Docket Management
Docket: 01N-0078 - Assessment Attitudes Toward Direct-to-Consumer Promo of Prescription Drugs
Comment Number: EC -9

Accepted - Volume 1

Comment Record
Commentor Mr. Arthur Levin Date/Time 2001-05-18 13:21:51
Organization Center for Medical Consumers
Category Consumer Group

Comments for FDA General
1. Is the proposed collection of information necessary for the proper performance of FDA's functions? Will the information have practical utility? We believe that the FDA has a responsibility to collect data on the effects of direct to consumer advertising of presciption drugs. After all, it was FDA's change in previous policy that gave rise to the explosion in dtc promotion that has occured post-1997. The utility of the information collected depends in large measure on whether the proposed survey asks the right questions. There is every possibility, given a good survey instrument, that the information can help the FDA judge the benefits and the risks of their change in dtc policy.
2. What is the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used? no comment
3. What are ways to enhance the quality, utility, and clarity of the information to be collected? The survey is a mix of hypothetical and experiential questions aimed at both doctors and patients. However,none are case study format - that is, tied to real dtc ads and drug products. The patient survey seems to be especially attitudinal in character. For example, it would be interesting to know whether any consumers have experienced harm as a result of proliferation of dtc advertising that they might not have been exposed to pre-1997. Or, are there things that patients misunderstood about benefits and risks of a product that they saw and heard in the dtc promotion. Or, did any patient follow the suggestion that more information be obtained from other sources (web site, print ad, 800 number)?
4. What are ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology? The Internet provides a unique way to simply the survey process. Responding to a menu driven survey instrument of this size would be much easier than doing so by telephone or other means.
5. General Comments While we are pleased that the FDA is taking a look at the effects of dtc - we regret that the survey instrument doesn't name names and at least try to mine more critical information about dtc and dtc policies.

EC -9