From: szycakes@juno.com Sent: Tuesday, November 12, 2002 10:50 PM To: fdadockets@oc.fda.gov Subject: FDA seeking comments on commercial advertising/patent extentions My name is Suzanne and I am writing to offer my comments to the US Food and Drug Administration with regard to the FDA's authority over "commercial speech" especially with regard to pharmaceutical companies' advertisement of prescription drugs. This year, in between Bio-chemotherapy treatments for Metastatic Melanoma, I had the need to be on several kinds of medications from Anti-diarrhea meds, to pain meds, to anti-nausea and anti-anxiety drugs as well. At one point, while attempting to fill one of the prescriptions I had been given to aid in my recovery in between Bio-chemotherapy rounds, I was told I could not get the number of pills prescribed as they were too expensive and my insurance company limited the supply. I was very distraught to learn this at a time this medication which was Zofran was needed most. Not only did they limit how much I could get in the prescription but they also limited me to not being able to refill the shortened prescription for at least another 30 days! There are often cases where a couple similiar kinds of drugs just don't cut it with people. This depends on what works best with the individual's own system. If these pills weren't more than $20.00 per pill (outrageous!), I would not have had a problem (had enough problems at the time with recovering) getting the much needed medication as prescribed by my doctors. What this comes down to is the high cost of advertising, means high cost of medication. Making exceptions to some drug companies by extending their patents beyond the norm means no generic drugs, no competition, but MONOPOLY! I do not believe the pharmaceutical industry needs any weakening of advertising laws, as they already found ways to spend over $2.5 billion in direct-to-consumer marketing in 2000, in addition to $4 billion they spent on marketing to doctors (not including an additional $8 billion in prescription freebies). As a result of these heavy ad campaigns, the pharmaceutical industry was the best performing sector of the US economy the last several years, according to Fortune Magazine, including a lead in every measurable growth area in 2001. 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 jacking up their prices at well over the rate of inflation ? Allegra?has gone up 11%, OxyContin up 15%, and Accutane up nearly 23%. The pharmaceutical industry is preying on its most vulnerable citizens: the sick, infirm, and aging, in its quest for profits. 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 assist in drug company profiteering. The FDA should not cave into the pharmaceutical industry as was done in 1997, when relaxed rules on drug advertising initiated this steady rise in drug costs. Instead, the FDA should concentrate on looking out for the needs of its citizens and assisting federal officials in finding ways to keep costs down, not helping them rise further out of control. Very Sincerely, Suzanne V. - (battling cancer) Manchester, NH