Q&A on the FDA Request for Comment on First Amendment and Commercial Speech Issues

What is the FDA's Request for Comment?

When are comments due?

How do I submit comments?

What should I say in my comments?

How should I present my comments?

What is the existing law with regard to commercial speech?

Why shouldn't commercial speech have strong constitutional protections?

Relevant FDA Notices and Related Material

Relevant FDA Notices and Related Material

Suggestions for Submitting Comments

On corporate constitutional rights and commercial speech

On Direct-to-Consumer pharmaceutical advertising

On Tobacco advertising

Background Infromation

Corporate Constitutional Rights and Commercial Speech

Direct-to-Consumer Pharmaceutical Advertising


If you want to comment on the issue of Direct-to-Consumer prescription drug advertising, you may want to consider saying:

* While it is vital that consumers be empowered with information about pharmaceuticals, DTC ads are about promotion, not education.

* Many DTC ads understate safety risks, which is likely to lead to inappropriately increased consumer demand.

* Much of the public mistakenly believes DTC ads receive special clearance from the FDA -- and that only the safest drugs can be advertised on television -- leaving consumers vulnerable to and overly trusting of DTC promotions.

* DTC ads generally fail to provide key information to consumers: success rate for the drug, alternative treatments, how long the drug must be used.

* Evidence shows that physicians are influenced by advertising to make poor prescription decisions; consumers are similarly affected.

* DTC ads encourage consumers to demand brand-name products from doctors. Evidence suggests doctors are influenced by these demands, and sometimes prescribe requested medicines despite ambivalence about the choice of treatment.

* DTC ads encourage to consumers to buy needlessly expensive products instead of cheaper generics, burdening the overall health care system.

* Given the proliferation of DTC advertising, the widespread abuses, and the paucity of evidence suggesting DTC ads contain significant educational information or improve patient well-being, the FDA should be moving the in direction of more rather than less regulation of DTC ads.

* The FDA should issue regulations specifically for DTC advertising, to establish clear rules for what is and is not permitted.

* One important step would be pre-review by the FDA of ads; the current system relies on self-restraint by drug manufacturers and a very inadequate and underfunded system of FDA warning letters sent after offending advertisements are aired or published.

* DTC advertisers should be required to run corrective ads after receiving FDA warning letters

* Consumers should be empowered with useful information. This should be provided by FDA on the Internet, in inserts included with pharmaceuticals, and elsewhere. The information should be written in easy-to-understand language, and include information on success rates, and comparative efficacy and pricing data. This is how consumers' right to know should be satisfied, not through promotional advertisements that are inevitably slanted.

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