GAO Finds Continued Need for FDA Drug Postmarket Safety Oversight Improvement; Seeks Timeline for Transfer of Certain Protocol Reviews from OND to OSE

December 10, 2009

By Jamie K. Wolszon

The U.S. Government Accountability Office (“GAO”) released a report earlier this week finding that FDA’s postmarket drug safety decision-making and oversight, while improved since a prior investigation a few years ago, continues to have gaps.  The GAO recommended that FDA establish a timeline for transferring responsibility for the review of protocols and findings of observational epidemological studies and the review of protocols and studies that assess medication error risks from FDA’s drug center’s Office of New Drugs (“OND”) to its Office of Surveillance and Epidemiology (“OSE”).

Senate Finance Committee Ranking Member Charles Grassley (R-IA) requested the report “Drug Safety: FDA Has Begun Efforts to Enhance Postmarket Safety, but Additional Actions are Needed.”  The report, dated November 2009, follows up on a 2006 GAO report that found deficiencies in agency postmarket drug safety decision-making and supervision. 

The 2006 GAO report, titled “Drug Safety: Improvement Needed in FDA’s Decision-making and Oversight Process,” found that the agency had not clearly defined the role of OSE and that communications problems between OSE and OND were undermining the decision-making process. 

OND mainly reviews premarket drug applications submitted by drug sponsors, but also has postmarket authority.  OND traditionally has had final responsibility to decide whether to take regulatory action.  OSE traditionally has acted as a consultant and not had independent decision-making responsibility.

The 2006 report also found limitations in the data FDA uses to identify postmarket drug safety issues and the systems the agency uses to track drug safety issues once identified.  The 2006 report recommended that FDA: revise and implement the agency’s draft policy intended to clarify the role of staff, including OSE, in major postmarket drug safety decisions; clarify OSE’s role in FDA scientific advisory committee meetings with postmarket drug safety issues; increase the independence of the drug center’s dispute resolution process; and systematically track OSE’s recommendations and subsequent safety actions.

Since 2006 when GAO issued its last report, Congress passed the FDA Amendments Act of 2007 (“FDAAA”).  FDAAA provided the agency with significant new drug postmarketing authority, and heightened the agency’s drug safety responsibilities and workload.  The new GAO report examines the steps FDA is taking to address the issues identified in the 2006 GAO report, and evaluates FDA efforts to meet the agency’s increased drug safety workload.

The new GAO report notes that the agency launched a Safety First Initiative in January 2008.  That initiative is intended to provide clearly defined roles and responsibilities for the post-market decision making process.  The initiative incorporates the principle the agency calls Equal Voice, intended to ensure the equal participation of all relevant parties. 

OSE and OND signed a Memorandum of Understanding in June 2008 that states the agency’s intent for the two offices to equally contribute.  That MOU has expired and subsequently been extended.  OND, according to GAO, generally retains the authority to decide the regulatory action.  FDA, the report adds, has stated that this authority generally remains with OND as the OND staff has the broadest expertise in evaluating and managing clinical risks and benefits of drugs. 

However, as part of the MOU, the agency envisioned transferring three roles from OND to OSE: 1. proprietary name review; 2. review of protocols and findings of observational epidemological studies; 3. review of protocols and studies that assess medication error risks.  FDA transferred proprietary name review in April 2009, but has yet to establish timelines for the remaining planned transfers. 

GAO now recommends that the FDA commissioner “develop a comprehensive plan for transferring the additional regulatory authorities from OND to OSE that includes time frames for the transfer and steps to ensure resources are properly aligned to allow OSE to assume these responsibilities.”

While FDA supports the idea of such a comprehensive plan, it resists committing to timelines.  “The details of such a plan, including timelines, remain dependent upon available appropriated and PDUFA funding as well as the Agency’s ability to recruit and retain the necessary staff to assume additional responsibilities,” the agency stated in a letter to GAO.  GAO responded: “we believe that the development of a comprehensive plan and time line is an important step towards ensuring the necessary funding levels and staffing needs are identified and secured.”

Categories: Drug Development