Biotech, pharma and medical devices: the numbers, the rules, the AI picture.

• Prescription drug advertising and promotional labeling: 21 CFR 202.1, 21 CFR 314.81(b)(3)(i) and FDA OPDP

  Under 21 CFR 202.1(e), prescription drug ads must include a brief summary of side effects, contraindications and effectiveness, and must not be false or misleading. An ad fails if effectiveness is presented in greater scope, depth or detail than risk information without fair balance. Examples of misleading ads include unsupported superiority claims and selective use of favorable studies. Under 21 CFR 314.81(b)(3)(i), applicants submit promotional materials to FDA on Form FDA 2253 at first use. FDA's Office of Prescription Drug Promotion (OPDP) reviews promotion, monitors medical meeting exhibits and issues untitled and warning letters.

  What it means: Every benefit claim on a product page, banner, email or social post needs balancing risk information in the same piece. FDA's 2014 draft guidance on character-limited platforms says firms promoting benefits there should present both benefit and risk. Keep a Form FDA 2253 log for launch materials and route every asset through medical, legal and regulatory review before it goes live.

  [7] law.cornell.edu

• Investigational products: 21 CFR 312.7 (drugs) and 21 CFR 812.7 (devices)

  A sponsor or investigator, or anyone acting for them, must not promote an investigational drug. That includes representing in a promotional context that it is safe or effective for the purposes under investigation. The rule says it does not restrict the full exchange of scientific information, including findings in scientific or lay media. For devices, 21 CFR 812.7 bars promoting or test marketing an investigational device before FDA approval and representing it as safe or effective for the use under study.

  What it means: Pipeline pages, investor decks, press releases and conference booths may describe the program, the trial design and results as data. They must not say or imply the candidate works or is safe. Label every candidate as investigational, avoid words such as breakthrough treatment or proven, and keep scientific presentations separate from commercial messaging.

  [8] law.cornell.edu

• Device claims: 21 CFR 807.97 and 807.39, FD&C Act section 502(q) and (r), and FTC health claim substantiation

  A 510(k) substantial equivalence finding does not denote official approval, and any claim that creates that impression is misbranding (21 CFR 807.97). Registration and a registration number do not denote approval either (21 CFR 807.39). Under 21 U.S.C. 352(q) and (r), restricted device advertising must not be false or misleading. It must include a brief statement of intended uses and relevant warnings, precautions, side effects and contraindications. The FTC's Health Products Compliance Guidance (December 2022) requires competent and reliable scientific evidence for health claims, generally randomized controlled human trials.

  What it means: Say FDA cleared for 510(k) products and FDA approved only for PMA products, and never suggest FDA endorsement. Describe the cleared intended use, not a wider one. For diagnostics, apps, wellness devices and tools sold outside FDA advertising rules, match every performance claim to evidence you could hand to the FTC.

  [9] law.cornell.edu

• Communications beyond the label: FDA guidance on communications consistent with labeling (June 2018) and on scientific information on unapproved uses (January 2025)

  FDA's June 2018 guidance sets three factors for whether a communication is consistent with the FDA-required labeling. They cover the indication, population and use limits; whether it increases potential for harm; and whether the labeling's directions allow safe use as described. FDA says it does not intend to rely on consistent communications alone to establish a new intended use. Its January 2025 final guidance on scientific information on unapproved uses recommends clear disclosures and separate web pages, with no direct links from promotional pages. FDA's page says that guidance is not for current implementation pending an OMB decision.

  What it means: Health economic data, real-world evidence and new analyses can appear in promotion only if they fit the labeling and have sound evidence. Publications about unapproved uses for health care professionals belong on a separate, clearly labeled page with the recommended disclosures, not one click from the product page. Confirm the current status of the 2025 guidance with counsel before relying on it.

  [10] fda.gov

• Interactions with health care professionals: PhRMA Code (effective January 1, 2022), AdvaMed Code (effective June 1, 2023) and CMS Open Payments

  The PhRMA Code limits meals with sales presentations to occasional, modest, in-office or in-hospital settings. It bars entertainment, recreation and practice-related reminder items such as pens, note pads and mugs. Educational items must be worth $100 or less. The AdvaMed Code bars branded promotional items even of minimal value, and entertainment in any form. It says information on unapproved uses should come from authorized personnel and be identified as such. Drug and device makers report payments to covered recipients to CMS Open Payments, which publishes them.

  What it means: Conference booths, sales kits and HCP programs need a compliance check, not just a design review. Swag with your logo is out for HCPs, and every meal or fee may become a public record. Content written for HCPs should be educational and accurate, and anything about unapproved uses goes through medical affairs, not marketing.

  [11] advamed.org

• Public companies: SEC Regulation FD (17 CFR 243.100 and 243.101) and the PSLRA safe harbor (15 U.S.C. 78u-5)

  A public issuer may disclose material nonpublic information to market professionals, or to holders likely to trade on it. If it does, it must disclose it publicly: at the same time if intentional, promptly if not. Public disclosure means a Form 8-K or another method reasonably designed for broad, non-exclusionary distribution. The SEC's April 2013 report says social media can work if investors were told in advance which channels will be used. The PSLRA safe harbor protects forward-looking statements identified as such and accompanied by meaningful cautionary statements, but excludes statements made in connection with an initial public offering.

  What it means: Trial readouts, regulatory decisions and partnering news should reach everyone at once, through the channels named on your investor page. Never release them first in a private briefing, a podcast or an executive's personal account. Label forward-looking statements on the site and in decks and tie the cautionary language to real risks. Marketing and investor relations should share one calendar and one approval step.

  [12] law.cornell.edu

• Google Ads healthcare and medicines policy and pharmaceutical manufacturer certification

  Google says pharmaceutical manufacturers must be certified by Google to serve ads, and may promote prescription drugs only in the United States, Canada and New Zealand. In those countries prescription drug terms may appear in ads and landing pages under local law, but keyword targeting them requires certification. Google bars promotion of speculative and experimental treatments. In the U.S., only the license holder may promote an FDA-licensed or approved cell or gene therapy. Clinical trial recruitment ads are not allowed in most locations.

  What it means: Apply for certification before launch, from the right child account, and have the client provide a written authorization letter if an agency applies. Check landing pages as well as ads, because a pipeline page can trigger review. Repeated policy violations can lead to account suspension, so build the policy check into campaign setup, not after a disapproval.

  [13] support.google.com

• EU Directive 2001/83/EC Article 88 and UK Human Medicines Regulations 2012, regulation 284

  Article 88(1) of the EU medicines directive requires member states to prohibit advertising to the general public of medicines available only on prescription. In the UK, regulation 284 of the Human Medicines Regulations 2012 bars publishing an advertisement likely to lead to the use of a prescription only medicine. Narrow exceptions include approved vaccination campaigns. The MHRA Blue Guide explains how the UK rules apply and was last updated on 28 March 2025.

  What it means: A U.S. product page, paid campaign or social post that reaches the public in Europe can break local law even if it is fine at home. Geo-target paid media, keep prescription product promotion behind HCP gates where the market requires it, and have local counsel review any page aimed at EU or UK audiences.

  [14] legislation.gov.uk

General information, not legal or regulatory advice. FDA guidance, industry codes, SEC rules and platform policies change, and some guidance cited here is draft or not yet in effect. Confirm the current rules with your regulatory affairs team and counsel, and run every claim through your own medical, legal and regulatory review before you publish.