Patients are better served when health care professionals have the most accurate and up-to-date medical information. This is true for data and information regarding FDA-approved uses and medically accepted alternative uses of FDA-approved medicines. Unfortunately, despite recent court rulings in the Caronia and Amarin cases explicitly allowing biopharmaceutical companies to provide truthful and non-misleading communications to health care professionals, the FDA continues to muddy the waters with inconsistent actions.
The most recent example involves the biopharmaceutical company Pacira’s treatment Exparel for postsurgical pain, which the FDA approved in 2011. In a September 2014 warning letter, the FDA accused the company of promoting the medicine for unapproved uses and overstating the drug’s effectiveness. The agency said Pacira could only market the therapy as a postsurgical treatment for the two surgeries noted in the clinical trials that supported the original approval of the treatment, despite the fact that the FDA-approved label for Pacira’s medicine did not include this limitation.
Pacira filed a lawsuit in federal district court, asserting that the FDA’s actions violated the company’s First Amendment rights to communicate about its medicine in a truthful and non-misleading manner. The company’s legal filings state that the information presented is consistent with the approved, on-label indication.
PhRMA filed an amicus brief in this case supporting Pacira’s position. In its brief, PhRMA stated, “Manufacturers should not have to guess whether FDA may announce, potentially years later, that its approval of a drug was actually for a much narrower indication than the labeling explicitly states.” In the Pacira case, the FDA is attempting “regulation through warning letter,” which not only violates the Agency’s own rules, but could also have a chilling effect on biopharmaceutical companies providing information that is entirely consistent with the FDA-approved label. This could have terrible repercussions for patients and health care providers, who could be deprived of new information that would aid prescribing and treatment decisions.
PhRMA continues to encourage the FDA to work with industry, health care providers, patients and other stakeholders to create a modernized regulatory framework encouraging the development and dissemination of accurate, data-driven information to improve patient care. It is critical to modernize the FDA’s regulatory framework not only to make more comprehensive and up-to-date information available to health care providers and payers, but also to eliminate any confusion resulting from the recent and ongoing legal proceedings and adhere to the rulings in cases such as Caronia and Amarin.