Direct-to-consumer prescription drug advertising restrictions are the regulations placed on pharmaceutical companies that use direct-to-consumer pharmaceutical advertising (DTCPA) to market their products and to educate the general public about the benefits and risks of prescription drugs (Ventola, 2011). The U.S. Food and Drug Administration (FDA) regulates DTCPA for all prescription drugs, including scheduled drugs.
To reduce patient misinformation about prescription drugs and to prevent over-prescription
While the FDA regulates DTCPA, drug manufacturers are not required to obtain clearance from the FDA prior to disseminating an ad. As a result, drug companies are held liable to FDA regulations only after a violation has been identified (Ventola, 2011). FDA DTCPA regulations apply to four categories of promotional materials (FDA, 2013):
- Product claim advertisements—DTCPA that names a drug and discusses its benefits and risks (FDA, 2013):
- Ads must not be false or misleading in any way.
- Companies are encouraged to use clear language that consumers will understand.
- All product claim ads, regardless of the media in which they appear, must include key components—such as the name of the drug, its FDA-approved uses, and its most significant risks—within the main part of the ad.
- Print product claim ads must include a brief summary of all risks listed in the product's approved prescribing information.
- Under the FDA Amendments Act of 2007, print advertisements must include the following statement: "You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088" (FDA, 2013, ¶ 6).
- Broadcast product claim ads (TV, radio, telephone) must include the drug's most important risks in audio form. In addition, they must either list all the risks or provide sources where viewers can find the FDA-approved prescribing information that presents all the risks.
- When the FDA finds a violation, a warning letter is sent to drug manufacturers requesting corrective action: a plan to withdraw the DTCPA and provide accurate information to the DTCPA's audience.
- Note: In 2003, the FDA sent such a letter to Purdue Pharma regarding the print marketing for OxyContin (FDA, 2015).
- Reminder advertisements—DTCPA that gives the name of a drug but not the drug's uses. These ads assume that the audience is already aware of the drug and its uses (FDA, 2013).
- The ads do not have to contain risk information, because they do not say what the drug does or how well it works.
- They cannot suggest, in either words or pictures, anything about the drug's benefits or risks (for example, a reminder ad for a drug that helps treat asthma should not include a drawing of a pair of lungs, as this implies the drug's usage).
- They are not allowed for drugs that the FDA considers to have serious risks.
- Note: Drugs with serious risks are required to have a special warning, often called a "boxed warning," in all of their advertising and in each drug's FDA-approved prescribing information. Boxed warnings are required for drugs that can cause serious adverse reactions, which either (a) are not proportional to their benefits, or (b) can be prevented through appropriate and monitored use. Boxed warnings are also required for drugs given FDA "approval with restrictions to safe use" (such as extended-release and long-acting opioids) (FDA, 2011, p. 11).
- Help-seeking advertisements—DTCPA that describes a disease or condition but does not recommend or suggest a specific drug treatment (FDA, 2013):
- Ads can include a drug company's name and can also provide a telephone number to call for more information.
- The FDA does not consider these "drug ads" and does not regulate true help-seeking DTCPA. If an ad recommends or suggests the use of a specific drug, it is considered a product claim ad and must comply with FDA rules.
- Help-seeking ads are regulated by the Federal Trade Commission.
- Other product claim promotional materials, such as "promotional labeling" and brochures, materials mailed to consumers, and other types of materials given out by drug companies. If these materials mention the drug's benefit(s), they must also include the drug's prescribing information.
- Note: The United States and New Zealand are the only industrialized countries that allow DTCPA of prescription drugs (World Health Organization, 2009).
- Additional restrictions on prescription drug DTCPA have been proposed (Ventola, 2011; Vogt, 2005), for example:
- Delaying advertising for new prescription products
- Note: The Pharmaceutical Research and Manufacturers of America trade association issued guidelines after the 2004 Vioxx recall, recommending that DTCPA for new prescription drugs be delayed until "the drug's safety profile is fully established and health care professionals are educated as to the drug's proper use" (Ventola, 2011, "Delay Advertising for New Products," ¶ 2). Although these guidelines are voluntary, in 2007, many drug manufacturers waited an average of 15 months after FDA approval before beginning DTCPA.
- Requiring FDA pre-clearance of DTCPA to ensure that it meets current regulations before being seen by the public
- Note: In 2008, the FDA planned to implement a pre-clearance program primarily funded by user fees from drug manufacturers; however, the program was cancelled due to inadequate funding.
- Establishing regulations for online DTCPA that require online content to include a notification if sponsored by a drug manufacturer
- Requiring DTCPA to replace qualifying statements with quantitative data from clinical trials
- Improving patient comprehension and ensuring that more consumers understand the information and product risks by requiring all language in DTCPA to adhere to a lower literacy standard
- Banning ads for specific products and replacing current DTCPA with non-branded information campaigns that promote the benefits of drug classes and encourage consumers to discuss treatment options with their healthcare providers
- Banning all prescription drug DTCPA
- Note: The United States did not allow DTCPA for prescription drugs until 1985, and maintained strict requirements over the content of ads until 1997 (World Health Organization, 2009).
- Delaying advertising for new prescription products
General public, prescription drug manufacturers
- Economic simulations have linked the expansion of prescription drug DTCPA from 1995 to 2005 with a 19% increase in prescription drug expenditures during that time (Dave & Saffer, 2010).
- A systematic review of the empirical literature on DTCPA found insufficient evidence to support claims that DTCPA is an effective educational vehicle or is effective at promoting adherence to prescribed regimens (Frosh, Grande, Tarn, & Kravitz, 2010).
- In a 2002 survey of 500 office-based primary care and specialist physicians, respondents reported that although DTCPA increases patient awareness of prescription drugs and potential treatments for health conditions, it does not increase awareness of potential risks. Physicians also reported increased pressure from patients to issue prescriptions (Aiken, Swasy, & Braman, 2004).
- DTCPA that presents numeric information (such as "25% of patients") has been linked to improved understanding of the risks and benefits of prescription drugs relative to non-numeric presentations (West et al., 2013).
Aiken, K. J., Swasy, J. L., & Braman, A. C. (2004). Patient and physician attitudes and behaviors associated with DTC promotion of prescription drugs: Summary of FDA survey research results. Retrieved from https://www.sciencedirect.com/science/article/abs/pii/S0362331913000311
Dave, D., & Saffer, H. (2010). The impact of direct-to-consumer advertising on pharmaceutical prices and demand. National Bureau of Economic Research Working Paper 15969. Retrieved from http://www.nber.org/papers/w15969.pdf
Frosch, D. L., Grande, D., Tarn, D. M., & Kravitz, R. L. (2010). A decade of controversy: Balancing policy with evidence in the regulation of prescription drug advertising. American Journal of Public Health, 100(1), 24–32. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2791253/
U.S. Food and Drug Administration. (2011). Guidance for industry: Warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products—Content and format. Retrieved from http://www.fda.gov/downloads/Drugs/Guidances/ucm075096.pdf
U.S. Food and Drug Administration. (2013). Prescription drug advertising. Retrieved from https://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/default.htm
U.S. Food and Drug Administration. (2015). Timeline of selected FDA activities and significant events addressing opioid misuse and abuse. Retrieved from https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm338566.htm
Ventola, C. L. (2011). Direct-to-consumer pharmaceutical advertising: Therapeutic or toxic? Pharmacy and Therapeutics, 36(10), 669–674, 681–684. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/
Vogt, D. U. (2005). Direct-to-consumer advertising of prescription drugs. Washington, DC: Congressional Research Service. Retrieved from http://congressionalresearch.com/RL32853/document.php
West, S. L., Squiers, L. B., McCormack, L., Southwell, B. G., Brouwer, E. S., Ashok, M., . . . Sullivan, H. W. (2013). Communicating quantitative risks and benefits in promotional prescription drug labeling or print advertising. Pharmacoepidemiology and Drug Safety, 22(5), 447–458.
World Health Organization. (2009). Direct-to-consumer advertising under fire. Bulletin of the World Health Organization, 87(8). Retrieved from http://www.who.int/bulletin/volumes/87/8/09-040809/en/