A new Manhattan Institute Project FDA report tries to move beyond the “too fast” or “too slow” debate over the FDA’s performance. The report’s authors, Joseph DiMasi and Christopher-Paul Milne of the Tufts Center for the Study of Drug Development
and Alex Tabarrok of the Mercatus Center, analyze performance and productivity levels within the FDA’s various drug review divisions. They conclude that drug approval is faster in some divisions, such as Oncology and Antiviral, compared with other divisions, such as Cardio-Renal and Neurology, even accounting for drug complexity.
This analysis allows policymakers and FDA leadership to approach a more objective, nuanced evaluation of FDA regulatory efficiency that could inform future policy decisions about how to improve the health of the American people and expand the economy.
One reason for the differences in approval times is public pressure. Americans desperately want cures for cancer and HIV/AIDS, and the FDA moves faster on these drugs. If patients with other illnesses can group together and appeal equally loudly for new drugs to cure their diseases, the FDA might speed up all its approval processes.
The supposed independence of government regulators is designed to ensure neutrality and lead to evidence-based decision making. But this sacrifices the ability to rapidly adapt to technological change, and can lock in outdated processes. Market competition requires successful private companies to adapt to changes in the market or they will fall behind more nimble competitors. Absent market pressures (or constant prodding from Congress and the public), federal agencies such as the FDA become sluggish.
The FDA controls industries that account for a quarter of consumer spending, and, in its role as drug regulator, its decisions can literally mean life or death for patients with life-threatening diseases. Keeping pace with innovation is imperative to the Agency’s success.
The report’s authors control for difference in workloads and drug complexity when evaluating FDA divisions. Even when this is done, the Oncology Division takes an average of 200 days to approve a drug instead of nearly 800 for Cardio/Renal, without seeming to sacrificing safety. Faster review decisions create incentives for pharmaceutical companies to invest more in research and development since they know they have a faster and more predictable path to market. This allows patients who need access to life-saving drugs to receive effective medical treatment earlier.
Median approval time for new drugs is three times as long in the slowest division as in the fastest. The Oncology division is about 60 percent faster in its approval process than the average of all other divisions. Faster approval in Oncology comes from more drugs designated for FDA’s fast-track or accelerated approval pathways, and is likely behind rapid advancements in the battle against cancer. The authors estimate that if this gap in performance between Oncology and other divisions were cut in half, the cost of developing a new drug would fall by an estimated $46 million—for a total savings across all non-oncology drugs of almost $1 billion a year.
Benefits of these savings would not be confined to pharmaceutical companies. Patients would be given better chances at living longer, healthier lives.
Dynamic medical advances require flexible regulatory frameworks for evaluating and approving them. As Manhattan Institute senior fellow Peter Huber argues in his new book, The Cure in the Code, 21st century medicine requires an individualized approach, rooted in evolving fields such as genomics. Personalized, effective, and safe medical treatment informed by genetic sequencing and other tools is possible—if the FDA extends the tools adapted in the battle against cancer and HIV/AIDS to other diseases.
The FDA’s quest to adapt to new medical realities is often stymied by a backlash over unexpected adverse events from approved drugs (infamous examples include Vioxx and Rezulin). Public backlash is inevitable since the negative effects are clearly visible. However, if the FDA fails to approve a safe drug, it is more difficult to assign blame since many of the negative effects are unseen or cannot be clearly linked to excess caution. Where flexibility is the rule, it is often because of deeply committed, highly vocal patient groups. Developing more personalized regulatory tools based on genetics or other factors would help ensure that patients had timely access to drugs that were most likely to benefit them.
The FDA faces many conflicting demands. It was created with the best of intentions, to keep consumers safe, but risk-benefit decisions facing patients are inherently varied, and often deeply personal. When the FDA has adapted to demands from patients to allow more flexible regulatory standards, as in the case of HIV/AIDS and cancer, patients have overwhelmingly benefitted.
Thankfully, as the new Manhattan Institute report shows, successful reform models exist—and they come from inside the FDA. When pressed, the FDA delivers. Lessons learned from the agency’s most efficient divisions can become a model of 21st century regulation—personalized, timely, and patient-centered.
Jared Meyer is a policy analyst at Economics21 at the Manhattan Institute for Policy Research. You can follow him on Twitter here.
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