The recent decision by the US Supreme Court to overturn federal ad restrictions concerning ‘compounded’ drugs has prompted the Food and Drug Administration to question its policies on marketing.

Last month, the Court ruled that the ban on advertising compounding (the mixture of medications by pharmacists for individual patients) violated the First Amendment, setting a precedent whereby commercial speech is protected by the constitution [WAMN: 01-May-02].

The FDA is responding by issuing a notice asking marketers how they think ad restrictions should be changed in light of the ruling.

“The Supreme Court has increasingly recognized the value of speech proposing a commercial transaction, which it calls ‘commercial speech’ and which is entitled to First Amendment protection so long as it is truthful and not misleading,” declares the notice.

Specific questions asked by the FDA include:

• Whether drug marketing can be policed by the FDA more comprehensively than the promotion of vitamins.

• Whether current restrictions on direct-to-consumer drug advertising are constitutional.

• Whether federal bodies should have more power to forbid statements on drug labels than they do for other marketing.

• Whether the FDA’s argument that drug ads not meeting its requirements are automatically misleading can be legally upheld.

• Whether claims for vitamins are any different to claims for food, and how such claims may be judged misleading.

The FDA is requesting comments within 75 days of the filing’s publication, expected this week.

Data sourced from:; additional content by WARC staff