# Presentation: 702775

## January 24-25, 2005
Walter A. Orenstein, M.D.
Director, Emory Vaccine Policy and Development
Associate Director, Emory Vaccine Center
Associate Director, Southeastern Center for Emerging Biologic Threats

**Walter A. Orenstein, M.D.**
**Director, Emory Vaccine Policy and Development**
**Associate Director, Emory Vaccine Center**
**Associate Director, Southeastern Center for Emerging Biologic Threats**

**Regulatory Considerations**
**2****nd**** NVAC Workshop on Strengthening **
**the Supply of Vaccines in the U.S.**

## The Critical Role of Regulation

**Assure vaccines are safe and effective prior to licensure and widespread use**
**Assure licensed and recommended vaccines continue to be safe and effective **
**Special obligation since vaccines usually administered to healthy persons**

## Responsibility for Regulation

**FDA**
**Approval for licensure**
**Monitoring of product and production processes post-licensure**

## Regulatory Issues Cited by NVAC as Immediate Factor in Recent Vaccine Shortages †

**Problems in complying with GMP – related inspections**
**Modification of GMP inspection teams to include more expertise in design and in control during the 1990s**
**Focus shifted to include quality systems, in process testing, and facility and process validation**
**Result – some facilities that had been previously acceptable now required significant physical changes to plants, quality systems, and processes**

**† ****NVAC.  JAMA 2003; 290:3122-3128**

## NVAC Conclusions Regarding Regulatory Issues †

**“...****. consensus exists that vaccine safety issues and maintaining credibility with the public requires a rigorous regulatory process.”**

**† ****NVAC.  JAMA 2003; 290:3122-3128**

## NVAC Recommendations Regarding Regulation I

**Harmonization**** **
**	****content and format of regulatory ****	****	****submissions**
**	****mutual recognition of lot release tests**
**Review of GMP Standards**
**	****science based regulatory standards**
**	****incorporate technological advances but ****	****allow flexibility to ensure continued ****	****production as long as safety and efficacy ****	****are not compromised**

## NVAC Recommendations Regarding Regulation II

**Increased Funding for CBER**
**	****recruit and retain highly qualified scientists**
**Streamlining the Regulatory Process**
**	****early and frequent communication between ****	****FDA and sponsors**
**	****product development, fast track, priority ****	****review and accelerated approval programs**
**	****determine if additional legislation is ****	****necessary to enhance and expedite review ****	****process**

## NVAC Recommendations Regarding Regulation III

**	****Reviewing the regulatory process for vaccine and biologics**
**	****should vaccines be regulated differently ****	****from drugs?**
**	****evaluate current policies and practices to ****	****determine if they inadvertently create ****	****impediments to supply**

## Structure of the Session

**	****FDA Report****	****	****	****Norman Baylor**
**	****Views from the Manufacturers'**
**	****	****Large producers****	****Alan Shaw, Merck**
**	****	****Smaller, new manufacturer**
**	****	****	****	****	****	****Lance Gordon, VaxGen**
**	**
**	****A case study of a vaccine licensed under different regulatory authorities – PCV7**
**	****	****	****	****	****	****Peter Paradiso, Wyeth**