The George Washington School of Public Health and Health Services co-hosted a conference Tuesday on key issues facing the U.S Food and Drug Administration as Congress prepares to address the laws governing drugs and medical devices.
In her keynote address, FDA Commissioner Margaret Hamburg acknowledged that this is a critical moment for the agency.
“In many ways, we are at a crossroads and decisions made now will matter in fundamental ways and for a very long time,” Dr. Hamburg said. “This is a challenging time – a time when many different, often competing, factors affect the way we do our jobs and the opportunities before us. Over the past several years, we have dealt with expanding responsibilities, a tightening economy and the pressures of globalization.”
Both the Prescription Drug User Fee Act and the Medical Device User Fee Act have to be reauthorized by next year. The decisions that Congress makes regarding these laws will impact many aspects of the agency’s operations, said Dr. Hamburg.
The all-day conference, which was held in the Jack Morton Auditorium, focused on patient safety, scientific integrity, institutional challenges and the efficacy of drugs and devices regulated by the FDA.
The conference was sponsored by SPHHS’ Project on Scientific Knowledge and Public Policy, which examines how scientific evidence is applied in legal and regulatory environments, and the Union of Concerned Scientists, a science-based nonprofit organization.
“At GW, we strive to offer our students and faculty exceptional leadership training by exposing them to real-world discussions and giving them the opportunity to learn from the most influential leaders of our time,” said SPHHS Dean Lynn Goldman before introducing Dr. Hamburg. “I think today is one of those great opportunities.”
FDA officials, consumer and patient advocates, physicians and academic scholars discussed potential reforms and the best way for the agency to improve the scientific basis for drug and medical device approval and monitoring.
“We owe it to the public…to make smart, data-driven, scientifically based decisions that benefit patients and consumers,” said Dr. Hamburg.
Dr. Hamburg stressed the importance of regulatory science, the science and tools needed to assess and evaluate a product’s safety, efficacy, quality and performance. Despite unprecedented spending on research and development, the pipeline of new drugs “is disturbingly dry,” she said. Part of the solution, Dr. Hamburg said, is to strengthen the field of regulatory science – one of her top priorities as commissioner.
“A robust field of regulatory science would enable us to use our knowledge of biological pathways and gene variance to help identify promising new drug candidates and new potential targets for treatment,” she said.
Dr. Hamburg also focused on the FDA’s important role as a catalyst for innovation in prevention and treatment efforts.
She discussed confronting HIV/AIDS, then a mysterious new illness, as a medical student. At that time, there was no effective treatment for HIV/AIDS, and the virus was a death sentence. Today, thanks to new treatments, HIV is a chronic but manageable disease.
“That development is a testament to the power of innovation and determination,” said Dr. Hamburg. “We know that if we want to continue to help foster the kind of innovation that we saw with the AIDS epidemic, we must continue to find new and better ways of doing things, while maintaining a gold standard of safety and effectiveness.”
Last fiscal year, the FDA approved 35 new medicines, including drugs for metastatic breast cancer, lupus and the first drug ever shown to be effective in extending the lives of patients with metastatic melanoma. Almost half of these new drugs were approved under “priority review” where the FDA had a six-month goal to complete its review for safety and effectiveness.
“We streamlined clinical requirements to permit smaller, shorter or fewer studies wherever possible,” said Dr. Hamburg.
After Dr. Hamburg’s keynote address, panel discussions examined how the FDA can better monitor clinical trials and approved drugs and how the agency can promote a culture of transparency and scientific integrity.
John Powers, assistant clinical professor of medicine in GW’s School of Medicine and Health Sciences, moderated a panel on the efficacy of drugs and devices regulated by the FDA and the importance of evidence-based medicine.
Susan Wood, associate professor of health policy and of environmental and occupational health in SPHHS, led a panel discussion on how the FDA can best allocate its limited resources and how conflicts of interest impact the work of agency advisory committees.
“We always welcome the opportunity to host events that bring together government agencies like the FDA, the academic community and patient care and safety advocacy organizations to address important public health problems,” said Dr. Goldman.