Getting new medications into patients’ hands can take a long time. But what about patients who can’t afford the wait?
As a new “Fast Facts” from the Alliance for Patient Access explains, the FDA’s accelerated approval pathway can make treatment options available sooner.
The Waiting Game
Bringing a new medication to the clinic is time intensive. Often taking 12-to-15 years, the standard FDA approval process requires multi-phase clinical trials and a lengthy review period before a doctor can even think of writing a prescription. Rigorous and thorough, this process provides U.S. patients some of the safest, most effective treatments in the world.
But, the “Fast Facts” considers, what about patients with serious, sometimes life-threatening conditions? Balancing safety with timely access is particularly important in these cases.
Making Treatments Available
The FDA uses four separate approaches to expediting medication approval: fast track, breakthrough therapy designations, priority review and accelerated approval.
Unlike other routes, accelerated approval expedites market authorization for medications that treat serious conditions and fill unmet needs. It’s used primarily when a disease’s severity is acute or its course is long.
Under the accelerated approval pathway, market authorization is granted based on a medication’s effect on what’s called a surrogate endpoint. These are measures — shrunken tumors from a cancer treatment, for example — that indicate a potential clinical benefit.
Accelerating Access While Ensuring Safety
Across the board, medications approved through all expedited approaches reach the clinic a year faster on average. And oncology treatments have been shown to reach the clinic about 3.4 years faster through accelerated approval.
Though accelerated approval brings medications to market faster, it still maintains safety protocol and requirements, the paper notes. Medications must still be tested in phase 4 trials. If the medication shows no clinical benefit, or its benefits are inconclusive, the FDA can order the medication to be removed from market.
Learn more about how expedited drug approval can safely and efficiently meet patients’ needs in, “Fast Facts: Accelerated Approval.”