FDA Launches Crackdown on Drug Advertisements
11/1/2025
The U.S. Food and Drug Administration (FDA) has announced reforms to pharmaceutical advertising guidelines that will require all prescription drug advertisements to include full and accurate safety disclosures. The announcement comes as a result of concerns that advertisers are not providing patients with a fair balance of information about drug products. The revised guidelines ensure that consumers receive balanced information about both the benefits and potential risks of medications, including all critical safety facts, in prescription drug advertisements. Under the new guidelines, if the FDA deems any omission or minimization of side effects, contraindications, or warnings in advertisements to be misleading, the FDA can initiate regulatory action against the drug manufacturer, which can result in fines or restrictions on advertising privileges.
Until 1997, pharmaceutical advertisements were required to include full contraindications, boxed warnings, and common precautions in advertisements. However, subsequent guidance by the FDA created a loophole that allowed drug manufacturers to recite a vague “major-risk statement” and then direct viewers to a website, toll-free number, or print insert for more complete information. The FDA’s revised guidance attempts to eliminate the loophole, and requires drug advertisers to present factual, uncontroversial statements that are already legally mandated and avoids undue burdens by preserving advertisers’ rights to continue to engage in commercial speech. The new guidance emphasizes transparency, patient safety, and the need for clear, understandable language in all promotional materials.
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Keith J. Roberts
Member
Litigation, Healthcare Law
973.364.5201 · 973.618.5585 Fax
kroberts@bracheichler.com
Shannon Carroll
Member
Healthcare Law, Litigation
973.403.3126 · 973.618.5988 Fax
scarroll@bracheichler.com
Paul J. DeMartino, Jr.
Counsel
Healthcare Law, Litigation
973.364.5228 · 973.860.4221 Fax
pdemartino@bracheichler.com
Related Practices: Healthcare Law, Litigation
Related Attorney: Keith J. Roberts, Shannon Carroll, Paul J. DeMartino, Jr.
Related Industry: Healthcare
