Court Case Questions REMS Restrictions
The FDA's restricted distribution programs, intended for medications with toxicity risks or other potential dangers, may also be used to impede biosimilar competition, according to a Federal Trade Commission amicus brief filed in the US District Court for the District of New Jersey.
The FDA’s restricted distribution programs, intended for medications with toxicity risks or other potential dangers, may also be used to impede biosimilar competition, according to a Federal Trade Commission amicus brief filed in the US District Court for the District of New Jersey.
According to an FTC press release, distribution restrictions on brand name drugs, often implemented as part of the FDA’s Risk Evaluation and Mitigation Strategies (REMs) programs, can be used to prevent generics manufacturers from obtaining product samples. In the New Jersey case, generics manufacturers Actavis, Apotex, and Roxane allege that Actelion Pharmaceuticals’ distribution restrictions prevent them from buying the brand name manufacturer’s Tracleer (bosentan) and Zavesca (miglustat) through customary channels. Actelion’s refusal to sell its products directly precluded the 3 generics companies from developing equivalent products and violated antitrust laws, the FTC release added.
Tracleer (bosentan) is indicated for the treatment of pulmonary arterial hypertension and Zavesca (miglustat) is indicated for the treatment of type 1 Gaucher disease. In its legal filing, Actelion states that it is not required to sell its products to potential competitors. The manufacturer also contends that its rights regarding sales to potential competitors would apply without an FDA mandate.
Actelion’s position poses a significant threat to competition, if adopted by the court, while also undermining portions of the Hatch-Waxman Act, the FTC’s brief explains. If biosimilar and generics firms cannot obtain samples of brand products, the act cannot function as intended, the brief continues.
The Generic Pharmaceutical Association (GPhA) filed a brief in the case as well, and released a statement supporting the FTC position.
“GPhA strongly supports the FTC’s opposition of this anti consumer practice,” Ralph G. Neas, president and chief executive officer of the GPhA, said in a press release. “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 case raises important issues for generics manufacturers, because close to half of new drugs are subject to the FDA’s safety restrictions, particularly in the area of distribution channels, Neas noted. That tendency creates the ample opportunity to block competition from biosimilar and generics manufacturers, he added.
“The resolution of this case will have profound effects on a multibillion dollar industry and the prescription drug choices of hundreds of millions of Americans,” Neas said. “We applaud the FTC for taking this strong action in support of consumers and taxpayers. They are right on the policy, right on the law, and taking the right action for the American people.