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# Follow FDA Online Misinformation Guidance: Attorneys
- URL: https://www.fdaweb.com/follow-fda-online-misinformation-guidance-attorneys/
- Published: 2024-09-10T12:00:00.000Z
- Updated: 2026-09-14T14:40:48.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, Devices, #legacy-id-D5157741

Attorneys **Wyatt Kernell** and **Sonia Nash** (Cooley) say companies should carefully review an FDA 7/8 draft guidance on addressing misinformation about medical devices and prescription drugs as part of preparing any tailored response communication to be sure their communication falls within the agency’s enforcement discretion policy. Writing in an online [post](https://www.jdsupra.com/legalnews/fda-s-draft-guidance-on-addressing-5845024/?ref=fdaweb.com), Kernell and Nash say companies should consider incorporating the guidance’s principles into their medical, legal, and regulatory review process, as well as updating policies and procedures on how they handle social media communications.

The draft applies when a company voluntarily responds to Internet-based misinformation and explicitly excludes TV and radio ads, even when disseminated by firms over the Internet, such as through streamed TV shows. “The new draft guidance takes an expansive view of misinformation,” the attorneys write, “defining it as ‘positive or negative incorrect representations or implications about a firm’s product created or disseminated by independent third parties,’ which does not need to be specific to a company’s product in order for a company to respond.”

If companies follow the guidelines in the draft, FDA has said it does not intend to enforce applicable requirements related to promotional labeling and advertising, as well as postmarketing submission of promotional communications, the attorneys say.