Senate HELP Committee Passes Bill To Speed Generic Drugs to Market
The Senate Health, Education, Labor and Pensions Committee yesterday unanimously approved a bill (S 1225) that would save consumers "billions of dollars" by speeding the market entry of generic drugs, the AP/Las Vegas Sun reports. The bill would amend the 1984 Hatch-Waxman Act to allow brand-name companies only one 30-month stay in cases where the brand-name company claims patent infringement by a generic drug company. Currently, brand name companies can obtain multiple 30-month stays from the FDA to keep generic competition from the market. Also under current law, the first generic drug to come to market has 180 days of exclusivity, which has led to some brand name companies' paying generic drug makers to not bring their product to market. The bill would eliminate the 180 days of exclusivity for any generic drug company that enters such anticompetitive deals or fails to come to market "in a timely fashion," the AP/Sun reports (Abrams, AP/Las Vegas Sun, 6/11). According to a HELP committee release, in 1990, the average price for brand-name drugs was $27.16 and the average price for generic drugs was $10.29, but by 2000, the average price for brand name drugs was $65.29 and the average price for generic drugs was $19.33 (Rich, CongressDaily Markup Reports, 6/11). The bill would save consumers an estimated $60 billion over the next decade, according to CongressDaily (CongressDaily, 6/11). Committee Chair Judd Gregg (R-N.H.) said that the bill is "a victory for every person in America who has ever used a prescription drug," adding that it might be attached to a Medicare drug benefit bill. Sen. Charles Schumer (D-N.Y.), one of the bill's sponsors, said that attaching the bill to a Medicare drug benefit measure "will force the House to consider it," the AP/Sun reports. Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America, said PhRMA believes that current law "works well for patients and that further legislation is unnecessary" (AP/Las Vegas Sun, 6/11).
President Bush today is expected to announce new FDA rules that are designed to "close loopholes that manufacturers of brand-name drugs use to delay generic competition" as well as speed the approval process for generic drugs, the Wall Street Journal reports (Abboud, Wall Street Journal, 6/12). Like the Senate HELP Committee bill, the rule would limit to one the number of 30-month stays a brand-name company can obtain (Harris, New York Times, 6/12). Bush is also expected to announce that he and FDA Commissioner Mark McClellan have asked for $13 million for the FDA Office of Generic Drugs to hire 40 new generic-drug reviewers and to improve efficiency in fiscal year 2004. The FDA wants to cut three months or more from the 20 months on average it takes the agency to approve a generic drug. The FDA also hopes to increase the number of meetings generic-drug reviewers hold with generic drug companies to help facilitate the approval process; currently, 93% of generic-drug applications are not approved in their first FDA review (Wall Street Journal, 6/12). In addition, the FDA will study how to speed the approval process of generic drugs not delivered in pill form, such as inhalers, the Times reports (New York Times, 6/12). The Bush administration estimates that the new FDA generic drug approval changes will save $3.5 billion a year. According to the Journal, PhRMA does not oppose the new FDA rules (Wall Street Journal, 6/12).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.