PhRMA adopts program for reporting counterfeit drugs

July 1, 2003

Pharmaceutical Representative

PhRMA announced that it has adopted a voluntary program to report counterfeit drugs to the FDA.

The Washington-based Pharmaceutical Research and Manufacturers of America announced that it has adopted a voluntary program to report counterfeit drugs to the Food and Drug Administration.

"This program reaffirms our member companies' commitment to the highest standards of drug quality and patient safety," said Alan F. Holmer, president of PhRMA. "The information provided by PhRMA members under this program will assist FDA in carrying out its responsibilities to protect the safety and integrity of the nation's drug supply by quickly and effectively removing counterfeit drugs from the marketplace."

Under the voluntary program, PhRMA member companies agree to notify the FDA's Office of Criminal Investigations within five working days of determining that there is a reasonable basis to believe a product has been counterfeited. The program also applies to counterfeits discovered in foreign countries if there is clear evidence that the counterfeits are intended for distribution in the United States. The reporting program went into effect May 1, and both the FDA and PhRMA plan to assess its value at the end of one year.

FDA commends program

Representatives of the FDA said the agency was pleased with the new program and added that reporting such verified incidents in a timely fashion would help the agency to take swift enforcement actions, when necessary, to protect the public health.

"This action adds to our tools for protecting the public against counterfeit drugs," said FDA Commissioner Mark B. McClellan. "The FDA works with local, state and federal law enforcement authorities to protect Americans from the health risks of bogus drugs. PhRMA's members already assist in these efforts by actively investigating credible reports about the distribution of counterfeit drugs. This formal collaborative agreement will strengthen the FDA's ability to assure the safety and effectiveness of drugs used by Americans." PR

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