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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?
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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 Administration’s 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 doctors’
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: rjprushnok@yahoo.com
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