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Firms Take Another Step to Stop Counterfeits

Cheryl A. Thompson

The 33 member companies of the Pharmaceutical Research and Manufacturers of America (PhRMA) have been urged by the trade organization to participate in a new program to report counterfeit drugs to FDA.

Through the voluntary program, participants and their subsidiaries agree to notify FDA’s Office of Criminal Investigations within five working days of deciding that a product has probably been counterfeited, according to PhRMA. The agreement, scheduled to go into effect May 1, also applies to counterfeit drugs discovered in other countries but intended for distribution in the United States.

PhRMA spokesman Bruce Lott said that the program “is not a response to a particular indicent” but rather “formalizes a process and standardizes it to some degree.” Discussions between PhRMA and FDA regarding the program have been occurring for some time, he said.

FDA said the two groups would assess the program’s value after one year.

Participating companies would identify to FDA’s criminal investigations office the persons who investigate incidents of counterfeit products on behalf of the firms, Lott said. The conversation “Have you heard anything about ...” would occur, he said, at an earlier stage than has usually been the case. Basically, the new program would “help streamline” an existing process, he explained.

“We expect most, if not all, of our member companies” to sign on, Lott said one week before the program, developed by a PhRMA committee of member companies’ representatives, took effect.

In recent years, counterfeits have surfaced for several high-profile pharmaceuticals: Neupogen, a granulocyte colony-stimulating factor, and Epogen, an erythropoietin product, both by Amgen Inc.; Serostim, the growth hormone by Serono Inc.; Gamimune, an i.v. immunoglobulin preparation by Bayer Corporation; Zyprexa, an antipsychotic agent by Eli Lilly and Company; and Combivir, the two-drug antiretroviral by GlaxoSmithKline.

Reconnaissance International, a Colorado firm specializing in “pharmaceutical anticounterfeiting solutions,” suggested that the price for certain therapies and the existence of a black market for such drugs as Serostim, rumored to be favored by weightlifters, other athletes, and perhaps even racehorse owners, explain why counterfeiters undertake their illegal activity. According to Reconnaissance, at least one of the patients with AIDS who unknowingly used counterfeit Serostim has sued Serono, wholesalers Cardinal Health Inc. and McKesson Corporation, specialty pharmaceutical supplier Chronimed Inc., and others responsible for distribution of the product. “Criminals unconnected with the legitimate manufacturer, Serono,” Reconnaissance reported, “had managed to slip this fake into the US pharmaceutical supply.”

FDA Commissioner Mark B. McClellan, in a prepared statement, said that the launch of the PhRMA program “adds to our tools for protecting the public against counterfeit drugs.”

PhRMA’s interest in stemming the flow of counterfeit drugs also extends to the importation of pharmaceuticals. The organization has been vocal on Capitol Hill, urging Congress to reject legislation that would permit wholesalers and others to bring into the United States pharmaceuticals from other countries, whether originally made in this country or elsewhere.