FDA Hearing to Discuss PDUFA, Agency's User Fee Program to Maintain Drug Safety

Statement to the Media by David Fassler, Board Member of Mental Health America

Contact:    Heather Cobb, (703) 797-2588 or hcobb@mentalhealthamerica.net
                    Jason Halal, (703) 797-1943 or jhalal@mentalhealthamerica.net

WASHINGTON, D.C. (February 17, 2006) - At a hearing today, the Food and Drug Administration shared its draft recommendations to Congress for the reauthorization of the Prescription Drug User Fee Act (PDUFA), legislation that supplements the FDA's drug review program funding with user fees paid by pharmaceutical manufacturers.  Mental Health America's board member, David Fassler, M.D., a child psychiatrist, testified at the hearing with the organization's recommendations. 

Mental Health America supports the development of a healthcare system that's based on and responsive to the latest research, doctors' expertise and the values of people.  The opportunity to make changes to the user fee program at FDA only comes around every five years.  This is a chance to improve transparency for the American public and enhance drug safety.

As an organization dedicated to improving the mental health of all Americas, particularly the millions who live with mental health conditions, Mental Health America supports many of the FDA actions and initiatives that align with key recommendations made recently by the Institute of Medicine.  Namely, we applaud efforts to:   strengthen the science supporting and underlying the FDA's medical product safety system at every stage of the product life cycle; improve communication among all stakeholders engaged in promoting safe, appropriate use of medical products; and enhance agency operations and management to ensure implementation of the review, analysis, consultation and communication systems and processes needed to strengthen the U.S. drug safety system. 

However, Mental Health America offers a number of specific recommendations for improving the FDA through PDUFA that specifically aim to protect people and families with mental health needs.  These four recommendations would promote transparency and enhance drug safety:  

1. The FDA must retain ultimate authority over resource allocation within the agency. This would afford the agency much-needed flexibility to promote timely response to the latest research, adverse event reports and public health trends. We also believe the FDA should have the ability to require companies to conduct research on specific aspects of safety or efficacy, even after a medication or device receives initial approval. Scientific knowledge is constantly evolving -- the most current information, clinical data and research available should influence and drive the modification of FDAactivities and priorities.

2. With the constantly evolving science base, consumers must be present "at the table" during every stage of the review process. Their experience, perspective and knowledge is valuable and vital - from pre-market testing and development through post-market surveillance. One stellar model already within the walls of FDA: The Office of Special Health Issues excels as a channel through which consumers' issues and viewpoints are brought to the FDA medical and regulatory staff's attention.  This FDA initiative affords patients with cancer and HIV-whose treatment needs are unique-to have a voice in FDA's decision-making process.  The agency should expand the Office of Special Health Issues to include consumers in the drug review process for other serious and life-threatening diseases, such as mental illness.  Accordingly, specific resources should be allocated to support these efforts.  

3. The FDA's proposed reauthorization contains a commitment to expand the review of direct-to-consumer advertisements for pharmaceutical products. While such ads can help inform the public about specific disorders and the availability of treatment, recent research indicates that they often tend to overemphasize benefits while minimizing potential risks and side effects. This area clearly needs more oversight from the FDA.

4. The FDA has an obligation to monitor the impact of their actions on public health and access to medical care, and to revisit specific decisions when and if warranted by subsequent data and research findings.

By implementing these recommendations, the FDA could take a significant step toward improving health outcomes, especially for the millions of individuals living with mental illness in our country.  Mental Health America and its national network of 320 affiliates look forward to working with the FDA and Congress to improve PDUFA and the agency's ability to safeguard the health of Americans.

Mental Health America is the country's leading nonprofit dedicated to helping ALL people live mentally healthier lives.  With our more than 320 affiliates nationwide, we represent a growing movement of Americans who promote mental wellness for the health and well-being of the nation - everyday and in times of crisis.