Prescription Drug Ads
Pros and Cons
Video exploring critical thinking and how it leads to great citizen involvement
Should Prescription Drugs Be Advertised Directly to Consumers?
Prescription drugs ads
The $300 billion a year US pharmaceutical industry spent $3.1 billion on advertising prescription drugs directly to consumers in 2012. [18] 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
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Prescription Drug Ads ProCon.org is a nonpartisan, nonprofit website that presents research, studies, and pro and con statements on questions related to the advertising of prescription drugs directly to consumers.
Did You Know?
  1. Bayer Pharmaceuticals sold heroin [1] as an over-the-counter remedy for coughs in the early 1900s.

  2. The US Food and Drug Administration did not begin to regulate prescription drug advertisements until Oct. 10, 1962 with the passage of the Kefauver Harris Amendments. [2]

  3. Every $1.00 spent advertising prescription drugs is estimated to increase their retail sales by $4.20. [3]

  4. The United States and New Zealand are the only two countries where direct-to-consumer (DTC) advertising of prescription drugs is legal. [4]

  5. As of May 2011, the average number of prescriptions for new drugs with DTC advertising is nine times greater than prescriptions for new drugs without DTC ads. [7]
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Pro & Con Arguments: "Should prescription drugs be advertised directly to consumers?"
PRO Advertising Prescription Drugs


  1. Direct-to-consumer (DTC) prescription drug ads encourage people to seek medical advice from health professionals. 64% of physicians surveyed in Apr. 2013 agreed that DTC ads encourage patients to contact a health professional. [42] A 2010 Prevention Magazine survey reported that 29 million patients talked to their doctors about a medical condition after seeing DTC prescription drug ads and most discussed behavioral and lifestyle changes; over half of those patients received non-prescription or generic drugs rather than the brand-name prescription drug seen in the ad, meaning that talking to the doctor was the real benefit. [32] Patients with lower incomes and education levels who are less likely to seek medical care in general were more likely to see a doctor after seeing DTC prescription drug ads. [44] A 2005 Journal of Family Practice article found that 83% of prescription drug print ads focused on patient-physician communication and 76% promoted dialogue with health care professionals. [40] According to a 2004 FDA survey, 77% of people said DTC ads increased awareness of new drugs and 58% thought the ads gave enough information to help them decide whether to speak to a doctor. [43] 73% of doctors thought patients asked thoughtful questions because of DTC ads and about 33% of patients thought of a question to ask their doctors as a result of a DTC drug ad. [43]


  2. DTC prescription drug ads inform patients about diseases/medical conditions and possible treatments. 44% of patients responding to a 2007 survey published in Clinical Orthopaedics and Related Research said DTC prescription drug ads helped educate them about drugs, medical conditions, and treatments. [44] An Apr. 2013 FDA survey found that 48% of doctors agree that DTC ads "inform, educate, and empower" patients. [45] The FDA requires that benefits and risks of drugs be included in ads to inform patients. [36]


  3. DTC prescription drug ads encourage patient compliance with treatment instructions. 81% of doctors surveyed for a 2007 article published in Clinical Orthopaedics and Related Research thought DTC prescription drug ads had a positive impact on patient compliance (taking drugs as directed). [44] The most compliant group of prescription drug takers were patients who requested a prescription as a result of having seen a DTC ad. [46] 18% of people responding to a FDA survey said DTC ads reminded them to take their medications. [43]


  4. Diseases and medical conditions are more likely to be treated when consumers see DTC prescription drug ads. According to a 2004 FDA survey, 88% of the physicians who had patients ask about drugs seen in DTC ads reported that the patients had the conditions the drugs treat and were thus able to get treatment. [43] For example, Procrit is a drug used to counteract anemia and can be used to help chemotherapy patients with fatigue. Prior to an ad campaign for the drug, it was rarely prescribed because chemotherapy patients were not reporting fatigue caused by the chemotherapy to their doctors. After seeing the ad, however, patients reported fatigue and could be appropriately diagnosed. [46] In 2007 the FDA approved a drug for fibromyalgia, a condition that previously had no drug treatment, so patients with the condition were made aware of a possible treatment through DTC prescription drug ads and could speak to their doctors in order to receive treatment. [29]


  5. DTC prescription drug ads help remove the stigma associated with certain diseases and medical conditions. According to a 2013 CMI/Compass survey, 52% of physicians agree that DTC ads help remove stigma associated with health conditions. [45] The removal of stigma makes it easier for patients to acknowledge their health issues and feel comfortable discussing their health problems with physicians and others. [31] The advertisements for Viagra, for example, have made male sexual dysfunction and treatment commonplace. [30] Ads for drugs treating mental illnesses like depression has contributed to de-stigmatizing those conditions, which have helped patients get treatment. [31]


  6. DTC prescription drug ads create revenue for pharmaceutical companies, which can be used for research & development (R&D) to create new life-changing drugs. Drug development is expensive so pharmaceutical companies need to recoup that expense through advertising. For every $1 spent on DTC ads, sales of prescription drugs rose by $4.20. [35] In 2012, the pharmaceutical industry spent $3.1 billion on direct-to-consumer advertising. [47] On average, drug development for a single drug costs at least $4 billion and as much as $11 billion. [33] Drug companies that develop new drugs have a period of market exclusivity before generic drugs can be made by any company. [34] Revenue is needed to recoup R&D costs before generic drugs enter the marketplace and lower the prescription drugs’ retail prices.


  7. DTC prescription drug ads should be allowed as protected free speech. Doctors, hospitals, medical device makers, insurance companies and all types of health care-related companies can advertise their products. Prescriptions drug companies should be allowed to advertise their legal, FDA-approved, life-improving products too. Uwe Reinhardt, PhD, Professor of Political Economy, Economics and Public Affairs at Princeton University, in an Oct. 9, 2002 interview with Frontline, stated: "There is the First Amendment. You make new products. Why can't you tell people about it? Why should that industry be forbidden to do it, when the auto industry can advertise SUVs? Right? You can ask yourself." [57] In 1975 in Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, Inc., the US Supreme Court (7-1) found that "a State may not suppress the dissemination of concededly truthful information about entirely lawful activity, fearful of the information's effect upon it disseminators and its recipients" when considering whether Virginia could prevent prices from being included in DTC prescription drug ads. [37]
CON Advertising Prescription Drugs


  1. Direct-to-consumer (DTC) drug ads misinform patients. 63% of physicians surveyed in Apr. 2013 believed DTC prescription drug ads misinformed patients and 74% of physicians believed DTC prescription drug ads overemphasized the benefits of the drugs, resulting in misinformed patients. [42] According to a study published in the Sep. 2013 issue of Journal of General Internal Medicine, 60% of claims made in DTC prescription drug ads aired from 2008 to 2010 "left out important information, exaggerated information, provided opinions, or made meaningless associations with lifestyles.” [48] The study found 43% of the claims in DTC drug ads were "objectively true” while 55% were "potentially misleading” and 2% were "false.” [49] DTC prescription drug ads are often above the recommended 8th grade reading level for mass-distributed information, meaning a lot of consumers cannot understand the information presented. [46] Most DTC prescription drug ads spend more time on benefits than negative side effects. [46] 84% of regulatory letters sent by the FDA from 1997 to 2006 cited ads for minimizing risks and/or exaggerating effectiveness of drugs. [46]


  2. DTC prescription drug ads promote drugs before long-term safety information is known. According to an Apr. 2013 survey, 68% of doctors agree that prescription drugs are marketed before safety profiles can be known. [42] Although the FDA does not approve ads before they air on TV or radio, 50% of consumers surveyed thought DTC prescription drug ads were approved by the government. [46] 43% of consumers surveyed thought the drug had to be 100% safe before being advertised but not all drugs have completed long-term safety trials before advertising begins. [46] Vioxx was advertised, requested by patients, and prescribed from 1999 to 2004 for arthritis and pain relief before being withdrawn from the market for causing strokes and heart attacks. [46] Vioxx was listed as the primary suspected cause of death in 4,540 mortalities from Jan. 1, 1999 to June 30, 2005. [50] Other drugs like Bextra (for arthritis), Quaalude (a sleeping aid), Cylert (for ADHD), Darvon (for pain relief), and Zelnorm (for irritable bowel syndrome) have been taken off the market for safety concerns after being advertised to the public. [46] Between the 1970s and 2014, at least 35 drugs were pulled from the market, most for safety concerns. A Sep. 2006 Institute of Medicine (IOM) report recommended that DTC advertising be banned for new drugs for two years. [22]


  3. Normal conditions and bodily functions are medicalized and stigmatized by DTC prescription drug ads. DTC prescription drug ads tell consumers that normal attributes, such as thinner eyelashes, or normal aging processes, such as lower testosterone levels and wrinkles, are medical conditions that need to be remedied with drugs. DTC ads create the idea that normal conditions are "bad," resulting in the stigmatization of non-problematic conditions. Botox is promoted to treat wrinkles and Latisse is advertised for thin eyelashes while AndroGel is marketed for "LowT” or low testosterone resulting in erectile dysfunction and other conditions. [51] Ads for "Low T” drugs include statements like, "Some men may think loss of energy is just a part of aging. However, low energy may not just be a sign of getting older—it may also be a symptom of Low T.” [52]


  4. DTC prescription drug ads encourage over-medication. 81% of doctors surveyed in 2013 believe that DTC prescription drug advertising promotes drug overutilization. [42] DTC prescription drug ads tend to emphasize that drugs are needed to improve health, but not that health can be improved through behavior modification like diet or exercise. [46] Attention Deficit Hyperactivity Disorder (ADHD) is diagnosed in children and ADHD medication is prescribed about 25 times more frequently in the United States than in the UK (which does not allow DTC prescription drug ads). [53] [54] An estimated one in 10 adolescent boys in the US take ADHD drugs, as do 2.6 million adults. [58] From 1996 to 2005, the pharmaceutical industry tripled spending on marketing for psychotropic drugs, including a 500% increase in DTC ads. [55] Americans' use of psychotropic drugs, such as Prozac (an antidepressant) and Lunesta (a sleep aid), increased 22% from 2001 to 2010, resulting in one in five adults taking at least one psychotropic drug. [55] Steven Holton, PhD, a psychology professor at Vanderbilt University, states "I would say at least half the folks who are being treated with antidepressants aren't benefitting from the active pharmacological effects of the drugs themselves but from a placebo effect." [55]


  5. Health care professionals may feel pressured by DTC prescription drug ads to prescribe drugs that may not be in the best interest of the patient. 94% of oncology nurse practitioners surveyed for an article published in the Journal of Clinical Oncology had a patient request an advertised drug, 74% had a patient request an inappropriate drug, and 43% responded that they felt pressured to prescribe the inappropriate drug. [41] Over half of requests for prescription drugs seen in DTC ads were honored by doctors. [46] Kurt C. Stange, PhD, Professor of family medicine and community health at Case Western Reserve University, states, "Consumer advertising, delivered to the masses as a shotgun blast, rather than as specific information to concerned patients or caregivers [from healthcare professionals], results in more prescriptions and less appropriate prescribing.” [53]


  6. DTC prescription drug ads weaken relationships between patients and healthcare providers. 80% of doctors surveyed in Apr. 2013 thought DTC prescription drug ads weakened doctor-patient relationships. [42] Patients who are convinced that an advertised drug will solve their problems often mistrust a doctor’s advice if the doctor suggests an alternate solution. [46] After being denied the requested drug, almost 50% of patients surveyed were disappointed with their doctors, 25% responded that they would try to convince the doctor to prescribe the desired medication or obtain the drug somewhere else, and 15% said they would change doctors. [46] If a patient is denied a requested drug, the patient may stop thinking about the doctor as a learned intermediary and ignore important information from the doctor. Many doctors complain that it takes a lot of appointment time to explain to a patient why a specific drug may not be the best or most appropriate option instead of spending that time discussing appropriate treatment options, tests and screenings, and lifestyle changes. [46]


  7. DTC prescription drug ads increase health care costs. 78% of doctors surveyed in 2013 agreed that DTC prescription drug ads increased the cost of healthcare. [42] 37% of doctors surveyed said they often or sometimes prescribed brand name drugs because the patient requested the brand name drug rather than prescribe the equivalent and cheaper generic drug. [56] Brand name drugs cost 30 to 80% more than generic drugs. [56] Because generic drugs are not advertised and do not require R&D budgets to develop, they are cheaper than brand-name drugs. According to a Nov. 23, 2009 study published in Archives of Internal Medicine, the cost of Plavix increased (as did the amount of Medicaid funds spent for Plavix in pharmacies) due to the need to recoup the high costs of DTC drug advertising. [28]


  8. DTC prescription drug ads are banned in every country but the United States and New Zealand. All other countries ban all forms of DTC prescription drug ads (except Canada, which allows limited forms of reminder ads). The United States is 5% of the world’s population but accounts for 42% of global prescription drug spending. [45] The World Health Organization (WHO) stated in 2000, "Advertisements to the general public should... not generally be permitted for prescription drugs," and in 2007 the WHO group on DTC prescription drug ads "made a unanimous recommendation to prohibit direct-to-consumer advertising." [39] [38]
Comment Comment
Background: "Should prescription drugs be advertised directly to consumers?"
Ad for cocaine toothache drops
(Click to enlarge image)
Ad for Cocaine Toothache Drops, 1885
Source: http://wings.buffalo.edu/aru/
preprohibition.htm (accessed May 26, 2009)
The $300 billion a year US pharmaceutical industry spent $3.1 billion on advertising prescription drugs directly to consumers in 2012. [18] 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.

Advertisement for Lydia E. Pinkham's Vegetable Compound 1882
(Click to enlarge image)
Ad for Lydia E. Pinkham's Vegetable Compound in Frank Leslie's Popular Monthly Magazine, Apr. 1882.
Source: Cooper Collection, www.wikipedia.com (accessed Feb. 21, 2014)
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.

1700s-1800s

In the 1700s and 1800s drug compounds (also called "patent medicines”) were advertised in newspapers in ways that were often exaggerated or deceptive. [1] For example, 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. [3]

1900-1949

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). [2] [12] By the early 1900s, patent medication ads accounted for nearly half of the total ad revenue for newspapers. [1] Physicians wrote prescriptions for drugs but prescriptions were not required to obtain drugs from physicians, pharmacists, or people like Lydia Pinkham. [2]

In 1905 the AMA established the Council on Pharmacy and Chemistry that was responsible for setting standards and evaluating "ethical drugs.” [4] 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. [4] Further, the Council asked medical journals to not include ads for drugs that were advertised directly to the public. [2] 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." [2] This professionalization of the drug trade encouraged makers of "ethical drugs” to focus on making promotional materials for physicians rather than consumers. [2]

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. [21] The Act required accurate labels showing content and dosage for certain drugs like alcohol, cocaine, heroin, morphine, and cannabis. [21] 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.). [2] 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. [5] [2] In 1914 the Federal Trade Commission (FTC) was created to regulate interstate advertising but drug ads in medical journals were exempted. [12]

Ad for Bayer Heroin 1900s
(Click to enlarge image)
Ad for Bayer Brand Heroin in the New York Medical Journal, circa 1900s.
Source: http://web.missouri.edu/
~sherk/Bayer-heroin.jpg (accessed May 26, 2009)
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. [2] [6] [11] 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. [2] 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. [2] [7]

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. [1]

Ad for Novocain 1941
(Click to enlarge image)
Ad for Novocaine, an anesthetic, 1935.
Source: www.vintage-ads.livejournal.com (accessed Feb. 21, 2014)
1950-1969

The 1951 Durham-Humphrey Amendments to the FDCA distinguished between prescription and over-the-counter (OTC) drugs. [8] 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. [8] 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. [2] [12]

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. [2] About 90% of pharmaceutical advertising was aimed at physicians by the 1960s. [2]

Advertisement for nembutal, 1958
(Click to enlarge image)
Ad for Nembutal, 1958. The drug is a sedative and used to control convulsions in an emergency but, in high doses, is used for euthanasia and capital punishment.
Source: www.vintage-ads.livejournal.com(accessed Feb. 21, 2014)
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. [9] [2] Dr. Frances Kelsey of the FDA halted the US approval of thalidomide and the US Congress immediately acted to overhaul federal drug regulation. [2] [9] 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). [2] [12] The amendments required drug companies to provide information about side effects, contraindications, and effectiveness in all advertisements, including print and broadcast ads. [2][12]

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.” [2] [12] 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.” [2] At the time, most drug ads still appeared in medical journals or other print materials distributed to physicians. [2] [1]

1970-2000

In the late 1970s and early 1980s pharmaceutical companies began experimenting with advertising to customers through public relations techniques rather than paid ads. [2] 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. [2] [23] 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. [2] [29]

Advertisement for Triavil
(Click to enlarge image)
"Lady, Your Anxiety Is Showing," Ad for Triavil, a tranquilizer antidepressant, 1970 in the Journal of the American Medical Association.
Source: www.bonkersinstitute.org (accessed Feb. 21, 2014)
In 1983 the FDA requested a voluntary moratorium on direct-to-consumer prescription drug advertising. [2] [29] 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.” [2] [29] 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. [2] [29] These regulations placed a de facto ban on broadcast DTC prescription drug ads. [2] [29] 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. [2] [29]

Between 1985 and 1990 pharmaceutical companies used DTC advertising for at least 24 drugs. [2] 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. [2] Additionally, "lifestyle" drugs (e.g., drugs for erectile dysfunction, depression, and baldness) became popular in the early 1990s. [2] 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." [24] DTC prescription drug advertising rose from $12 million in 1989 to $340 million by 1995. [12]

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. [25] In Aug. 1997 the FDA released a draft copy of "Guidance for Industry: Consumer-Directed Broadcast Advertisements.” [1] [2] 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. [2] 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]

top 20 prescription drugs for dtc spending 2012
(Click to enlarge image)
The top 20 prescription drugs by DTC spending in 2012
Source: www.mmm-online.com, Apr. 1, 2013
$2.24 billion was spent on DTC prescription drug advertising in 1999; double the $1.1 billion spent in 1998. [12] In 2000, for every $1.00 spent on advertising, pharmaceutical retail sales increased by $4.20. [26]

2001-2014

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.” [2]

In 2005 the Pharmaceutical Research and Manufacturers of American (PhRMA) issued their "Guiding Principles: Direct to Consumer Advertisements about Prescription Drugs." [15] These voluntary guidelines initiated the "ask your doctor for more information" line in DTC prescription drug ads. [15] The "Guiding Principles," updated in Dec. 2008, were adopted by at least 24 pharmaceutical companies, including AstraZeneca, Bayer HealthCare Pharmaceuticals, Eli Lilly, and GlaxoSmithKline. [16]

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. [22] 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." [22]

In 2007 the pharmaceutical industry was estimated to be spending $4.8 billion dollars a year advertising prescription drugs directly to the public. [27] In 2008, the sale of prescription drugs was a $291 billion dollar a year business in the United States. [27]
Advertisement for Viagra 2010
(Click to enlarge image)
Ad for Viagra, 2010.
Source: www.pharmamkting.blogspot.com (accessed Feb. 21, 2014)

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" [14], 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. [27] 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." [26]

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. [19] 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." [17] The OPDP has a staff of 70 people and receives 80,000 submissions each year, 25% of which are DTC ads. [10]

On Feb. 12, 2014 the FDA issued a comment request for the public to consider having fewer risks mentioned in DTC broadcast ads. [20] 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." [20] 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." [20]
Video Gallery

UC Davis physician Richard Kravitz discusses patients asking their doctors for prescription drugs.
Source: UCDavis, "TV Drug Ads Contribute to 'Patient-Centered' Care," www.youtube.com, Dec. 14, 2009
Art Ulene, MD, discusses his in role in the FDA allowing broadcast DTC prescription drug ads.
Source: HealthCareVlogs, "Part 6: Prescription Drug Advertising Comes to Television," www.youtube.com, July 29, 2013


Andrew Kleit, PhD, is interviewed about the effects of DTC prescription drug ads.
Source: WSPU, "Effect of Drug Ads," www.youtube.com, July 8, 2009
Consumer Reports Examines a DTC Latisse Ad.
Source: Consumer Reports, "Consumer Reports AdWatch," www.consumerreports.org, Apr. 2012

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