The key question may be how FDA should assess neutrality of prescription drug maker presentations of information about side effects and effectiveness.

FDA Taking Comments on Rx Ads' Side Effects Content

The requirement that direct-to-consumer TV and radio ads for prescription drugs present information about side effects and contraindications in a clear, conspicuous, neutral manner was in the Food and Drug Administration Amendments Act of 2007.

FDA asked Monday for public comments on how makers of prescription drugs should explain the side effects and contraindications in their direct-to-consumer TV and radio ads for such drugs. The Food and Drug Administration Amendments Act of 2007 required that they communicate the information in the ads in a clear, conspicuous, neutral manner, and the key question may be how FDA should assess neutrality.

FDA said it will accept comments until June 28. They may be submitted, identified by Docket No. FDA-2009-N-0582 and/or RIN 0910-AG27, via www.regulations.gov.

The current regulations on prescription drug ads say they must contain "a true statement" of certain information, including "information in brief summary relating to side effects, contraindications, and effectiveness." The 2007 law added a provision that "in the case of an advertisement for a drug subject to section 503(b)(1) presented directly to consumers in television or radio format and stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications shall be presented in a clear, conspicuous, and neutral manner." The law gave the HHS secretary 10 months from its enactment to set standards for determining whether an ad's major statement fulfills that requirement.

FDA looked to other agencies' rules, including some from the Federal Trade Commission, Securities and Exchange Commission, and Department of Transportation.

FDA said in the Monday proposed rule that it is not aware of any previous standard or regulation that defines "neutral manner" in the context of required disclosures; the agency said it believes "neutral manner" means "unbiased manner" and has proposed its standards accordingly.

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