Testimony to the FDA Nonprescription Drugs Advisory Committee and Endocrinologic and Metabolic Advisory Committee Meeting

July 13, 2000

The National Consumers League, America’s oldest consumer advocacy organization, is pleased to testify today about the possible switch of low-dose statin medications to nonprescription status. NCL has a long history of advocating for and educating consumers about safe and appropriate medication use, both prescription and nonprescription. NCL is aware of the growing trend by consumers to take a more active role in their own health care, and we are working to ensure that consumers are well informed in order to make the most beneficial choices about their own health.

According to consumer surveys we have commissioned during the past several years, consumers see their increased role in the health care system as a positive change. An overwhelming majority, 86 percent, of consumers feel that having an increased role in their own health care is positive.[1]

NCL has also focused more specifically on the area of coronary heart disease, America’s leading cause of death and disability.[2] In a survey NCL commissioned in 1998 to discern consumer knowledge and attitudes about CHD, 88 percent of respondents said they would like to know as much as possible about lowering their risk of CHD[3], and 52 percent did not know their cholesterol level.[4]  Further, 64 percent of Americans are confused about how to live a healthy lifestyle.[5] On a positive note, 85 percent cited their doctor as the most reliable source for information about lowering their risk of CHD.[6]

Because of the continued confusion about CHD and cholesterol, and because consumers are taking a more active role in health care decision making, NCL feels that it is important understand consumer attitudes toward possible OTC cholesterol lowering medications. And more importantly, we wanted to see how a new OTC product would be perceived and how consumers say they would use such a product. We were concerned that consumers would not consult their doctors before or during use of an OTC statin; however, our survey results overwhelmingly demonstrate consumer willingness to continue to consult with their doctors and follow their advice.

Another concern has to do with the use of dietary supplements. Many consumers are currently using these products, which are untested and unproven to safely or effectively treat high cholesterol, as well as many other serious health conditions. Further, many consumers do not tell their doctors about them, which possibly may lead to dangerous interactions or side effects. In our most recent survey, 28 percent of the population use these products regularly or often, and 65 percent use vitamins. If consumers are already using products to treat their cholesterol, they should at least be using ones that are well tested and have a well-documented history of use.

It is quite apparent that low dose cholesterol lowering drugs work when used appropriately and lower people’s cholesterol levels. If the FDA determines that the safety profile of a low dose statin medication is sufficient, and that consumers will be able to them appropriately, we are recommending that if such a product does switch to a nonprescription status, it is important that there be a dual status (prescription/nonprescription) for such a medication. Further, there must be clear label directions about warnings, precautions, side effects, and interactions. We would also like to see clear label directions urging people to check with their physicians before using such a product, and to continue to have regular physician visits while taking the medication. And of course, we want to make sure the labeling and package inserts are easy to read and understand.

National Consumers League

Brett Kay

Health Policy Associate

For more information, write the National Consumers League at 1701 K Street, N. W., Suite 1200, Washington, DC 20006; 202-835-3323.

The National Consumers League, founded in 1899, is America's pioneer consumer organization. NCL's three-pronged approach of research, education and advocacy has made it an effective representative and source of information for consumers and workers. NCL is a private, nonprofit organization representing the consumer on marketplace and workplace issues.