Generics Marketing Receives Another Letter

The Office of Prescription Drug Promotion posted a new letter to its website for the marketing of a generic product (disulfarim tablets) by Alvogen.

Alec Gaffney provides a nice overview of the letter in Regulatory Focus.

Traditionally, generics marketing has not received as much attention from OPDP or its predecessor DDMAC. That has probably been true in large part because there was not as much marketing of generics.

But the post-blockbuster era in pharma meant that lots of drugs with extremely high sales volumes lost their patent exclusivity and generics companies have leapt in to more competitive markets attempting to distinguish themselves and promote their offerings.

FDA has not apparently believed there was any need to provide generics-specific guidance on marketing, as none of the generics guidances provided by the Agency have focused on marketing.

With the recent enforcement actions for generics marketing (in addition to disulfarim, see here, here, and here), and the soon-to-be-approved biosimilars with different possible approvals (interchangeability and biosimilarity), it would be good to hear more from FDA about how it views some of the unique aspects of marketing follow-on products.