Last week, I was able to attend SBIA’s Generic Drug Forum in Bethesda, Maryland, and I’m sure that many readers of Lachman’s blog also attended virtually. The Forum offered a diverse array of presentations applicable to the generic industry at large. In this blog, I will focus on one presentation related to PLAIRs (Pre-Launch Activities Importation Requests). The presentation itself provided some valuable insight into the flow of information within the Agency, the contents of a PLAIR, and when application sponsors should submit PLAIRs based on application type and priority status. Perhaps most importantly, the presentation discussed the types of products that are considered eligible for the PLAIR process. Slide 5 of the presentation from the FDA contained the following bullets describing the scope of PLAIR eligibility:

  • “A finished dosage form drug product that is being imported to prepare for U.S. market launch based on anticipated approval of a pending NDA, ANDA, or BLA regulated by CDER
  • A finished dosage bulk product that may either require minimal further processing (such as final packaging and/or labeling) or be in final packaged form
  • PLAIR does not apply to APIs (Active Pharmaceutical Ingredients) or drug products subject to a pending supplement.”

The bolded and underlined emphasis for “does not” was provided by the FDA.

It was this last bullet that resulted in my thinking to myself during the presentation… “Why are ALL pending supplements excluded from the PLAIR process?” It would stand to reason that some supplements (especially those that otherwise satisfy the criteria under the first bullet) should be considered eligible to engage in the PLAIR process. This resulted in me asking the following question during the panel’s Question and Answer period: “Why didn’t the FDA include New Strength Supplements (NSS) in the PLAIR process and was exclusion of NSSs due to legal or policy reasons?” The FDA’s representative responded to my question by confirming that there was no legal concern, but the FDA made a decision to exclude all supplements because the volume of supplements is very large and ever-increasing. The Agency representative also made reference to another presentation that indicated over 10,000 supplements were submitted in Fiscal Year 2023, which included approximately 1,600 Prior Approval Supplements.

I completely understand and agree that not all, or even most, categories of supplements should be considered for the PLAIR process but, from my perspective, the FDA’s policy of not including ANY supplements simply because the volume of work is quite substantial really isn’t a great reason, especially from industry’s vantage point. This is especially true when an NSS represents the potential first generic launch of a product into the U.S. market. The FDA’s policy of excluding all supplements also appears to be inconsistent with the FDA’s stated goals of improving access to drugs and enhancing competition.

Unfortunately, the FDA does not publish statistics related to the volume of NSSs that are approved so there isn’t any way of assessing how much of a burden adding NSSs to PLAIR eligibility would represent. From my time at the Office of Generic Drugs, I don’t recall there being all that many NSSs received on a monthly basis, so my view is that this would amount to, at most, a handful of supplemental applicants that would be eligible to request a PLAIR for the addition of a new strength (if the scope of the PLAIR program were expanded to include these NSS supplements). Even then, not all of the applicants would necessarily request a PLAIR for their NSSs so the volume would be applicable only for a relatively small subset of the NSSs received by the FDA.

Speaking from experience, I know that addressing questions on these panels can be both tough and intimidating because, no matter how prepared you may be, it is impossible to anticipate all versions of questions that you may be asked when you are a panelist from the FDA. You are on the spot with a lot of eyeballs trained on you and you are expected to respond rapidly, with very little time to think through your answer. Perhaps there is a better reason why NSSs are excluded from the PLAIR process; if that isn’t the case, the FDA should consider a change in its thinking as this could improve the public’s access to new strengths of drug products.