FDA to Study if Consumers, Doctors Can Spot Deceptive Drug Ads

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By Bronwyn Mixter

Can consumers and health-care professionals spot deceptive prescription drug promotions? The FDA intends to find out.

However, a consumer group representative pointed to the dwindling number of warning letters sent by the Food and Drug Administration over drug advertising and said the agency should focus on more enforcement actions against bad ads, rather than simply studying them.

The FDA is proposing a study to examine consumers’ and health-care professionals’ ability to detect and report deceptive representations in prescription drug promotions on websites. Plans for the study were submitted to the White House Office of Management and Budget for review and clearance, according to a Dec. 12 Federal Register notice (82 Fed. Reg. 58,411). Also on Dec. 12, the FDA issued a final guidance for industry on product name placement, size, prominence, and frequency in promotional labeling and advertisements for prescription drugs.

These actions are part of a process to make sure the FDA’s policies related to advertising “protect consumers and help ensure that the information provided to them is useful for protecting their health,” FDA Commissioner Scott Gottlieb said in a statement. “The FDA plays an important role in helping to make sure these presentations are truthful, balanced, and nonmisleading, and we need to study promotional material to constantly improve our oversight over these activities,” he said.

Consumer Group’s Concerns

But a consumer group faulted the study, saying it focuses too much on consumers and physicians to catch deceptive advertising.

Not many people will know when an ad is deceptive because they either don’t know what’s in a drug’s label or they don’t know what a company is required to disclose in a website advertisement, Sammy Almashat, a researcher with Public Citizen’s Health Research Group, told Bloomberg Law recently.

“We would like to point out that the FDA has primary responsibility to enforce its own laws and unfortunately, this has been happening less and less over the previous decade or so,” Almashat said.

Almashat also pointed out a decline in the number of FDA warning letters and untitled letters notifying companies that they violated advertising regulations. While the number of enforcement letters has declined, the number of drug ads hasn’t decreased at all, he said.

So far in 2017, the FDA’s Office of Prescription Drug Promotion (OPDP) issued only three warning and untitled letters for advertising violations. In 2016, the OPDP issued 11 letters.

“Essentially there’s little to no enforcement going on of prescription drug promotion, especially direct-to-consumer advertising; because OPDP simply doesn’t have the resources to follow up on all these ads and when they do identify an ad, they have to go through this very lengthy review process before they can even send a letter,” Almashat said.

Lack of Fines

Another flaw of advertising enforcement is FDA’s failure to fine companies for infractions, Almashat said.

The FDA Amendments Act of 2007 gave the FDA the authority to impose civil fines on companies when direct-to-consumer ads are false or misleading.

Since 2007, “there has never been a fine to any company for violating any prescription drug promotion regulation,” Almashat said. “The most the FDA is doing is issuing warning letters that have no consequences whatsoever for the company.”

Advertising Guidance

The FDA also released a final guidance for industry on the placement, size, prominence, and frequency of drug product names in promotional labeling and advertisements.

“The disclosure of the product name in promotional materials is important for the proper identification of the products to ensure their safe and effective use,” the agency said.

The guidance explains the use of proprietary names and established names in promotional materials. The proprietary name of a drug refers to the brand name and the established name, also called the generic name, refers to the ingredients in the product. For example, Belsomra is the proprietary name for Merck & Co.'s insomnia drug and the established name is suvorexant. Among other things, the FDA said it recommends that the established name be placed either directly to the right of or directly below the proprietary name.

The recommendations in the guidance pertain to product names in traditional print promotional labeling and advertisements (for example, journal ads, detail aids, brochures), audiovisual promotional labeling (for example, videos shown in a health-care provider’s office), broadcast advertisements (such as television advertisements, and radio advertisements), and electronic and computer-based promotions (including the internet, social media, and emails).

This guidance is the final version of a revised draft guidance issued on Nov. 20, 2013.

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bloomberglaw.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bloomberglaw.com

For More Information

The Federal Register notice on the study is at http://src.bna.com/u40 and the final guidance is at http://src.bna.com/u3Z.

Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.

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