FDA Actions Against Health Economic Promotions, 2002–2011

Sep 1, 2012, 00:00 AM
10.1016/j.jval.2012.05.002
https://www.valueinhealthjournal.com/article/S1098-3015(12)01607-5/fulltext
Section Title : Health Policy Analysis
Section Order : 19
First Page : 948

Objective

To investigate Food and Drug Administration (FDA) regulatory actions against drug companies' health economic promotions from 2002 through 2011 to understand how frequently and in what circumstances the agency has considered such promotions false or misleading.

Methods

We reviewed all warning letters and notices of violation (“untitled letters”) issued by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) to pharmaceutical companies from January 2002 through December 2011. We analyzed letters containing a violation related to “health economic promotion,” defined according to one of several categories (e.g., implied claims of cost savings due to work productivity or economic claims containing unsupported statements about effectiveness or safety). We also collected information on factors such as the indication and type of media involved and whether the letter referenced Section 114 of the Food and Drug Administration Modernization Act.

Results

Of 291 DDMAC letters sent to pharmaceutical companies during the study period, 35 (12%) cited a health economic violation. The most common type of violation cited was an implied claim of cost savings due to work productivity or functioning (found in 20 letters) and economic claims containing unsubstantiated comparative claims of effectiveness, safety, or interchangeability (7 letters). The violations covered various indications, mostly commonly psychiatric disorders (6 letters) and pain (6 letters). No DDMAC letter pertained to Food and Drug Administration Modernization Act Section 114.

Conclusion

The FDA has cited inappropriate health economic promotions in roughly 12% of the letters issued by the DDMAC. The letters highlight drug companies' interest in promoting the value of their products and the FDA's concerns in certain cases about the lack of supporting evidence.

https://www.valueinhealthjournal.com/action/showCitFormats?pii=S1098-3015(12)01607-5&doi=10.1016/j.jval.2012.05.002
HEOR Topics :
  • Ethical
  • Health Policy & Regulatory
  • Industry
  • Insurance Systems & National Health Care
  • Organizational Practices
  • Pricing Policy & Schemes
Tags :
  • FDAMA Section 114
  • Food and Drug Administration
  • health economics
  • promotional claims
Regions :
  • North America