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# FDA Advertising/Promotion Letters Drop Again in 2015
- URL: https://www.fdaweb.com/fda-advertising-promotion-letters-drop-again-in-2015/
- Published: 2016-01-06T12:00:00.000Z
- Updated: 2026-09-15T02:25:31.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, #legacy-id-D5134365

> FDA warning and untitled letters to drug makers on their advertising and promotion violations dropped to an all-time low last year. CDER’s Office of Prescription Drug Promotion’s (OPDP) issued nine such [letters](http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm432949.htm?ref=fdaweb.com#OPDP) in 2015, one less than it issued in 2014\. In contrast, OPDP had issued on average 28 letters annually since 2011.  
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> Are FDA’s recent losses in court on First Amendment grounds causing the decline? Maybe drug companies have stepped up their voluntary compliance efforts. Whatever the reasons, OPDP is only saying that enforcement is one component of its multi-faceted program for overseeing prescription drug promotion. “It augments our efforts to encourage voluntary compliance by industry, which includes our work on guidances, advisory comments on draft promotional materials, and outreach to our stakeholders,” an FDA spokesman told us. “OPDP’s top priorities are policy and guidance development, labeling reviews, core launch reviews and TV ad reviews, enforcement, and training and communications.”  
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> OPDP says it uses a risk-based approach to “carefully allocate its resources among these activities to have the greatest beneficial public health impact. Therefore, it is apparent that that one cannot get a complete picture of OPDP’s program area by looking at a snapshot of time for enforcement letters.”  
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> Late last year, OPDP director **Tom Abrams** provided his annual perspective on drug promotions at a Food and Drug Law Institute conference in Washington, DC. Abrams said his office’s high priority areas include:Newly approved products Products with significant risksProducts cited for violations in the pastProducts cited in complaints Products promoted with far reaching campaigns   
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> Abrams recognized the importance of the agency’s [Bad Ad program](http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance/drugmarketingadvertisingandcommunications/ucm211498.htm?ref=fdaweb.com), an outreach program designed to increase awareness of healthcare professionals about the role they can play in helping FDA ensure that prescription drug promotion is truthful and not misleading. The program has been expanded to nurses, physician assistants, and nurse practitioners. In fact, the program was the driving force behind a recent Warning Letter ([see earlier story](http://fdaweb.com/login.php?sa=v&aid=D5132966&searchWords=kardashian&cate=S&stid=%241%24Xi%2F.Uu%2F.%24Np2HaqXF2WZbdT48qUQv81&ref=fdaweb.com)) to Duchesnay over social media posts on Facebook, Instagram, and Twitter verified to be registered to celebrity **Kim Kardashian** about her use of Diclegis (doxylamine succinate and pyridoxine HCl) for treating pregnancy-related nausea and vomiting.  
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> Abrams said at the time that the most common violations cited in regulatory letters for 2015 were:Omission and minimization of risk informationOmission of material facts Unsubstantiated comparative claims Overstatement of efficacy claims  
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> To illustrate the types of violations seen in print advertising, Abrams displayed a recent violative sales aid used by Valeant Pharmaceuticals’ subsidiary ECR Pharmaceuticals for TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules. The aid omitted risk information, inadequately communicated the full indication for the drug, and presented unsubstantiated claims. A [Warning Letter](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM457566.pdf?ref=fdaweb.com) from OPDP to ECR said that by “failing to present any information regarding the risks associated with TussiCaps, including serious and potentially fatal risks, the sales aid is misleading because it suggests that the drug is safer than has been demonstrated, and is especially concerning in its potential impact on the public health.” Additionally, OPDP was bothered by a study the company submitted to support claims of patient preference for TussiCaps over liquid formulations. The letter said the study was inadequate because it did not specifically evaluate TussiCaps compared to other formulations.