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Feds fire on patent law that delays generics

Physicians say the move would help patients get access to safe and effective generic drugs.

By Joel B. Finkelstein, amednews staff. June 30, 2003.

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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.

These multiple 30-month stays prevented FDA approval of generic drug manufacturers' applications for four to 40 months beyond the initial 30-month period, the FTC found.

The new rule revises the FDA's implementation of the Hatch-Waxman provisions by letting pharmaceutical companies file only one 30-month delay per generic drug application.

The FDA estimates that implementing the rule could cut drug spending by $35 billion in the next 10 years because generic drugs can cost less than one-quarter of brand-name equivalents.

The rule was modeled on recommendations in the FTC report. The FTC found that many 30-month delays were invoked based on patents for frivolous items, such as label changes or pill shapes.

The regulation addresses this issue by tightening the criteria for allowing drug companies to list new patents in the Orange Book, the FDA's official compendium of patented and approved pharmaceutical products.

The FDA also announced plans to undertake more scientific studies of generic drugs' bioequivalence to speed determinations of whether generics work in the same way as name-brand products.

These evaluations will help increase physicians' and patients' confidence in generic drugs, Dr. Coble said. "This commitment to education and safety in the FDA generic drug program is just as important as the time and money saved in getting generic drugs to consumers."

Legislation also in the works

The government's action on the drug patenting issue was welcomed by the generic industry and consumer groups, which have condemned loopholes in the law. But those groups are still pushing for legislation, not only to codify the new rule's provision for a single 30-month delay, but also to go even further in ensuring that generics come to market as soon as possible.

"More measures outside of FDA's authority are necessary to ensure timely access," said Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Assn.

On Capitol Hill, a bipartisan group of senators has hammered out legislation that attempts to achieve that goal. The Senate Health, Education, Labor and Pensions Committee recently passed the Greater Access to Affordable Pharmaceuticals Act.

The bill "would eliminate the various practices some brand-name pharmaceutical and generic companies have used to delay consumers' access to low-cost affordable medicines," said panel Chair Sen. Judd Gregg (R, N.H.), the bill's chief sponsor.

Besides placing the single 30-month delay rule into law, the bill would permit generic drugmakers to bring countersuits against pharmaceutical companies that have listed questionable patents in the Orange Book, said a GPhA spokesman.

"It is truly a blend of brand and generic pharmaceuticals that allows Americans to live healthier, more productive lives," Jaeger said.

Pharmaceutical Research and Manufacturers of America is reviewing the bill and the FDA rule, said the group's president, Alan F. Holmer. "However, we believe that the current Hatch-Waxman law works well for patients and that further legislation is unnecessary," he said.

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