Generics See Mixed Results on Obtaining Samples: GAO

Generic drug companies have had mixed results from FDA efforts to help them get timely samples from brand-name companies for bioequivalence testing, according to a new Government Accountability Office (GAO) report. One on the most notable delays occurs with brand products where FDA has required risk evaluation and mitigation strategies (REMS), GAO says. “For example, a company’s strategy may include restricting a drug’s distribution to prescribers with special training,” it says.

According to FDA and the Federal Trade Commission (FTC), drugs with and without REMS have been the subject of practices that can delay or prevent generic drug development and marketing. Both agencies have taken actions designed to address some of these practices, such as:

• An FDA 2014 draft guidance on how generic companies could obtain a letter stating that the agency would not consider it a REMS violation to provide reference standard drug samples to the generic company requesting the letter.
• In February, FDA published a list of drug companies whose reference standard drugs were the subject of access inquires made to FDA by generic drug companies.
• FTC has reviewed inquiries it received from FDA and generic companies, and has filed amicus briefs in two cases involving drugs with REMS. According to FTC, to date, the agency has not brought a case charging a drug company with violating federal antitrust law for refusing to provide samples to a generic drug company.
• To address practices that may delay negotiations between reference drug and generic drug companies for creating required REMS shared systems, FDA issued waivers and related guidance that allowed generic companies to develop a separate, but comparable, REMS shared system.
  

In GAO’s report, four generic drug companies and five reference drug companies that were interviewed disagreed on the usefulness of FDA’s and FTC’s efforts to address the sample delay practices. “Officials from three of the generic companies in our review said that the safety determination letters were not useful because they were not enforceable and did not require a reference drug company to provide a generic company with samples of a reference standard drug,” the report said. “In its comments on FDA’s draft guidance on obtaining a safety determination letter, one stakeholder representing generic companies expressed concern that reference drug companies now use safety determination letters as another requirement to obtain samples.”

Regarding FTC’s filing of amicus briefs, two generic companies interviewed said that the briefs were generally a positive step. “Officials from two companies said the amicus briefs helped negotiations with reference drug companies,” GAO said. “A third generic company said the amicus briefs helped raise awareness about issues generic companies are having. Officials from a fourth generic company said FTC’s actions could impact the company’s efforts to develop generic versions of reference listed drugs in the future. Officials from the five reference drug companies we interviewed did not have any comments on FTC’s specific amicus briefs.”