New FDA heads spell out their public health mission
This article was originally published in Scrip
The US FDA must work to improve and protect the public health by collaborating with industry and other federal agencies to stimulate development of new medical products, address safety threats and speed reimbursement, the agency's new leaders say in the New England Journal of Medicine.
Dr Margaret Hamburg, the FDA's new commissioner, and principal deputy commissioner Dr Joshua Sharfstein spell out their vision of the agency's public health role in a perspective piece that appeared online on May 26th.
Dr Hamburg was sworn in as FDA commissioner on May 22nd, four days after being confirmed by the Senate. Dr Sharfstein had served as acting commissioner since late March, pending Dr Hamburg's confirmation.
The two individuals, both former heads of health departments in major cities, were expected to bring a strong public health focus to their jobs at the FDA. At a recent congressional hearing on the agency's budget, Dr Sharfstein testified that management's goals will be aimed at ensuring that FDA funding is used for projects that protect and advance public health (scripnews.com, May 22nd, 2009).
In their NEJM article, the leaders take issue with agency critics who judge the FDA's performance based upon the number of regulatory actions it takes.
The FDA's job is to support access to innovative, safe and effective medical products and, in doing so, to promote health, prevent illness and prolong life, Drs Hamburg and Sharfstein say. "The ultimate measure of the FDA's success should reflect its fundamental goals and go beyond such intermediate measures as the number of facilities inspected or drugs approved.
"The traditional tools of a regulatory agency are regulation, approval or disapproval of applications and enforcement," the FDA leaders say. "As a public health agency, the FDA should always ask whether delays in approval or safety problems can be prevented – a mandate that requires extensive and creative engagement with regulated industries, patient and consumer groups, and others."
They intend to move the agency beyond its traditional regulatory confines in facing difficult public health problems.
"The FDA should actively pursue opportunities to help advance science in the domains it regulates and address threats to the safety of medical products and food – even if those opportunities and threats lie outside the realm of the agency's usual routines," the NEJM piece says. "We expect to collaborate with other federal agencies and outside partners to address problems that the agency cannot solve alone."
The leaders say they intend to work closely with the Centers for Disease Control and Prevention (CDC) to identify priority areas for joint action, such as response to infectious disease emergencies and development of safety systems to prevent lethal overdoses and drug interactions.
"We look forward to working with the National Institutes of Health, the pharmaceutical and biotechnology industries, academic medical centres and research universities to accelerate the development of cures. As scientists identify fruitful pathways for research on treatments for debilitating diseases, FDA regulators should discuss with them the level of evidence necessary for the initiation of human trials and the eventual approval of treatments."
Drs Hamburg and Sharfstein recognise the importance of reducing the time gap between product approval and reimbursement decisions, and they call for increased FDA collaboration with the Centers for Medicare and Medicaid Services, industry, and patient and consumer groups to speed coverage decisions. "One emerging opportunity is the area of personalised medicine, in which the agency should work with scientific leaders on novel approaches to treating illness."
globalisation
Turning to the challenges posed by globalisation, they say the agency should facilitate the development of safety standards where none exist and work with international partners to build a system with multiple levels of oversight.
As Dr Sharfstein emphasised in his congressional testimony several days earlier, the NEJM article says greater transparency into the agency's decision-making will improve its credibility and boost public confidence that decisions are being made based upon science. "Whenever possible, the FDA should provide the data on which it bases its regulatory decisions and other guidance and explain its decision-making process to the public."