TV Drug Ads, Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Completing the Puzzle

FDA regulations have always permitted sponsors of television and radio ads to present a brief summary. Or, instead, they could make "adequate provision" for interested people to get the approved labeling.

Before August 1997, FDA had not described "adequate provision" for consumer-directed ads, so drug companies were not taking advantage of the option because they were uncertain about whether their ads would meet FDA's standards.

The draft guidance doesn't change the regulation, but rather describes one way to meet the requirement. Under the approach described in the guidance, "adequate provision" is accomplished if the ad contains the following:

• a toll-free telephone number so consumers can request the approved package labeling by mail, fax, or prerecorded telephone message
• a reference to print ads about the product in consumer magazines so consumers can read more detailed drug information, or to brochures containing the package labeling that a consumer can find conveniently in public places such as libraries, pharmacies, doctors' offices, and grocery stores
• a statement that additional product information is available from a doctor or pharmacist
• an Internet address where package labeling can be found.

Whether the brief summary or "adequate provision" is used, however, the most important risk information must always be included in the ad itself. This information is often referred to as the "major statement."

Joint Responsibility

Some consumer-directed ads can raise awareness that drugs are available to treat certain conditions, including diseases such as seasonal allergies that might not require a doctor's care, and undertreated conditions such as depression and impotence. "We have a huge patient population for which there are drugs available to help them live longer and better lives," says John Kamp of the American Association of Advertising Agencies. He adds that government agencies and medical professionals "can use their tools until they're blue in the face and not reach the people who will be reached through television."

While a doctor's prescription is necessary to get these medications, some at the 1995 public hearing expressed a concern that this alternative source of drug information would interfere with the doctor-patient relationship. The National Consumers League's Golodner and others, however, feel that consumers will communicate with their physicians more, not less, if they are aware that a drug exists for their condition.

"In health care," Golodner says, "there is a general trend toward having consumers more responsible for their own health. Now, consumers can go to their physicians with a little more information."

A related issue raised at the 1995 public hearing is whether such ads would lead to patients pressuring doctors to prescribe unneeded medications. Many speakers emphasized the doctors' duty to advise their patients responsibly. Mary Jane Sheffet, from Michigan State University's marketing department, told FDA, "The doctor needs to be there as a gatekeeper."

With the health concerns of both supporters and opponents in mind, the agency continues to review its policies on direct-to-consumer promotion. FDA will finalize the draft guidance on consumer-directed broadcast advertising, the first step of the review, after considering all comments received during the 60-day comment period, which ended last Oct. 14.

As more ads have been reviewed by FDA, Ostrove says, the agency "has become more and more confident that the appropriate information, including risk information, can reach consumers and be helpful to them."

But the foremost goal of advertisers will always remain the same: to get people to use their products. So Ostrove urges consumers to regard prescription drug ads with thoughtfulness.

"These are prescription drugs with real potential downsides," she says. "We don't want people going to their doctor and saying, 'I want this drug.' The message should be, 'I saw this ad. Is it right for me?'"

In Trouble with FDA

Generally, FDA does not require pre-clearance of promotional materials. But the agency often reviews drug companies' draft promotional materials at their request.

If FDA finds that an advertisement a company is using is false or misleading, the agency may take enforcement action against the company. The agency regulates all of a drug company's prescription drug promotions, including the promotional tactics of its salespeople.

For the least serious violations of advertising regulations, FDA will send the drug company an "untitled letter" outlining FDA's findings.

For more serious violations, FDA may issue a "warning letter" requesting that the company immediately stop the violative advertising and, in many cases, take other corrective steps.

For example, the company may be asked to send a "Dear Doctor" letter to alert those who prescribe the medication to FDA's finding. The company may also be asked to run corrective advertisements setting forth FDA's concerns and bringing the ad's language into compliance. Finally, a warning letter may request that a company send its future promotional materials to FDA for clearance before they are used.

Beyond sending untitled letters and warning letters, FDA may stop violative promotions by seizing affected products or enjoining the use of promotions that make the same or similar claims. These actions and the most serious remedy, criminal prosecution of the company or the individuals involved, are used rarely — generally when intentional and serious misstatements are involved.

The threat of agency action isn't the only thing that keeps companies honest, says John Kamp of the American Association of Advertising Agencies. "A drug company won't play fast and loose with the rules because its most important asset is its reputation with the American people."

Drug Promotion in Cyberspace

Like many other companies, prescription drug marketers are beginning to take advantage of the extensive reach of the Internet to promote their products. FDA monitors the Internet to check the quality of the information provided, and encourages consumers to remain vigilant to separate the good information from the bad. (See "Health Information On-Line" in the June 1996 FDA Consumer.)

"Generally, FDA is treating Internet promotion like it does other forms of promotion," says Melissa Moncavage, a public health advisor with FDA's division of drug marketing, advertising, and communications. "Although the Internet is brand new, the promotion content issues are largely the same as print, broadcast, and other traditional media."

To address those issues that are unique to the Internet, FDA held a public meeting in October 1996 to hear from consumers, patient groups, health professionals, manufacturers of FDA-regulated products, and others.

The questions discussed at the meeting included:

• Where should promotional product information be located on a company's Website?
• How can promotional information on the Internet be clearly distinguished from other information?
• How can Internet users be ensured access to a balanced presentation of risks and benefits?
• Should Websites distinguish between Internet promotions directed to health professionals and consumers? How?
• How should the promotional materials of multinational companies be addressed to ensure compliance with U.S. drug laws and regulations?

Also, in a Sept. 16, 1996, Federal Register notice, FDA requested written comments on some of these same Internet-related drug promotion issues. The agency is considering the written comments, suggestions of meeting participants, and information received since the meeting, and plans to publish a draft guidance to clarify its policies.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.