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Regulatory Focus™ > News Articles > 2019 > 11 > GAO: Drugmakers Have Mixed Views on FDA, FTC REMS Actions

GAO: Drugmakers Have Mixed Views on FDA, FTC REMS Actions

Posted 15 November 2019 | By Michael Mezher 

GAO: Drugmakers Have Mixed Views on FDA, FTC REMS Actions

A report from the Government Accountability Office (GAO) released Thursday finds that generic and branded drugmakers are split over the US Food and Drug Administration (FDA) and Federal Trade Commission’s actions to improve generic drugmakers’ access to reference drug samples when the drugs are subject to a risk evaluation and mitigation strategy (REMS).
In 2017, former FDA Commissioner Scott Gottlieb famously told drugmakers to “end the shenanigans” that inhibit generic drug competition, some of which involve the use of a REMS to restrict generic drugmakers from purchasing the samples they need to conduct bioequivalence studies.
In the report, GAO says that both FDA and FTC have taken action in recent years to facilitate generic drugmakers’ access to samples, including the issuance of FDA’s draft guidance on obtaining safety determination letters, FDA’s website on reference listed drug (RLD) access inquiries, FTC’s review of access inquiries for antitrust violations and FDA’s 2018 guidance on shared REMS waivers.
GAO notes that while FTC “has not brought a case charging a drug company with violating federal antitrust law for refusing to provide samples to a generic drug company,” the agency has filed amicus briefs in two cases involving access to samples, Actelion Pharmaceuticals Ltd. v. Apotex Inc and Mylan Pharmaceuticals, Inc. v. Celgene Corporation.
For the report, GAO interviewed representatives from four generic drugmakers and five reference drug companies. GAO says it selected the generic companies based on their experience with making access inquiries or negotiating a shared REMS system, while the reference drug companies were companies with products that were subject to sample access inquiries.
GAO also surveyed the landscape of products subject to a REMS and found that as of March 2019, there were 74 active REMS for 523 drugs, 143 of which are reference drugs.
According to GAO, there are approved generic versions of less than half (64) of those reference drugs, and that nearly half (35) of the REMS include distribution restrictions. Ten of the REMS systems are shared, though generic drugmakers have received waivers after failing to negotiate a shared system with the reference drug company.
Reactions to FDA and FTC’s actions to facilitate access to samples among the generic and reference drug companies’ were mixed, GAO says.
Three of the four generic drugmakers said FDA’s safety determination letters “were not useful because they were not enforceable and did not require a reference drug company to provide … samples,” and one company “expressed concerns that reference drug companies now use safety determination letters as another requirement to obtain samples.”
On the other hand, GAO says that three of the reference drug companies said the safety determination letters “address their safety concerns regarding sharing samples.”
Reaction to FDA’s RLD Access Inquiries list among generic drug companies varied from believing the list was helpful but not having a significant impact on access to being unaware of the list’s existence.
Two of the reference drug companies interviewed, both of whom appear on the RLD Access Inquiries list, told GAO, “they were unaware of any inquiries made to their companies requesting samples” and another told GAO, “they did not know why they were on [the list[ because they company had sold the reference standard drug to another company and had informed FDA that this had occurred.”
FDA explained the latter situation to GAO by pointing out that the list “reflects the owner of the reference standard drug at the time the agency reviewed an inquiry,” and noting that it does not independently verify the access issues in the inquiries it receives.
FTC’s filing of the two amicus briefs was positively received by generic drugmakers, who said the briefs “helped negotiations with reference drug companies” and raised awareness about issues generic drugmakers face accessing samples. The reference drug companies did not provide any comments to GAO regarding the amicus briefs.
The generic and reference drug companies were also split on the issue of shared REMS waivers. Three of the generic drugmakers had received shared REMS waivers, with one company saying FDA’s recent guidance was helpful.
GAO says the reference drug companies expressed concerns about shared REMS waivers, with several saying the separate REMS could place a greater burden on healthcare providers who may have to navigate multiple REMS systems. Other stakeholders, including groups representing pharmacists and pharmacies echoed these concerns.

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