Clarification of FDA's authority over drug advertising

Letters to the editor are a regular feature. We welcome all comments and will publish a selection. We are editing for length and clarity and require full names.

Clarification of FDA's role and authority regarding drug advertising directed directly to consumers

While several inaccuracies in KFF Health News' Elisabeth Rosenthal's recent opinion piece on direct-to-consumer advertising of prescription drugs have been corrected in response to direct inquiries from the FDA, in this letter the FDA would like to provide readers with additional information about the agency's oversight clarify and correct any remaining false impressions (“Perspective: When it comes to TV drug commercials, what you see is not necessarily what you get,” September 9). The FDA is strongly committed to protecting the public health by ensuring that prescription drug advertising by or on behalf of a drug manufacturer, distributor, or packager is communicated in a truthful, balanced, and accurate manner.

Federal law has long required that prescription drug advertisements contain a truthful statement about the side effects, contraindications, and effectiveness of the advertised prescription drug (with information about serious side effects and contraindications on television or radio referred to as a “material statement”). Show). This requirement has existed for many decades and helps ensure a truthful and non-misleading presentation of information about the prescription drug, as well as a balanced presentation of safety and effectiveness information.

In 2023, the FDA issued a final rule establishing five standards to ensure that the main message in human prescription drug advertisements in TV/radio format is presented to consumers in a clear, conspicuous, and neutral manner. From the article mentioned above, it is unclear how to determine whether an advertisement complies with this rule. However, the rule and the FDA's clearly stated guidance explicitly set forth specific criteria for each standard in order for the ad to be considered compliant. The FDA believes these standards will help consumers better understand the side effects of the advertised drug so that they are better informed when involved in health care decisions. Companies have until November 20, 2024 to make their ads compliant.

Additionally, the article does not address one of the agency's critical post-marketing surveillance tools for prescription drug advertising. Federal law generally does not require companies to submit advertising communications prior to use, but companies are required to submit advertisements at the time of initial distribution. These submissions, along with other tools such as the Bad Ad Program, provide significant support to FDA's monitoring of advertising activities.

The FDA takes seriously its responsibility to monitor prescription drug advertising and ensure that it complies with applicable FDA laws and regulations. We will continue to monitor and take appropriate action if prescription drug advertisements are found to contain false or misleading information.

— Catherine Gray, Director of the FDA's Office of Prescription Drug Promotion, Washington, DC

Jerry Berger, former director of media relations at a Harvard Medical School teaching hospital, shared the article on the social platform X:

And then there's the question of how much the total spend on that advertising impacts pricing. With TV drug advertisements, what you see is not necessarily what you get @kffhealthnews

– jerrymberger (@jerrymberger) September 9, 2024

—Jerry Berger, Boston

How to raise the bar on cybersecurity

I just finished reading the article “Cyberattacks are plaguing the healthcare industry.” Critics Call Fed's Response Weak and Broken” (Sept. 19), and while it gets to the point about the inadequacy of federal cybersecurity management, I think it should have gone deeper into outlining other creative options, to raise the cybersecurity bar for all healthcare providers. Similar to the adoption of electronic health records, cyber preparedness requires providers to economically deploy technology and resources; a “Meaningful Use”-like program, if you will (but hopefully better defined and implemented!). The federal government must also take a more active role in deploying “offensive resources” to neutralize threats as they arise and before they spread to the healthcare ecosystem.

– Robert Swaskoski, vice president of enterprise risk management at Heritage Valley Health System, Sewickley, Pennsylvania

An employee benefits specialist outside of Atlanta weighed in on social media:

“Responsibility for the nation #HealthCare #Cybersecurity is shared by three offices in two different agencies.” Maybe that’s part of the problem? Do you think? https://t.co/PF8Sa2F5Ou

— Catherine Collingwood Estes 🕊️🧡🇺🇸 (@collingwest) September 19, 2024

—Catherine Collingwood Estes, Duluth, Georgia