For decades, most drugs for critical illnesses passed through a standard battery of tests before regulators allowed them onto the market. A smaller portion was “fast-tracked” to make them available to patients sooner.
Now that dynamic has flipped, with The Wall Street Journal reporting that most drugs are now released faster than ever through federal programs expediting their approval.
The U.S. Food and Drug Administration approved a record 43 new drugs last year through fast-track programs that skip or shorten major steps other drugs must pass, or 73% of total new drugs. That compares with 10 expedited drugs, or 38% of the total, approved 10 years ago.
The proportion of new drugs receiving expedited approvals has been at least 60% for each of the past five years. It was below 60% in the previous five.
The result is a rising proportion of new drugs for fatal diseases that lack extensive evidence they can actually work. Many continue to lack that proof years after entering the market.
It is an acceptable trade-off, says Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, because some patients get access sooner to drugs that later prove effective.
A Wall Street Journal review of FDA data shows how that trade-off is playing out in the biggest new-drug category: cancer. The FDA is approving a rising proportion of expedited cancer drugs without ample evidence they extend patients’ lives beyond another drug or placebo in clinical trials, the Journal found, and many still lack evidence they improve survival rates for patients. Read the full story.