Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -427

Accepted - Volume 6

Comment Record
Commentor Mr. Jonathan Thatcher Date/Time 2002-09-13 19:59:00
Organization Kronos Compounding Pharmacy
Category Company

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? The FDA has a duty to protect the public health, and this is best accomplished by providing clear and accurate information to those to whom the communication is most applicable and pertinent. As a compounding pharmacy, our mission is to provide such truthful information to the medical professionals that prescribe our products as well as the consumers that require counseling regarding the effects of these drugs. The Supreme Court recently held that broad-based restrictions on commercial free speech should not be employed to further public health concerns where other, more direct means were available. Per se restrictions on accurate product advertising and usage information distributed to a physician, or restrictions on the information disseminated from a physician to a patient restrict free speech and do not inherently enhance public safety. We would encourage the FDA to increase the quality and amount of information available by enhancing the content and scope of referenced texts, accredited CME programs and peer-reviewed articles. The best way to ensure the protection of the public is to ensure the efficient provisioning of accurate information with sufficient detail to provide a solid basis to make medical decisions.
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? Misleading Promotional Speech Any truthful information which is clearly communicated in an understandable way is not by its nature misleading. Any other form of communication has the potential to mislead. We recommend that more emphasis be placed on developing specific accredited sources of medical information and review, and then use those to provide or validate information regarding products and effects. Failure to develop additional broad based and authoritative resources may result in the deterioration of the FDA into the role of speech police, which would distort its mission and dilute its effectiveness.
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? Information Regarding Off-Label Indications The need of a physician to obtain information regarding off-label indications when such information is based on solid scientific evidence and medical opinion needs to be weighed against the need to maintain the integrity of the new drug approval process. Such off-label uses should be supported by peer-reviewed journal articles and referenced medical texts.
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? Speech-related Regulations and Public Health Certain current regulations may have the effect of restricting truthful speech which may be beneficial to public health. A number of alternatives to free speech restrictions exist. For example, the FTC’s scheme of issuing guidelines for truthful advertising furthers the government’s interest while allowing advertisers to freely apply the guidelines to their own business objectives. By far the best protection is an informed base of qualified medical practitioners with access to all accurate and applicable information, prescribing accurately dosed therapies to a well-educated and aware patient population. Any regulation that restricts accurate information from medical professionals and their patients is detrimental to the health care system.

EC -427