Prescription Drug Promotion from 2001-2014: Data from the U.S. Food and Drug Administration

Sullivan, Helen W.; Aikin, Kathryn J.; Chung-Davies, Eunice

doi:10.1371/journal.pone.0155035

Cited by 18 publications

(7 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Even today, the majority of drug advertisements are focused mainly on clinicians but there is the gradually increasing trend of direct‐to‐consumer (DTC) advertisements. The US Food and Drug Administration received three times as many non‐Internet submissions for promotional approval directed towards healthcare professionals over customers (Figure ) .…”

Section: The Drug Promotion Armamentariummentioning

confidence: 99%

“…Trend of submissions to US Food and Drug Administration (FDA) for non‐Internet promotion; direct‐to‐consumer vs . Professionals (2001–2014) …”

Section: The Drug Promotion Armamentariummentioning

confidence: 99%

“…Trend of submissions to US Food and Drug Administration (FDA) for non-Internet promotion; direct-to-consumer vs. Professionals (2001-2014) [7] Drug promotion practices: a review Even with the advent of DTC advertisements, promotion to professionals still occupy the lion's share of this segment. Much of the promotional literature is presented by the medical representatives during their physician's visit and by virtue of the lack of scientific credibility of the data depicted in the literature or due to the commercial nature of the representative's visit, the practice of drug promotion through literature often loses its significance as an effective method of disseminating latest drug information.…”

Section: Figurementioning

confidence: 99%

See 2 more Smart Citations

Drug promotion practices: A review

Jacob

2018

Br J Clin Pharmacol

View full text Add to dashboard Cite

Over the years, the pharmaceutical industry has been at the forefront of research and innovation in drug discovery and development. The process of drug discovery extending from preclinical studies to multicentric clinical trials and postmarketing phase is a costly affair running into billions of dollars. On the flip side, not all investigational molecules clear the trial phases and get approved, which puts pressure on the manufacturers to maximize the profit from approved drugs. It is in this key area that the practice of drug promotion plays its role. The World Health Organization defines drug promotion as "all informational and persuasive activities by manufacturers and distributors, the effect of which is to influence the prescription, supply, purchase or use of medicinal drugs". With its humble intent of creating awareness among healthcare professionals and updating their knowledge on recent advances in treatment options, drug promotion has been an important tool, but gradually it has evolved to embrace aggressive marketing strategies and sometimes unethical business and scientific practices where the need for profit-making eclipses commitment to patient care and scientific exploration. In this review, we discuss the evolution of drug promotion practices, the various types, its merits and demerits, the influence of drug promotion on physician prescribing behaviour, the role of regulatory bodies, unethical promotional practices and finally summarize with future directions.

show abstract

Section: The Drug Promotion Armamentariummentioning

confidence: 99%

“…Trend of submissions to US Food and Drug Administration (FDA) for non‐Internet promotion; direct‐to‐consumer vs . Professionals (2001–2014) …”

Section: The Drug Promotion Armamentariummentioning

confidence: 99%

Section: Figurementioning

confidence: 99%

See 1 more Smart Citation

Drug promotion practices: A review

Jacob

2018

Br J Clin Pharmacol

View full text Add to dashboard Cite

show abstract

“…The number of drugs approved under the accelerated approval regulatory pathway has been increasing . At the same time, prescription drugs are increasingly marketed online to consumers, including promotion of products indicated for serious or life‐threatening medical conditions such as cancer . Information about the limitations inherent in the accelerated approval pathway may be relevant to patients making treatment decisions.…”

Section: Introductionmentioning

confidence: 99%

“…2 At the same time, prescription drugs are increasingly marketed online to consumers, including promotion of products indicated for serious or life-threatening medical conditions such as cancer. [7][8][9][10] Information about the limitations inherent in the accelerated approval pathway may be relevant to patients making treatment decisions. Communicating these limitations in clear and understandable language may help consumers make informed decisions about their medical treatments in consultation with health care providers.…”

Section: Introductionmentioning

confidence: 99%

Disclosing accelerated approval on direct‐to‐consumer prescription drug websites

Sullivan

O’Donoghue

David

et al. 2018

Pharmacoepidemiology and Drug

Self Cite

View full text Add to dashboard Cite

Purpose We examined direct‐to‐consumer (DTC) websites for brand‐name accelerated approval prescription drugs to determine whether and how accelerated approval is communicated to consumers. Methods From the 34 brand‐name prescription drugs under the Food and Drug Administration's accelerated approval pathway presubmission requirement for promotional materials in December 2016, we identified a sample of 26 that had active DTC websites. Two raters independently coded the websites for the presence, placement, content, and readability of an accelerated approval disclosure. Results Most (73%) of the websites contained an accelerated approval disclosure. Most of the disclosures (84%) included the basis for accelerated approval, whereas 68% stated that the clinical benefit of the product was unknown and 47% conveyed the need for additional research to confirm study findings. On average, the disclosures required at least a high school reading level, and most conveyed the information in medical terms. Conclusions Direct‐to‐consumer websites for brand‐name accelerated approval prescription drugs do not consistently communicate the accelerated approval information for the product to consumers in a prominent, comprehensive, or readable manner.

show abstract

Medical Marketing in the United States, 1997-2016

Schwartz

Woloshin

2019

JAMA

287

205

View full text Add to dashboard Cite

IMPORTANCE Manufacturers, companies, and health care professionals and organizations use an array of promotional activities to sell and increase market share of their products and services. These activities seek to shape public and clinician beliefs about laboratory testing, the benefits and harms of prescription drugs, and some disease definitions. OBJECTIVE To review the marketing of prescription drugs, disease awareness campaigns, health services, and laboratory tests and the related consequences and regulation in the United States over a 20-year period (1997-2016). EVIDENCE Analysis (1997-2016) of consumer advertising (Kantar Media data for spending and number of ads); professional marketing (IQVIA Institute for Human Data Science, Open Payments Data [Centers for Medicare & Medicaid Services]); regulations and legal actions of the US Food and Drug Administration (FDA), Federal Trade Commission (FTC), state attorneys general, and US Department of Justice; and searches (1975-2018) of peer-reviewed medical literature (PubMed), business journals (Business Source Ultimate), and news media (Lexis Nexis) for articles about expenditures, content, and consequences and regulation of consumer and professional medical marketing. Spending is reported in 2016 dollars.

show abstract

Prescription Drug Promotion from 2001-2014: Data from the U.S. Food and Drug Administration

Cited by 18 publications

References 14 publications

Drug promotion practices: A review

Drug promotion practices: A review

Disclosing accelerated approval on direct‐to‐consumer prescription drug websites

Medical Marketing in the United States, 1997-2016

Contact Info

Product

Resources

About