FDAMA Section 114: Why the Renewed Interest?
The FDA regulates the use of information by biopharmaceutical companies in their promotional activities. Section 114 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) was specifically designed to allow companies to more readily disseminate health care economic information (HCEI) to those who need it for formulary decision making. However, very little HCEI has been distributed promotionally under this provision over the past 17 years. There are recent discussions by stakeholders regarding the need for updates, revisions, or guidance regarding Section 114.In light of recent renewed interest in Section 114 of the FDAMA, the purpose of this commentary is to equip managed care decision makers with the information they need to understand and respond to industry communications that are governed by Section 114. This commentary reviews and synthesizes the regulatory history and language of the statute and changes to the promotion regulation generated by Section 114. It explores the reasons for the section's limited use to date, for recent renewed interest, and why changes by various stakeholders are suggested at this time. Also discussed is what managed care pharmacists need to know about Section 114, and suggestions are included regarding the active role pharmacists can play in this change process. Renewed interest in FDAMA Section 114 appears to stem largely from the increasingly visible and growing interest in comparative effectiveness research, the emergence of "big data," the expanding range of data sources available for deriving HCEI, and recent court decisions that might indicate a change in the regulatory environment. Various stakeholders are proposing recommendations regarding changes to FDAMA Section 114. Managed care pharmacists should be aware that companies are restricted when communicating HCEI promotional messages; this may mean seeing the use of FDAMA Section 114 as the "competent and reliable" effectiveness standard in promotion. If the managed care pharmacy community communicates clearly about what information it needs and the format in which it wants to receive that information, companies, policymakers, and regulatory bodies can work collaboratively with managed care pharmacy to create a regulatory environment that supports transparent communication of desired information.
University of Maryland School of Pharmacy, 220 Arch St., 12th Fl., Baltimore, MD 21201. eoehrlein@umaryland.edu.
Eleanor M
EM
Perfetto
Laurie
L
Burke
Elisabeth M
EM
Oehrlein
Mena
M
Gaballah
D057186:Comparative Effectiveness Research / Q000331:legislation & jurisprudence* / Q000379:methods*; D003657:Decision Making; D004345:Drug Industry / Q000379:methods*; D006801:Humans; D008329:Managed Care Programs / Q000331:legislation & jurisprudence*; D010593:Pharmaceutical Services / Q000331:legislation & jurisprudence*; D010595:Pharmacists; D010604:Pharmacy / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration