Bill Would Make US FDA Issue Final Rule On Risk Information In Broadcast DTC Ads

Proposed rule issued in March 2010 requires ‘major statement’ on a drug’s side effects in ‘a clear, conspicuous, and neutral manner’ for TV and radio ads. Bill would mandate a final rule within six months.

TV ad
US FDA has yet to release final rule on presenting drug risks in TV and radio ads • Source: Shutterstock

The US Food and Drug Administration’s 12 year delay in issuing a final rule on the presentation of the “major statement” of a drug’s side effects and contraindications in television and radio advertisements has gotten the attention of Congress.

Five members of the House, led by Rep. Abigail Spanberger, D-VA, introduced a bill, Banning Misleading Drug Ads Act, on 5 July that would require the agency to finalize...

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