Drug company advertising in medical journals about the health-economic advantages of their products for 2000-2006 versus 1990-1999.

BACKGROUND

Section 114 of the 1997 Food and Drug Administration Modernization Act (FDAMA) effective February 19, 1998, permitted some additional flexibility for drug companies to provide "health care economic information" to "a formulary committee or other similar entity" and may have caused a decline in economic messages used in print advertisements in medical journals. We previously investigated the promotional claims made by pharmaceutical companies about the economic advantages of their prescription products in print advertisements in 6 leading medical journals from 1990-1999.

OBJECTIVE

To examine the hypotheses that (1) economic promotion in journals declined after the effective date of Section 114 of the FDAMA, and (2) increased calls for U.S. Food and Drug Administration (FDA) scrutiny of health-economic information was associated with an increase in the reporting of supporting information for economic advertisements in 2000- 2006 compared with the 1990s.

METHODS

Two researchers independently reviewed all pharmaceutical print advertisements in 3 issues each year of 3 general medical and 3 specialty journals (totaling 18 issues each year) from 2000 through 2006. The type of economic claim (e.g., advertisements using the words "price," "costs less," "value") as well as the presence of supporting information for an advertisement's claims (e.g., published studies) were tabulated using a standardized data collection form. The research method was similar to that used in previous research of economic claims in advertisements in the same 6 medical journals from 1990-1999, and we compared the results from previous research for 1990-1999 with the new findings for 2000-2006. The list of health economic terms was expanded in the 2000-2006 research to include "less hospitalization"/"less treatment," "formulary"/"coverage," "co-pay"/"cost-sharing," and "in community longer."

RESULTS

Our results are derived from 2,144 pharmaceutical advertisements from the 10-year period 1990-1999 and 1,372 from the 7-year period 2000-2006. Economic content occurred in 11.1% (237/2,144) of advertisements in the 1990s, and 7.6% (104/1,372) in 2000-2006 (P < 0.001). The frequency of economic advertisements rose in the 1990s to a peak in 1997 at 16.2% (31/191) (test for trend: P < 0.001) and declined thereafter, reaching a low of 3.9% (9/234) in 2002 (test for trend: P < 0.001) before rising again to 13.7% (25/182) in 2006 (test for trend: P=0.030). Economic claims centered mainly on direct costs (i.e., "less expensive") and benefit design (i.e., "one co-pay") and less on cost-effectiveness (i.e., "value"). The percentage of economic advertisements that included any supporting information was similar in the 1990s and 2000s (63.7% [151/237] vs. 61.5% [64/104], P = 0.70). The source of information to support an advertisement's economic claims shifted away from price information (e.g., "average wholesale price" or "Red Book") towards published studies and "data on file."

CONCLUSION

Drug companies continue to advertise the economic advantages of their products in medical journals, though the practice declined somewhat after the 1997 FDAMA Section 114 legislation. Use of supporting references in the body of advertisements has not improved over time. The promotion of health economic information warrants more scrutiny by regulators and medical journal editors.