The Biologics Price Competition and Innovation Act (“BPCIA”) requires applications to market a biological product be submitted for review by the FDA under § 351 of the Public Health Service Act (“PHS Act”). However, it carved out a limited exception for biological products that are in a product class that had already been approved under § 505 of the Food, Drug, and Cosmetic Act (“FD&C Act”) prior to enactment of the BPCIA. For biological products in that limited category, the applicant was given the option to seek approval under §505 of the FD&C Act provided that the application was submitted prior to enactment of the BPCIA, or was submitted not later than 10 years after enactment of the BPCIA. Thus, the BPCIA created a 10-year transition period wherein certain biological products could be approved under § 505 instead of § 351.
March 23, 2020, marks the end of that 10-year transition period. According to the BPCIA, on that date, all NDAs for biological products that were approved under §505 of the FD&C Act will be “deemed to be a license for the biological product” under § 351 of the PHS Act. The FDA has now published guidance on how it will interpret the “deemed to be a license” transition provision of the BPCIA.
In brief, the FDA interprets the “deemed to be a license” provision to only apply to NDAs that have been approved as of the transition date. The FDA explains that the statutory language does not provide a path for approved NDAs to be transitioned to a BLA, either before or after the specified transition date. Consequently, the FDA will not approve any application for a biological product submitted under § 505 that is pending or tentatively approved on March 23, 2020, and will instead issue a complete response letter to any such application. For this reason, the FDA suggests that applicants who are contemplating submitting a § 505 application for a product that will be transitioned consider instead submitting the application under § 351.
The FDA also explains that all biological products subject to the transition provision will be removed from the Orange Book on the transition date. Those products will then be listed in the Purple Book. Moreover, any unexpired exclusivity (except for orphan drug or pediatric exclusivity) for an approved NDA that is transitioned to a BLA will no longer be in effect. Orphan drug and pediatric exclusivity will remain in force because the § 351 also provides for those types of exclusivity.
On the question of exclusivity, the FDA makes it clear that transitioned NDAs will not be granted the exclusivity that applications originally approved under § 351 enjoy. More specifically, transitioned NDAs will not be granted a 12-year period wherein the FDA may not approve a § 351(k) application, or a 4-year period wherein an applicant may not submit a § 351(k) application to the FDA. The FDA’s reasoning is that those exclusivity periods begin on the date that the § 351(a) application was first licensed, and a transitioned § 505 application was not first licensed under § 351(a). As articulated by Commissioner Gottlieb in remarks accompanying the release of the guidance documents, the FDA’s reasoning is also guided by a desire to encourage competition, which would be blunted by granting an additional 12 years of exclusivity to these products, some of which were first approved over 30 years ago.
So, what products will be impacted by this transition provision? The FDA has published a preliminary list of products that are anticipated to be affected by the transition provision. Perhaps the most notable are the various insulin products, although there are a number of other significant products listed.
The FDA has also published a Question and Answer document on the “Deemed to be a License” Provision. In this document, the FDA explains that transitioned applications will be deemed § 351(a) BLA. These transitioned NDAs will also be subject to the requirements under the PHS Act, including those requirements that differ from the FD&C Act. However, the FDA also indicates its belief that there will be minimal disruption due to those differences. The FDA specifically identifies differences in labeling and CMC requirements that transitioned BLAs will need to address. However, the FDA specifically addresses those differences and provides its guidance in the Q & A document.