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A Snapshot of Drug Advertising Laws in the USA: Impact on Consumer Protection and Health

Updated: Jul 24

Traditional drug advertisements involve drug ads and promotional material targeted at healthcare professionals to increase clinician knowledge of advancement in treatment options. On the other hand, direct-to-consumer advertising (DTCA) is pharmaceutical advertising directed at patients to increase their awareness of available drugs and treatment options.

There has been renewed interest in the value of DTCA in recent years, which makes it seem like a modern phenomenon, but the practice dates back to early medical training. The argument in support of DTCA is that targeting consumers instead of healthcare providers gives patients power and agency over their drug consumption (Schwartz & Woloshin, 2016). While this argument has some merits, it is vital that we know the history of drug advertisements in the United States to understand how DTCA has shaped public perception of drugs, drug use, and public health. Only with this understanding can we make a sound judgment on the need for DTCA in present times and the future of healthcare.

(Image Source: American Druggist & Pharmaceutical Records.)

In the 1800s and early 1900s, it was common to see drug ads in conventional mass media such as magazines and newspapers. In the last twenty years, DTCA has become an even more prominent mode of drug advertisement because of the increased media promotion avenues available. However, the actors involved and the implication on public health has evolved. In the early 1900s, drug prescription and drug use were only market-and people-driven as there was no legal authority to regulate the market. Manufacturers produced the drugs and promoted them relentlessly to promote sales. With no external entity regulating advertisements and no other source of information, people believed the drug ads and bought the drugs. There were only two actors: sellers and buyers, and the goal was sales.

Source: Kansas City Weekly Journal

The first specific legislation to regulate drugs was enacted in 1906 with the Pure Food and Drug Act. President Theodore Roosevelt signed the law to protect consumers from fraudulent advertising and the marketing of impure and adulterated foods and drugs. The law banned the sale of food, drinks, and drugs that were mislabeled and/or tainted. Then in 1911, the Supreme Court further ruled that the 1906 Food and Drug Act was insufficient because it only required drug manufacturers and marketers to provide true and accurate statements about their ingredients, but it did not forbid false medical claims. This meant that as long as the ingredients of a drug have been adequately identified to be accurate and correct, manufacturers and marketers could claim that it could treat any ailment. In a swift response to the Supreme Court’s ruling, Congress passed the Shirley Amendment in 1912, which forbade drug manufacturers from labeling drugs with false therapeutic claims meant to deceive and defraud buyers. Later in 1933, there was a complete revision and rewrite of the 1906 Food and Drug Act, which was endorsed by the Food and Drug Administration (FDA). Despite this amendment, the release and sales of the Elixir Sulfanilamide, an untested drug, led to the deaths of 107 persons, many of whom were children (Silverman & Lee, 1974; Mogull, 2008).

A summary of drug advertising laws in the United States from 1906 to 2006. Mogull (2008).

The tragic event led to the enactment of the Federal Food, Drug, and Cosmetic Act (FDC) of 1938. This legislation demanded that manufacturers show that new drugs are safe before marketing. The Federal Trade Commission was also authorized to supervise the advertisement of all FDA-regulated products except prescription drugs. This heralded the beginning of “prescription-only” drugs, further emphasized by Congress’s enactment of the Durham-Humphrey Amendment in 1951. The amendment states that certain medications cannot be used without medical supervision and can only be sold if prescribed by a licensed medical professional. In contrast, all other drugs can be sold without such prescriptions. Consequently, drug manufacturers began to target medical professionals in more ads, but DTCA continued on a much lower scale for non-prescription drugs (Auton, 2004).

The 1960s to 1970s was a critical point in the protection of patient safety and health. In 1970, the FDA made an official announcement requiring a “patient package insert.” The patient package insert provides information about the risks and benefits of medicines, especially those sold over the counter (OTC) without a prescription. Through the 1980s and 1990s, the patient package insert remained the norm, with an update in 2006.

DTCA had a major break into the drug market again in the late ’90s and has remained a prominent feature in media since then. The major difference is that the FDA now requires the submission of pharmaceutical companies’ advertising and promotional materials for a proper review before advertising their products. It is also mandatory that DTCA materials effectively communicate all drug benefits, including side effects, risks, and contraindications, in a balanced manner. Television and radio ads that cannot devote enough air time for this are required to provide sources for additional information.

A conceptual framework of DTCA and their impact on public health Frosch et al. (2010)

From the early 2000s till date, there have been claims that FDA laws were excessive and violated freedom of speech and requests for deregulation. In response, the FDA conducted surveys to determine the impact of DTCA on patients and physicians. The conclusion was that DTCA creates more awareness of conditions and treatments and helps healthcare practitioners and patients ask better questions (USFDA, 2004). They argued that although DTCA has both positive and negative impacts, the positives outweigh the negatives. Frosch et al. (2010) also posit that DTCA has educational value and could promote patient decision-making and medication adherence. They, however, warn that uncontrolled DTCA could be a slippery slope that can lead to inappropriate prescribing and damaging public health consequences. Backed by this evidence and arguments, DTCA continues to be prominent in the U.S. under the regulation and guidance of the FDA. To ensure transparency in DTCA, the Department of Health and Human Services (HHS) approved a mandate that list prices for certain prescription drugs should be included in ads (Sullivan, 2019).

The 2021 National T.V. ad spending by pharmaceutical brands in the United States.

Over the years, there have been significant legislative changes in drug advertising, with succeeding laws mostly adding to the preceding laws to ensure the safety and effectiveness of drugs before marketing to consumers. Drug advertising laws were initially only intended to prevent fraud, but it has evolved to protect consumers and improve public health. Although there are debates over intensifying and relaxing drug regulations for human rights violations, drug-related catastrophes, including Elixir Sulfanilamide (1937) and Thalidomide (1961) events continue to be cautionary tales for why regulations are important. These developments paved the way for pre-market testing and approval of drugs with proof of safety and efficacy, along with fair, balanced, and appropriate advertising and promotional activities. Despite the arguments being made by drug companies that DTCA is beneficial to consumers, laws continue to regulate the industry. The lingering question is, “Are the regulations enough to prioritize consumer protection and public health, or are we still where we used to be?”


Editorial Note: This post is part of the Pharmaceutical Inequalities series, funded by the Holtz Center and the Evjue Foundation.


American Druggist & Pharmaceutical Records.

Applequist, J., & Ball, J. G. (2018). An Updated Analysis of Direct-to-Consumer Television Advertisements for Prescription Drugs. Annals of family medicine, 16(3), 211–216.

Auton, F. 2008. The Advertising of Pharmaceuticals Direct to Consumers: A Critical Review of the Literature and Debate. Int J Advert. 23: 5-52

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 health100(1), 24–32.

Kansas City Weekly Journal

Mogull, S.A. (2008). Chronology of Direct-to-consumer advertising regulation in the United States. AMWA (23), 3: 106-109.

Schwartz LM, Woloshin S. Medical Marketing in the United States, 1997-2016. JAMA. 2019;321(1):80–96. doi:10.1001/jama.2018.19320

Silverman, M., Lee, P.R. (1974). Pills, Profits, and Politics. Berkeley: Univ. Calif. Press.

Southern Tide Media (n.d). Say ‘Yes’ to Drugs? The History of Pharmaceutical Marketing

Sullivan, T. (n.d.). HHS finalizes rule requiring manufacturers disclose drug prices in TV ADS: Requires ads to include WAC list price. Policy & Medicine. Retrieved December 31, 2022.

The Practical Druggist and Review of Reviews (1917).35(5).

U.S. Food and Drug Administration (2004). Patient and Physician Attributes and Behaviours Associated with DTC Promotion of Prescription Drugs – Summary of FDA Survey Research Results.

#Advertising #Policy #Drugs #FDA #marketing #Pharmaceuticals

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