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 an in-depth review of the enforcement letters issued by FDA to prescription drug and medical device companies during 2019 concerning product promotion. We will not review the one hour presentation in this Bulletin, but we will highlight some of our key takeaways and predictions for 2020.
1. FDA’s Office of Prescription Drug Promotion (OPDP) continues to focus on violations and diseases that raise significant public health concerns, and promotion directed to consumers.
- Sponsors of drugs with the following characteristics should be particularly careful: risk evaluation and mitigation strategies (REMS), Black Box Warnings, controlled substances, potentially life-threatening risks, vulnerable patient populations, and drugs that treat diseases affecting millions of people.
- 8 of the 10 letters issued by OPDP involved consumer-directed promotion (e.g., websites and Internet banners, direct-to-consumer videos, direct-to-consumer print and TV ads).
2. The most common violations cited were false or misleading risk presentations and false or misleading claims about efficacy.
- Because false or inherently misleading speech is not protected by the First Amendment, OPDP continues to mostly avoid issuing letters that raise difficult constitutional issues.
- Be careful to present risk information with a prominence and readability reasonably comparable to benefit claims.
- For TV ads, the “major statement” of risks must be in the audio or audio and visual parts of the presentation [risk only in SUPERS (visual) does not comply with 21 C.F.R. 202.1(e)(1)], and risks should not be undermined by competing modalities and information (e.g., attention-grabbing visuals, music, unrelated risk and benefit information).
- If Internet banners state the indication and/or make claims, they require complete risk information.
- The statement of the indication must include the complete Indication and any limitations of use from the approved labeling.
- Off-label promotion was cited in one letter – a blatant violation and the same claim was charged as false or misleading.
3. Be extra careful when discussing investigational/unapproved new drugs and medical devices — avoid conclusory statements about safety or effectiveness.
4. Keep in mind that “prior communications” with OPDP and/or the FDA review division will be cited in enforcement letters, including letters to prior sponsors for similar violations.
5. All Center for Devices and Radiological Health (CDRH) letters involved promotion as evidence of a new intended use.
- Products had cleared 510(k)s (for product or component) – CDRH relied on inspections and promotion (e.g., website, brochures, labeling, training materials) as evidence of major changes/modifications to intended use.
- Promotion of 510(k) cleared product as an “FDA approved device” will be viewed as misleading.
6. Issues under consideration by OPDP during 2020
- Particularly close oversight of opioid promotion
- New outreach on the Bad Ad Program (more complaints likely)
- Assistance to sponsors in transitioning from paper to electronic submissions of promotional materials (FDA Form 2253)
- Extensive social science research program (e.g., whether a link to risk information is sufficient for character-space limited online promotion, the effectiveness of disclosures, whether proprietary names that suggest the drug’s indication or suggest an overstatement of efficacy are misleading) – possible areas for policy development
7. Issues that we are seeing more frequently
For more information, please contact Alan G. Minsk.