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GOVERNMENT & MEDICINEFeds fire on patent law that delays genericsPhysicians say the move would help patients get access to safe and effective generic drugs.By Joel B. Finkelstein, AMNews staff. June 30, 2003. Washington -- Hoping to stem the rising cost of prescription drugs, the Bush administration and Congress have acted to close loopholes in federal law that let brand-name pharmaceutical companies keep generic drugs out of the marketplace. Pharmaceutical companies should be rewarded for investing in innovative drug research, said Food and Drug Administration Commissioner Mark B. McClellan, MD, PhD. But they should not be allowed to "manipulate government" to artificially extend the patent life of blockbuster drugs, thereby costing the American people billions in higher drug costs. "Fast access to ... generic drugs is a great way to make innovations available to patients at low cost," he said. Outgoing AMA President Yank D. Coble Jr., MD, applauded the new rule, which is effective Aug. 19. "The Food and Drug Administration has made a great leap forward in providing America's patients with access to safe and effective generic drugs by revising its regulations and review procedures." The 1984 Hatch-Waxman Amendments let makers of brand-name drugs delay by 30 months the approval of generic drugs, if there is any alleged patent infringement. The Pharmaceutical Research and Manufacturers of America, which represents makers of brand-name drugs, opposes any changes to the current system, which it argues properly encourages innovation. But in some cases, brand-name makers have used the law to file questionable lawsuits to trigger the automatic 30-month delay, according to a report by the Federal Trade Commission. Some companies also have invoked multiple overlapping delays to push back the launch of generic drugs beyond 30 months. [...]Full text of AMNews content is available to AMA members and paid subscribers.
Copyright 2003 American Medical Association. All rights reserved.
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