GOVERNMENTBill would ease access to generic drugsThe Senate measure would limit pharmaceutical brand-name patent extensions and allow reimportation from Canada.By Markian Hawryluk, amednews staff. Aug. 19, 2002. Washington -- Unable to pass a Medicare prescription drug benefit, the Senate instead approved a number of measures aimed at making drugs more affordable to all Americans. Before departing for a month-long recess in August, the Senate voted 78-21 in favor of a bill designed to ease the entry of generic drugs when brand-name manufacturers move to protect their markets. The legislation, sponsored by Sens. John McCain (R, Ariz.) and Charles Schumer (D, N.Y.), would close several loopholes used by brand-name pharmaceutical manufacturers to extend their patent protections. Manufacturers have been accused of filing frivolous patents to gain additional 30-month periods of market exclusivity when companies seek to market a generic alternative. Under the Hatch-Waxman Act, passed in 1984, brand-name manufacturers must list the patents that apply to each drug. Rather than requiring a generic to repeat the extensive and costly new drug application process, the act allows the company to incorporate the original manufacturer's safety and efficacy data by showing the generic drug is equivalent to the brand-name product. Generics must certify equivalency for every patent listed for a drug, or assert that a patent is invalid or not infringed. If the original manufacturer sues to challenge those assertions, it triggers a 30-month protection against generic competition. With carefully timed filings of additional patents, a brand-name drug manufacturer can extend its patent life almost indefinitely, critics say.
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Copyright 2002 American Medical Association. All rights reserved.
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