The US pharmaceutical industry spent $6.1 billion on advertising prescription drugs directly to consumers in 2017. Since 1962 these ads have been regulated by the Food and Drug Administration (FDA) to ensure that they are not false or misleading. The United States and New Zealand are the only two countries where direct-to-consumer (DTC) advertising of prescription drugs is legal.
Proponents of DTC prescription drug ads contend that the ads inform patients about diseases and possible treatments, encourage people to seek medical advice, help remove stigma associated with medical conditions, and provide needed sales revenue to fund costly research and development (R&D) of new drugs.
The increased use of mass media advertising for prescription drugs has been controversial. Opponents of DTCA argue that it misleads consumers into taking costly prescription drugs that they do not need and that in seeking to sell products, pharmaceutical marketers turn normal human experiences with things like hair loss or shyness into diseases. Then, after the September 2004 withdrawal of Vioxx due to evidence of increased cardiovascular risk, critics called for at least a partial ban on DTCA. In contrast, advocates of DTCA argue that prescription drug ads are an appropriate and highly valued source of information for empowering health care consumers.
On June 6, 1906 the first federal drug legislation, the Pure Food and Drug Act, was signed by Theodore Roosevelt to regulate product labels but did not regulate advertisements. The Act required accurate labels showing content and dosage for certain drugs like alcohol, cocaine, heroin, morphine, and cannabis. The US Supreme Court ruled in 1911, in US v. Johnson, that the Pure Food and Drug Act did not apply to false statements about curative effect (e.g. that a drug cures blindness) but did apply to false statements about the identity of the drug (strength, quality, ingredients, etc.). In 1912 Congress passed the Sherley Amendment to the Pure Food and Drug Act, which overruled part of the US Supreme Court ruling and made the 1906 Act applicable to false therapeutic claims if the maker had intent to defraud the customer. In 1914 the Federal Trade Commission (FTC) was created to regulate interstate advertising but drug ads in medical journals were exempted.
In 1937 a drug called elixir sulfanilamide, which included diethylene glycol (normally used as antifreeze), caused the deaths of over 105 people in 15 states and prompted Congressional action. The resulting legislation, the 1938 Food, Drug, and Cosmetic Act (FDCA), added two provisions applicable to the regulation of drugs: new drugs had to be proven safe before marketing, the Sherley Amendment was eliminated so intent to defraud did not have to be proven to prosecute false therapeutic claims. The FDCA left the burden of determining whether a drug was proven safe on the manufacturer and distributor of the drug rather than on the FDA.
The 1951 Durham-Humphrey Amendments to the FDCA distinguished between prescription and over-the-counter (OTC) drugs. The Amendments stated that a drug must be prescription if it “is not safe for use except under the supervision of a practitioner licensed by law to administer such drug” because of its toxicity or potential for harmful effect. Additionally, some drugs were considered too dangerous for consumers to safely interpret the labels so those labels were written for doctors and pharmacists to relay the label information to patients in clear terms.
In 1958, the pharmaceutical industry estimated that its “detail men” (salesmen who visited doctors’ offices) had paid for 3,790,809,000 pages of ads in medical journals, sent 741,213,000 pieces of direct mail, and made 20 million calls. About 90% of pharmaceutical advertising was aimed at physicians by the 1960s.
By 1961, at least 10,000 babies were born with phocomelia (which results in malformation of the limbs) in Europe, Australia, and Japan as the result of the use of thalidomide to treat nausea and insomnia in pregnant women. Dr. Frances Kelsey of the FDA halted the US approval of thalidomide and the US Congress immediately acted to overhaul federal drug regulation. On Oct. 10, 1962, the Kefauver-Harris Amendments were passed, which strengthened the premarket review process and transferred regulatory authority of prescription drugs to the FDA (the FTC had control of both prescription and OTC drug review, and continues to have control over the OTC drug review process). The amendments required drug companies to provide information about side effects, contraindications, and effectiveness in all advertisements, including print and broadcast ads.
In 1969 the FDA issued advertising regulations that required that drug ads be a “true statement of information in brief summary relating to the side effects, contraindications, and effectiveness.” The 1969 regulations did not mention direct-to-consumer drug ads but stated that any broadcast ads “‘shall include information relating to the major side effects and contraindications of the advertised drugs in the audio or audio and visual parts of the presentation, and unless adequate provision is made for dissemination of the approved or permitted package labeling in connection with the broadcast presentation, shall contain a brief summary of all necessary information related to side effects and contraindications.” At the time, most drug ads still appeared in medical journals or other print materials distributed to physicians.
The 1970s also marked the beginning of the patients’ rights movement, which sought certain legal protections for patients, in response to cases of abuse of human biomedical research subjects publicized in the 1960s. In the 1970s, this movement expanded from research subjects to patients. In 1975, Karen Ann Quinlan, age twenty-one, fell into an unexplained coma and remained in a persistent vegetative state and on a respirator for several months. When Quinlan’s father signed a release to permit her doctors to turn off the respirator, they refused. The medical consensus at the time of the Quinlan decision was that the traditional relationship among the physician, patient, and family should prevail over a detailed legal standard. But this case and others that followed imposed a formality on medical decisions. Ethics committees, a feature of most hospitals today, were first recommended after the New Jersey Supreme Court handed down the Quinlan decision
In the late 1970s and early 1980s pharmaceutical companies began experimenting with advertising to customers through public relations techniques rather than paid ads. In 1982 Pfizer launched “Partners in Health Care” to increase public awareness of conditions like hypertension, diabetes, and depression. Though the campaign did not mention any drugs by name, it prominently featured the Pfizer logo. In 1982 Eli Lilly and Company advertised Oraflex through 6,500 press kits including films to TV networks and radio stations that emphasized the drug might stop the progression of arthritis (a claim not approved for the product label); the drug was pulled five months after it was introduced because of adverse drug events.
In 1983 the FDA requested a voluntary moratorium on direct-to-consumer prescription drug advertising. In Sep. 1985 the FDA lifted the moratorium with no new regulations in place; the DTC ads simply had to meet the existing requirements set forth for ads to physicians: “include a brief summary of the drug’s side effects, contraindications, warnings, and precautions, and provide ‘fair balance’ between the drug’s risks and benefits.” Because the “brief summary” required side effects, contraindications, warnings and precautions as well as a “fair balance” of risks and benefits, ads would have been too long for TV or radio commercials. These regulations placed a de facto ban on broadcast DTC prescription drug ads. The drug companies instead turned to print media where small fonts could be used, or used broadcast reminder ads that (1) only give the drug’s name but no other information (“Talk to your doctor about Claritin”) or (2) only give a condition but no drug name (“Talk to your doctor about allergies.”) and could therefore avoid having the lengthy explanation of the risks required by full ads.
