The US Food and Drug Administration (FDA) announced on 17 May 2018 that it had published a list of companies that block generics.
Brand-name manufacturers have been accused in the past of using Risk Evaluation and Mitigation Strategy (REMS) programmes, as well as other tactics, following the end of patent exclusivity to block generics manufacturers from obtaining samples of brand-name drugs needed for bioequivalence testing and FDA approval [1]. This they do under the guise of patient safety concerns [2]. Generics developers generally need 1,500 to 5,000 units of the brand-name drug to perform what are often relatively straightforward studies for FDA approval. Without these samples, generics makers may not be able to develop generic alternatives. However, tactics adopted by some originator companies make it hard for generics companies to purchase these brand-name drugs at a fair value and in the open marketplace.
The list contains the names of companies and drugs for which FDA has received complaints about not being able to obtain samples. It has been published as part of FDA’s aim of advancing policies that increase competition as a way to help make drugs more affordable and improve access. FDA hopes that publishing this list will increase transparency and help reduce unnecessary hurdles to development and approval of generics.
The list was accompanied by a statement from FDA Commissioner Scott Gottlieb, which said that ‘even in the case of limited distribution programs such as those required by certain REMS, there should be a path forward for generic drug development’. However, ‘despite this, the FDA has received more than 150 inquiries from generic drug developers seeking assistance in obtaining samples from brand companies’.
FDA is taking a two-pronged approach to tackling this problem. First, the agency will determine whether these products have in place a REMS programme with Elements to Assure Safe Use (ETASU) that may impact distribution, which has been cited as a reason to refuse to provide samples. In many cases FDA has found that there is no such REMS programme in place and has then informed the generics company that there are no FDA-required restrictions on the distribution of the drug that would impede obtaining samples. Second, FDA is also notifying the Federal Trade Commission (FTC) about these inquiries and is encouraging generics makers to raise these cases with the FTC if they believe that anticompetitive conduct has taken place.
The agency also points out that even in cases where FDA confirms there is an existing REMS programme with ETASU for the brand-name drug that impacts distribution, generics developers should be able to secure samples of the product. To facilitate this, FDA first evaluates the generics makers’ bioequivalence testing protocols to ensure that their plan for testing the product contains safety protections comparable to the brand-name product’s REMS programme. The agency then sends a Safety Determination Letter to the brand-name company stating that the REMS program does not mean the brand-name drugmaker cannot sell their product to generics developers for comparative testing. To date, the agency has issued 21 of these letters in response to requests from generics companies.
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References
1. GaBI Online - Generics and Biosimilars Initiative. REMS issues come under FDA spotlight [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 22]. Available from: www.gabionline.net/Generics/General/REMS-issues-come-under-FDA-spotlight
2. GaBI Online - Generics and Biosimilars Initiative. Healthcare alliance proposes ways to reduce drug costs in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 22]. Available from: www.gabionline.net/Generics/General/Healthcare-alliance-proposes-ways-to-reduce-drug-costs-in-the-US
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