2nd Quarter 2007

Peri-Scope

Meetings

Edgar H. Adams, Sc.D., and Jeffrey J. Stoddard, M.D., attended the Food and Drug Administration's (FDA) public hearing on the use of medication guides to communicate drug risk information to patients, Washington, D.C., June 12-13, 2007. Dr. Stoddard presented a formal statement on optimization of risk communication approaches, stressing balance of risk and benefit information, and invoking the CDC's Vaccine Information Statements (VIS) as effective risk communication vehicles. http://www.fda.gov/cder/meeting/medication_guides_200706.htm

Luis Gutierrez presented a formal statement at a public workshop co-sponsored by the Agency for Healthcare Research and Quality (AHRQ) and the Food and Drug Administration (FDA). Topic: Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges public workshop, Rockville, MD, June 25-26, 2007. His statement provided perspectives on the implementation of RiskMAPs shaped by Covance's experience in this arena. http://www.fda.gov/cder/meeting/riskMAPs.htm

Status of PDUFA and REMS Legislation

By Edgar Adams

On May 9, 2007, Senate Bill 1082, the Food and Drug Administration Revitalization Act (FDARA), an act to amend the Federal Food, Drug and Cosmetic and Public Health Service Acts to reauthorize drug and device user fees and ensure the safety of medical products and for other purposes, passed the Senate 93 to 1. The act consists of 8 titles but the two most visible are Title 1, Prescription Drug User Fees Act (PDUFA), and Title 2, Risk Evaluation and Mitigation Strategies (REMS). The act also reauthorizes the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA).

On June 28, H.R. 2900, a bill "to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes" was introduced and permission was given to extend the time to file report on the bill to July 9.

H.R. 2900 contains the PDUFA legislation, H.R. 1561, the Enhancing Drug Safety and Innovation Act of 2007, and still contains the Risk Evaluation and Mitigation Strategies provision.

The Senate version that was passed contains specific provisions based on whether a risk evaluation and mitigation strategy is needed, while the House version requires the inclusion of a proposed risk evaluation and mitigation strategy. The House bill also contains the requirement for a symbol on the label and in direct-to-consumer (DTC) ads indicating the newly approved status of the drug or indication.

It is likely that H.R. 1561 will be folded into H.R. 2900 and the differences ironed out in committee in the near future.