Managed Care - February 2008 - (Page 20) MEDICATION MANAGEMENT FDA Approach to Generics May Be a Mixed Blessing A recently announced initiative is supposed to speed approval of generic drugs, but does it address some fundamental flaws in the approval process? By Martin Sipkoff he Food and Drug Administration has a backlog of more than 1,300 abbreviated new drug applications (ANDAs) for generic drugs, with about 800 more ANDAs expected this year. That’s double the backlog just two years ago. To address this growing problem, the agency recently announced the Generic Initiative for Value and Efficiency (GIVE) program. “We expect the backlog of pending applications to increase,” says Gary Buehler, director of the FDA’s office of generic drugs in the Center for Drug Evaluation and Research. “The purpose of the GIVE initiative is to keep pace with the increasing number of generic drug applications.” Buehler says GIVE will “increase the number and variety of generic drug products available.” Faster approval times for generic copies of medications approaching patent expiration could also boost competition significantly and drive prices down faster. T pared to $111.02 for a branded medication, according to the National Association of Chain Drug Stores. Office of Generic Drugs The FDA’s Office of Generic Drugs approved 682 products in fiscal year 2007, a 30 percent increase over the previous year. But the agency’s average approval time for generic drugs is about 17 months, according to the FDA. This is far longer than the six months required by federal law. The FDA now has 215 full-time staff members dedicated to the review of ANDA filings for generic drugs. Under GIVE, the agency will employ more people to undertake reviews, although the number of new staffers has not been publicized. The program is also designed to raise efficiency by enhancing software for handling submissions and internal documents relating to reviews. It will also improve coordination and resource sharing with other FDA departments, say officials. And GIVE will provide training on correct application processes to manufacturers to reduce time spent on resolving problem applications. An ANDA is required to prove that the generic has pharmaceutical equivalence, i.e., the generic product contains the same active ingredients as what the FDA calls reference listed drugs or RLDs. It must be identical in strength, dosage form, and route of administration, and meet applicable standards of strength, quality, purity, and identity. Market demand Market demand for generics is certainly increasing, and patent expirations have surged in the last two years. According to IMS Health, prescription drugs with combined sales of $10 billion lost patent protection in 2007, on top of drugs with sales of $19 billion losing patent protection in 2006. These market opportunities are an incentive to the growing number of manufacturers of generics. At the same time, health care costcontainment efforts by private and public insurers are increasing demand: About 2 out of 3 drugs sold is a generic. In 2006, the average retail price of a generic drug was $32.23, comContributing Editor Martin Sipkoff is a long-time health care journalist. Significant adjustments GIVE changes none of that, but it makes two significant adjustments in the ANDA process: First, it institutes a new review process for the chemistry, manufacturing, and data in the ANDA, known as a question-based review or QBR. 20 MANAGED CARE / FEBRUARY 2008
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