The systematic use of DTCA and its harmful effects have led WADA to oppose this type of advertising. WADA was concerned that “the increasing prevalence of advertising is driving demand for expensive treatments despite the clinical effectiveness of cheaper alternatives.” The AMA`s position is representative of the growing skepticism of DTCA in the medical community. If the country`s largest medical association is voicing concerns about this practice, why are pharmaceutical companies still using DTCA? American Medical Association. WADA calls for temporary moratorium on the direct marketing of new prescription drugs; 2005. Available at: www.ama-assn.org/ama/pub/category/print/16467.html. Retrieved 11 July 2006. Food and Drug Administration. Guide for the Industry: Consumer-Oriented Radio Advertising. www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125064.pdf. Retrieved 1 October 2013. The lack of FDA regulations imposing a DTCPA waiting period for newly approved drugs is also criticized.5 The Pharmaceutical Research and Manufacturers of America (PhRMA) has published proposed guidelines for submitting DTCPA to the FDA for approval, as well as wait times for consumer advertisements for new drugs.5 However, These guidelines are criticized as being very discretionary. voluntary and unenforceable.5 For more information, see the final report, which summarizes the three direct mail consumer surveys conducted by Prescription Drug Promotion Research. Recently, there has been some controversy about direct-to-consumer advertising (DTC) and whether such drug advertising should be allowed.
The U.S. pharmaceutical industry announces direct mail policies. PhRMA press release; 2005. Available at: www.phrma.org/news_room/ press_releases. Retrieved 11 July 2006. Want to know more about the hidden and real costs of advertising DTP drugs? Connect with us! Send an email gupta22r@mtholyoke.edu to have a discussion about this market. The FDA oversees prescription drug advertising under the federal Food, Drug and Cosmetic Act and related regulations. This means that the agency must ensure that the information provided by pharmaceutical companies on prescription drugs is truthful, balanced and accurate.
This will be achieved through a comprehensive monitoring, enforcement and education programme, as well as the promotion of better communication of labelling and advertising information for health professionals and consumers. The survey of 500 physicians, released in November 2004, is the third in a series of evaluations used by the FDA to better understand how DTC advertising for prescription drugs affects the patient-physician relationship. Some critics argue that FDA regulations regarding DTCPA are too lax.5 They complain that FDA rules do not prevent DTCPA violations because drug manufacturers are only held liable after a violation is detected.5 Since pharmaceutical companies are not required to obtain DTCPA approval prior to distribution (“pre-authorization”), misleading advertising could continue until a letter is issued by the DDMAC. 20 The FDA may require that a DTC notice be amended in response. a violation; However, critics say it won`t make consumers forget the misleading information they saw in the original ad.5 Even if pharmaceutical manufacturers voluntarily submitted more DTC ads to the FDA for pre-approval, the agency said that “the FDA`s current resources for this work would likely cause delays in reviews and discourage [manufacturers] from submitting the documents. 6 Boden WE, Diamond GA. DTCA for PTCA – Crossing the Line in Consumer Health Education? NEJM. 2008;358(21):2197-2200. Proponents of DTCA have addressed the promise of an informed and healthy population, touting DTCA`s ability to give consumers access to multiple sources of health information and encourage patients to explore a much wider range of treatment options than relying solely on information from their doctors [11].
Proponents also claim that patients who have a wealth of health information on hand are more likely to seek their doctor`s advice [12] and turn to their doctor to discuss conditions they may have overlooked in previous appointments [13]. Some evidence suggests that these claims are true. In a 2004 FDA survey, 53% of physicians reported having better conversations with their patients about medical treatment options through DTCA and found that their patients asked more thoughtful and informed questions about their medical care [13]. Other proponents argue that DTCA can reduce underdiagnosis and undertreatment of certain conditions [14], help reduce the stigma associated with certain diseases [15], and potentially promote adherence to their current treatments [16]. It can increase the cost of drugs of equal effectiveness. Because DTCA represents marketing, critics believe that branding and presentation can lead to ill-informed choices.