Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -404

Accepted - Volume 6

Comment Record
Commentor Mr. Ray Prushnok Date/Time 2002-09-11 12:33:45
Organization New Mexico Public Interest Research Group (NMPIRG)
Category Consumer Group

Comments for FDA General
2. Is FDA's current position regarding direct-to-consumer and other advertisements consistent with empirical research on the effects of those advertisements, as well as with relevant legal authority? What are the positive and negative effects, if any, of industry's promotion of prescription drugs, biologics, and/or devices? Does the current regulatory approach and its implementation by industry lead to over-prescription of drugs? Do they increase physician visits or patient compliance with medication regimes? Do they cause patient visits that lead to treatment for under-diagnosed diseases? Does FDA's current approach and its implementation by industry lead to adequate treatment for under-diagnosed diseases? Do they lead to adequate patient understanding of the potential risks associated with use of drugs? Does FDA's current approach and its implementation by industry create any impediments to the ability of doctors to give optimal medical advice or prescribe optimal treatment? Dockets Management Branch Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville MD, 20825 RE: Docket 02N-0209 My name is Ray Prushnok and I am writing on behalf of the New Mexico PIRG and our 4,000 members to offer comments on the US Food and Drug Administrationís authority over commercial speech especially with regard to pharmaceutical companies' advertisement of prescription drugs. New Mexico PIRG opposes any weakening of advertising laws relating to the pharmaceutical industry. The pharmaceutical industry spent over $2.5 billion in direct-to-consumer marketing in 2000, in addition to $4 billion spent on marketing in doctorsí offices (not including an additional $8 billion in free prescription samples). As a result of these promotions, the pharmaceutical industry was the best performing sector of the US economy the last several years, according to Fortune Magazine. Their profits were driven largely by enormous returns on aggressively marketed pharmaceuticals - with 34 of these high profile drugs making up more than 50% of the industry's skyrocketing profits. In addition to selling to more and more consumers, drug companies are raising their prices at well over the rate of inflation. One example is the prescription drug Accutane. The cost of Accutane skyrocketed nearly 23% in one year. The pharmaceutical industry is targeting our most vulnerable citizens: the sick, infirm, and aging, in order to expand their profit margins. The Food and Drug Administration should maintain and improve its role as the watchdog for what Americans consume in the name of health, rather than facilitate drug company profiteering. The FDA should not give in to pharmaceutical industry pressure as was done in 1997, when relaxed rules on drug advertising initiated this steady rise in drug costs. Instead, the FDA should concern itself with the needs of its citizens and assisting federal officials in finding ways to keep costs down. Please accept these as official public comments. If you have any questions feel free to contact me at 505/254-1244. Thank you, Ray Prushnok Consumer Protection Fellow New Mexico PIRG 135 Harvard SE, ABQ, NM 87106 PO Box 40173, ABQ, NM 87196 P: 505/254-1244 F: 505/254-2280 E:

EC -404