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PHARMACEUTICALS
Under regulations finalized by FDA, drug manufacturers will have only one opportunity to delay the marketing of generic drugs by 30 months because of alleged patent infringement. The new rule also improves the drug approval process.
Generic pharmaceutical makers have been trying for years to change the Hatch-Waxman Act, which permits multiple 30-month "stays" on the sale of a generic drug if the original patent holder files challenges based on alleged patent violations (C&EN, Sept. 23, 2002, page 53). Such challenges can delay a generic drug for years. The FDA rule will close statutory loopholes that delay generic competition and will reduce generic drug approval times, notes Kathleen D. Jaeger, president and CEO of the Generic Pharmaceutical Association. "We believe the rule is an important step toward improving consumer access to affordable generic drugs." The Pharmaceutical Research & Manufacturers of America, which represents research-based drug and biotech companies, is less sure of the changes. "The new FDA rule revising Hatch-Waxman is lengthy and complex, and we are studying it closely," PhRMA President Alan F. Holmer says. "We need to be sure the rule clarifies current law in a way that supports continued development of new and better medicines." In Congress, the generic drug legislation could be offered as an amendment to the Medicare bill on the Senate floor, which may be voted on soon. In the House, Republican leaders have opposed a stand-alone generics bill. |
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