If you have been in the generic industry for, as they say, a minute, you know that one of the major and years old problem generic applicants have faced is being able to obtain samples of the reference listed drug (RLD) product to use in required bioequivalence (BE) testing to support approval of an abbreviated new drug application (ANDA). The problem usually arises when the designated RLD is also the reference standard, that is, the drug upon which the comparative BE testing is required, is either distributed in a closed system and/or has a restrictive Risk Evaluation and Mitigations Strategies (REMS) program.
Innovators have taken the position that there is no legal requirement for them to make drug samples of their product available through purchase by a prospective generic sponsor for the purposes of conducting required BE testing prior to submission and an ANDA. Failure to be able to demonstrate bioequivalence through the required OGD testing requirements, means that no ANDA can be filed with the Agency because any application that does not contain required BE testing will be considered incomplete.
We have blogged about this in the past here, here, and here. Generic sponsors have found some pretty covert ways to try to gain access to samples but none of that has been made public and only a very few applicants have been successful.
FDA has imposed various other options in an attempt to address this issue, as explained in the posts cited above, but there has been little success. However, now the Creates Act (see brief summary of relevant parts in yet another Lachman Blog post here, provides some teeth as the law “establishes a private right of action that allows developers to sue brand companies that refuse to sell them product samples needed to support their applications. If the product developer prevails, the court will order the sale of samples, award attorneys’ fees and litigation costs to the product developer, and may impose a monetary penalty on the brand company.”
And now the first suit under this provision has occurred as Teva sued to gain access by forcing the innovator to sell samples of Galafold (migalastat) an orphan drug “indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data”. Could this be the straw that breaks free “protected” samples for BE testing? Keep a close eye on this case as it may provide a road map to success or if not successful in the courts could further delay generic entry for innovator products that are subject to these restrictive REMS and distribution systems.