Bush To Propose New Regulations To Increase Access to Generic Drugs
President Bush today plans to announce a proposal that would increase patients' access to generic drugs by reducing the period of time that patents can protect brand-name medications from competition, the Los Angeles Times reports. The proposed regulation, which is similar to legislation (S 812) passed by the Senate in July but does not require congressional approval, would restrict drug companies' ability to seek patent extensions based on minor changes to packaging or "changes that occur to drugs once they are ingested" and would save consumers, Medicare, Medicaid and private insurers about $3 billion annually, according to White House officials (Gerstenzang, Los Angeles Times, 10/21). Bush's proposal, which was outlined to reporters during a conference call Sunday night, "essentially will call for a new interpretation" of the 1984 Hatch-Waxman Act, which contains loopholes that can allow brand-name drug makers to delay generic drug competition, the Washington Post reports. 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 (Goldstein, Washington Post, 10/21). A Federal Trade Commission study earlier this year found that brand-name pharmaceutical companies are increasingly using the stays to prevent generic drugs from reaching consumers (AP/Baltimore Sun, 10/21). Such tactics often delay competition for years, according to the report. The Bush plan would allow only one 30-month extension per patent. In addition, it would prohibit brand-name companies from filing new patents on their drugs to cover different packaging of old medicine, different ingredients added to the medicine or "different forms" of the drug. The regulations also would require drug makers to provide more detailed information when they file patents and certify they are true, the Post reports (Washington Post, 10/21). The new regulations would take effect shortly after a 60-day comment period (Los Angeles Times, 10/21).
Bush's proposal "might prove more lenient" than the Senate legislation in several areas, the Post reports. While Bush's regulations would allow a single 30-month extension on any patent a company holds on a medication, the Senate bill would allow a single 30-month extension only on patents filed at the time the drug was originally approved. In addition, the Bush measure does not include provisions in the Senate proposal that would allow generic drug makers to sue brand-name companies for filing patents meant solely to prevent competition (Washington Post, 10/21). The proposal illustrates that White House officials are "clearly eager to portray the president as engaged on the issue of prescription drug costs" before next month's elections, the New York Times reports (Bumiller, New York Times, 10/21). Sen. Charles Schumer (D-N.Y.), a sponsor of the Senate bill, said that in light of the fact that Bush did not express support for the Senate legislation, his plan "sounds like an Election Day conversion." Schumer added, "This devil will be in the details. This [proposal] could be good, but given the White House's previous record, it could also be another loophole that will allow the drug companies to further delay approval of generics" (Washington Post, 10/21). Although representatives from the Pharmaceutical Research and Manufacturers of America did not comment on the proposal, it is likely to be "strongly opposed" by brand-name drug makers, the Wall Street Journal reports. Kathleen Jaeger, head of the Generic Pharmaceutical Association, said the White House is "moving in the right direction" (Adams, Wall Street Journal, 10/21). NPR's "Morning Edition" today reported on the Bush administration's generic drug initiative (Rovner, "Morning Edition," NPR, 10/21). The full segment will be available online in RealPlayer after noon ET.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.