This new year should be verrrrry interesting…… especially with respect to the FDA and a host of changes that are likely to be implemented in the agency. One area that is likely to come under the microscope is the FDA Accelerated Approval Pathway.
In short, the pathway is a shortcut to approval of a new therapy. On its surface, the rationale behind accelerated approval makes a lot of sense. Why delay making a therapy with great ‘promise’ available, especially a life-saving therapy, to reach desperate patients as soon as possible.
As noted in the article below, the pathway was implemented in 1992 in response to the HIV/AIDS epidemic, accelerated approval enables drugs to be approved based on a surrogate endpoint that is reasonably likely to predict clinical benefit. These FDA approvals allow pharmaceutical companies to begin selling these drugs on the condition that they conduct confirmatory trials. Since its inception, the pathway has helped bring nearly 300 new drugs to the market, many for conditions with high unmet need.
Well, as with most things, perfection in pharmaceuticals is also a rare commodity. Fortunately, the number of therapies that originally received accelerated approval, only to be later yanked off the market due to ‘unforeseen consequences’ (sometimes fatal), have been relatively few. None the less, only a few ‘oops’ beg the question…. Are even a few deaths or other serious adverse events worth the risks?
The article below is a good read that adds perspective to the question of accelerated approvals and their future in the FDA approval process.
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