DID FDAMA SECTION 114 LEAD TO A DECLINE OF ECONOMIC-CONTENT DRUG ADVERTISING IN MEDICAL JOURNALS?

Author(s)

Jennifer A. Palmer, MS, Research Associate, Peter J. Neumann, ScD, Professor, Alison R. Timm, BS, Research AssistantTufts-New England Medical Center, Boston, MA, USA

OBJECTIVES: To quantify and characterize economic-content in pharmaceutical advertisements in leading medical journals from 1990-2003, and to determine if economic ads declined in journals after enactment of Section 114 of the 1997 Food and Drug Administration Modernization Act (FDAMA). METHODS: Two researchers reviewed all pharmaceutical advertisements in three leading general medical (New England Journal of Medicine, JAMA, and Annals of Internal Medicine) and three specialty journals (Circulation, Gastroenterology, Neurology) in three specified months each year for 2000 through 2003. Using a standardized data collection form, we investigated economic claims (e.g., ads using the words “value”, “price”, “savings”, “hospitalization”), as well as presence of supporting evidence. This work builds upon our previous research of economic claims from 1990-1999, using an identical methodology. We hypothesized that economic promotion in journals declined after 1997 FDAMA Section 114, because that law encouraged such promotion in direct-to-managed care communications and signaled the FDA's growing vigilance over the area. RESULTS: We reviewed 2,144 pharmaceutical ads from 1990-1999 and 779 from 2000-2003. Economic content occurred in 11.1% of ads in the 1990s, and 7.6% of ads in 2000-2003 (p=.0058). The frequency of economic ads peaked in 1997 at 16.2% and declined thereafter (test for trend: p=.0017), reaching a low of 6.3% in 2002. The presence of any supporting evidence for economic claims was similar in the 1990s and early 2000s (63.7% vs. 57.6%, p=0.39). The most common type of economic claim was that a product was “less expensive/costs less” (50.6% in the 1990s vs. 32.2% from 2000-2003). CONCLUSION: The frequency of economic-content advertising in medical journals has declined somewhat in recent years, possibly spurred by Section 114 of FDAMA. Other factors, such as growth in communication of health economic information through dossier submissions to formulary committees in response to unsolicited requests, may have also played a role.

Conference/Value in Health Info

2007-05, ISPOR 2007, Arlington, VA, USA

Value in Health, Vol. 10, No.3 (May/June 2007)

Code

PHP45

Topic

Health Policy & Regulatory

Topic Subcategory

Approval & Labeling

Disease

Multiple Diseases

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