Letters to the Editor is a periodic characteristic. We welcome all comments and can publish a range. We edit for size and readability and require full names.
Clarifying the FDA’s Role and Authority Over Direct-to-Consumer Drug Ads
While a number of inaccuracies within the current opinion piece about direct-to-consumer prescription drug ads by KFF Health News’ Elisabeth Rosenthal have been corrected in response to FDA’s direct requests, on this letter the FDA seeks to offer extra details about the company’s oversight to readers and proper any misimpressions which will stay (“Perspective: With TV Drug Ads, What You See Is Not Necessarily What You Get,” Sept. 9). The FDA is strongly dedicated to defending public well being by guaranteeing prescription drug promotion by or on behalf of a drug producer, distributor, or packer is truthful, balanced, and precisely communicated.
Federal legislation has lengthy required prescription drug ads to current a real assertion concerning the unwanted effects, contraindications, and effectiveness related to the marketed prescription drug (with info regarding main unwanted effects and contraindications known as the “major statement” in TV or radio adverts). This requirement has been in place for a lot of a long time and helps to make sure a truthful and non-misleading presentation of details about the prescription drug, in addition to a balanced presentation of security and efficacy info.
In 2023, the FDA issued a final rule establishing 5 requirements to assist be sure that the foremost assertion in adverts for human prescribed drugs in TV/radio format is introduced to customers in a transparent, conspicuous, and impartial method. The aforementioned article suggests it’s unclear learn how to decide whether or not an commercial complies with this rule. However, the rule and the FDA’s plain language guidance pointedly define particular standards for every normal to ensure that the advert to be thought-about compliant. The FDA believes these requirements will assist customers higher perceive the marketed drug’s unwanted effects, so they’re higher knowledgeable once they take part in well being care decision-making. Companies have till Nov. 20, 2024, to convey adverts into compliance.
Additionally, the article doesn’t focus on one of many company’s essential post-marketing surveillance instruments for prescription drug adverts. Federal legislation usually doesn’t require corporations to submit promotional communications prior to make use of, however corporations are required to submit ads on the time of preliminary dissemination. These submissions, along with different instruments just like the Bad Ad program, significantly assist the FDA’s surveillance of promotional actions.
The FDA takes critically its accountability to observe prescription drug adverts and to make sure they’re compliant with FDA’s relevant legal guidelines and laws. We will proceed to observe and take acceptable motion if prescription drug ads are discovered to comprise false or deceptive info.
— Catherine Gray, director of the FDA’s Office of Prescription Drug Promotion, Washington, D.C.
Jerry Berger, previously the director of media relations at a Harvard Medical School instructing hospital, shared the article on the social platform X:
And then there’s the matter of how a lot all that is spent on these adverts have an effect on the pricingWith TV Drug Ads, What You See Is Not Necessarily What You Get https://t.co/HGxkg949UA by way of @kffhealthnews
— jerrymberger (@jerrymberger) September 9, 2024
— Jerry Berger, Boston
How to Raise the Cybersecurity Bar
I simply completed studying the article “Cyberattacks Plague the Health Industry. Critics Call Feds’ Response Feeble and Fractured” (Sept. 19), and whereas it’s on level by way of the inadequacy of the federal cybersecurity administration, I feel it ought to have gone deeper into outlining different inventive choices to lift the cybersecurity bar amongst all well being care suppliers. Similar to the adoption of digital well being data, supplier cyber-preparedness wants an financial infusion of know-how and assets; a “Meaningful Use”-like program if you’ll (however, hopefully, higher outlined and carried out!). The federal authorities additionally must take a extra lively position in making use of “offensive resources” to neutralize threats once they come up and earlier than they develop throughout the well being care ecosystem.
— Robert Swaskoski, vice chairman of enterprise danger administration for Heritage Valley Health System, Sewickley, Pennsylvania
An worker advantages specialist exterior Atlanta chimed in on social media:
“Responsibility for the nation’s #healthcare #cybersecurity is shared by three workplaces inside two completely different companies.” Maybe that is a part of the issue? Ya suppose? https://t.co/PF8Sa2F5Ou
— Catherine Collingwood Estes 🕊️🧡🇺🇸 (@collingwest) September 19, 2024
— Catherine Collingwood Estes, Duluth, Georgia
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