Practice Tip: Navigating the FDA's Recent RiskMAP Guidance

While FDA Guidance documents do not technically create legal obligations for manufacturers, as one writer noted, they still carry “the same weight as a 'recommendation' from the Godfather.” Barlas, S., Drug Safety Drama: FDA Opens Curtain on a New Era and New Guidance Documents, 29 Pharmacy & Therapeutics J. 752, 752 (Dec. 2004). The recently released guidance documents concern: 1) Premarketing Risk Assessment (focusing on risk assessment during the later stages of clinical development); 2) Development and Use of Risk Minimization Action Plans (focusing on specialized risk management systems); and 3) Pharmacovigilance Assessment (focusing on post-market risk assessment strategies). See Guidance for Industry: Premarketing Assessment, U.S. Dep't of Health and Human Services Food & Drug Administration (FDA), available at www.fda.gov/cder/guidance/6357fnl.htm (last modified March 24, 2005) at 1; Guidance for Industry: Development and Use of Risk Minimization Action Plans, FDA, available at www.fda.gov/cder/guidance/6358fnl.pdf (last modified March 24, 2005) at 1 [hereinafter FDA RiskMAP Guidance]; Guidance for Industry: Good Pharmacovigilance Practices and Pharma-coepidemiologic Assessment, FDA, available at www.fda.gov/cder/guidance/6359OCC.htm (last modified March 24, 2005) at 1. These guidances were produced in part to fulfill the FDA's commitment to certain risk management performance goals agreed to in relation to the Prescription Drug User Fee Act (“PDUFA”) upon its reauthorization in June 2002. Under PDUFA III, drug companies agree to pay fees that boost FDA resources, and the FDA agrees to time goals for its review of new drug applications. As the FDA works to increase its efficiency in shepherding drugs through the approval process, improvements in the way drug safety is assessed and monitored can lead to earlier identification of safety problems and enable a more proactive approach to minimizing these risks.