{"id":939,"date":"2024-10-02T09:00:00","date_gmt":"2024-10-02T09:00:00","guid":{"rendered":"https:\/\/medical-article.com\/?p=939"},"modified":"2024-10-02T09:00:00","modified_gmt":"2024-10-02T09:00:00","slug":"setting-the-record-straight-on-the-fdas-authority-over-drug-ads","status":"publish","type":"post","link":"https:\/\/medical-article.com\/?p=939","title":{"rendered":"Setting the Record Straight on the FDA\u2019s Authority Over Drug Ads"},"content":{"rendered":"

Letters to the Editor<\/a>\u00a0is a periodic feature. We\u00a0welcome all comments<\/a>\u00a0and will publish a selection. We edit for length and clarity and require full names.<\/em><\/p>\n

Clarifying the FDA\u2019s Role and Authority Over Direct-to-Consumer Drug Ads<\/strong><\/p>\n

While several inaccuracies in the recent opinion piece about direct-to-consumer prescription drug advertisements by KFF Health News\u2019 Elisabeth Rosenthal have been corrected in response to FDA\u2019s direct requests, in this letter the FDA seeks to provide additional information about the agency\u2019s oversight to readers and correct any misimpressions that may remain (\u201cPerspective: With TV Drug Ads, What You See Is Not Necessarily What You Get<\/a>,\u201d 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.<\/p>\n

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 \u201cmajor statement<\/a>\u201d 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.<\/p>\n

In 2023, the FDA issued a final rule<\/a> 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\u2019s plain language guidance<\/a> 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\u2019s 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.<\/p>\n

Additionally, the article does not discuss one of the agency\u2019s 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<\/a> at the time of initial dissemination. These submissions, in addition to other tools like the Bad Ad program<\/a>, greatly aid the FDA\u2019s surveillance of promotional activities.<\/p>\n

The FDA takes seriously its responsibility to monitor prescription drug ads and to ensure they are compliant with FDA\u2019s 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.<\/p>\n

\u2014 Catherine Gray, director of the FDA\u2019s Office of Prescription Drug Promotion, Washington, D.C.<\/em><\/p>\n

Jerry Berger, formerly the director of media relations at a Harvard Medical School\u00a0teaching hospital, shared the article on the social platform X:<\/p>\n

And then there’s the matter of how much all that’s spent on these ads affect the pricingWith TV Drug Ads, What You See Is Not Necessarily What You Get https:\/\/t.co\/HGxkg949UA<\/a> via @kffhealthnews<\/a><\/p>\n

\u2014 jerrymberger (@jerrymberger) September 9, 2024<\/a><\/p>\n

\u2014 Jerry Berger, Boston<\/em><\/p>\n\n

How to Raise the Cybersecurity Bar<\/strong><\/p>\n

I just finished reading the article \u201cCyberattacks Plague the Health Industry. Critics Call Feds\u2019 Response Feeble and Fractured<\/a>\u201d (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 \u201cMeaningful Use<\/a>\u201d-like program if you will (but, hopefully, better defined and implemented!). The federal government also needs to take a more active role in applying \u201coffensive resources\u201d to neutralize threats when they arise and before they expand across the health care ecosystem.<\/p>\n

\u2014 Robert Swaskoski, vice president of enterprise risk management for Heritage Valley Health System, Sewickley, Pennsylvania<\/em><\/p>\n

An employee benefits specialist outside Atlanta chimed in on social media:<\/p>\n

“Responsibility for the nation\u2019s #healthcare<\/a> #cybersecurity<\/a> is shared by three offices within two different agencies.” Maybe that’s part of the problem? Ya think? https:\/\/t.co\/PF8Sa2F5Ou<\/a><\/p>\n

\u2014 Catherine Collingwood Estes \ud83d\udd4a\ufe0f\ud83e\udde1\ud83c\uddfa\ud83c\uddf8 (@collingwest) September 19, 2024<\/a><\/p>\n

\u2014 Catherine Collingwood Estes, <\/em>Duluth, Georgia<\/em><\/p>\n

KFF Health News<\/a> is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF\u2014an independent source of health policy research, polling, and journalism. Learn more about KFF<\/a>.<\/p>\n

USE OUR CONTENT<\/h3>\n

This story can be republished for free (details<\/a>).<\/p>","protected":false},"excerpt":{"rendered":"

Letters to the Editor\u00a0is a periodic feature. We\u00a0welcome all comments\u00a0and will publish a selection. We edit for length and clarity and require full names. Clarifying the FDA\u2019s 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\u2019 Elisabeth Rosenthal have been…<\/p>\n","protected":false},"author":0,"featured_media":940,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[],"class_list":["post-939","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles"],"_links":{"self":[{"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/posts\/939"}],"collection":[{"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/medical-article.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=939"}],"version-history":[{"count":0,"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/posts\/939\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/media\/940"}],"wp:attachment":[{"href":"https:\/\/medical-article.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=939"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medical-article.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=939"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medical-article.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=939"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}