AGG recently presented a webinar on “FDA Regulation of Rx Drug and Medical Device Advertising & Promotion: The Year in Review.” The webinar focused primarily on enforcement letters and three guidance documents issued by the Food and Drug Administration (FDA) during 2018 concerning product promotion. We will not review the one-hour presentation in this Bulletin, but we will highlight some considerations and predictions for 2019.
- We strongly encourage companies to develop materials that satisfy the two guidance documents FDA finalized during 2018, which we summarized here.
- Lowering the evidence standard from “substantial evidence” to “scientifically appropriate and statistically sound” [“Medical Product Communications That Are Consistent With The FDA-Required Labeling” (“CFL” Guidance)], and “competent and reliable scientific evidence” [“Drug & Device Manufacturer Communications With Payors, Formulary Committees & Similar Entities” (“Payor” Guidance)] is very significant
- for decades, FDA refused to accept less than “substantial evidence”
promotional claims based on studies that were not considered “substantial evidence” could result in enforcement letters
- We understand that FDA’s Office of Prescription Drug Promotion (OPDP) has received a number of requests for advisory opinions on proposed CFL pieces
- companies should consider either getting legal advice on proposed CFL promotion or submitting requests for advisory opinions
- requests for advisory opinions provide companies with an added level of comfort, but can take some time to receive a response
- these are case-by-case determinations; more complex issues (e.g., questions involving study design or statistical analyses) will require consults to the medical review divisions, statisticians and, sometimes, FDA’s Office of Chief Counsel
- We do not expect to see any additional (and much anticipated) guidance from FDA during 2019 on dissemination of “off-label” information to healthcare providers
- our sense is that FDA believes that finalizing the CFL Guidance and Payors Guidance is sufficient for now
- unless there is outside pressure (e.g., Congressional interest or new lawsuits), the status quo is not likely to change
- FDA has a number of higher priority matters, and the agency has steered clear of issuing enforcement letters on potentially thorny First Amendment issues that could generate industry challenges
- We recommend that companies’ internal promotional review committees review all pieces, not only the underlying concepts that will be used to develop a piece
- The internal review committee should review each promotional item because, even if the committee approved the message in one setting, the venue or message might have changed, and the whole story, in totality, could change
- Similarly, companies must consider promotional activities as a whole.
- for example, space constraints in a one-page document may not allow the company to add the appropriate context and disclaimers; if that is the case, a one-page document may not be the appropriate forum for the company to present the information
- Issues under consideration by OPDP during 2019
- use of “real world evidence” in promotion; we might see a guidance document addressing this issue in 2019 or 2020
- how quickly companies must revise promotional pieces when they make labeling changes; FDA’s regulations provide that applicants must promptly revise all promotional labeling and advertising to make the materials consistent with any labeling changes [pre-approval supplements and changes-being-effected (CBE) supplements]; companies have been asking FDA what “promptly” means