President Bush Announces New FDA Rules To Improve Access to Generic Medications
As expected, President Bush yesterday announced new FDA rules that will limit the ability of brand-name pharmaceutical companies to block the entry of generic medications into the market, the Wall Street Journal reports (Abboud, Wall Street Journal, 6/13). The regulations will allow brand-name pharmaceutical companies to receive only one 30-month delay in cases in which brand-name companies claim patent infringement by generic pharmaceutical companies; current law allows multiple delays (California Healthline, 6/12). In addition, brand-name pharmaceutical companies that make alleged false claims in the patent process could face criminal charges (Reynolds, Los Angeles Times, 6/13). Bush also said that he will ask the FDA not to block approval of generic medications over patent disputes that involve "minor issues," such as details about the packages used or the inclusion of ingredients not related to the effectiveness of the treatments, the New York Times reports (Stevenson, New York Times, 6/13). Bush, in an address at New Britain General Hospital in New Britain, Conn., said that the new rules will "bring generic drugs to the market much more quickly -- in some cases, years earlier" (White House release, 6/12). The regulations will save consumers, health insurers and other health care purchasers $35 billion over the next decade, according to FDA estimates. Generic medications account for about 50% of prescriptions written in the United States each year, but because they can cost less than two-thirds the price of brand-name treatments, they only account for 8% of annual expenditures on prescription drugs. The new regulations are similar to those included in a bill (S 1225) that the Senate Health, Education, Labor and Pensions Committee approved on Wednesday. However, the rules do not include a provision in the bill that would eliminate the 180 days of market exclusivity currently awarded to the first generic medication to reach the market in cases in which generic pharmaceutical companies enter anticompetitive agreements with brand-name companies (Wall Street Journal, 6/13). The new regulations will take effect Aug. 18 (Ibarguen, Knight Ridder/Philadelphia Inquirer, 6/13).
In addition to the new rules, FDA officials yesterday said that they will make internal reforms to reduce approval times for generic medications, the Washington Post reports (Milbank, Washington Post, 6/13). Over the next three to five years, the reforms will reduce by at least three months approval times for generic medications, according to HHS (HHS release, 6/12). FDA Commissioner Dr. Mark McClellan said that the agency has made improved availability of lower-cost generic medications "one of our major priorities" (Los Angeles Times, 6/13).
The generic pharmaceutical industry is "euphoric about the support it is getting from the Bush administration," according to the Journal (Wall Street Journal, 6/13). HHS Secretary Tommy Thompson said, "These changes will enable consumers to save billions of dollars each year by making it easier for generic drug manufacturers to get safe and effective products on the market" (HHS release, 6/12). However, opponents said that the new rules are "largely cosmetic, failing to address the broader variety of abuses the Senate legislation would resolve," Knight Ridder/Philadelphia Inquirer reports (Knight Ridder/Philadelphia Inquirer, 6/13). Sen. Charles Schumer (D-N.Y.), a sponsor of the Senate bill, said the regulations do not "go far enough" because they "could be knocked out by a lawsuit" and do not "provide a way for generics to challenge the listing of frivolous patents" (New York Times, 6/13). Ron Pollack, executive director of Families USA, said that the group favors the Senate legislation over the rules. He added that the regulations are part of an effort by the Bush administration to "derail protections that would enable seniors and others to get generics much more quickly" (Knight Ridder/Philadelphia Inquirer, 6/13). The Pharmaceutical Research and Manufacturers of America "signaled" opposition to the new regulations, as well as the Senate bill, the New York Times reports (New York Times, 6/13). According to the Post, the new rules are "a quick fix to reduce prescription costs" as Congress debates the addition of a prescription drug benefit to Medicare (Washington Post, 6/13). The announcement of the regulations also is part of a Bush effort to "address health care issues ahead of next year's election," the New York Times reports (New York Times, 6/13). PBS' "NewsHour With Jim Lehrer" yesterday included a report on the new rules ("NewsHour with Jim Lehrer," PBS, 6/12). A transcript of the report is available online.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.