FDA To Reject Requests To Limit Branded Generic Approvals
FDA officials on Tuesday will likely reject requests that the agency end a "little-known" approval process for branded generics that can "shave years off their time to reach the market," the Wall Street Journal reports. Under a process called 505(b)(2), the FDA can approve a branded generic -- a medication that functions the same as the brand-name original but has small differences in chemical composition -- without the evidence of safety and effectiveness required for new brand-name medications; the FDA also can approve branded generics without the evidence required for regular generics, which have the same chemical composition as brand-name medications. Pfizer, the Biotechnology Industry Organization and generic pharmaceutical company Apotex have filed petitions to ask the FDA to "sharply limit" the use of 505(b)(2) over concerns that the agency has "overstepped its authority and trampled on their intellectual property," the Journal reports. The FDA to date has approved more than 100 applications for branded generics under 505(b)(2). The applications include requests for different dosage forms such as patches, different strengths of medications and switches of prescription drugs to over-the-counter status (Abboud/Wilde Mathews, Wall Street Journal, 10/14).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.