The future of expedited drug approvals
Thursday, March 09, 2017
The Trump administration is poised to select a head of the Food and Drug Administration (FDA) who intends change the current process of drug approvals in the U.S.
The new administration will seek to build upon Obama administration regulations to speed up drug approvals, albeit with a much different approach. This new process will possibly change the current drug development model that has been used by the FDA for many years.
At the prospective forefront of this change are the two candidates vying for the head of the FDA.
Jim O'Neill, a managing director of Mithrell Capital Management, and Dr. Scott Gottlieb, a former FDA commissioner, each want to bring sweeping reforms to the FDA. Both candidates are in favor of expediting the drug approval process that can take several years if all phases of clinical trials are required prior to gaining approval.
The mission that both candidates have in mind is to modify the current structure and process of the FDA. The agency has been viewed as too restrictive by some drug companies, with the drug approval process also being both long and expensive in those companies’ eyes.
O’Neill’s new approach, while viewed to be radical, would be to approve drugs once they are considered to be safe, rather than waiting for the determination to be made about both their safety and effectiveness profiles.
Once a drug is approved, the approach would continuously monitor patients and provide any updates related to efficacy. This is a current practice in Japan.
Similarly, Gottlieb is a proponent of the FDA having more flexibility when it comes to approving generic versions of complex therapeutics. This proposed change is one that may take some time to implement, given the longstanding process that the FDA has in place for approvals.
While proponents of this new approach believe that it may help to reduce the cost of drug development, increase competition, and boost the United States’ investment in biotechnology, others believe that a less restrictive review process could place patients at serious risk if drugs are permitted without clinical evidence to support them.
It is believed that this approach is particularly dangerous when it comes to the approval of novel drugs that could be given to patients without proper comprehensive testing. There are different sides of the issue that each want to see a positive change in the direction of FDA approvals, but this should not be at the cost of patient care.
Regardless of the selection that is made for the head of the FDA, it is apparent that there is a movement towards cutting existing regulations at the FDA.
Only time will tell what the impact of the changes to the FDA standards will be for patients, the pharmaceutical industry, and the FDA itself.
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