The Creates and Restoring Equal Access to Equivalent Samples Act of 2016 (CREATES) (summary of the Act can be found here and the full Act here) is designed to stop the abuse of the restricted distribution systems and Risk Evaluation and Mitigation Strategies (REMS) programs. How do these two things impede generic access? Brand companies refuse to sell samples of their product to potential generic sponsors so they can conduct the required bioequivalence testing in order to support submission of an ANDA. Brand name companies also (in many cases) refuse to allow generic firms from sharing in their approved REMS program even though there is already legislation that suggests that they should permit them to share in the program. There are major benefits to a single shared REMS program such as less burden on prescribing physicians and health care providers, better access to a complete set of data on the program’s effectiveness, and also less burden on the patient.
To date, the FDA and the FTC have tried unsuccessfully to stop some of this “anticompetitive” behavior and, as we all have postulated, this proposed legislation is the next step in the battle. The CREATES bill provides a mechanism for the aggrieved party “to bring an action in Federal court for injunctive relief (i.e. to obtain the sample it needs, or to enter court supervised negotiations for a shared safety protocol). The bill also authorizes a judge to award damages to deter future delaying conduct.” The court process will still be a delay but perhaps a delay with a positive outcome, as now many firms can’t even get an application into the FDA because they cannot perform the bioequivalence studies due to lack of samples.
Will the CREATES Act solve the problem? It is one thing to pass a piece of legislation, but it is another thing entirely to be able to enforce it. In a previous post (here), we alluded to a potential constitutional issue related to forcing someone to sell something of theirs to another party. While I am not a lawyer, it occurs to me that this issue may create a challenge to any law that undo’s that protection. In these days of prescription drug price hikes that has created significant interest in Congress, the States and with consumers, a legislative fix that can stand up in the courts appears the only way to address this facet of access to generic products.