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FDA addresses new drug obstacles

WASHINGTON, March 16 (UPI) -- The U.S. Food and Drug Administration is calling for measures to speed new drugs to market, the Wall Street Journal reported Tuesday.

In a report to be released Tuesday, the agency said the industry needs better ways to evaluate safety and to figure out at an early stage if the product is working. It also suggests changes within the FDA itself to spur slowing research and development.

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The report suggests the FDA can play an "important role" because its reviewers have access to data that stretches across all companies as part of their approval process.

Dr. Janet Woodcock, acting deputy FDA commissioner for operations, told the newspaper drug companies are focusing on the most lucrative products while important areas such as Third World diseases and rare illnesses become "increasingly challenging."

In terms of gauging safety, the agency says, the industry needs new techniques for assessing a drug's liver toxicity and methods to identify gene-therapy risks, among others. The report suggests several available technologies could help, including computer modeling.

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