Editing Food and Drug Administration (section)

=====Advertising and promotion=====
{{more citations needed section|date=August 2019}}
The FDA's Office of Prescription Drug Promotion (OPDP) has responsibilities that revolve around the review and regulation of prescription drug advertising and promotion. This is achieved through surveillance activities and the issuance of enforcement letters to pharmaceutical manufacturers.<ref>{{Cite web | work = Center for Drug Evaluation and Research |date=October 19, 2023 |title=The Office of Prescription Drug Promotion (OPDP) |url=https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp |access-date=October 23, 2023 | publisher = U.S. Food and Drug Administration |language=en |archive-date=October 23, 2023 |archive-url=https://web.archive.org/web/20231023220954/https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp |url-status=live }}</ref> Advertising and promotion for over-the-counter drugs is regulated by the [[Federal Trade Commission]]. The FDA also implements regulatory oversight through engagement with third-party enforcer-firms. It expects pharmaceutical companies to ensure that third-party suppliers and labs comply with the agency's health and safety guidelines .<ref>{{Cite journal | vauthors = Van Loo R |date=April 1, 2020 |title=The New Gatekeepers: Private Firms as Public Enforcers |url=https://scholarship.law.bu.edu/faculty_scholarship/800 |journal=Virginia Law Review |volume=106 |issue=2 |page=467 |access-date=October 25, 2020 |archive-date=October 28, 2020 |archive-url=https://web.archive.org/web/20201028034638/https://scholarship.law.bu.edu/faculty_scholarship/800/ |url-status=live}}</ref>{{rp|4}}

The drug advertising regulation<ref>21 CFR 202: Prescription Drug Advertising.</ref> contains two broad requirements: (1) a company may advertise or promote a drug only for the specific indication or medical use for which it was approved by FDA. Also, an advertisement must contain a "fair balance" between the benefits and the risks (side effects) of a drug. The regulation of drug advertising in the U.S. is divided between the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), based on whether the drug in question is a prescription drug or an over-the-counter (OTC) drug. The FDA oversees the advertising of prescription drugs, while the FTC regulates the advertising of OTC drugs.<ref>{{cite journal | vauthors = Weinmeyer R | title = Direct-to-consumer advertising of drugs | journal = The Virtual Mentor | volume = 15 | issue = 11 | pages = 954–958 | date = November 2013 | pmid = 24257087 | doi = 10.1001/virtualmentor.2013.15.11.hlaw1-1311 | url = https://journalofethics.ama-assn.org/article/direct-consumer-advertising-drugs/2013-11 | url-status = live | archive-url = https://web.archive.org/web/20240131130241/https://journalofethics.ama-assn.org/article/direct-consumer-advertising-drugs/2013-11 | archive-date = January 31, 2024 | doi-access = free }}</ref>

The term [[off-label]] refers to the practice of prescribing a drug for a different purpose than what the FDA approved.<ref>{{Cite web |date=January 1, 2014 |title=Off-Label Drug Use in Cancer Treatment |url=https://www.cancer.gov/about-cancer/treatment/drugs/off-label |access-date=January 14, 2023 |website=NCI |language=en |archive-date=January 14, 2023 |archive-url=https://web.archive.org/web/20230114030805/https://www.cancer.gov/about-cancer/treatment/drugs/off-label |url-status=live }}</ref>

Due to this approval requirement, manufacturers were prohibited from advertising [[COVID-19 vaccine]]s during the period in which they had only been approved under [[Emergency Use Authorization]].<ref>{{Cite web |title=FDA rules have blocked COVID-19 vaccine makers from advertising on TV |url=https://www.tampabay.com/news/health/2021/10/25/fda-rules-have-blocked-covid-19-vaccine-makers-from-advertising-on-tv/ |website=Tampa Bay Times |access-date=September 27, 2024 |language=en |quote=Food and Drug Administration rules prohibit advertising of drugs that have not been fully approved by the FDA}}</ref>