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FTC stance on abuse of REMS programs win support of GPhA.

WASHINGTON -- The Generic Pharmaceutical Association, which remains at odds over the Federal Trade Commission's position on some agreements between generic drug manufacturers and innovator companies, is applauding the FTC's stance of opposing abuse of so-called REMS programs. GPhA recently issued a statement supporting the FTC announcement that the agency had filed an amicus curiae brief in Actelion Pharmaceuticals Ltd. v. Apotex Inc. in a federal district court.

"GPhA strongly supports the FTC's opposition of this anti-consumer practice," said GPhA president and chief executive officer Ralph Neas. "At a time of great budgetary challenges for consumers and for the federal government, it is especially important that barriers to fair and timely generic drug and biosimilar competition are addressed, and the FTC's forceful arguments make a compelling case."

The FTC, in its own press release, stated that the case involves allegations that Actelion Pharmaceuticals has prevented Actavis, Apotex and Roxane from offering competing generic versions of Actelion's brand drug products, Tracleer and Zavesca, by precluding them from obtaining samples of those drugs to perform necessary testing. The FTC brief explains that Actelion's position, if adopted by the court, could pose a significant threat to competition in the pharmaceutical industry.

In the Hatch-Waxman Act, Congress designed a regulatory framework to encourage the introduction of generic drugs while preserving incentives for innovation. The act created a mechanism for accelerated approval of genetic drugs based on a showing that the generic formulation is bioequivalent to the brand drug, which has been successful in facilitating generic competition and generating significant savings for consumers.

"Actelion's lawsuit is the latest in a series of efforts by brand name drug manufacturers to frustrate Congress' decision to encourage generic competition," Neas said. "The fact that nearly 40% of new drugs are currently subject to FDA [Food and Drug Administration]-imposed safety restrictions, often restricting distribution channels, facilitates brand name drug manufacturers' efforts to block potential generic competitors. They are abusing this channel, designed to protect patients, to block competition."

The case involves provisions from the Food and Drug Administration Amendments Act of 2007, which authorizes the FDA to require companies seeking approval for new drugs and some already approved drugs that present unusual risks to submit a Risk Evaluation and Mitigation Strategies (REMS) program to address "elements as necessary to assure safe use of the drug because of its inherent toxicity or potential harmfulness." GPhA notes that the FDA only requires REMS for certain drugs with higher-risk profiles.

The FTC case states that these provisions are being invoked not to protect against risk but to deter market competition.

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Title Annotation:RX RETAIL PHARMACY: Generic Drugs
Publication:Chain Drug Review
Date:Apr 22, 2013
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