Setting the Record Straight on the FDA’s Authority Over Drug Ads

Letters to the Editor is a periodic feature. We welcome all comments and will publish a selection. We edit for length and clarity and require full names.

Clarifying the FDA’s Role and Authority Over Direct-to-Consumer Drug Ads

While several inaccuracies in the recent opinion piece about direct-to-consumer prescription drug advertisements by KFF Health News’ Elisabeth Rosenthal have been corrected in response to FDA’s direct requests, in this letter the FDA seeks to provide additional information about the agency’s oversight to readers and correct any misimpressions that may remain (“Perspective: With TV Drug Ads, What You See Is Not Necessarily What You Get,” Sept. 9). The FDA is strongly committed to protecting public health by ensuring prescription drug promotion by or on behalf of a drug manufacturer, distributor, or packer is truthful, balanced, and accurately communicated.

Federal law has long required prescription drug advertisements to present a true statement regarding the side effects, contraindications, and effectiveness associated with the advertised prescription drug (with information relating to major side effects and contraindications referred to as the “major statement” in TV or radio ads). This requirement has been in place for many decades and helps to ensure a truthful and non-misleading presentation of information about the prescription drug, as well as a balanced presentation of safety and efficacy information.

In 2023, the FDA issued a final rule establishing five standards to help ensure that the major statement in ads for human prescription drugs in TV/radio format is presented to consumers in a clear, conspicuous, and neutral manner. The aforementioned article suggests it is unclear how to determine whether an advertisement complies with this rule. However, the rule and the FDA’s plain language guidance pointedly outline 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 advertised drug’s side effects, so they are better informed when they participate in health care decision-making. Companies have until Nov. 20, 2024, to bring ads into compliance.

Additionally, the article does not discuss one of the agency’s crucial post-marketing surveillance tools for prescription drug ads. Federal law generally does not require companies to submit promotional communications prior to use, but companies are required to submit ads at the time of initial dissemination. These submissions, in addition to other tools like the Bad Ad program, greatly aid the FDA’s surveillance of promotional activities.

The FDA takes seriously its responsibility to monitor prescription drug ads and to ensure they are compliant with FDA’s applicable 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, D.C.

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

— Jerry Berger, Boston

How to Raise the Cybersecurity Bar

I just finished reading the article “Cyberattacks Plague the Health Industry. Critics Call Feds’ Response Feeble and Fractured” (Sept. 19), and while it is on point in terms of the inadequacy of the federal cybersecurity management, I think it should have gone deeper into outlining other creative options to raise the cybersecurity bar among all health care providers. Similar to the adoption of electronic health records, provider cyber-preparedness needs an economic infusion of technology and resources; a “Meaningful Use”-like program if you will (but, hopefully, better defined and implemented!). The federal government also needs to take a more active role in applying “offensive resources” to neutralize threats when they arise and before they expand across the health care ecosystem.

— Robert Swaskoski, vice president of enterprise risk management for Heritage Valley Health System, Sewickley, Pennsylvania

An employee benefits specialist outside Atlanta chimed in on social media:

— Catherine Collingwood Estes, Duluth, Georgia