BioCentury
ARTICLE | Politics & Policy

Senators McCain, Schumer introduce generics bill

September 14, 2000 7:00 AM UTC

John McCain (R-Az.) and Charles Schumer (D-N.Y.) introduced legislation on Thursday that is intended to remove impediments to the rapid approval and marketing of generic versions of brand name drugs. The Greater Access to Affordable Pharmaceuticals Act (GAAP) "closes loopholes in the patent laws that allow brand-name drug manufacturers to keep generic competitors out of the marketplace," according to a statement issued by McCain and Schumer. Under the bill, generic manufacturers would only have to demonstrate that their products do not violate two patents: the relevant substance and use patents. Under current law, generic makers can be forced to address patents on formulation, dosage and other features.

The GAAP contains several provisions that are intended to accelerate generic drug competition. It mandates that if the first drug maker to challenge a brand name's patent reaches an agreement with the brand-name manufacturer to stay off the market, the 180-day exclusivity accorded under the Hatch-Waxman Act to the first company to file for generic approval would roll over to the next applicant. The roll-over would also apply if the first generic maker loses in patent challenge litigation. According to McCain and Schumer, the bill would prevent challenges to generic competitors such as Bristol-Myers Squibb's litigation against Ivax's attempt to market paclitaxel. ...