Administration Seeks to Limit Prescription Drug Advertising

Last week, the Administration announced that it would seek to place limitations on prescription drug advertisement on broadcast stations.  The concern has been that FDA rules have allowed drug companies to include less information.  The Administration wants all advertising to contain more safety information than is now required.  The White House Memorandum stated:

"My Administration will ensure that the current regulatory framework for drug advertising results in fair, balanced, and complete information for American consumers.

The Secretary of Health and Human Services shall therefore take appropriate action to ensure transparency and accuracy in direct-to-consumer prescription drug advertising, including by increasing the amount of information regarding any risks associated with the use of any such prescription drug required to be provided in prescription drug advertisements, to the extent permitted by applicable law.  The Commissioner of Food and Drugs shall take appropriate action to enforce the Federal Food, Drug, and Cosmetic Act’s prescription drug advertising provisions, and otherwise ensure truthful and non-misleading information in direct-to-consumer prescription drug advertisements."

In response, the US Department of Health and Human Services and the U.S Food and Drug administration stated:

“The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today announced a major reform of pharmaceutical advertisements that will require drug companies to include full safety warnings during their direct-to-consumer ads.  Since 1997, an FDA loophole has allowed them to merely footnote vital information such as full contraindications and common precautions via webpages and 1-800 toll-free numbers.

The proliferation of simplistic pharmaceutical ads on television and digital media distorted physician prescribing habits and patient decisions...”

This issue will be subject to the FDA’s administrative rule making process.  It promises to be a highly contentious issue.  The question will be how much information must be provided in an advertisement.  While recognizing the problem, we must recognize that local stations depend on advertising revenue to provide news and public affairs programs.  Requiring extensive data may render the traditional 30 second spot problematic for prescription drug advertisements.  This could have a significant negative impact on all local broadcasters.  Moreover, providing additional, lengthy labels on radio ads can effectively remove ads from local radio stations.   We will watch this process closely.

You can access the  White House memo here.

You can see the joint press release from the US Department of Health and Human Services and the Food and Drug Administration here.