During last week’s FDA/CMS Summit for Biopharma Executives, I had the opportunity to discuss the many recent legal and regulatory developments regarding communicating scientific data and clinical findings to health care professionals. Given the pace of change in this area during 2015, it was not overly surprising that news broke on another important decision, this one involving Pacira Pharmaceutical’s suit against the FDA.
Pacira is not a case about so-called “off-label speech.” It is a case in which the FDA attempted to prohibit a company from providing information that was consistent with indications on the drug’s FDA-approved labeling. Making this point, PhRMA filed an amicus brief in the Pacira suit, seeking to ensure that manufacturers’ rights to communicate accurate information to doctors—recently upheld in Caronia and Amarin—are protected. Arguing for a clear regulatory framework to guide communications, PhRMA wrote in its brief:
If FDA can effectively rescind or narrow its approval of a drug and invalidate truthful communications that track the language of the indications set forth in the drug’s approved labeling, without notice or compliance with the requisite procedures, manufacturers will not know what they can and cannot say about their products. Not only would this arbitrary approach impede business planning; it would also violate the First Amendment right of pharmaceutical manufacturers to share truthful, non-misleading information about the medicines they research and develop.
As part of the settlement, FDA rescinded its 2014 letter warning Pacira against sharing accurate data on Exparel with physicians, even though the communications were consistent with the broad indication on the drug’s FDA-approved labeling. This matter offered a chance to examine the impact of FDA’s attempts to limit communication between biopharmaceutical companies and health care professionals and the ability of the FDA to narrow the effective scope of product labeling by the threat of regulatory enforcement.
Pacira filed a lawsuit in September 2015, asserting that the FDA’s warning letter and associated actions violated the company’s right to share truthful, non-misleading medical information about its product. Under this week’s settlement agreement, Pacira can share important clinical findings and data that can help health care providers effectively treat patients.
While the agreement between Pacira and FDA rightly resolves this dispute, the underlying question—whether the company’s First Amendment right to communicate truthful, accurate data about their product to health care professionals was violated—will not be directly addressed by the courts. In the wake of rulings in Caronia and Amarin, the FDA’s actions in this case intensify confusion for companies seeking to share the best available data on their medicines with health care professionals.
This issue will remain at the forefront, as Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, recently identified “[r]egulation of drug advertising and promotion in light of current jurisprudence around the 1st Amendment” as a “Front Burner Priority” for FDA in 2016.
The Amarin matter has been stayed by the district court in New York while negotiations between FDA and Amarin Pharmaceuticals continue toward a settlement on the dispute over Vascepa marketing.
The Pacira settlement is an important step towards ensuring that clinicians have access to the best available data on FDA-approved medicines. But, as the legal landscape continues to shift, PhRMA stands ready to work with FDA and health care professionals to develop a clear regulatory framework that prioritizes the sharing of accurate, timely data to improve health outcomes for patients, and eliminates confusion surrounding the communication between biopharmaceutical companies and clinicians.