FDA publishes list of companies that have potentially used ‘gaming’ tactics to delay generics
Commissioner of the US Food and Drug Administration (FDA), Dr Scott Gottlieb, has released a statement highlighting new efforts to raise awareness of situations where drug makers may be ‘pursuing gaming tactics to delay generic competition’, including the publication of a list of companies that have potentially blocked access to samples of branded drugs.
This statement reveals the agency’s ongoing efforts to improve affordability of drugs through the improvement of competition and supports the public health goals as laid out by President Trump and the health and human services secretary Alex Azar.
“There isn’t one single action that’s going to solve this issue. We will achieve these public health goals through the coordinated effort of different federal agencies working in partnership with industry and other stakeholders,” said Gottlieb in a statement published on the FDA’s website. “At the FDA, we’re taking steps across a broad range of areas to improve new and generic drug competition as a way to improve access and affordability. Among these efforts, we’re especially focused on addressing tactics we sometimes hear of branded companies pursuing as a way to forestall expected generic entry.”
As the agency’s commissioner has laid out in other discussions around drug pricing, some companies are pursuing ‘gaming tactics’ — a practice used to prevent generic manufacturers accessing samples of a brand drug — to delay generic drug development. Through these new actions it is hoped that unnecessary hurdles to generic development will be reduced.
More commonly, complaints from generics’ manufacturers are arising when branded drugs are subject to limited distribution programmes. As Gottlieb stated: “In some cases, these limitations on distribution may be asserted in connection with a Risk Evaluation and Mitigation Strategy (REMS), a programme that the FDA implements for certain drugs to help ensure that the benefits of these drugs outweigh their risks. We have heard that some drug makers have either refused to sell samples of products with REMS with Elements to Assure Safe Use (ETASU) impacting distribution to potential generic competitors, or have imposed conditions on the sale of such samples that generic companies find hard or impossible to comply with.”
Additionally, other cases have arisen where brand companies have put in place specific agreements with other parties involved in the supply chain that specifically restricts these parties from selling samples to generic drug developers. “But I want to be very clear: a path to securing samples of brand drugs for the purpose of generic drug development should always be available,” Gottlieb continued. “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.”
The FDA has received over 150 inquiries from developers of generic drugs asking for help in acquiring samples. This has led the agency to take the action of publishing a list of these inquiries on its website, which Gottlieb stated will be periodically updated. Information to be featured on this list will include, among other things, the branded company name, the drug product and the number of inquiries received by the FDA about samples of the product. Additionally, it will be specified whether or not the products have been the subject of a safety determination letter from the agency making clear there are no REMS-related reasons preventing samples of the product from being released.
“We’re taking these steps today because we believe greater transparency will help reduce unnecessary hurdles to generic drug development and approval,” Gottlieb asserted.