On January 18 2017, the U.S. Food and Drug Administration released a pair of draft guidances on medical product communications. These rules could have significant implications for the ways manufacturers present new medical products and explain their indications to medical professionals or consumers. FDA Commissioner Robert Califf explained the reasoning behind these documents in a statement.
"We are committed to an ongoing dialogue with industry and other stakeholders, and, when needed, providing guidance to clarify the agency's thinking on these issues," he said. "Today, the FDA released two separate draft guidances that will each help provide clarity for medical product companies, as well as other interested parties, on FDA's current thinking and recommendations for a few different types of communications about medical products."
The two pieces of guidance each address a different aspect of how the FDA will regulate communications. While the documents undergo a 90-day period of public comment, it's vital for drug and device makers to consider modifying their approaches to communications with insurance payors and formulary committees as well as to product labeling.
Setting new rules for Healthcare Economic Information
One of the documents concentrates on how pharmaceutical firms provide Healthcare Economic Information to formulary committees, payors, and other groups tasked with selecting drugs or making reimbursement decisions. HCEI includes statements like pointing out how a certain drug would save consumers money as opposed to another, similar product.
"The guidance explains what forms of HCEI are acceptable."
The guidance provides a series of questions and answers to explain what forms of HCEI are acceptable and to whom this information may be provided. According to the draft, HCEI can only go to audiences of experts in healthcare economic analysis, rather than individual doctors. The information should always be based on strong scientific evidence and relate to an FDA-approved indication for the drug. Providing this context might involve pointing out dosage information, uses in various practice settings, the burden on the patient caused by the illness and data on using the drug for different durations.
In addition, this draft clarifies the expectations for pharmaceutical and medical device design firms when communicating with payors about products still undergoing investigation. Organizations can do so without violating FDA regulations against promoting investigational products by sticking to factual, unbiased information. The maker must explicitly state the product's current stage of development and that its safety and effectiveness must still be established.
Knowing the limits for off-label marketing
The second guidance concentrates on off-label marketing, suggesting how the promotional review committees for manufacturers should move forward in providing information about drugs that is consistent with FDA-approved labeling. The agency will consider three major factors in determining whether communications meet this standard:
- The communication should not make suggestions that are different from the labeling in terms of indication, patient population, directions for use or limitations on dosage.
- The representations made by the firm cannot increase the likelihood that patients' health will be put at risk.
- It must be possible to use the product in the suggested way without conflicting with the directions on the label.
The draft laid out several examples of the types of information manufacturers can provide about a product's uses while remaining consistent with the approved labeling. Acceptable statements include comparing how the drug or device works for its labeled indication to another one with the same indication, offering details about the mechanism of action, patient-reported outcomes from using the product, and providing context for any adverse reactions associated with the product. On the other hand, the draft specifically pointed out communications that are inconsistent with the labeling, like promoting use of a drug or device to treat a different disease or condition from the approved one, patients not included in the cleared population or in an unapproved dosage.
The FDA emphasized that its goal is to prevent danger to patients resulting from false or misleading claims about the effects of drugs or other medical products. Law 360 noted that manufacturers could still benefit from more explanation when it comes to how the FDA will handle off-label communications for products the agency has already approved or cleared for use.
These two pieces of guidance from the FDA could have significant implications for medical device innovation for going forward. The comment period on the drafts will remain open through April 19, 2017 before the agency starts work on preparing the final versions.