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.
Opponents contend that DTC drug ads misinform patients, promote drugs before long-term safety-profiles can be known, medicalize and stigmatize normal conditions and bodily functions like wrinkles and low testosterone, waste valuable medical appointment time, and have led to our society’s overuse of prescription drugs.
In the 1700s and 1800s drug compounds (also called “patent medicines”) were advertised in newspapers in ways that were often exaggerated or deceptive. Lydia E. Pinkham’s Vegetable Compound was mass advertised starting in 1876 and purported to “cure entirely the worst form of Female Complaints, all ovarian troubles, Inflammation and Ulceration, Falling and Displacements, and the consequent Spinal Weakness, and is particularly adapted to the Change of Life,” in addition to curing headaches, depression, indigestion, insomnia, and other ailments.For example,
By the twentieth century, drugs were separated into two classes: (1) “ethical drugs” that were listed in the United States Pharmacopoeia (USP) by the American Medical Association (AMA) including morphine, quinine, and aspirin; and (2) patent medications that were mostly made of water with a bit of alcohol or opium and other unknown ingredients, which were advertised without regulation (including Lydia E. Pinkham’s Vegetable Compound, Hamlin’s Wizard Oil, Kick-a-poo Indian Sagwa, and Warner’s Safe Cure for Diabetes). By the early 1900s, patent medication ads accounted for nearly half of the total ad revenue for newspapers. Physicians wrote prescriptions for drugs but prescriptions were not required to obtain drugs from physicians, pharmacists, or people like Lydia Pinkham.
In 1905 the AMA established the Council on Pharmacy and Chemistry that was responsible for setting standards and evaluating “ethical drugs.”The Council was created to encourage consumers to use drugs prepared and prescribed by physicians and to discourage the use and prescription of “quack” patent medications. Further, the Council asked medical journals to not include ads for drugs that were advertised directly to the public. According to Julie Donohue, PhD, Associate Professor of Health Policy and Management at Harvard University, “at the heart of these efforts were the goals of reducing self-treatment and encouraging deference to professional medical judgment.” This professionalization of the drug trade encouraged makers of “ethical drugs” to focus on making promotional materials for physicians rather than 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: (1) new drugs had to be proven safe before marketing; and (2) 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 Wheeler-Lea Act of 1938 gave the Federal Trade Commission (FTC) the power to prosecute “unfair or deceptive acts or practices” aimed at customers.
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.
In the late 1970s and early 1980s pharmaceutical companies began experimenting with advertising to customers through public relations techniques rather than paid ads. 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 1982
In 1983 the FDA requested a voluntary moratorium on direct-to-consumer prescription drug advertising. 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.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
Between 1985 and 1990 pharmaceutical companies used DTC advertising for at least 24 drugs.Drugs were moving from prescription status to OTC status (like Aleve, Claritin, and Rogaine) and marketing campaigns aimed at consumers established the brand name, which in turn helped sales once the drug was available over-the-counter. Additionally, “lifestyle” drugs (e.g., drugs for erectile dysfunction, depression, and baldness) became popular in the early 1990s. In 1992 the AMA dropped opposition to DTC advertising because it said the “era of healthcare reform” demanded “individuals [take] responsibility for their healthcare, which means they will need more information.” DTC prescription drug advertising rose from $12 million in 1989 to $340 million by 1995.
According to a statement given on May 7, 1997 by Kenneth R. Feather, former FDA Regulatory Review Officer, the FDA was under pressure from the pharmaceutical industry and consumers to allow DTC prescription drug ads on television and radio.In Aug. 1997 the FDA released a draft copy of “Guidance for Industry: Consumer-Directed Broadcast Advertisements.” The Guidance, finalized in 1999, required that broadcast ads give brief information about the major risks instead of a long summary of risks and warnings. These revised guidelines opened the doors to broadcast DTC prescription drug ads. In 1997 the AMA sent a letter to the FDA stating the potentially dangerous effects of DTC prescription drug ads, and recommended in 1999 that the ads refer patients to their doctors for more information.
$2.24 billion was spent on DTC prescription drug advertising in 1999; double the $1.1 billion spent in 1998.In 2000, for every $1.00 spent on advertising, pharmaceutical retail sales increased by $4.20.
In 2003 the National Consumers League called DTC prescription drug ads “an effective vehicle that motivates consumers to seek information, especially from health care professionals.”
In 2005 the Pharmaceutical Research and Manufacturers of American (PhRMA) issued their “Guiding Principles: Direct to Consumer Advertisements about Prescription Drugs.”These voluntary guidelines initiated the “ask your doctor for more information” line in DTC prescription drug ads. The “Guiding Principles,” updated in Dec. 2008, were adopted by at least 24 pharmaceutical companies, including AstraZeneca, Bayer HealthCare Pharmaceuticals, Eli Lilly, and GlaxoSmithKline.
A Sep. 2006 Institute of Medicine (IOM) report recommended that a “special symbol” (like the black triangle used in the UK) be placed on the packaging of all new drugs for two years and that DTC advertising be banned for those two years.The IOM also stated that the “FDA lacks the clear, unambiguous authority needed to enforce sponsor compliance with regulatory requirements and instead relies on the prospect of productive negotiations with industry.”
In 2007 the pharmaceutical industry was estimated to be spending $4.8 billion dollars a year advertising prescription drugs directly to the public.In 2008, the sale of prescription drugs was a $291 billion dollar a year business in the United States.
On May 26, 2011 the Congressional Budget Office released its study, “Potential Effects of a Ban on Direct-To-Consumer Advertising of New Prescription Drugs”, in response to congressional proposals about restricting new prescription drugs from DTC advertising for their first two years. According to the study the average number of prescriptions for new drugs with DTC advertising is nine times greater than prescriptions for new drugs without DTC ads. The study concluded, “Although [a moratorium] would allow more time for possible safety problems with some drugs to be uncovered and to become widely known, some individuals who would benefit from a new drug might be unaware of its availability and not seek treatment in the absence of consumer advertising. Thus, the health effects of a moratorium would depend on whether the benefits of fewer unexpected adverse events were larger than the health costs of possibly reduced use of new and effective drugs.”
In 2012, the Office of Prescription Drug Promotion (OPDP) of the FDA released a study that concluded that DTC ads were improved with more quantitative benefit information and visual aids like charts and tables.The OPDP is the FDA office that “protect[s] the public health by assuring prescription drug information is truthful, balanced and accurately communicated… through a comprehensive surveillance, enforcement and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers.” The OPDP has a staff of 70 people and receives 80,000 submissions each year, 25% of which are DTC ads.
On Feb. 12, 2014 the FDA issued a comment request for the public to consider having fewer risks mentioned in DTC broadcast ads.The FDA is concerned that the “major statement” (the long disclosure of risks) is “often too long, which may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic noncompliance due to fear of side effects.” They have proposed limiting the “major statement” to risks “that are serious and actionable” and having the ad “include a disclosure to alert consumer that there are other product risks not included in the ad.”
Direct-to-consumer prescription drug advertising grew 62% from 2012 to 2016, representing the most growth in any leading ad category and making prescription drugs the seventh-largest advertiser.The industry spent $6.1 billion in 2017 on prescription drug ads, mostly during TV shows. 72% of the commercial breaks during CBS Evening News had at least one prescription drug advertisement, and 62% of breaks during General Hospital contained the ads.
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