Bass, Berry & Sims attorney Jennifer Michael provided insight to multiple media outlets on a ruling issued September 30 by the U.S. District Court for the Southern District of New York denying a pharmaceutical company’s request to vacate an OIG advisory opinion that effectively precludes the manufacturer from providing financial assistance directly to certain patients prescribed the manufacturer’s drug. The court also denied the manufacturer’s request for a declaratory judgment that the manufacturer’s contributions to an existing charity — which would use the funds to assist certain patients with their copayments for the manufacturer’s drug — do not violate the Anti-Kickback Statute.
The opinion’s wording, however, may leave the door open to drugmakers to challenge unfavorable advisory opinions in the future, said Jennifer, a former Chief of the Industry Guidance Branch in the Office of Counsel to the Inspector General at HHS. In an article for MarketWatch, she pointed to the opinion’s statement that “formal deference” to the OIG’s advisory opinion or other HHS guidance “is not appropriate here.”
Jennifer told Endpoints News that the end result is not surprising and that the court was clear that it was not going to adopt Pfizer’s narrower reading of the anti-kickback statute. She also noted that the opinion could embolden other companies to challenge unfavorable HHS opinions in the future, and that other manufacturers would be unlikely to move forward with new direct copay assistance programs as a result of this opinion.
The full articles are linked below and available online:
- “Pfizer Loses Legal Battle with Big Implications for Drug Pricing,” MarketWatch (October 1).
- “Pfizer Loses Closely Watched Court Case on Kickbacks and Subsidizing Drugs,” Endpoints News (October 1).