Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -374

Accepted - Volume 6

Comment Record
Commentor Mr. Mark Makino Date/Time 2002-09-09 17:35:02
Organization Mr. Mark Makino
Category Individual

Comments for FDA General
1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction? Drugs, unlike dietary supplements, have proven effects both good and bad. Promotional speech about drugs is misleading because the promoter seeks primarily to sell the product rather than inform the consumer. Consumers are not savvy medical professionals or learned intermediaries and thus need the drug's effects spelled out to them more rigorously.
3. May FDA distinguish claims concerning conventional foods from those relating to dietary supplements, taking into account limits on claims that can be made about foods in the Nutrition Labeling and Education Act, 21 U.S.C. 301, 321, 337, 343, 371? What must an administrative record contain to sustain or deny claims on food labels? How can information best be presented in a succinct but non-misleading fashion? To what extent do assertions in claims need qualifications or disclaimers added to the label to avoid any misconceptions that consumers may draw? Is there a basis to believe that consumers approach claims about conventional foods and dietary supplements differently? The burden of proof should be first on the seller when it comes to claims on labels. The maker of the food/drug/supplement should have to test until it has proven to the FDA that it does what they say it does. This should defuse any issues of proof.
4. Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Is there any relevant authority or social science research on this issue? claims should be larger than disclaimers, but the disclaimers should always be prominently places, no less than 1/2 the font size of the claims on the same package.
5. How can warnings be made most effective in preventing harm while minimizing the chances of consumer confusion or inattention? Is there any evidence as to which types of warnings consumers follow or disregard? place the warning on the opposite side of the package. That way it doesn't interfere with the hook but any consumer who even attempts to examine the package will notice it.
6. What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels? The label is to inform the consumer, the ad is to attract them. The label can be seen as a stricter no advertising zone in which the FDA gets to say more of what is printed, the ad is the company's speech, which altho it should not be protected under the first amendment, should be freer than the labels. The ad brigns the consumer to the store, and the label informs them of what the drug/food/supplement really does.
7. Would permitting speech by manufacturer, distributor, and marketer about off-label uses undermine the act's requirement that new uses must be approved by the FDA? If so, how? If not, why not? What is the extent of FDA's ability to regulate speech concerning off-label uses? Yes, such advertising should not be allowed, as it is a loophole which allows companies to advertise a a product as something other than what it was tested for. The FDA should restrict and regulate speech concerning off-label uses as strongly as it regulates the stated uses.
8. Do FDA's speech-related regulations advance the public health concerns they are designed to address? Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech? Regulating speech of food and drug companies is essential to public health. Since the FDA will never have as much money as Coke or McDonalds, issuing competing ads is an impossibility.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Commercial speech should not be constitutionally protected. Please inform the Judicial Branch.

EC -374