Free Sample Essays > Marketing
Page: 1
Prescription drugs ads
PRESCRIPTION DRUG ads are a common sight on television and in magazines. In theory, these ads-called "direct-to-consumer (DTC) advertising"-educate consumers so they can make better medical choices. But in reality, says a new government report, misleading prescription drug ads may run for weeks.
The General Accounting Office (GAO), an arm of Congress that researches questions from Congress, issued its report in October 2002. Titled "Prescription Drugs: FDA Oversight of Direct-to-Consumer Advertising Has Limitations," the report says that for several reasons, the U.S. Food and Drug Administration (FDA) has been hampered in its oversight of drug ads, resulting in the appearance of misleading ads.
One of FDA's many jobs is to regulate the content of ads directed at consumers or doctors. FDA regulations require that when drug ads make claims for a product, the information must be accurate, and both benefits and risks must be presented fairly. Companies must submit all drug ads to FDA when the ads are first published or broadcast. FDA then reviews the ads. If an ad violates the regulations, FDA sends the company a "regulatory letter" requesting that the ad be pulled.
However, GAO found problems with this system. For one thing, some companies are slow in sending their ads to FDA for review. Sometimes, companies that withdraw one misleading ad then produce another one. In addition, the Department of Health and Human Services ordered changes in the review process for regulatory letters starting Jan. 31, 2002. As a result, it takes much longer for letters to go out.
When GAO looked at the 14 regulatory letters that FDA had sent out in 2001, it found that many cited multiple violations. Violations included making misleading claims about how well the drug worked, minimizing the drug's risks, not making clear what problem the drug was approved to treat, and not saying that the drug was available by prescription only.
According to FDA, companies always respond to regulatory letters by stopping the ads. But GAO found that some companies received multiple regulatory letters, often for the same product. For example, between 1997 and 2002, one pharmaceutical company received 14 regulatory letters!
Another problem involves the new review process for regulatory letters mentioned above, which determined that, as of 2002, no untitled or warning letters could be issued until FDA's Office of the Chief Counsel reviewed them. Before 2002, FDA sent out letters within several days of receiving an ad. Letters thus reached companies near the beginning of an ad's play. But in 2002, after the changes went into effect, letters took as long as 78 days to go out. Misleading ads thus stay on the air longer. Because one-third of television direct-to-consumer ads are broadcast for two months or less, some may complete their run before a company even hears from the FDA.