Generic drug approval process streamlined

Medical societies and health activists hope the new rule means better availability of more affordable medications.

By Victoria Stagg Elliott, amednews staff. Sept. 1, 2003.

This month marks an important change in the regulatory climate surrounding generic drugs.

The Food and Drug Administration will start implementing its final rule governing the speed at which generic drugs can move into the marketplace. The rule aims to speed consumers' access to generic drugs and reduce the number of barriers to their approval. It limits to one the number of automatic 30-month patent infringement stays that a drug company can file in order to delay a generic drug's entry.

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Also, a company can only make a new patent claim on an existing name-brand medication on the basis of actual changes in the drug's active ingredient, formulation, composition and delivery method -- not in an effort to simply block a competing generic drug from getting the FDA's nod.

The agency hopes that this step will reduce the number of patent claims that do more to extend market protection of a name-brand drug than to document a true innovation.

"The final rule balances innovator drug companies' need for intellectual property protections and the desire to have equivalent generic drugs approved and marketed," according to an FDA statement. "[This] will help speed the approval of generic drugs and should result in billions of dollars in health care savings for consumers."

The FDA will be working to streamline the approval process for generic drugs and is also working with Congress to ensure that legislation on the subject wending its way through the House and the Senate is consistent with agency policy.

The new rule has been praised by the American Medical Association, patient advocates and the Generic Pharmaceutical Assn.

"The AMA applauds [Health and Human Services] Secretary Tommy Thompson and FDA Commissioner Mark McClellan, [MD, PhD], for their work to provide all Americans with safe, effective and affordable drugs in a timely fashion," said Yank D. Coble Jr., MD, AMA immediate past president.

The AMA is also studying the issue of inappropriate patent extensions.

Concern was expressed, however, by the Pharmaceutical Research and Manufacturers of America. Their chief worry is that the FDA's new rule might undermine innovation.

"Our patent laws and regulations provide a key incentive for continued innovation in medicines," said Bruce N. Kuhlik, PhRMA's senior vice president and general counsel. "Better treatments and new cures can come only from pharmaceutical research companies, and only if patent incentives are maintained."