Direct-to-Consumer Marketing of Prescription Medications

In today's society it is practically impossible to watch a television show without encountering a promotion for a pill. Every other commercial makes the viewer feel as if they have trouble sleeping or have allergies indoors, outdoors, and everywhere in between. All these commercials must have some effect on the watchers and sadly it seems to have a negative result. After working in a medical office for over five years, I have noticed that many patients would come in and say "I saw a commercial for this pill. Can you call the pharmacy?" Those patients would see a commercial on television and happily come in to request a prescription for a medication which they think they need. Unfortunately many of those desires are fulfilled which means patients are taking medications that they practically prescribed themselves. The amount of prescriptions being filled each year grows tremendously. This is all thanks to the rising amount of direct-to-consumer (DTC) advertisements, which is the promotion of prescription drugs through newspaper, magazine, television and internet marketing, being broadcast nationwide. The concern is the amount of patients which are being misled to believe that they actually need the medication while more appropriate treatments are readily available. It is important that the information released to patients is accurate and not misleading. Currently the Food and Drug Administration is what keeps the commercials from getting completely false. However, I am sure that more can be done to prevent viewers from taking unnecessary drugs.

"The Food and Drug Administration (FDA) regulates the promotion of prescription drugs, including the content of DTC advertisers, under the authority of the Federal Food, Drug and Cosmetic Act (FFDCA)."[i] The regulations have four requirements:

(1) the advertisement cannot be false or misleading

(2) it must present a fair balance between the risks and benefits of the drug

(3) must reveal facts of the material of the drug being advertised including consequences of taking the drug

(4) & must have all the risks which are listed in the labeling disclosed in the advertisement.

The misinformed public is a very dangerous situation especially when it involves their health. DTC advertising prompts millions of viewers to ask their primary care physicians for prescriptions, which is why it is important that the FDA tries to limit the exposure of misleading advertisements. Advertisers argue that DTC advertisements help inform the public so they are better prepared when going to see their doctors and know what it is they are taking. The opposing view is that patients are being misinformed and being fooled to believe they are sicker than they actually are. If they were to be kept on the air patients would continue purchasing and taking medications they may not need.

"Prescription drug spending increased at an annual rate of about 18 percent from 1997 through 2001 and is the fastest growing component of health care spending in the United States."[ii] The increase in spending is not primarily due to the raise in prices of the prescription drugs but due to the enlarged utilization meaning that the number of prescriptions being filled has increased. This only proves that DTC marketing leads to more and more patients filling prescriptions that they may not need. Also the types of drugs that are highly marketed are those that are prescribed for chronic conditions such as diabetes, arthritis, allergies, and asthma therefore need to be taken continuously.[iii] The pharmaceutical companies would get a greater profit off patients who take a drug continuously than just a one time thing.

"From 1999-2000, prescriptions written for the 50 most heavily advertised drugs rose 24.6 percent, compared to a 4.3 percent for all other drugs combined."[iv] This tremendous rise is just another connection to marketing and the amount of patients that could be possibly taking unnecessary drugs. A survey done by the FDA found that of the 360 physicians surveyed asking the question 'Has a patient asked you to prescribe a certain brand-name drug?' 59 percent of them said 'yes.' Of those 59 percent more than 57 percent agreed to fill the prescription.[v] Sadly, doctors are giving in to their patient's requests and handing them prescriptions which in the long run could ruin their health. Not only do advertisers need to change their policy but so should the doctors. As medical professionals, doctors should take it upon themselves to be more responsible when dealing with patient needs.

The drug industry argues that DTC advertising helps alert patients of potential conditions and encourages them to see their doctor for treatment. Critics of DTC marketing argue that the industry's advertising technique is in an "emotional style"[vi] where the images of the advertisements are appealing and the side effects are somewhat hidden and quickly said at the end or a stated in fine print. FDA proposed a policy that all the risks must be listed in the commercial but advertisers felt it was practically impossible to create a compelling commercial and list all the risks in a 30 second time limit. A new bill proposed by Senator Kennedy of Massachusetts and Senator Enzi of Wyoming suggested that all new drugs on the market are not allowed to advertise directly to consumers for two years. The drug companies must wait to see if the drug has a positive effect on patients and if it truly does help individuals. Other than that the drug may also be recalled after a while which is another good reason to wait a couple of years before promoting the drug. Also any companies that do advertise must state when their drugs were approved.[vii]

By this fall, Congress needs to reauthorize drug-approval user fees. The FDA, in fact, is proposing a fee hike to speed drug reviews and the money would be used to hire additional staff to review DTC advertising. [viii] Unfortunately, this would not play out too well due to the fact that the additional staff that would be hired cannot possibly be qualified to review the advertisements without the proper training. The FDA, by hiring people without the proper qualifications, would be criticized for not doing their job properly while they are already being criticized for being too lenient on advertisers since the amount of warning letters of violations sent out has decreased over the past few years. Since the FDA isn't doing a very good job at making sure viewers aren't being misguided, there should be a significant change.

One option for regulating advertisements would be to pre-approve promotions before they aired. Senator Kennedy actually argues that the FDA doesn't go far enough when reviewing ads. He agrees that they are more emotional than informational and convince many viewers that they are sicker than they actually are. Currently it is not an obligation for advertisers to send their commercials to the FDA for clearance but some companies do it voluntarily to pre-clear their spots. If they would avoid going through a review then they might receive a warning letter stating their violation of the regulations. Unfortunately the warning letters do not put any pressure on most of the advertisers since their commercials still continue to air for months after they receive their warning letters. Many advertisers fear that making pre-clearance mandatory would limit their ability to create an influential commercial while avoiding violations. Also the advertisers argue that pre-approving the commercial before it is aired would be equal to prior restraint, which is a violation of the First Amendment.

Presently, the United States and New Zealand are the only two nations where DTC advertisements for prescription drugs are legal. New Zealand's Ministry of Health which is similar to the United State's FDA, hopes to ban DTC advertising in the future. The ban was supposed to start in December of 2006 but has yet to take effect.[ix]

Another option for regulating the promotion of prescription drugs would be removing DTC advertising completely and to solely advertise to medical professionals. Currently representatives from pharmaceutical companies leave samples at medical offices and promote their medication to doctors. It should be the responsibility of the doctor to take care of their patients and suggest what treatment should be fitting rather than the patient being easily persuaded to take a pill.

Drug industries may have the right to advertise their product; however a product that affects health should be carefully promoted. Since this industry involves the public's wellbeing it should be treated exceptionally than other products. The image that the drug industry portrays, by investing so much time and money in advertising, is that they only care about making a huge profit rather than patient needs. The information that these companies release should be for the greater good instead of the greater profit. This is why advertisements for drugs should be treated particularly in a way that is for the best of the general public.

[i] United States General Accounting Office, "Prescription Drugs: FDA Oversight of Direct-to-Consumer Advertising Has Limitations" October 2002, pg. 2.

[ii] Robert W. Dubois, Anita J. Chawla, Cheryl A. Neslusan, Mark W. Smith, and Sally Wade, "Explaining Drug Spending Trends: Does Perception Match Reality?" Health Affairs, vol. 19 (2000), 231-39.

[iii] National Institute for Health Care Management Research and Education Foundation, Prescription Drugs and Mass Media Advertising, 2000.

[iv] Statistic from the NIHCM Foundation, Prescription Drugs and Mass Media Advertising, 2000.

[v] Survey done by FDA which was presented at the Global Summit in 2003. http://www.fda.gov/cder/ddmac/globalsummit2003/sld018.htm

[vi] http://www.sourcewatch.org/index.php?title=Direct-to-consumer_advertising

[vii] Teinowitz, Ira. "Stage set for Senate to shackle DTC advertisers; Bill would allow ban of up to 2 years and require FDA to pre-clear drug ads." Crain Communications. February 26, 2007.

[viii] Teinowitz, Ira. "Stage set for Senate to shackle DTC advertisers; Bill would allow ban of up to 2 years and require FDA to pre-clear drug ads." Crain Communications. February 26, 2007.

[ix] Belkin, Lisa. "Prime Time Pushers." Mother Jones Journal. April 19^, 2007.