Source: http://pharmapdf.com/c/commlawreview.org1.html
Timestamp: 2019-04-25 20:09:38+00:00

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There are two bases for regulating advertisements, one unique to medicines and other things ingested, to ensure safe products, and the other common to all advertisements, to ensure fair competition. In 1962, Congress gave the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) concurrent jurisdiction over the regulation of prescription drug advertising.4 The FDA stepped forward to write preliminary regulations in 1975,5 fulfilling its mission to “promote the public health by… taking appropriate action on the marketing of regulated products in a timely manner.”6 Although both FDA and FTC regulations apply to advertising of prescription drugs,7 they focus on different aspects of the same advertisements to ensure truthfulness. The FDA ensures truth in medical claims and ingredients listed “to ensure that drug products purchased by consumers are safe and effective”8 and the FTC is concerned with the advertisement with regard to consumer protection in claims made.9 This is in keeping with the FDA’s mission to protect the health and safety of Americans by ensuring unadulterated foods and fair labeling10 and the FTC’s mission to ensure consumer protection and prevent unfair competition.11 The agencies have the same roles in regulating the labeling and advertising of over-the-counter 3 Id. at 774. 4 21 U.S.C.A. § 352(n) (2007). 5 Timothy S. Hall, The Promise and Peril of Direct-to-Consumer Prescription Drug Promotion on the Internet, 7 DePaul J. Health Care L. 1, 8 (2003). 6 21 U.S.C. § 393(b)(1) (1998). 7 21 U.S.C.A. § 352(n) (2007). 8 U.S. Food and Drug Administration, Prescription Drug Marketing Act (PDMA), http://www.fda.gov/cder/regulatory/PDMA/default.htm (Accessed May 8, 9 15 U.S.C. § 45(a)(2) (2000) as amended. 10 U.S. Food and Drug Administration, What FDA Regulates, http://www.fda.gov/ comments/regs.html (Accessed April 25, 2008). 11 Fed. Trade Commn., About the Federal Trade Commission, http://ftc.gov/ftc/about. shtm (Accessed April 25, 2008). 12 Hall, 7 DePaul J. Health Care L. at 7. The FDA regulates for truthfulness the advertising of all medications, whether directed at customers or sent to medical professionals.13 “Advertising” in this case, defined by §202.1, includes “advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communications systems.”14 In addition to its work on advertising, the FDA regulates all drug labeling, which includes any written matter describing or marketing a drug. Any violation of the many standards of § 202.1 causes the drug to be considered “misbranded.”15 The FDA requires all marketing materials meant for medical professionals to be FDA-approved before dissemination. Disseminating these materials without approval constitutes misbranding, so manufacturers get this approval or correct advertisements as required to avoid regulatory action by the FDA.16 Materials meant for potential customers, however, are not required to be approved before they run. The FDA does request the opportunity to approve them. In practice, this request is a requirement. “FDA's substantial enforcement authority functions to give the agency great in terrorem powers to ensure that even its ‘voluntary’ policies are followed.”17 There is little to no area for state regulation of There are three major types of direct-to-consumer advertisements: product-claim, reminder, and help-seeking.19 Product-claim advertisements are the type with which consumers are most acquainted. These are ads that give the name of a drug and explain what it is for or which symptoms it might alleviate. On radio and TV, these are generally 30-second advertisements. These are the only ads that are regulated by the FDA, and the only ads to make claims. Reminder ads are shorter than product-claim advertisements. These sound more like, “My allergy symptoms leave me in a fog. Talk to your doctor about how you can live Claritin clear.” There are no claims about the drug or what it does. Its purpose is to remind the potential customer of the full advertisement he or she saw before. They generally have the same Product-claim ads that list benefits of a drug must also list the contraindications, the side effects or risks, of the drug. Help-seeking ads are less familiar to viewers. These advertisements look more like public service announcements in that their purpose is to bring light to a medical condition, generally by listing symptoms. They do not mention or hint at any prescription drug but encourage a viewer who recognizes symptoms to speak with a doctor about possible treatments. Because they contain no claims or references to prescriptions, they are not required to list any warnings. The FDA does not consider this type of ad to even be a prescription drug ad and so does not regulate them.20 1313 Id. at 7. 14 21 C.F.R. § 202.1(l)(1) (2008). 15 William A. Dreier, Liability for Drug Advertising, Warnings, and Frauds, 58 Rutgers L. Rev. 615, 629 (2006). 16 Id. at 636-37. 17 George W. Evans and Arnold I. Friede, The Food and Drug Administration’s Regulation of Prescription Drug Manufacturer Speech, 58 Food & Drug L.J. 365, 424 18 Dreier, 58 Rutgers L. Rev. at 631. 19 Woodcock, Janet M.D., Statement before Senate Special Committee on Aging (Washington D.C., July 22, 2003) (available at 2003 WL 21701807) referencing FDA’s Guidance for the Industry: “Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms available at http://www.fda.gov/cder/guidance/6019dft.pdf (Accessed May 8, 2008). (Dr. Janet Woodcock was the Director for Center for Drug Evaluation and Research at the Federal Drug Administration at the time of this statement.) cited in Winkler, Student Author, You Wanted the Best, You Got the Best! The Current Direct-to-Consumer Prescription Drug Advertisement Dilemma, 26 Biotechnology L. Rep. 331 (2007). 20 Josef Winkler, Student Author, You Wanted the Best, You Got the Best! The Current Direct-to-Consumer Prescription Drug Advertisement Dilemma, 26 Biotechnology L.

References: § 352
 § 393
 § 352
 § 45
 §202
 § 202
 § 202