DESCRIPTION
The Food and Drug Administration Amendments Act of 2007 (FDAAA) is arguably the most significant reform of drug safety in five decades. Its implementation will affect all sectors of FDA-regulated industry. For instance, in the area of drug safety and surveillance, FDAAA provides FDA with expanded authority to require a system of Risk Evaluation and Mitigation Strategies (REMS) for select drugs, order labeling changes, require post-market clinical studies, and fine those who fail to comply. In the area of clinical trials, FDAAA expands the current clinical trial registry into a comprehensive and publicly available Internet-based clinical trials database. Parties conducting clinical trials are required to register with the database and link to any existing published results, with civil monetary penalties imposed upon those who fail to comply.
The FDAAA also reauthorized the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), creating new fee structures about which regulated industry needs to be aware. Under PDUFA, drug user fees will increase to 70% of FDA's resource base for drug reviews, while MDUFA creates two new device industry fees, designed to offset the reduction in individual device fees.
In the area of pediatrics, Congress reauthorized two programs designed to increase research and labeling for pediatric use: The Best Pharmaceuticals for Children Act (BPCA), which provides six months of exclusivity if the sponsor conducts qualifying pediatric studies, and the Pediatric Research Equity Act (PREA), which authorizes FDA to require manufacturers of new drugs or biologics to conduct pediatric studies under certain circumstances. Additionally, the new Pediatric Medical Device Safety and Improvement Act (PMDSIA) offers manufacturers incentives to develop pediatric-specific devices.
Many of these provisions will require FDA to develop guidance for industry or initiate rulemaking. In the coming months, it will be essential for companies in regulated industry to assess the impact of FDAAA both on their strategic business plans and on their current (and future) regulatory obligations. This seminar will assist MBC members in becoming informed and active participants in the feedback process as FDA begins implementation of FDAAA.
I. Overview of FDAAA
Paul Kim, Foley Hoag LLP
II. Panel Discussion and Questions:
Moderator: Paul Kim, Foley Hoag LLP
Panelists:
- Carolyn Jones, Director, Regulatory Policy - Biogen Idec
- Naseem Kabir, Associate Director, Regulatory Affairs - Genzyme
- Sarah Larson, Program Manager, Program Development & Operations - Genzyme
III. Closing Remarks
Nick Littlefield, Law & Policy Committee
COST:
This event is free of charge and open to MBC Member companies and their employees only.