As Expected, Bush Proposes New Rules To Hasten Access to Generic Drugs
As expected, President Bush yesterday announced new regulations that would hasten the approval of generic drugs by reducing the period of time that patents can protect brand-name medications from competition, the New York Times reports. In announcing the new rules, Bush "join[s] a chorus of critics" who claim that brand-name pharmaceutical companies have raised drug prices and stifled competition from lower-cost generics by "improperly manipulating drug and patent laws." In his announcement, televised from the White House Rose Garden, Bush said, "Our message to brand-name manufacturers is clear. You deserve the fair rewards of your research and development. You do not have the right to keep generic drugs off the market for frivolous reasons."
The proposal, scheduled to be published in the Oct. 24 Federal Register, will undergo 60 days of public comment before a final version is issued. White House officials estimate the plan would save consumers $3.2 billion in its first year and $35 billion over 10 years. It would also reduce revenues for brand-name drug makers by $51.5 billion over 10 years, administration officials said (Pear, New York Times, 10/22). Bush's proposal calls for a new interpretation of the 1984 Hatch-Waxman Act, which contains loopholes that allow brand-name drug makers to delay generic drug competition. Under the current law, the FDA provides brand-name pharmaceutical companies with a 30-month stay on patent protection whenever a generic drug maker challenges the brand-name patents (California Healthline, 10/21). The Bush regulations, which would not require congressional approval, would limit drug makers to one 30-month delay per patent; currently, companies can delay competition by receiving multiple patent stays on a single medication (Adams/Hitt, Wall Street Journal, 10/22). In addition, the rules would "make clear" that drug companies cannot file patents on product aspects such as "packaging, metabolites and intermediates that are unlikely to represent significant innovations." Drug makers would also have to provide the FDA with additional information when filing patents to "discourage ... patents that are not permitted" (HHS release, 10/21).
Health insurance administrators, AARP officials, many Republicans and the generic drug industry "praised" the new proposal, the Washington Post reports (Goldstein, Washington Post, 10/22). South Dakota Gov. William Janklow (R) said, "This is going to save the public a lot of money" (Wall Street Journal, 10/22). The brand-name pharmaceutical industry had few comments about the announcement. Jeff Trewitt, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said the proposal was "complex" and would be reviewed (Washington Post, 10/22). Some legislators criticized the rules as coming too close to next month's mid-term elections. House Minority Leader Richard Gephardt (D-Mo.) called the announcement a "cynical election-year ploy" intended to attract the votes of seniors facing high prescription drug costs (New York Times, 10/22). Senate Majority Leader Tom Daschle (D-S.D.) said the proposal contains "loopholes and omissions" and has inadequate enforcement mechanisms (Wall Street Journal, 10/22).
Others lawmakers criticized the rules for omitting provisions contained in a bill (S 812) passed in July by the Senate but never approved by the House. The Senate bill includes language that would give generic drug makers the right to sue brand-name manufacturers who filed new patents solely to prevent competition. It would also require brand-name drug makers to file any suits against generic competitors within specific time limits. Sen. Charles Schumer (D-N.Y.), a sponsor of the Senate legislation, said that Bush's proposal "closes one door to the pharmaceutical industry in their attempt to delay generics, but it opens up several others" (Carter, AP/Philadelphia Inquirer, 10/22). Jake Hansen, vice president of the generic drug company Barr Laboratories, said the new regulations "would probably take care of 70% of the problems" addressed in the Senate bill. Several brand-name drug company lawyers predicted yesterday that the industry would file a lawsuit opposing the new rules (New York Times, 10/22). Marc Scheineson, a former FDA official now specializing in food and drug law, said that although the White House appears to be on "solid legal ground," the "incentive for the industry to litigate is enormous" (Washington Post, 10/22).
Although Bush's proposal is "actually weaker" than the Senate bill passed earlier this year, it should still "help to reduce the shady maneuvering by unscrupulous pharmaceutical companies," an editorial in today's New York Times states. The new rule is a "modest step," but it is a policy that "most people involved in the acrimonious debates over prescription drug prices will be able to support." While the president was "[g]oaded into action by election-year politics," generic drug makers, consumers and seniors should accept the new proposal, the Times concludes, because in a year when Congress was unable to pass a Medicare prescription drug benefit, "this was the best they could get" (New York Times, 10/22).
The following broadcast media programs yesterday included coverage of Bush's generic drug initiative:
- ABCNews' "World News Tonight": The segment includes comments from Schumer and National Institute for Health Care Management President Nancy Chockley. The full segment is available in RealPlayer online (Judd, "World News Tonight," ABC, 10/21).
- NBC "Nightly News": The segment includes comments from Gephardt and Dr. Judy Feder, Dean of Policy Studies at Georgetown University's Public Policy Institute. The full segment is available in RealPlayer online (Gregory, "Nightly News," NBC, 10/21).
- NPR's "All Things Considered": The full segment is available in RealPlayer online (Rovner, "All Things Considered," NPR, 10/21).
- NPR's "Talk of the Nation": The full segment is available in RealPlayer online (Gonyea, "Talk of the Nation," NPR, 10/21).
- PBS' "NewsHour with Jim Lehrer": A transcript is available online. The full segment also is available in RealPlayer online (Dentzer, "NewsHour with Jim Lehrer," PBS, 10/21).
- MPR's "Marketplace": A transcript and audio of the segment in RealPlayer are available online (Palmer, "Marketplace," MPR, 10/21).