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2/5/2004

FDA Issues New Guidance on Drug Ads

Donna Young

One week after Rep. Henry A. Waxman (D-Calif.) blasted the Food and Drug Administration (FDA) for failing to take action against prescription drug manufacturers for "false and misleading" advertisements directed at consumers, FDA released new guidelines yesterday for drug makers.

However, FDA focused on direct-to-consumer (DTC) print ads for prescription drugs, and ignored broadcast commercials, except for products that are "restricted" medical devices, such as hearing aids, certain types of contact lenses, and pacemakers.

The agency also released new guidelines for so-called help-seeking ads—paid announcements that are designed to educate patients and health care practitioners about particular diseases or health conditions but do not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device.

FDA Commissioner Mark B. McClellan, speaking during a press teleconference yesterday, said that based on the "science" that the agency had reviewed, and FDA's "limited resources," regulators decided to focus on developing guidance documents for those three key areas.

Pharmaceutical companies spend about $3 billion per year on DTC prescription drug advertising, according to industry estimates.

Drug makers often use product-labeling information approved by FDA to fulfill the brief summary—a statement required for advertisements appearing in print media about adverse effects, contraindications, and effectiveness of using the promoted product.

But critics argue that product labeling is meant for health care practitioners, and many brief summaries are too technical and difficult for most consumers to understand.

McClellan said a print ad that uses product-labeling information is "technically in compliance with the law in terms of . . . containing information on benefits and risks, but it doesn't convey that information as effectively as it should to many consumers who find it too detailed and off-putting."

In an FDA 2002 patient survey, the agency found that 41 percent of patients did not read any of the brief summary for a medication advertised in a print publication, and about 32 percent of patients read "a little" of the brief summary.

"That's a concern since this section of the ad is designed to get the message across about key risks and benefits," McClellan said.

FDA's survey mostly focused on the brief summary. However, more patients based their expectations of receiving a prescription from a physician on the patient's exposure to a television or radio commercial than on a print ad.

McClellan noted that about 80 percent of physicians who responded to a separate survey in 2002 said that their patients were somewhat to very aware of an advertised drug's benefits.

But, according to the survey, only 5 percent of those physicians said that their patients were clearly cognizant of the risks associated with the drug.

The physician survey did not differentiate print from broadcast ads in its questions.

In developing its new guidance for disclosing risk information in print ads, McClellan said, the agency used a "less-is-more" philosophy.

FDA advised drug manufacturers to present risk information in consumer-friendly language that is clearer and less cluttered, and to focus their risk disclosures on the most important and the most common risks.

McClellan noted that by using a less-lengthy format in print announcements, manufacturers will cut down on advertising costs.

The guidance also allows pharmaceutical companies to present key risk information in the main body of an advertisement, he noted.

Help-seeking communications can be "effective tools" for getting disease awareness information to patients and health care providers, McClellan said.

FDA's guidance, he added, will help drug companies distinguish between what is required for an ad promoting a specific drug product, and communications that provide information about a certain health-related condition.

Prescription drug ads are regulated by FDA; help-seeking communications are not.

But, McClellan warned, any communication that combines disease awareness with promotion of a product is considered to be an ad subject to FDA regulation.

Drug ads and help-seeking announcements should be separate pieces "perceptually distinct in use of graphic, visual, thematic, or other presentation elements," and should not be presented in close physical or temporal proximity," the guidance states.

Although makers of so-called restricted medical devices have, for several months, been advertising their products on television and radio, for the first time, McClellan said, FDA is providing clear and specific guidance to those companies about broadcast commercials.

Under the draft guidance, a manufacturer of a restricted medical device may satisfy the statutory requirement for risk information disclosure by presenting a "major statement" of product risks and by identifying alternative means for consumers to obtain complete risk information.

The public has 90 days to submit comments about the three guidance documents to FDA, said an agency spokespereson. After the comment period ends, the agency "will review the comments, make appropriate changes to the drafts, and publish" the final guidance documents. However, she added, comments may be submitted after the final documents are published, in accordance with FDA policy.

"By putting out these guidances," McClellan said, "we believe that evidence-based regulation as a result of these guidances will help FDA use its limited resources to police the marketplace as effectively as possible. We want to make clear that we will take action against sponsors whose ads violate the law by presenting false or misleading information to the public.

But just last week, Waxman strongly criticized McClellan for being weak on enforcing prescription drug regulations. Waxman asked the Special Investigation Division of the House Committee on Government Reform to analyze FDA's enforcement actions taken during 2003.

Waxman had requested a similar investigation in October 2002, which found that the number of FDA enforcement actions for false and misleading drug advertising dropped significantly in the first two years of the Bush administration.

Two months later, the General Accounting Office (GAO)—the investigative arm of Congress—issued a report that found that FDA had been slow to enforce federal regulations concerning DTC ads for prescription drug products.

GAO said that a policy change by the Bush administration in January 2002 that requires FDA's Office of the Chief Counsel to review letters informing drug companies about violations before the letters may be sent—a process that can take several weeks—had adversely affected FDA's ability to issue regulatory letters in a timely manner.

The report (PDF) issued last week found that, after a dramatic decline in 2002, FDA enforcement activities involving prescription drug advertising declined even further in 2003.

The number of enforcement letters issued by the Bush administration in 2003 was 75 percent below the average level of the last two years of the Clinton administration, the report states.

The Clinton administration issued an average of 95 enforcement letters per year about false and misleading drug ads during 1999 and 2000. The Bush administration issued 27 enforcement letters in 2002 to drug makers about their misleading ads, and 24 in 2003.

Broadcast and print ads "do not run for that long," McClellan maintained.

FDA can have a "far more effective enforcement strategy that's not based on Whack-a-Mole"—a popular amusement park game where animatronic moles pop up and down while players try to hit them with a hammer—that is, "trying to get after all the ads that are out there without providing clear guidance as to what is and isn't out of bounds," he asserted.

FDA is "providing as much guidance as possible upfront so that responsible companies will comply and so that we can focus our limited resources in the cases where there are real problems," he added.

Rachel Behrman, deputy director of FDA's Office of Medical Policy, defended the agency's decision to focus on print advertising only for prescription medications, and not broadcast drug commercials.

"It's also worth noting that in a broadcast ad, it's much easier to follow the less-is-more philosophy," she said. "It's very short, and in general the ads do a better job, if you will, of emphasizing just the key important points in a way that's very understandable and a way that the information can be easily retained. We felt there was a significantly bigger problem in print."

Behrman said that most of the enforcement actions taken by FDA last year for false and misleading advertisements were for print ads.

According to FDA, the agency issued four violation letters to prescription drug companies for print ads in 2003, three violation letters for broadcasts commercials, and two letters that were about violations in both print and broadcast ads for medications. The remaining of the total 24 letters issued last year dealt with violations on Web sites, printed labeling materials, or oral presentations that included false or misleading information about a prescription drug product.