Enforcement or Scientific Collaboration? The Brave New World of FDA Risk AssessmentPresented by Cathy Burgess
Recorded On: Thursday, June 17, 2010
PURCHASE:
RECORDING HIGHLIGHTS:
“FDA will be prepared to act swiftly and aggressively to protect the public… If we find that we must move quickly to address significant health concerns or egregious violations, we will consider immediate action – even before we have issued a formal warning letter.” FDA Commissioner Hamburg, August 6, 2009 “An approach of extremes puts the agency in the position of not commenting on science… A binary approach that cycles between what can be seen as false assurance and draconian enforcement can lead the public to doubt the quality of industry products.” FDA Commissioner Hamburg, April 21, 2010 FDA’s recent enforcement initiative, with post-inspection deadlines, accelerated issuance of warning letters and aggressive follow-up signaled a significant change in FDA’s approach to regulatory violations. As a result of this initiative, the number of Warning Letters has more than doubled in the past year, with an average of x warning letters each month. Moreover, the number of seizures and injunctions is on the rise. At the same time, there have been instances where the agency has taken a much more flexible approach in addressing problems. For example, when alerted to a viral contaminant in the rotavirus vaccine, Rotarix, FDA asked healthcare providers to temporarily halt use of the vaccine while the agency investigated. When salmonella was discovered in hydrolyzed vegetable protein, the agency tried to take a balanced approach, only recalling products without a “kill step” in their preparation. In this 90 minute audio conference, Cathy Burgess will discuss the pattern of recent warning letters and give participants pointers on FDA’s current areas of focus. In addition, Cathy will provide tips on how to avoid warning letters and how to respond if you receive one.
YOUR EXPERT(S):
Cathy Burgess
is a counsel in Crowell & Moring’s Health Care Group. She advises clients on FDA regulatory matters affecting prescription and OTC drugs, biologics, medical devices and cosmetics. Her practice primarily focuses on compliance, especially related to good manufacturing practices and quality systems. She advises clients on compliance programs, adequacy of SOPs, investigation reports, inspection management, responding to Form FDA 483s and Warning Letters and recalls. She also conducts internal investigations and special audits related to FDA compliance. Cathy also provides advice on legislative matters affecting FDA regulated entities. She assists in development of legislative strategies, assists clients with testimony, prepares staff for interviews with committee staff and provides advice on pending legislation. Prior to joining the firm, Cathy was associate general counsel for the American Red Cross, where she served as regulatory counsel for the organization. One of her primary responsibilities was providing legal assistance and strategic advice to Red Cross management and the Board of Governors' Audit Committee on matters related to the Red Cross Amended Consent Decree. In 1992, Cathy was the number two person on the defense team in Cathy earned her J.D. from the Catholic University of America’s Columbus School of Law. |
