Bush plan may speed development of generic drugs
BY Advocate.com Editors
October 22 2002 12:00 AM ET
President Bush unveiled a proposal on October 21 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 would restrict drug companies' ability to seek patent extensions based on minor changes to packaging or other minute changes to the medications, such as adding inert ingredients to the drug formulations or slightly altering how the medications are digested by the body. The new policy would save consumers, Medicare, Medicaid, and private insurers about $3 billion annually. Under current law the Food and Drug Administration provides brand-name pharmaceutical companies with a 30-month stay whenever a generic drugmaker challenges their brand-name patents. A Federal Trade Commission study earlier this year found that pharmaceutical companies are increasingly using the stays to prevent generic drugs from reaching consumers, often delaying competition for years. Bush's plan would allow drugmakers only one 30-month extension on any drug. After the stay expires, the pharmaceutical company would be unable to prevent generic drug manufacturers from producing cheaper versions of the medications. The new regulation will take effect shortly after a 60-day comment period, according to White House sources.