Sens. unveil generic legislation

Sens. Charles E. Schumer (D-NY) and John McCain (R-AZ) have introduced the Greater Access to Affordable Pharmaceuticals Act, which, if passed, would modify the 1984 Hatch-Waxman Act to make it easier for generic drugs to enter the marketplace.

Under the legislation:

•Â The number of patents that a generic drug company must address for FDA approval would be limited to two – the drug substance patent and the method of use patent.

•Â If the first generic drug maker to file and challenge a brand name's patent reaches an agreement with the brand-name manufacturer to stay off the market, that company's 180-day market exclusivity would roll over to the next applicant.

•Â Only citizen petitions that present specific and substantial scientific evidence that the approval of a generic drug poses a significant threat to public health and safety would delay that drug's approval.

•Â The discrepancy between the FDA's regulations and statutes on bioequivalence testing methods would be eliminated.

Mixed reviews

The legislation has received mixed reviews from various health industry organizations. "Since generic drugs, on average, cost two-thirds less than the cost of equivalent brand-name drugs, this initiative would help cut the growth of drug costs," said Chip Kahn, president of the Washington-based Health Insurance Association of America.

The Pharmaceutical Research and Manufacturers of America, however, said the proposed legislation unfairly favors the generic pharmaceutical industry. "The Hatch-Waxman Act was carefully balanced, and any reopening of it needs, likewise, to be balanced," said Jeff Trewhitt, a spokesperson for the Washington-based group. "The Schumer-McCain bill is a one-sided approach that focuses solely on expediting access to generic medicines." PR