US FDA Modernization Act, section 114: uses, opportunities and implications for comparative effectiveness research.

Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts, USA.
PharmacoEconomics (Impact Factor: 3.34). 08/2011; 29(8):687-92. DOI: 10.2165/11590510-000000000-00000
Source: PubMed

ABSTRACT Section 114 of the 1997 US FDA Modernization Act (FDAMA) is an important vehicle for pharmaceutical companies to promote the economic value of their drugs to formulary decision makers, but little is known about how the Section has been interpreted and used.
We conducted a web-based survey of a convenience sample of 35 outcomes directors of major pharmaceutical and biotechnology companies. We asked them about their interpretation of, and experiences with, Section 114, as well as their views regarding the FDA's role in the matter, and whether the advent of comparative effectiveness research (CER) will affect the use of Section 114 promotions.
Of the 35 experts, 16 (46%) completed the survey. 81% stated they always or frequently consider using Section 114 when making promotional claims for drugs. 75% stated that the FDA should issue guidance on how to make such promotions to payers, especially what qualifies as "healthcare economic information" and "competent and reliable scientific evidence." Most expected to use Section 114 to a greater extent in the future, and agreed that the increased focus on CER would increase Section 114 use.
The survey suggests strong awareness about Section 114 among the outcomes directors and some use of the Section for promotional purposes. It also reflects a belief that CER will increase use of Section 114 promotions, and that guidance from the FDA is needed. More clarity - and, ideally, flexible interpretation - from the FDA is warranted, especially given the rise of CER.

  • [Show abstract] [Hide abstract]
    ABSTRACT: This article provides a perspective from the pharmaceutical industry on a hypothetical comparative effectiveness research case, highlighting tension between the reality of conducting comparative effectiveness research and the regulation of biopharmaceutical industry communication. Specifically, under current law and regulations, Aesculapion, the hypothetical maker of the fictional migraine headache drug Hemikrane, would have limited ability to communicate findings or to respond to inaccurate "what-if" scenario communications. Principles for communicating drug information could increase decision makers' access to information while making it easier for them to assess the quality and potential biases of different information sources. The article proposes two complementary approaches: formal Food and Drug Administration guidance clarifying how industry can participate meaningfully and proactively in the comparative effectiveness research discourse, possibly based on 1997 legislation governing communication of "health care economic information"; and stakeholder collaboration on development and adoption of voluntary "good communication principles."
    Health Affairs 10/2012; 31(10):2213-9. DOI:10.1377/hlthaff.2012.0745 · 4.64 Impact Factor
  • New England Journal of Medicine 07/2013; 369(3):209-11. DOI:10.1056/NEJMp1300312 · 54.42 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: We surveyed US-based leaders in health economics and outcomes research (HEOR) departments in drug and device companies to examine their views on the state of the field. We created a questionnaire that was emailed to 123 US-based senior HEOR professionals at 54 companies. Of the 123 recipients, 74 (60%) completed the survey. Most respondents (92%) expected their company's HEOR use to increase, and 80% reported that their organization's senior management viewed HEOR work as critical. Approximately 62% agreed that Academy of Managed Care Pharmacy (AMCP) dossiers are useful to US health plans, and 55% stated that Food and Drug Administration Modernization Act (FDAMA) Section 114 is useful. Approximately 49% believed the US government should use cost-effectiveness analysis in coverage and reimbursement decisions, but only 31% expected this to occur within 3 years. The findings suggest strong support for the function at senior management levels and optimism about the field.
    Expert Review of Pharmacoeconomics & Outcomes Research 10/2013; 13(5):657-61. DOI:10.1586/14737167.2013.838027 · 1.67 Impact Factor