Washington Post Examines Increasing Attention Being Given to Generic Drug Access

The Washington Post today examines the increasing attention being devoted by lawmakers and lobbyists to legislation that would reform patent laws governing access to generic drugs. In July, the Senate passed a generic drug bill (S 812) that would essentially "remove some of the methods that brand-name drug manufacturers have used to prolong their monopolies over the medications they create," the Post reports. The legislation would eliminate a loophole in the 1984 Hatch-Waxman Act that allows brand-name pharmaceutical companies to receive an automatic 30-month patent extension from the FDA for each lawsuit they file against generic drug makers for alleged patent infringement (Goldstein, Washington Post, 8/16). The bill, which was sponsored by Sens. Charles Schumer (D-N.Y.) and John McCain (R-Ariz.) and passed 78-21, would allow brand-name drug makers only one 30-month patent extension per product. It also would prevent brand-name drug companies from paying generic manufacturers to keep their products off the market and would allow generic drug companies to legally challenge "frivolous patents," including "superficial changes" in a treatment's color or physical design intended only to "stifle competition" (California Healthline, 8/1). The Post reports that the generic drug issue has "catapulted into the front ranks of lobbying and partisan bickering" and "reflects the place of pharmaceuticals in rising health care costs -- and in public opinion." Ron Pollack, executive director of Families USA, said, "I think what happened in the Senate is a reflection of the drug industry now having surpassed the managed care industry as everyone's whipping boy." Consequently, legislation limiting brand-name drug makers' power to extend patents has "gained quick support from an unusual coalition of consumer advocates, employers, unions and governors," the Post reports.

But the Post notes that the prospects of a similar generics bill proposed by Rep. John Thune (R-S.D.) pending in the House are "iffy." The legislation faces opposition from brand-name drug makers, who claim the reforms would have a negative effect on their research and development budgets. The Senate bill is "substantial overkill" and contains several measures that would "change the calculus" of research and development spending, Pharmaceutical Research and Manufacturers of America consultant Gregory Glover said. Moreover, while the Bush administration supports limiting drug makers to one 30-month patent extension per patent, it opposes other aspects of the legislation. White House spokesperson Scott McClellan said some parts of the bill would create "an entire new class of patent litigation" that could increase drug costs. The House Energy and Commerce Committee plans to examine "abuses" in the drug-approval process before scheduling a vote on Thune's proposal, a spokesperson said (Washington Post, 8/16).