Since becoming responsible for overseeing the advertising of prescription drugs, the FDA has created an extensive set of classifications and guidelines for the drug industry.

Drug advertisements are classified into three categories: (1) help-seeking advertisements (2) reminder ads and (3) product claim advertisements. Help seeking advertisements are designed to inform consumers about certain diseases.  The name of a specific drug is not permitted within them.  The purpose of the ads is to heighten consumer awareness about diseases, and motivate them to seek medical attention—and of course a prescription.  Reminder ads provide the name of a specific drug but are not permitted to divulge its intended use, safety, or effectiveness.  This type of ad is used by companies to build name recognition.  A product claim advertisement mentions a specific drug’s name, and describes the disease for which it is intended.[1]

 

Classes of DTCA Ads

Product claim ads are at the heart of the DTCA controversy.  These ads clearly have the most effect on consumers because they discuss a medical problem along with a solution.  As a result the FDA places the most stringent requirements upon these types of ads.  These requirements include what is called a "brief statement." A brief statement contains a medication's indications, and its intended uses, the drug's most important warnings, precautions, side effects, and contraindications.  In reality, the brief statement is not brief at all and can be very lengthy.[2] 

The FDA also requires that all advertisements be presented in a "fair and balanced" way.  This means that ads cannot be dominated by benefits or downplay side effects.[3]

These regulations are vague in nature and subject to the FDA's interpretation.  Prior to 1997, however, its interpretation was quite strict.  As noted before, when drug companies began using DTCA in the 1980's, the FDA required them to provide consumers with the same amount of information as they did physicians.  This meant that all product claim advertisements were required to list almost all of a drug's side effects and warnings in the brief statement.  As result television advertisements became prohibitably expensive.  If  a drug manufacturer wished to buy a television ad it was required to list so much information that it became nearly impossible to fit it all into a 30 second spot.  This did not leave enough time to provide a marketable message, and made television ads at the time usless.[4]

As a result, some drug manufacturers began using reminder ads on television to promote their products.  Ads for Claritin and Allegra stated the drugs’ names and supplied the consumer with images of bright sunny meadows and a statement claming: “At last, a clear day is here.” [5] Consumers were baffled.  Their confusion spread to the physician's office.  Ads such as these were vague in their information and created confusion for physicians and patients.  The lack of information about indications, benefits, and side effects resulted in more questions than answers for consumers.  Many argued that changes were needed so that ads with more substantial informational content could be broadcast.[6]

Because of this confusion the FDA felt pressure to change its regulations regarding product claim advertisements.  In 1997 the FDA reinterpreted its set regulations for prescription drug advertisements.  The “Draft Guidance for Industry and FDA” of 1997 made product claim television ads feasible for the drug companies.  In it, the FDA offered a different interpretation of the brief statement requirement.  The requirement before had forced drug companies to include a statement “conveying all of the [medication’s] most important warnings, precautions, side effects, and contraindications.”[7]  The “Draft Guidance” reinterpreted this so that the manufacturers simply had to list the “most serious and most common risks associated with the medication" in what it called "adequate provisions".[8]  With this change drug companies could broadcast product claim advertisements on television without listing the pages of medical definitions and studies that the previous regulation had required.

The "Draft Guidance" explains, in some detail what requirements product claim advertisements must fulfill on television.  One major requirement is that the ad make available additional information upon consumer request.  This is done in four ways.

• Ads must provide an operating toll-free telephone number, through which consumers should be given the option of having the full drug labeling mailed to them in a timely manner or have the labeling read to them over the phone.

• They must refer the consumer to additional and alternative sources of advertising, such as print ads which are still required to list a full brief statement.

• Provide an Internet web page address which contains labeling.

• State that healthcare providers may provide additional information.[9]

The FDA is responsible for ensuring that these standards are met.  Currently, however, the regulations do not require drug companies to send their advertisements to FDA before they are aired.  Instead, the companies are required to submit their advertising at the time of its initial dissemination.  The FDA has requested advertisers to voluntarily submit ads before they air, but it is not a legal regulation.[10]

The FDA does have a process for reprimanding companies if their advertisements do not meet the set regulations.  "Warning letters" and "untitled letters" are used for this purpose.  There are two types of  letters that the FDA issues.  The first type is an "untitled letter" which is used for minor violations, such as not providing sources of additional information clearly or not presenting the ad in a fair and balanced way.  A company that receives an untitled letter is simply required to cease broadcasting the advertisement in question, and submit a written explanation to the FDA.  The second, and more forceful type of letter is called a "warning letter," and is given to companies who use an ad that may present immediate harm to the public.  A warning letter is one step away from legal action, and is the FDA's way of letting a company know that they have committed a serious violation.[11] In addition, companies that receive warning letters may be required to take corrective actions.  For example, the FDA may require that such companies send out "dear doctor" letters to alert physicians who may have prescribed their drug.  Companies receiving warning letters may also be required to submit future advertisements before broadcasting them.[12]

From 1997 to 2001 the FDA issued thirty untitled letters and three warning letters.[13]  Although this provides evidence that the FDA is playing a role in regulating DTCA, many feel that these numbers show an inability of the FDA to regulate so many ads.  "The agency simply doesn't have enough staff," says Michael Montagne, a professor at Massachusetts College of Pharmacy and Health Science.  "It's not a case of an ad not making it through the media.  It's always someone catching it after the fact."[14]  There is evidence that the FDA's ability to oversee DTCA has been diminishing even before the 1997 "Draft Guidance."

Year	Number of Launch Campaigns	Number of Warning Letters	Number of Untitled Letters[15]
1993	118	4	247
1994	185	2	210
1995	306	0	163
1996	<300	2	137

In 2002 the General Accounting Office (GAO), the investigative arm of the Congress, conducted a study on the FDA and DTCA and found that the agency was under equipped to regulate DTC ads.[16]

 It is hard to believe that the FDA can guarantee that DTC ads result in a benefit to consumers using a system that is apparently loosing its ability to oversee advertising. Next