Article

Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies.

BMC Health Services Research (Impact Factor: 1.66). 01/2013; 13(1):27. DOI: 10.1186/1472-6963-13-27
Source: PubMed

ABSTRACT BACKGROUND: The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997--2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. METHODS: Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. RESULTS: Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997--2000) the average number of regulatory letters per year was 242.8 +/- 45.6, during the Bush Administration (2001--2008) it was 120.4 +/- 33.7, and during the first three years of the Obama administration (2009--2011) it was 177.7.0 +/- 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 +/- 36.4), Bush (29.5 +/- 16.2) and Obama (41.7 +/- 11.1). CONCLUSIONS: Most regulatory letters released by FDA headquarters were related to marketing and advertising activities of pharmaceutical companies. The number of regulatory letters was highest during the second Clinton administration, diminished during the Bush administrations, and increased again during the Obama administration. A further assessment of the impact of changes in federal administration on the enforcement activities of the FDA is required.

0 Bookmarks
 · 
80 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: This study explores the ethical issues contained in warning letters (WLs) issued to institutional review boards (IRBs) by the United States Food and Drug Administration (FDA). The online FDA Warning Letter Index was reviewed for letters issued to IRBs in the United States under the violation categories "Institutional Review Board" and "IRB" for the period January 1997 through July 2004. The resultant letters were evaluated for violations in 4 regulatory themes: having and following written procedures for research review; documentation of research review; IRB membership and conflict of interest; and informed consent. Fifty-two (52) FDA WLs were issued to IRBs during this period. Hospital/medical centre IRBs received the most letters (n = 34), followed by university IRBs (n = 9) and private IRBs (n = 9). The most common regulatory violations were failure to have and follow adequate written procedures about how the review of research is conducted (50 WLs); failure to prepare and maintain adequate documentation of IRB activities (47 WLs); and failure to provide adequate continuing review of approved studies (36 WLs). Nineteen WLs were issued for consent form issues. Warning letters are informative with regard to clinical research regulations and research subject protection. The content of these letters consistently indicates weaknesses in review and documentation activities of audited IRBs, potentially signalling similar issues among IRBs across the United States. Our findings, in a setting of overburdened IRBs who, in general, passively monitor studies, raise concerns about study oversight and optimal protection of research subjects.
    Clinical and investigative medicine. Médecine clinique et experimentale 01/2005; 27(6):316-23. · 0.97 Impact Factor
  • JAMA The Journal of the American Medical Association 09/2006; 296(8):920-2. · 29.98 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: On July 2, 2012, the Department of Justice announced the largest settlement ever in a case of health care fraud in the United States. GlaxoSmithKline (GSK) agreed to plead guilty to three criminal counts and settle civil charges brought under various federal statutes; the company will pay a total of $3 billion to the federal government and participating states. Since 2009, the federal government has collected more than $11 billion in such settlements under the False Claims Act. In the Federal District Court in Boston a few days later, GSK pleaded guilty to two criminal counts for sales of misbranded . . .
    New England Journal of Medicine 09/2012; 367(12):1082-5. · 54.42 Impact Factor

Full-text (2 Sources)

Download
25 Downloads
Available from
Jun 3, 2014