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The generic drug industry is moving closer to tapping into the nearly $10 billion worth of biological products going off patent in the next five years. The FDA is expected this spring to release a guidance on the scientific challenges in creating generic biologics.
Generic firms will be able to determine if they are eligible for 180 days of marketing exclusivity under a move by the FDA to disclose the submission dates of the first substantially complete abbreviated new drug applications (ANDAs) challenging brand drug patents.
Indicating a shift toward a tougher enforcement strategy, the percentage of warning letters issued by the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) for misleading ad practices jumped dramatically in 2003 compared to the percentage of warning letters issued by the division in previous years.
FDA Commissioner Mark McClellan was peppered with questions about reimportation of Rx drugs and congressional oversight during what might have been a tougher-than-expected confirmation hearing yesterday.
The Generic Pharmaceutical Association (GPhA) has come out against the practice of generic firms cutting deals with brand firms to market authorized versions of their products — a practice the trade group contends devalues the 180-day exclusivity provision in the federal drug patent law.
In two new developments on the reimportation front last week, Pfizer denied two Canadian drug wholesalers Pfizer products, saying they violated the company’s unauthorized distribution policy, and a Chicago couple became the first plaintiffs in a federal class action lawsuit against the HHS and the FDA to allow the reimportation of drugs from Canada.
Several House members, angry that a previous request for information on Medicare cost estimates has not been answered, last week fired off another letter to HHS Secretary Tommy Thompson and invoked the little-known “Seven-Member Rule,” demanding the secretary supply them with the information by March 15.