New York Times Examines Generic Drugs' Path To FDA Approval

Main Category: Pharma Industry / Biotech Industry
Also Included In: Public Health
Article Date: 27 Feb 2006 - 11:00 PDT

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The New York Times on Thursday examined recent criticism that FDA "is falling behind in its review of generic drug applications" and profiled the approval this week of a generic version of the allergy nasal spray Flonase. According to the Times, FDA currently has a backlog of more than 850 applications for generic medications, compared with 320 in 2001. The Bush administration has proposed no budget increase for the FDA Office of Generic Drugs, which reviews applications for generic medications, but several members of a House appropriations subcommittee have suggested to acting agency Commissioner Andrew von Eschenbach that Congress might increase the budget for the office. Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Association, has said that the federal government would have to spend only an additional $15 million annually to eliminate the backlog. Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, last week also suggested that user fees from generic pharmaceutical companies could help reduce the backlog. Generic pharmaceutical companies have said that they would consider the fees, provided FDA addresses "unintended loopholes and regulatory abuses" that delay the approval of their products, according to Jaeger. However, FDA "has little control over some delaying factors, including the patenting of many aspects of a drug's manufacture and use," and "Flonase is a case in point," the Times reports. Prior to approval of the generic version, GlaxoSmithKline, which manufactures Flonase, filed two "citizen petitions" to request that FDA reconsider different areas of the review process, and others also filed at least two such petitions. The petitions required FDA to respond after consideration and delayed approval of the generic version of Flonase (Harris, New York Times, 2/23).

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