Caution: Drug advertisements may be hazardous to your health!

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm072077.htm

It does not go without notice (and with some irritation) how frequently drug advertisements (both prescription and over- the-counter) fill the media, especially television, newspapers and the internet. If you think oversight of food safety is chaotic, so too is oversight of drug safety, efficacy, and advertisement. “A drug is "prescription only" when medical professionals must supervise its use because patients are not able to use the drug safely on their own. Because of this, Congress laid out different requirements for prescription and non-prescription or "over-the-counter" drugs. Congress also gave the Food and Drug Administration (FDA) authority to oversee prescription drug ads. In turn, the FDA passed regulations detailing how it would enforce those requirements. These regulations are also known as "rules." However, while the FDA oversees ads for prescription drugs, the Federal Trade Commission (FTC) oversees ads for over-the- counter (non-prescription) drugs.”

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm072077.htm

What Is Direct-to-Consumer Drug Advertising? “DTCPA can be defined as an effort (usually via popular media) made by a pharmaceutical company to promote its prescription products directly to patients. The U.S. and New Zealand are the only countries that allow DTCPA that includes product claims. Most other countries don’t allow DTCPA at all; however, Canada does allow ads that mention either the product or the indication, but not both. The pharmaceutical industry and lobby groups have tried unsuccessfully to overturn bans against DTCPA in Canada and other countries or regions, such as in the European Union (EU). Notably, in 2008, 22 of the 27 EU member states voted against proposed legislation that would have allowed even limited “information to patients” to be provided. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/

“Researchers Adrienne E. Faerber of The Dartmouth Institute for Health Policy & Clinical Practice and David H. Kreling of The University of Wisconsin-Madison School of Pharmacy found that potentially misleading claims are prevalent throughout consumer-targeted prescription and non-prescription drug advertisements on television.” …”Over the past 15 years, researchers and policymakers have debated whether drug advertising informs consumers about new drugs, or persuades consumers to take medicines that they may not need. "Healthcare consumers need unrestricted access to high- quality information about health," said Faerber of The Dartmouth Institute, "but these TV drug ads had misleading statements that omitted or exaggerated information. These results conflict with arguments that drug ads are helping inform consumers." http://www.sciencedaily.com/releases/2013/09/130916140455.htm Researchers found false claims, (factually false or unsubstantiated) rare (only 1 in 10 claims false). False advertising is illegal and can lead to criminal and civil penalties. “Most claims were potentially misleading -- 6 in 10 claims left out important information,

exaggerated information, provided opinions, or made meaningless associations with lifestyles.” “False or potentially misleading claims may be more frequent in over-the-counter drug ads than ads for prescription drugs -- 6 of 10 claims in prescription drug ads were misleading or false, while 8 of 10 claims in OTC drug ads were misleading or false.” http://www.sciencedaily.com/releases/2013/09/130916140455.htm

Food for thought: how many hours each year of television drug advertising do you watch compared to how many yearly hours/minutes of visits with your primary care physician? DTC advertising has been subject to charges such as it encourages consumers to pressure doctors for drugs they don’t need, glamorizes drugs that have later been found to have dangerous side effects, and promotes medical drugs for recreation uses (e.g., erectile-dysfunction drugs).

Significant dates Food and Drug Law History:

www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/ucm128305.htm

Other sites to consider:

http://www.commercialalert.org/news/archive/2006/10/ten-years-later-direct-to-consumer-drug-advertising (up through 2014) and http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/