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Should prescription drugs be advertised directly to consumers?
This ProCon.org  website provides a summary of the debate on whether or not prescription drugs should be advertised directly to consumers.
Overview Background Pro & Con Arguments
Did You Know? Images & Videos Take the Survey

 


Overview: "Should prescription drugs be advertised directly to consumers?"
Direct to consumer prescription drug advertisements are regulated by the United States Food and Drug Administration (FDA) to ensure that they are not false or misleading. Many research organizations and industry groups claim that the ads are educational and play a central role in providing a number of benefits to consumers.

Others argue that these drug ads are nothing but sales pitches. They argue that drug companies are unconcerned with benefiting consumers or their health, and that the FDA does an inadequate job of making sure the ads are not false or misleading.

Due to a lack of any comprehensive resource designed to weigh the pros and cons of whether prescription drugs should be advertised directly to consumers, we decided to explore this issue from our nonpartisan perspective in our first ever "micro" site.


Background: "Should prescription drugs be advertised directly to consumers?"
In 1906 the advertising of drugs was first regulated by the Federal Food and Drug Act (52 KB) . The Act gave the US Food and Drug Administration (FDA) the power to regulate drug labeling to prevent companies from making false claims about the contents or effects of medicines.

On June 25, 1938, President Franklin Roosevelt signed the Food, Drug, and Cosmetic Act (most recently amended on Dec. 31, 2004). This Act replaced the 1906 Act and brought the regulation of medication (in addition to the regulation of labeling) under the control of the FDA thereby spawning the prescription drug industry. The government restriction was imposed to protect consumers from drugs considered to be unsafe and to regulate drugs such as barbiturates and amphetamines.

On Oct. 10, 1962, the Kefauver Harris Amendments (2 MB) to the Food, Drug, and Cosmetic Act transferred regulatory authority of prescription drug advertising from the Federal Trade Commission to the FDA. The Amendments required drug companies to provide information about side effects, contraindications, and effectiveness in all advertisements, including print and broadcast ads.

The US Food and Drug Administration continues to regulate prescription drug advertisements to ensure that the ads are not false or misleading in any way.

In Aug. 1999 the FDA issued guidance on direct-to-consumer (DTC) advertising of prescription drugs through broadcast media when it released its industry guidance document Consumer-Directed Broadcast Advertisements (36 KB) . The 1999 guidance document described how companies could make "adequate provision" of prescription drug packaging information in broadcast media advertisements without directly disclosing the more detailed risk information that must accompany print advertisements.

Between 1999 and 2000 it is estimated that direct-to-consumer advertising increased retail sales of the 25 most popular drug categories by 12%. The top five were antidepressants, antihyperlipidemics (cholesterol-lowering), proton pump inhibitors (acid reflux/heartburn), nasal sprays, and antihistamines. For every $1.00 spent on advertising, pharmaceutical retail sales increased by $4.20 (193 KB) .

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.

As of 2009, the United States and New Zealand are the only two countries where direct to consumer (DTC) advertising of prescription drugs is legal (932 KB) .

There is much debate about whether advertisements for prescription drugs are a pro or con for Americans and their health. Due to a lack of any comprehensive resource designed to weigh the pros and cons of whether prescription drugs should be advertised directly to consumers, we decided to explore this issue from our nonpartisan perspective - in our first ever "micro" site.

Sources: click here

Pro & Con Arguments: "Should prescription drugs be advertised directly to consumers?"
PRO Advertising Prescription Drugs
  1. Prescription drug advertisements inform consumers about potential medical conditions they may have and about drugs that could help treat those conditions. A consumer better informed about medical issues is more likely to contact his/her doctor to discuss the condition or related drugs. These ads therefore provide a helpful public health service.

  2. Just because someone sees an ad on television doesn't mean he/she will rush out to take a drug. Prescription drug consumers have access to physicians, pharmacists, product packaging, internet websites, medical literature and more to educate them about prescription products.

  3. Prescription drug advertisements lessen the stigma associated with many health conditions and thus make it easier for patients to acknowledge their potential health issues and reveal and discuss their health problems with physicians and others.

  4. Direct to consumer advertising of prescription drugs is important and profitable for drug makers. They make over $4.00 for every $1.00 spent in direct to consumer advertising of such drugs. Drug makers, like any other legal company, have every right to make profits.

  5. Without the profits drug companies make from advertising prescription drugs to consumers, those companies would have less money to develop life-saving and life-improving medications.

  6. Brand name drug makers invest substantial amounts of money to research, test, acquire FDA approval, manufacture, and develop a market for specific prescription drugs. Generic drug competitors have none of those research and development (R&D) expenses. Advertising prescription drugs is necessary for brand name drug makers to recoup their R&D expenses and remain competitive against generic drug companies.

  7. Prescription drug advertisements are already regulated by the FDA to ensure that they are not false or misleading. Additional regulation is not necessary.

  8. Advertising is a form of speech, and it should be protected under the First Amendment. Any law prohibiting the advertisement of prescription drugs directly to consumers would violate the US constitution.

  9. Advertising prescription drugs uses ad agencies, video/photography equipment, graphic designers, public relations firms, copy editors, and a host of other professional services and equipment makers. Therefore, having such ads keeps people employed and helps the overall economy.

  10. Doctors, hospitals, and health care insurance providers can advertise their services directly to consumers. Fairness dictates that drug companies should be able to advertise their products directly to consumers as well.
CON Advertising Prescription Drugs
  1. Direct to consumer prescription drug ads, like most advertisements, are intended to sell the product being advertised. Such ads use marketing tactics that manipulate, create false impressions, and otherwise mislead consumers instead of educating them about the drugs.

  2. Direct to consumer drug ads cause people to pick medicines based on the effectiveness of the advertisement rather than the effectiveness of the medication.

  3. Direct to consumer prescription drug advertisements cause patients to want and request medications that might be unnecessary or even harmful, thus leading to an over-medicated and unhealthy society.

  4. Pharmaceutical companies are for-profit business entities whose purpose is to make money. These companies advertise prescription drugs solely to increase their profits, not to improve public health.

  5. The money spent on advertising prescription drugs is passed on to consumers by raising the price of those drugs.

  6. Potentially harmful side effects and interactions are not sufficiently detailed in the drug advertisements. The average person cannot adequately research all the scientific studies done to evaluate the effectiveness of new drugs. Patients, therefore, find themselves requesting prescription drugs based on advertisements with little knowledge of all the relevant medical information.

  7. Patients seeing prescription drug ads can lose trust in doctors and the medical establishment when it seems that the medical community (including pharmaceutical companies) is more interested in taking their money than improving their health.

  8. Prescription drug ads are not effectively reviewed to insure that they are not false or misleading. The FDA has been criticized by the Government Accountability Office (GAO) for its inability to ensure that all ads are reviewed adequately.

  9. Direct to consumer prescription drug ads harm public health by advocating drug use as a primary response to medical conditions that can often be remedied in other ways such as diet, exercise, stress reduction, and other preventative measures.

  10. Doctors may lose patients if they refuse to prescribe drugs that their patients have seen on television and now want. As a result, some physicians may sign prescription requests just to keep their patients happy and coming back, thereby becoming "rubber stamps" for patient requests.

  11. Patients may hear a prescription drug's numerous side effects in an advertisement and forgo needed treatment out of fear without realizing that all medications have side effects. Patients need a balanced view of risks and benefits which cannot be presented in a short advertisement.
Sources: click here

Did You Know?
  1. Bayer Pharmaceuticals sold heroin 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 KB) .

  3. Every $1.00 spent advertising prescription drugs is estimated to increase their retail sales by $4.20 (193 KB) .

  4. The United States and New Zealand are the only two countries where direct to consumer (DTC) advertising of prescription drugs is legal (932 KB) .

Images & Videos

A. Image Gallery
Advertisement for Cocaine Toothache Drops, 1885.
Source: http://wings.buffalo.edu/aru/preprohibition.htm (accessed May 26, 2009)
Advertisement for Mrs. Winslows Soothing Syrup for Children Teething, 1887. The syrup's primary active ingredient was morphine.
Source: www.cas.umt.edu (accessed May 26, 2009)
Advertisement 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)
Advertisement for methamphetamine, 1951. The advertisement was published prior to the 1962 Kefauver Harris Amendment which required information on side effects, contraindications and effectiveness.Source: www.bonkersinstitute.org (accessed May 26, 2009) Advertisement for Ritalin, 1987. Published in a medical journal after the 1962 Kefauver Harris Amendment.Source: www.bonkersinstitute.org (accessed May 26, 2009)

Advertisement for Micardis, 2006. Also published after the 1962 Kefauver Harris Amendment. Source: http://todaysseniorsnetwork.com (accessed May 26, 2009)

B. Video Gallery
Television Commercial for Cymbalta, a prescription anti-depression medication, post 1999. This commercial does not contain detailed information on side effects and risk, but rather makes "adequate provision" of this information as required under the 1999 FDA guidance on direct to consumer advertising.
Source: www.youtube.com (accessed May 28, 2009)
Television Commercial for Lunesta, a prescription sleep aid medication, post 1999. This commercial does not contain detailed information on side effects and risk, but rather makes "adequate provision" of this information as required under the 1999 FDA guidance on direct to consumer advertising.
Source: http://video.google.com (accessed May 28, 2009)
Television Commercial for Zoloft, a prescription anti-depression medication, post 1999. This commercial does not contain detailed information on side effects and risk, but rather makes "adequate provision" of this information as required under the 1999 FDA guidance on direct to consumer advertising.
Source: www.youtube.com (accessed May 28, 2009)

 


 Readers' Comments
We post pro, con, and not clearly pro or con comments in the approximate ratio that we received them. We sometimes edit comments for brevity, clarity, and spelling. We may also remove comments posted when we find better comments covering the same issues or for other good reasons.
PRO Advertising Prescription Drugs CON Advertising Prescription Drugs
  1. "Discussions of DTC advertising occur infrequently during physician-patient office conversations (only 3% of the time). However, when discussed, DTC plays an important and often positive role by helping physicians describe and gain patient buy-in to treatments that the physician him/herself has determined to be appropriate."
    Jeff Kozloff, President, Verilogue, July 20, 2009

  2. "Drug companies, like all commercial organizations, should be allowed to market their products directly to consumers (patients) as long as they comply with government regulations. It takes years and years and millions upon millions of dollars to move a drug through the development pipeline to market. All of that is done in compliance with FDA regulations. Then a companiy's drug is only patent protected for a very short time. People need to remember that the pharma industry is developing life saving and quality of life enhancing products. They should be allowed to capitalize on their investments in R&D."
    Anonymous, July 17, 2009

  1. "It seems wrong to allow companies to manipulate our views on something as vital as our health. Besides, the costs of those ads get passed along to us. I sure as hell don't want to pay extra just so I can be 'educated' about Viagra or Cialis and then feel compelled to buy it through my doctor/drug dealer. It's illegal in every damn country on Earth (except the US and New Zealand - which by the way does not even have prescription drugs) for a good reason."
    Ron B., Aug. 3, 2009

  2. "No more tax breaks for companies advertising prescription drugs. No more advertising prescription drugs at all. To send the message that everything can be cured with medication does not support the goal of curtailing drug abuse. To expose adolescent children to sexual advertising is just plain wrong."
    Arden, July 27, 2009

  3. "You have an informed presentation of both sides, more professional than others I've read. I'm biased on the con side, but I recognize that comes from personal experience with several people in my family/friends circle who have 'rubber stamp' doctors and a medicine cabinet full of the prescriptions that were marketed DTC. Like Pavlov's Dog, if they get the message enough times they come to believe it, and go running to the doctor with the symptoms they've been 'educated' to have."
    Loni, July 22, 2009

  4. "Clearly too many folks are swayed by 'noisy' commercials for prescription drugs that could ultimately be 'life-threatening' to some. And I am of the belief that some of the advertised medicines have not been tested for long-term effects on humans. More clinical tests or trials should be performed by those wishing to take part on them; and not advertised to the general public. I am referring to drugs such as Celebrex; some weight-loss drugs that are available that will eventually cause an untimely death if taken improperlly, etc."
    Anonymous, June 13, 2009


  5. "The television commercials that advertise antidepressant medications directly to the public are doing a major public disservice. The widespread and exponentially growing occurrence of depression in our society is a natural response to the alienation that a fast paced modern technological lifestyle is engendering. Imperial wars, global warming, social violence, pollution, and the economic rat race are just a few of the depressing things we all deal with day to day. But the drug companies would have us believe that these things are not what are depressing us. They would have us believe it is our own minds that are faulty. Just pop a pill and it will all go away. You will become a happy well adjusted citizen once again. It is a lie... their mind control drugs will not make you happy."
    Jeff, June 2, 2009
NOT CLEARLY PRO OR CON Advertising Prescription Drugs
  1. "The drug companies were more ethical when they were not permitted to market to consumers. Well, marginally. As a pharmaceutical marketer, we did everything legal to hook doctors to our brand from medical school on. Now there are no-holds-barred and drug companies seem to have no integrity at all."
    Anonymous, July 25, 2009

  2. "If you don't want the drugs, don't buy them. If your doctor thinks they're bad for you, then he shouldn't prescribe them. Simple as that. I don't need government making my medical decisions. That's what my doctor is for."
    Phil, July 8, 2009

  3. "The presentation of this topic was excellent. I am so glad someone has taken the time out to acknowledge that this does need to be discussed. I often raised this question with my family members each time I saw a commercial b/c I never heard of such a thing before and over the last several years, a slew of prescription drug commercial has popped up. I thought that was something that you discussed in the privacy of your doctor's office."
    Anonymous, July 6, 2009

  4. "What sticks out is that most of the pro arguments are profit oriented while the con arguments apply to public health issues."
    Anonymous, June 27, 2009
Please take our short survey to give your opinion on whether or not you think prescription drugs should be advertised directly to the public. We'd also like to know what you think of our first ever "micro" site. At the end of the survey you may also leave us a comment for posting in our Readers' Comments section above.

Sources
Sources/References: The summary and pro and con arguments were written by ProCon.org staff based upon input from the following primary and secondary sources (in alphabetical order by source):
Marc-Andre Gagnon and Joel Lexchin, "The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States," Public Library of Science Medicine, Jan. 2008

Sean Gregory, "Are Direct-to-Consumer Drug Ads Doomed?," TIME magazine, Feb. 4, 2009

Henry J. Kaiser Family Foundation, "Impact of Direct-to-Consumer Advertising on Prescription Drug Spending," www.kff.org, June 2003

IMS Health, "IMS Heatlh Reports U.S. Prescription Sales Grew 1.3 Percent in 2008 to $291 Billion,"
www.imshealth.com, Mar. 19, 2009

Pharmaceutical Research and Manufacturers of America, "Pharmaceutical Marketing in Perspective: Its Value and Role as One of Many Factors Informing Prescribing,"
www.phrma.org (accessed June 1, 2009)

Pharmaceutical Research and Manufacturers of America, "Testimony and Official Submissions,"
www.phrma.org, Sep. 29, 2005

Pharmaceutical Research and Manufacturers of America, "The Facts About Pharmaceutical Marketing & Promotion,"
www.phrma.org(accessed June 1, 2009)

Private email correspondance with various medical experts

Science Daily, "Big Pharma Spends More on Advertising Than Research and Development, Study Finds,"
www.sciencedaily.com, Jan. 7, 2009

US Food and Drug Administration (FDA), "A History of the FDS and Drug Regulation in the United States,"
www.fda.gov(accessed June 1, 2009)

US Food and Drug Administration (FDA), "Drugs and Foods under the 1938 Act and Its Amendments,
www.fda.gov(accessed June 1, 2009)

US Food and Drug Administration (FDA), "Guidance for Industry: Consumer-Directed Broadcast Advertisements,"
www.fda.gov, Aug. 1999

US Food and Drug Administration (FDA), "Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs - Summary of FDA Survey Research Results,"
www.fda.gov, Nov. 19, 2004

US Food and Drug Administration (FDA), "The 1906 Food and Drugs Act and Its Enformement,"
www.fda.gov(accessed June 1, 2009)

US Food and Drug Administration (FDA), "The 1938 Food, Drug, and Cosmetic Act,"
www.fda.gov(accessed June 1, 2009)

Keith J. Winstein and Suzanne Vranica, "Drug Firms' Spending on Consumer Ads Fell 8% in '08, a Rare Marketing Pullback, Wall Street Journal, Apr. 16, 2009

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Last updated on 11/6/2009 7:11 PM PST