Will Ask Marketers for Feedback Regarding Current Restrictions

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WASHINGTON (AdAge.com) -- The Food and Drug Administration is opening the door to major changes in advertising rules following a recent U.S. Supreme Court decision on drug advertising and marketing.

In a filing to be unveiled tomorrow, the FDA is suggesting that the court's decision raises sufficient questions regarding existing FDA rules.

The agency plans to ask marketers to comment on how current restrictions on advertising need to be altered to reflect the protection the Supreme Court extended to commercial speech in its ruling regarding the advertising of compounded drugs. The FDA is requesting the comments be made within 75 days of the notice's publication, which could be later this week.

"The Supreme Court

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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," the FDA's filing states.

Calling the decisions "a challenge to the FDA," the agency is asking marketers a series of questions about its future regulation of marketing. Among them:

  • Can the FDA regulate drug marketing messages more comprehensively than those for vitamins?

  • Can the FDA legally maintain a position that drug marketing messages are automatically misleading unless they comply with FDA requirements?

  • What sort of effects to direct-to-consumer drug ads have, and does the FDA's current rules meet constitutional tests?

  • Can the FDA distinguish claims made for vitamins from claims made for foods and what kind of evidence or record is necessary to term a claim as misleading?

  • Does the government have greater rights to proscribe label statements for drugs than for other advertising?

The request comes just two weeks after the Supreme Court overturned FDA rules that barred pharmacists from advertising drugs they mixed to form a new medication, a process known as compouding.

The FDA rules had used the ad ban to limit the mixed drug's distribution, because the compound would not have gone the the agency's elaborate testing process of individual ingredients.

In the April 29 decision, Justice Sandra Day O'Connor said, "If the First Amendment means anything, it means that regulating speech must be a last -- not first -- resort."

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