Dusa Pharmaceuticals Inc., a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd., of Mumbai, India, agreed to pay $20.75 million to resolve whistleblower allegations that it violated the U.S. False Claims Act in how it promoted Levulan Kerastick (aminolevulinic acid) to doctors. The whistleblower, former Dusa sales rep Aaron Chung, is to receive about $3.5 million of the settlement, the Department of Justice (DoJ) said on Aug. 24. As part of a two-stage process to treat actinic keratosis (AK), Levulan Kerastick was approved to be topically applied to a targeted lesion. Then, following a 14- to 18-hour incubation period, the lesion was to be illuminated with Dusa’s blue light photodynamic therapy, in accordance with FDA labeling for the drug. However, between 2014 and 2016, the DoJ alleged, Dusa encouraged doctors to use much shorter and “demonstrably less effective” incubation times, promoting a one- to three-hour incubation period through paid physician speaker programs, peer-to-peer discussions, sales promotions and the dissemination of misleading responses to doctors’ questions. Dusa failed to inform doctors that the shorter incubation period led to significantly lower AK clearance rates and, in some instances, it falsely stated that the clearance rates were the same, according to DoJ. While the settlement includes a corporate integrity agreement, it does not contain a determination of liability.
The FDA said it won’t be ready next month to begin implementing new reporting requirements for drug manufacturing volume data as authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The new requirements, intended to prevent and mitigate possible drug shortages in the U.S., enhanced the FDA’s visibility into drug supply chains. Under CARES, the FDA could begin implementing the additional reporting requirements as early as Sept. 23, 2020. However, the agency said its electronic submission portal for that data will not be ready by then, as staff is still working to define the data to be reported and create the portal.
The FDA sent a warning letter this month to Wintac Ltd., a Bangalore, India-based contract manufacturer of sterile drugs. Posted to the FDA website Tuesday, the letter stems from an inspection in February, shortly before the agency suspended inspections due to COVID-19. The warning letter cited the company for its failure to thoroughly investigate Ralstonia picketti contamination found on a media fill line in November 2019. Rather than identify corrective action to resolve potential root causes, the company closed a narrow investigation without “sufficiently assessing how other batches manufactured on the line may have been or will be compromised,” the FDA said. Citing passing results of subsequent media fill runs, the company concluded there was no impact to product quality. The FDA said similar deficiencies were observed with Wintac’s investigation into another failing media fill used to qualify a new aseptic filling line in June 2019. The FDA investigator also noted that multiple aspects of Wintac’s “cleanroom and aseptic processing line design … represent fundamental contamination risks.”