PhRMA Authors Call for FDA to Establish Off-label Communication Safe Harbor

April 27, 2015 – Because “sharing more information rather than less” about the off-label uses of approved drugs “is critical to healthcare delivery,” the FDA should interpret the Federal Food, Drug & Cosmetic Act “in a way that creates a clear, meaningful safe harbor for manufacturers to share with healthcare professionals a much greater amount of truthful, non-misleading information about both approved uses and medically accepted alternative uses of FDA-approved medicines,” according to a recent article published in the Food and Drug Law Journal (Vol. 70, No. 1 (2015)).

The article, “Embracing 21st Century Information Sharing: Defining a New Paradigm for the Food and Drug Administration’s Regulation of Biopharmaceutical Company Communications with Healthcare Professionals,” was written by James M. Spears, executive vice president and general counsel at the Pharmaceutical Research and Manufacturers of America (PhRMA), Jeffrey K. Francer, vice president and senior counsel at PhRMA, and Natalie A. Turner, who was a PhRMA legal fellow.

The authors assert that FDA’s current view of how to handle healthcare communications prohibits drug companies from sharing “accurate, data-driven information” about their approved products, and that the agency’s interpretation of the law creates a “Catch-22” for manufacturers because in trying to avoid a misbranding charge by updating their labels to include adequate directions for use, their products then are deemed new drugs subject to marketing approval. Further, even though the FDA acknowledges the importance of the legal practice of prescribing approved drugs for off-label uses, it has not provided a safe harbor for companies to communicate with healthcare professionals about those uses, the authors explain.

“The Coalition has stated time and time again that it makes little sense to silence the main source of the most information about drug products: the company that manufactures and continuously collects data about those drugs,” said Coalition for Healthcare Communication Executive Director John Kamp. “The PhRMA authors really hit the nail on the head when they stated that sharing information with healthcare professionals improves quality of care. The FDA needs to adjust its thinking – and its guidance – to reflect that reality.”

The PhRMA authors contend that the FDA’s current regulatory framework is not consistent with First Amendment jurisprudence, as demonstrated by decisions in Sorrell v. IMS Health and United States v. Caronia, which underscored that content- and speaker-based restrictions are subject to heightened scrutiny regardless of whether the restricted speech is commercial or not.

Further, the agency’s regulations create a scenario where the drug company is the only entity that cannot speak about the product it developed, whereas any other speaker may do so. As a result, the authors state, these cases “provide a strong foundation for a challenge to FDA’s regulations under both heightened and intermediate scrutiny.”

To resolve these issues and protect the public health, PhRMA proposes five key principles for a new FDA regulatory framework, which are summarized below:

(1)    All communications about medicines should be truthful and non-misleading. Accordingly, regulators should not discriminate based on the identity of the speaker or the content of the message or impose a double standard, the authors state. The FDA “should provide a clear definition of the term ‘false and misleading speech’ and require regulated labeling to be accompanied by sufficient information to establish context for [a] medically sophisticated audience.”

(2)    Balance patient benefit and potential risk to determine appropriate limitations on healthcare communications by biopharmaceutical companies. The authors assert that any limitations on healthcare communications should be proportionate to the patient risk, based on specific factors. They state that healthcare professionals “deserve access – without having to ask for it – to much more robust information than is typically contained in the approved labeling.” They contend that there is a bigger risk to patients “if their healthcare professionals are denied full access to information from manufacturers.”

(3)    Permit manufacturers to use robust disclosures/disclaimers to disclose limitations of data rather than prohibit certain healthcare communications. For example, the article states, “FDA could revise its interpretation of the ‘substantial evidence’ requirement; instead of requiring that any information disseminated by a manufacturer generally be supported by at least two adequate and well-controlled clinical trials, FDA could allow a manufacturer to meet the [SE] requirement for labeling in other instances if the information sharer provides robust disclosures.”

(4)    Provide incentives for sponsors to continue to seek supplemental indications for approved medicines. The authors suggest that the FDA consider “how it might streamline the process for sponsors to obtain additional labeled indications by allowing the use of real world evidence data in supplemental new drug applications.”

(5)    Allow companies to provide adequate directions for use for both approved and medically accepted alternative uses of FDA-approved medicines. According to PhRMA, a modified regulatory framework “should comply with First Amendment principles and amend FDA’s overly broad and circular interpretation” of adequate directions for use, and the FDA could identify specific categories of speech that are rendered truthful and non-misleading because they bear sufficient disclosures.

The article concludes with a strong recommendation that the FDA create a safe harbor for manufacturers to share “a much greater amount of truthful, non-misleading information about both approved uses and medically accepted alternative uses of FDA-approved medicines.”