FDA Outlines Rules for Telling Clinicians About Unapproved Uses of Drugs, Devices

The FDA has released revised draft guidance on communicating with healthcare professionals (HCPs) about unapproved uses of approved drugs and devices.

Once it’s finalized, the document will reflect FDA’s stance on how companies can communicate scientific information to clinicians regarding unapproved uses of products already on the market. Comments are open through December 24.

“In developing this draft guidance, FDA has sought to strike a careful balance between supporting HCP interest in scientific information about unapproved uses of approved/cleared medical products to inform clinical practice decisions for the care of an individual patient, and mitigating the potential that the government interests advanced by these statutory requirements will be undermined,” the agency wrote in the document.

In the guidance, “scientific information” refers to reprints; clinical reference sources including practice guidelines, reference texts, or independent clinical practice resources; and company presentations of information from reprints.

Communications must be “truthful, non-misleading, factual, and unbiased and provide all information necessary for HCPs to interpret the strengths and weaknesses and validity and utility of the information in the … communication,” FDA stated in the draft document.

In addition, source documents must be “scientifically sound,” the agency said, defining such quality in a Q&A section of the document. While randomized controlled trials are the gold standard, other types of studies indeed have valuable clinical information to offer, the agency stated.

However, FDA was more explicit about what kinds of studies would not be considered scientifically sound, including those “without an adequate comparison or control group, isolated case reports about medical products, and other reports that lack enough detail to permit scientific evaluation.”

The same goes for “communications that distort studies” or those that “include fraudulent data,” the document stated. It also warned against providing data generated in the early stages of product development.

The Q&A offered several parameters for necessary information that should be included during these communications, including a statement that the product is not approved for this specific use; a statement about what it is indeed approved for; and any limitations or cautions.

FDA also wants companies to include a copy of FDA product labeling, a statement of contraindications, a statement describing any potential risks, and full details on any studies included.

For presentations, FDA said all disclosures must be provided, and companies can’t use any persuasive marketing techniques. These presentations should also be separate and distinct from promotional communications about approved uses of the product, the document stated.

The guidance — which was prepared by the Office of Prescription Drug Promotion in FDA’s Center for Drug Evaluation and Research — also includes additional specific recommendations for reprints, clinical reference resources, and clinical practice resources.

The release of the draft guidance follows a 2016 public hearing on manufacturer communications about unapproved uses of approved products. When finalized, it will supersede a 2014 revised draft guidance titled “Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices,” FDA said.