US FDA Modernization Act, section 114: uses, opportunities and implications for comparative effectiveness research.
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.
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ABSTRACT: Comparative effectiveness research (CER) is increasing as an element of health care reform in the United States. By comparing drugs against other drugs or other therapies instead of just to placebo, CER has the potential to improve decisions about the appropriate treatment for patients. But the growth of CER also brings an array of questions and decisions for purchasers and policy makers that will not be easy to answer and which require significant dialogue to fully understand and address. To describe some of the impact, both positive and negative, that comparative effectiveness research (CER) may have on the pharmaceutical industry. As CER data proliferate, questions are being raised about who can access the data, who can discuss it, and in what forums. Regulations place different communication restrictions on the pharmaceutical industry than on other health care stakeholders, which creates a potential inequality. Another CER consideration will be the tendency to apply average results to individuals, even if not every individual experiences the average result. Policy makers should implement CER findings carefully with a goal toward accommodating flexibility. A final impact to consider is whether greater expectations for CER will have a negative or positive effect on incentives for drug innovation. In some cases, CER may increase development costs or decrease market size. In other cases, better targeting of trial populations could result in lower development costs. The rising expectations and growth in CER raise questions about information access, communication restrictions, flexible implementation policies, and incentives for innovation. Members of the pharmaceutical industry should be cognizant of the questions and should be participating in dialogues now to pave the way for future solutions.Journal of managed care pharmacy: JMCP 05/2012; 18(4 Suppl A):S9-12. · 2.68 Impact Factor
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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