FDA Creates New Opportunity in Generic Drug Development; Public Meeting Held July 18

PDG recently reported that FDA took the unprecedented step of publishing a list of off-patent, and off-exclusivity branded drugs without approved generics. The agency intends to update this list every six months. At the same time, the agency implemented a new policy designed to “expedite the review of generic drug applications where competition is limited.” One of the key components of the policy is expedited review of ANDAs until there are three approvals for the given product. Here’s a link to the press release.

As part of a now ongoing process, the Agency held a Public Meeting “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access” on July 18, 2017. The notice explained that “In some cases, however, the legal framework surrounding these exclusivities may have been applied to delay generic competition to an extent that may not have been intended by the Hatch-Waxman Amendments, and in ways that may not serve the public health. Relatedly, certain elements of the approval process for both innovator and generic drugs have been used in ways that may (depending on the circumstances) inappropriately hinder generic competition. For example, innovators in some cases have made late changes in patent use codes that create new obstacles to previously acceptable labeling carve-outs. The entry of generic products to the marketplace is also affected by factors external to regulation under the FD&C Act (e.g., the outcome of private party patent litigation, and commercial decisions not to market approved innovator or generic products). In other cases, restrictions on the distribution of innovator drug products, whether voluntarily adopted by the innovator or imposed as a requirement of FDA regulation, have prevented developers from accessing the product samples needed for testing to support ANDAs or other follow-on applications.” The meeting was held to “provide an opportunity for all interested stakeholders to submit comments concerning the appropriate balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs.”

The comment period will be open until September 18, 2017. Here’s a link to the latest from FDA. PDG’s Principal has participated in over 150 ANDA submissions. We are uniquely positioned to help you capitalize on this unique opportunity (including submission of a comment to the docket). Feel free to contact us to initiate or accelerate your generic development program.