PhRMA: Pre-Submission Advertising Guidance Violates Free Speech Rights

Posted 21 May 2012 | By Alexander Gaffney, RAC 

The Pharmaceutical Research and Manufacturers of America (PhRMA) is calling for program proposed by the US Food and Drug Administration (FDA) to be scaled back, saying the agency's proposal to review all advertising before it can be disseminated is overly burdensome and violates its commercial rights to free speech.

FDA proposed on 12 March to change how it reviews TV advertisements-see Regulatory Focus' 12 March story, "New FDA Draft Guidance on DTC Television Advertisements"-releasing draft guidance to require all direct-to-consumer (DTC) TV advertisements to be reviewed by FDA before dissemination.

In its letter to FDA, published 14 May, PhRMA said while it "strongly supports" the policy goals advocated by FDA, the specific proposal "is, in important respects, overbroad, unduly burdensome, and lacking in narrow, objective and definitive standards."

PhRMA, a trade organization representing numerous companies, also cites the constitution in its letter.

The first amendment, argues PhRMA, confers protections to the commercial speech of companies, which are violated by FDA's proposed draft guidance.

"Because FDA is proposing to implement and enforce what is, in essence, a prior restraint on valuable constitutionally protected commercial speech, PhRMA urges the Agency to reconsider the scope of its proposal and proceed cautiously and in a manner that fully protects the free speech rights of advertisers and patients," wrote PhRMA.

Such limits should, if they exist at all, conform to the constitutional principle of being, as the Supreme Court upheld in Central Hudson, "narrowly tailored to serve a compelling state interest."

"PhRMA recommends that if FDA intends to pursue this effort, it should be implemented by means of notice and comment rulemaking in a tailored, risk-based approach that conforms with the Supreme Court's directive that "the First Amendment mandates that speech restrictions be narrowly drawn," PhRMA continued.

The group, which is the largest pharmaceutical trade body in the US, also argues current regulations give FDA adequate review time in which they can pull non-compliant regulations from circulation.

Finally, PhRMA argues FDA should-if at all-implement its proposed guidance through a formal rulemaking process rather than by issuing Guidance for Industry, as the current proposed guidance makes a substantive change to its regulatory practices.

Read more:

PhRMA - Pharmaceutical Research and Manufacturers of America (PhRMA) - Comment

Regulatory Focus - New FDA Draft Guidance on DTC Television Advertisements

Regulatory Focus - FDA Reopens Comment Period on DTC Advertising Regulations

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