Exhibit 986

Prescription Drugs: Improvements Needed in FDA’s Oversight of Direct-to-Consumer Advertising, GAO-07-54

Exhibit 986 · GAO report

Prescription Drugs: Improvements Needed in FDA’s Oversight of Direct-to-Consumer Advertising, GAO-07-54

Drug company spending on DTC advertising—such as that on television and in magazines—of prescription drugs increased twice as fast from 1997 through 2005 as spending on promotion to physicians or on research and development.

Reports DTC spending of $4.2 billion in 2005, against $7.2 billion on promotion to physicians and $31.4 billion on R&D; that FDA reviews a small portion of DTC materials without documented criteria; that regulatory letters took an average of 4 months to issue from 2002 to 2005 against 2 weeks from 1997 to 2001; and that the 19 letters of 2004-2005 were issued an average of 8 months after first dissemination, by which time more than half of the materials had been discontinued. HHS disagreed with the recommendations.

Source: U.S. Government Accountability Office
Date: November 2006
Quoted from: Highlights, What GAO Found
Grade: Primary record
Document: https://www.gao.gov/assets/gao-07-54.pdf
Accessed: 2026-11-10
Cited by: Findings citing this exhibit
Note: Exhibit id uses the report number GAO-07-54.

Cited by

Finding INF-1.7: Primary record GAO reported in November 2006 that direct-to-consumer spending was $4.2 billion in 2005, that FDA reviews a small portion of such materials, and that regulatory letters took an average of 4 months to issue in 2002-2005 against 2 weeks in 1997-2001. By the time the 19 letters of 2004-2005 were issued, companies had stopped using more than half of the cited materials.