Dr. Hamburg's Agenda
NEW MEMBERS
We are pleased to announce that three additional organizations have recently joined the Alliance for a Stronger FDA: the Association of Medical Device Reprocessors, the PKD Foundation, and Patient Services Incorporated. These new member organizations further add to the Alliance’s broad coalition of patient groups, consumer advocates, biomedical research advocates, health professionals, and industry members.
THE GROSSMAN ANALYSIS
On July 22, Commissioner Hamburg spoke at the Alliance’s quarterly member meeting. She had been in office less than 8 weeks, but already had a strong vision of where the FDA needs to go. The Alliance’s summary still provides interesting reading.Dr. Hamburg thanked the Alliance for the important work it’s doing and its success in adding nearly $1 billion in agency funding. Even with the much-needed increases, she believes that workloads and resource constraints will continue to make the agency’s job difficult. Some of her key challenges and priorities include:
Improving the Public Health. FDA is going to measure success in terms of public health outcomes, how much illness is declining, etc. Because of the agency’s unique and critical mission and historic underfunding, the new approach will be to explicitly link budget needs to public health goals.
Increasing and Strengthening FDA’s Regulatory Science Capacity. Unfunded mandates are a serious challenge to FDA’s regulatory system, as are extraordinary advances in new science and technology. There is a need for stronger support for FDA regulatory science and the agency’s science base. She believes the agency will be able to recruit and retain more expert regulatory scientists in the future. She plans a larger and renewed collaboration with the broader scientific community.
Meeting the Demands that Globalization Places on the FDA Mission to Ensure the Safety of Food, Drugs and Devices. Not only must FDA develop a stronger scientific base, but scientific expertise must be available on a global basis.Dr. Hamburg made a number of other comments worth reporting upon:
She sees the link between public confidence in FDA and the performance of the agency and intends to improve both.
FDA needs to recreate a capacity to react and prevent crises — this is constrained by resources.
The recent GAO report documents severe resource problems. GAO’s comments have the full attention of the agency.
There is a tremendous increase in the workload for the agency that occurs on an ongoing basis. For example, the number of medical device application has risen 30% from 1999 to 2008.
Food safety legislation would help to close the gaps in the current systems and create more preventive controls. This also creates resource concerns, although this is a job that must be done.
The HR function is broken. FDA has to hire a large number of people and this is a lengthy process. Human resources at FDA is central to making everything else work.
She thanked the Alliance for helping FDA get the monies it needs to extend and enhance the agency’s IT infrastructure. At the same time, FDA needs to develop deep expertise in this field, for example, in bioinformatics.
NON-DEDUCTIBILITY LOBBYING EXPENSES NOTICEEach year, the Alliance sends out a notice to each member indicating the percentage of that member's dues payment that is not deductible for federal income tax purposes because it is a lobbying expense. In 2008, the Alliance sent out notices to each member indicating that 75% of each dues payment would constitute a non-deductible lobbying expense. After recently completing the Alliance’s 990 for 2008, we realized that a higher percentage will be required for 2009. At the Alliance Board meeting held on July 16, 2009, the Board determined that 90% of each dues payment for 2009 will constitute a non-deductible lobbying expense. Please be sure to forward this information to your accounting staff. If your organization has registered lobbyists, then the information should also be forwarded to whomever tracks and files quarterly reports.
Note: This analysis and commentary is written by Steven Grossman, the Deputy Executive Director of the Alliance.