Energy and Commerce Republicans Oppose Significantly Changing Hatch-Waxman Act, While Democrats Indicate Support

The House Energy and Commerce Subcommittee on Health on Oct. 9 held a hearing on Senate-passed legislation (S 812) that would increase patient access to generic drugs, CongressDaily reports (CongressDaily, 10/9). The Senate bill, passed earlier this year, would allow brand-name drug companies to receive only one 30-month patent extension per product, closing loopholes in the 1984 Hatch-Waxman Act that pharmaceutical companies have used to delay generic competition. The legislation 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" (Kaiser Daily Health Policy Report, 10/3). During the hearing, which focused on whether brand-name drug companies use current patent laws to delay generic competition, Republican members of the subcommittee said "they were reluctant to make dramatic changes" to the Hatch-Waxman Act, which they said has led to increased use of generic medications (Kaplan, Reuters, 10/9). House Energy and Commerce Committee Chair Billy Tauzin (R-La.) said that in large part "generic access to the market has not been stymied" under the Hatch-Waxman Act, but he added, "There are exceptions, and we ought to correct them" (CongressDaily, 10/9). Subcommittee Democrats, however, called for passage of the Senate bill and said that Republicans have opposed the legislation to win the favor of "deep-pocketed pharmaceutical companies," Reuters reports (Reuters, 10/9). Rep. Sherrod Brown (D-Ohio), ranking member of the subcommittee, said, "At some point our inaction on an issue this important to the American public is more than irresponsible. It is inhumane" (CongressDaily, 10/9).

FDA, FTC Opposition
During the hearing, acting FDA Commissioner Lester Crawford restated his opposition to the bill. "I would hope this bill would not become law," he said (Reuters, 10/9). He said that of the 442 most recent applications for generic treatments approved by the FDA, only 17 treatments -- some of the most expensive and popular on the market, according to the Generic Pharmaceutical Association -- faced extended patent challenges from brand-name drug companies. He added the bill would hamper innovation, encourage lawsuits, reduce patent protections and delay the availability of generic drugs, CongressDaily reports (CongressDaily, 10/9). Federal Trade Commission Chair Timothy Muris also expressed opposition to the bill. He said that although the legislation included past FTC recommendations, the bill contained other provisions that "could end up hurting consumers instead of helping them," Reuters reports. According to an FTC report, some pharmaceutical companies have used the Hatch-Waxman Act to delay generic competition with "bogus" patent violation claims, but Muris said, "There are several differences and inconsistencies between (the Senate-passed bill) and the FTC report. Muris said that the FTC supports a bill sponsored by Sen. Patrick Leahy (D-Vt.) that would require drug companies to inform federal regulators about prescription drug patent settlements (Reuters, 10/9).