexa (ranolazine, CV Therapeutics Inc.) received approval.

According to the FDA, CDER approved 20 new molecular entities in 2005 and CBER cleared 18 BLAs.

Anti-Human Cloning Bill Introduced

Sens. Orrin Hatch (R-Utah) and Dianne Feinstein (D-Calif.) last week reintroduced legislation that would prohibit the cloning of a human being but allow somatic cell nuclear transfer for therapeutic purposes to continue.

The bill, "The Human Cloning Ban and Stem Cell Protection Act of 2007," or S. 812, is written to allay critics' fears that the embryonic stem cell technique could be used for unethical purposes. In particular, the framework establishes stiff civil penalties for abusing somatic cell nuclear transplantation: The measure criminalizes human cloning, punishable by up to 10 years in prison, without exception, along with fines of $1 million or three times any profits made on anyone who clones or attempts to clone a human being, whichever sum is greater.

The legislation is co-sponsored by Sens. Edward Kennedy (D-Mass.), Arlen Specter (R-Pa.) and Tom Harkin (D-Iowa). All also are strong supporters of a bill to expand the number of embryonic stem cell lines eligible for federal backing, "The Stem Cell Research Enhancement Act of 2007," or S. 5. It has yet to come to the Senate floor for a vote, but the lawmakers earlier this year indicated that action would be taken this spring.

Companion legislation in the House of Representatives, H.R. 3, cleared a floor vote early this year, 253-174. (See BioWorld Today, Jan. 16, 2007.)

Off-Label Limits Worry Gottlieb

Former FDA official Scott Gottlieb last week penned an op-ed in the Wall Street Journal warning that federal government distrust of doctors' off-label prescribing practices could have deleterious effects on patients.

Strict limits on such treatment could result from pending legislation from Sens. Kennedy and Mike Enzi (R-Wyo.), whose bill would mandate risk-management plans for all drugs on the market instead of those the FDA deems in need of caution. Gottlieb, now a resident fellow at the American Enterprise Institute, also cautioned against prescribing limits imposed by the Department of Justice and the Centers for Medicare & Medicaid Services.

Echoing a speech he made in December, Gottlieb said any approach that imposes "one-size prescriptions in an area of science that is marked by variation" would harm patients.

His words were published Tuesday, a day after the House Committee on Oversight and Government Reform, chaired by Rep. Henry Waxman (D-Calif.), notified several drug and device makers that an investigation had been opened into allegations of inappropriate marketing and off-label promotions on their part.

He requested they respond with a range of documents by March 21.

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