Health Law Daily Prioritized review of generic drug applications could stop the next Shkreli
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Tuesday, March 15, 2016

Prioritized review of generic drug applications could stop the next Shkreli

By Bryant Storm, J.D.

Changes to the FDA’s prioritization of review for abbreviated new drug applications (ANDAs) will allow the agency to more quickly approve generic drugs that will be “first generic products.” In other words, the agency is expediting the approval process for drugs that are the only generic competitors of brand name treatments. The new policy will make price increases less profitable for drug manufacturers who would otherwise be the only manufacturer of a particular treatment.

Prioritization. According to the FDA’s new Manual of Policies and Procedures (MAPP) on the subject, the FDA will prioritize review of ANDA submissions related to:

  • patent certifications under 21 C.F.R. sec. 314.94(a)(12), including potential first generic products;
  • drug shortages;
  • special review programs, like the President’s Emergency Plan For AIDS relief;
  • public health emergencies;
  • certain government purchasing programs;
  • statutory mandates or other legal requirements;
  • requests for expedited review in cases of catastrophic or unforeseen events; and
  • “sole source” drug products.

Heightened review priority decisions will be made by the Office of Generic Drugs (OGD) Division of Project Management staff (including the Regulatory Project Manager (RPM)) and OGD management.

Price setting. The goal of the regulatory change is to increase consumer choice by limiting situations like the one exploited by the former CEO of Turing Pharmaceuticals, Martin Shkreli. Turing’s former executive gained infamy when the company acquired a patent-expired anti-parasitic treatment (Darapimin®) and increased the price from $13.50 to $750 per pill. Shkreli was able to set the exorbitant price because, in the absence of generic competition, Turing was the only manufacturer with FDA approval for the treatment (see CEO changes course on Daraprim® pricing after gouging claims spread, September 23, 2015). Due in large part to long approval times, manufacturers that hold exclusive manufacturing rights are able to exert significant power over drug pricing.

Backlog. At a Senate hearing in January, 2016, Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, touted the agency’s progress at catching up on the extensive backlog of ANDAs for generic drugs. The agency’s goal for reducing the backlog in 2016 is to review 75 percent of original ANDAs within a 15-month timeframe. At that hearing, Senator Lamar Alexander (R-Tenn.) noted that backlogs remain a concern as median generic approval times have grown from 30 to 48 months (see FDA lauds generic application movement, committee looks for more approvals, January 29, 2016).

Companies: Turing Pharmaceuticals

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