Dear Commissioner von Eschenbach:
The United States Senate Committee on Finance (Committee) has jurisdiction over theMedicare and Medicaid programs and, accordingly, a responsibility to the more than 80 millionAmericans who receive health care coverage under those programs to oversee the properadministration of the programs, including the payment for prescription drugs regulated by theFood and Drug Administration (FDA or Agency). As Ranking Member of the Committee, Ihave the duty to ensure that FDA upholds its responsibility to the public’s health by properlyregulating the nation’s drug supply and ensuring that the drugs Americans use are safe andeffective.
Recently, the FDA announced its “Safety First" Initiative, an effort within the Center forDrug Evaluation and Research (CDER) to “strengthen and modernize" FDA’s oversight of drugson the market. In an email to all CDER staff, Acting Center Director Janet Woodcock outlinedsome of the steps that will be taken to implement this initiative, including establishing thepositions of Deputy Director for Safety and Safety Regulatory Project Manager within the Officeof New Drugs (OND) and laying out the respective responsibilities of OND and the Office ofSurveillance and Epidemiology (OSE) in addressing drug safety issues.
Over the last four years I have investigated and questioned how the FDA handlespost-market surveillance of drugs, biologics, medical devices, and veterinary medicines to assesswhether or not the Agency is fulfilling its primary mission to protect public health. In particular,my investigations have shown repeatedly that serious adverse events that emerge after a drug ison the market do not necessarily get prompt attention from the Office of New Drugs (OND).Further, safety concerns raised by the Office of Surveillance and Epidemiology (OSE) weresometimes ignored by OND, which is responsible for determining what, if any, regulatoryactions will be taken to address a post-marketing drug safety issue.
I have frequently pointed out that this imbalance between the office responsible formonitoring post-marketing drug safety and the office that puts drugs on the market in the firstplace has resulted in delayed action and even inaction on serious post-marketing safety concerns.As you are aware, the Institute of Medicine also identified thisimbalance in authority between OND and OSE as a major weakness in the drug safety systemand recommended joint authority in the post-approval setting.
Congress didn’t take the opportunity to address this fundamental problem, and it appearsthat FDA’s response to the call for strengthening and better defining OSE’s role may be merelycosmetic. Dr. Woodcock claims in her email to CDER staff that “OSE will be playing anexpanded role in the resolution of certain drug-related safety issues and assuming lead regulatoryresponsibility for areas related to observational epidemiologic studies and medication errorprevention." As I understand it, however, these regulatory responsibilities have always been inOSE’s domain; so there's nothing new there. The memorandum of agreement to be establishedunder the Safety First Initiative will only be making these responsibilities explicit. In addition,according to The Wall Street Journal, an FDA official stated that, “I think we really believethat…the team that has been in charge of drug development, that knows the drug best of all,really needs to be in charge."[1]
Accordingly, I request that the FDA provide a briefing for my Committee staff to discussthe Agency’s Safety First Initiative. I would appreciate FDA elaborating on the details of theinitiative and the timeframes for implementation. In particular, please explain FDA’s decision tomaintain what appears to be the status quo-OSE continuing to play the role of consultant toOND on post-marketing safety matters. In addition, I would appreciate a discussion of thespecific responsibilities of the new positions to be created within OND and what their roles andresponsibilities will be vis-à-vis OSE.
The Wall Street Journal also reported that the FDA is creating a new appeals process sothat scientific disagreements between offices can be appealed to higher-level officials, up to theOffice of the Commissioner. Please have your staff prepared to describe FDA’s plans for thenew appeals process and how it would improve on the current ad hoc system for resolvingdisputes.
I look forward to hearing more about the Safety First Initiative and request that thebriefing be scheduled by no later than March 26, 2008. Thank you for your cooperation.
Sincerely,
Charles E. Grassley United States Senator Ranking Member of the Committee on Finance
