As part of the Trump administration’s efforts to address rising drug prices in the US, the FDA has recently published a list of brand name companies which have been using delaying tactics to actively block generic drug competition. FDA commissioner, Scott Gottlieb, has claimed that the purpose of this new initiative is not to shame drug companies. It is, instead, an effort to increase transparency and create open dialogue in order to accurately identify where the problem lies.
The issue stems from the fact that generic companies require samples of brand name products in order to develop their generic versions. Companies need somewhere between 1,000 and 5,000 doses of an innovator product to carry out their studies and prove that their new drug is just as effective, if not more so, than the branded one.
However, in an effort to slow generic development and prevent market competition, brand name companies have found ways of withholding these samples. Some companies use a safety strategy with the FDA, known as a risk evaluation and mitigation strategy (REMS), to prevent generic companies from accessing their products. Other companies put a clause into their contract with a distributor to prevent the distribution of their products to any generic company.
The new list, which has been published on the FDA website, features the names of 39 companies using these delaying tactics, along with the name of their product and a note on how many inquiries the agency has received regarding each company’s samples. According to the FDA, the agency has received over 150 inquiries from generic companies, all of them requesting the FDA’s help gaining access to a branded company’s products. The names of the generic companies sending the inquires have not been disclosed.
The FDA plans to update the list on a semi-annual basis, so that it is kept up-to-date. It is hoped that this initiative will force brand name companies to stop “gaming the system” and will bring the US one step closer to controlling rising drug prices.