The GAO recently published a report, entitled Generic Drug Development – Stakeholders’ Views of Risk Evaluation and Mitigation Strategies Differ, that details a study of industry views on generic drug company access to approved reference drugs that are subject to risk evaluation and mitigation strategies (“REMS”). According to the Food and Drug Administration (“FDA”) and Federal Trade Commission (“FTC”), drugs with and without REMS have been subject to practices that can delay or prevent generic drug development and market entry. For the study, GAO interviewed FDA and FTC regulatory professionals from brand manufacturer and generic drug companies, and reviewed public documents, to provide recommendations about how to handle this issue.
The report notes the FDA and FTC are limited in what actions they can take when drugs subject to REMS are involved, as compared to non-REMS drugs. However, the report provided the following observations and recommendations to address practices that limit access to samples of reference standard drugs:
FDA issued a 2014 draft guidance on how generic companies could obtain a letter from the FDA stating that it would not consider providing reference standard drug samples a REMS violation. However, generic companies said that these letters are not useful because they do not require reference drug manufacturers to share samples. On the other hand, representatives from the reference drug manufacturers indicated that those letters address their safety concerns about providing samples to generics manufacturers.
FDA published a list of drug companies in February 2019 identifying reference drug manufacturers that were the subject of access inquiries made to the FDA by generic companies. Only one generic company said that the FDA list was helpful, while one reference drug company said it didn’t know why it was on the list.
FTC has reviewed inquiries it received from FDA and generic cases, but has not yet brought a case against a reference drug manufacturer for violating federal antitrust law for refusing to provide samples to generics companies. The FTC has, however, filed amicus briefs in two cases involving drugs with REMS.
FDA issued waivers and related guidance to address practices that delays negotiations between reference drug manufacturers and generic manufacturers that are intended to create required shared systems. These initiatives allow generic companies to develop a separate, but comparable shared system. Only one generic company said the guidance was helpful, while one reference drug manufacturer said such waivers put additional compliance burdens on healthcare providers.
This GAO report is the latest effort related to the issue of generic company access to reference approved drugs. In May 2019, the House passed a bill, entitled the Strengthening Health Care and Lowering Prescription Drug Costs Act, which requires owners of patented drugs to provide generic companies with samples to develop the requisite data for marketing approval applications of competing generics. Given the amount of recent attention, the issue of generic access to approved reference drugs bears watching.