Washington Insider: James G. Dickinson

The FDA has to respect First Amendment limitations regulating scientific communication

James G. Dickinson, editor of Dickinson’s FDA Webview (fdaweb.com)
James G. Dickinson, editor of Dickinson’s FDA Webview (fdaweb.com)

Lately there's been an abundance of good news out of Washington for prescription health product marketers, but there are signs that the age-old truism about too much of a good thing may be about to assert itself.

Consider the FDA's Internet and social-media guidance, especially the one on presenting risk and benefit information on media platforms with character space limitations.

This was recently hailed by the Minneapolis-based law firm DuVal & Associates as “a boon for marketers because it allows manufacturers to promote their products on ­Twitter (for example) and in sponsored Google and Yahoo ads,” which is where so much of the marketing action is going.

It is but a small example of industry getting its way with the FDA, which said in March that it intends to publish another sought-after draft guidance addressing the use of links to third-party sites this year. 

But such helpfulness can backfire. Public Citizen protested in March to Health and Human Services Secretary Sylvia Mathews Burwell that a draft guidance it published last June allowing marketers to distribute peer-reviewed scientific and medical publications to prescribers undermines important FDA-required risk information.

Public Citizen not only pointed out that 99% of commenters on the proposal, including 98% of those within the industry, strongly opposed it but also darkly hinted that the FDA had been concealing most of those comments. They weren't posted until Public Citizen's letter to Burwell hit the Internet six months after the comment period had closed.

Public Citizen's letter provoked the Washington Post headline, “FDA proposes to let drug companies undermine official safety warnings,” followed by a story that quoted PhRMA as defending the proposal and urging the FDA to respect “First Amendment limits on its ability to regulate scientific communication.”

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