The Lacuna Project

lacuna (n.) a gap in a record where something should be

Independent research. Not affiliated with any government, agency, or company.

Sector

Pharmaceutical industry (sponsors paying user fees)

Documented money flows

Findings that rest on exhibits naming this entity

  • INF-1.6: A 2019 JAMA study reports that direct-to-consumer prescription-drug advertising grew from $1.3 billion (79,000 ads) in 1997 to $6 billion (4.6 million ads, 663,000 of them TV commercials) in 2016, in 2016 dollars, and that FDA violation letters for misleading drug marketing fell from 156 to 11.
  • INF-1.8: FDA issued final guidance on consumer-directed broadcast advertisements in August 1999, after announcing a draft on 12 August 1997. The Food and Drug Administration Amendments Act of 27 September 2007 required FDA to set standards for a clear, conspicuous and neutral major statement in television and radio drug advertisements within 30 months; FDA proposed a rule on 29 March 2010 and published the final rule on 21 November 2023, with compliance required from 20 November 2024.
  • INF-1.9: On 9 September 2025 the President directed HHS and FDA to act on direct-to-consumer drug advertising, and FDA announced thousands of warning letters, about 100 cease-and-desist letters and rulemaking to remove the "adequate provision" option. FDA's announcement states that warning letters to pharmaceutical companies fell to one in 2023 and zero in 2024.
  • INF-1.12: A manuscript matching Kantar newspaper advertising by drug manufacturers to 81,656 newspaper articles on drugs from 1999 to 2012 reports that a newspaper receiving an additional $100,000 from a drug's maker in the prior 14 days was 9 to 20 percent less likely to mention that drug's side effects and 23 to 33 percent less likely to report an FDA safety alert about it. The manuscript's publication venue and peer-review status are unverified.

Exhibits naming this entity

  • Exhibit 984 August 1999. U.S. Food and Drug Administration (CDER, CBER, CVM): Guidance for Industry: Consumer-Directed Broadcast Advertisements
  • Exhibit 989 9 September 2025. U.S. Food and Drug Administration: FDA Launches Crackdown on Deceptive Drug Advertising (press release)
  • Exhibit 992 January 2019. Schwartz LM, Woloshin S, JAMA 321(1):80-96 (Dartmouth Institute): Medical Marketing in the United States, 1997-2016
  • Exhibit 993 undated (file name DTCA-2019). Focke F, Niessen-Ruenzi A, Ruenzi S, University of Mannheim: Pharmaceutical advertising biases media reports on drug safety (manuscript)