The new Commissioner of FDA, Scott Gottlieb, M.D., has been moving very quickly since assuming his post. In a recent announcement reported by RAPS in its Regulatory Focus (here), he indicated FDA’s upcoming plans to “begin releasing letters that FDA sends to brand drug companies when generics question the agency on whether they should be able to obtain samples of the brand drugs necessary to produce generic versions.”
Many of these drugs are provided to patients through restricted distribution programs in which the drugs are sent from a specialty pharmacy directly to the patient. Therefore, in this arrangement, generic pharmaceutical companies cannot go through the usual commercial channels to obtain innovator drug product samples to conduct the necessary comparative testing to establish bioequivalence between the brand and generic product. Without those samples, generic makers are unable to complete the work necessary to file an ANDA.
FDA has had a program in place to issue such letters for several years. The letters state that the generic company has provided FDA sufficient information in a bioequivalence protocol to assure that patients are protected to the same level as that of the REMS program covering the reference listed drug. While the letters provide the assurance the brand name companies say they need, their impact has been less than effective.
Now the question is, will public release of these letters cause enough of a public relations problem for the brand companies to force their hand, or will the letters have the same chance of effectuating change as in the past – basically slim to none? Can the letters shame the companies into providing the necessary samples so sponsors can conduct the necessary testing so then can submit an ANDA? What will happen if the letters are released? Will there be a follow-up by the Agency informing the public as to whether the brand company complied with the generic’s firm’s request for samples? Or will it be business as usual? We will have to wait and see!