With increasing numbers of new and generic drug applications being submitted to the FDA, the findings of new research suggests that the agency is using less data and providing much shorter review times before allowing these medications to be sold to the public.
Researchers with the Program On Regulation, Therapeutics, And Law (PORTAL) published a study this month in the Journal of the American Medical Association (JAMA), which raises concerns about current trends in the FDA’s drug approval process that have resulted in approval of less rigorously researched treatments.
The study looked at laws and FDA regulations from 1962 to 2018, as well as databases on approved new drugs, generic drugs, biologics and vaccines from the last few decades. The researchers also looked at special programs like the FDA’s Orphan Drugs, Fast-Track, Priority Review, Accelerated Approval and Breakthrough Therapy Programs.
From 1983 to 2018, there were significant changes in legislation and regulatory initiatives which have substantially changed drug approval at the agency, resulting in large increases in the number of drugs approved.
According to the findings, the mean annual number of new drug approvals went from 34 per year between 1990 and 1999, to 41 from 2010 to 2018. Generic drug approvals made a much larger jump, increasing from just 136 approved per year in 1970, to 284 in 1985, and there are currently 588 generic approvals per year from 2013 to 2018.
The various fast track and rapid approval programs used by the FDA also increased significantly. However, these increases also came with higher prescription drug user fees, which account for about 80% of the salaries of FDA personnel responsible for approving new drugs.
With those increases, however, the proportion of new approvals which were supported by at least two important clinical trials decreased from 80.6% from 1995 to 1997, to just 52.8% in 2015-2017. The time it took to review those drugs also dropped, declining from more than three years to review a drug in 1983 to less than one year by 2017.
“Over the last 4 decades, the approval and regulation processes for pharmaceutical agents have evolved and increased in complexity as special programs have been added and as the use of surrogate measures has been encouraged,” the researchers concluded. “The FDA has increasingly accepted less data and more surrogate measures, and has shortened its review times.”
Less Rigorous Approval Processes Means More Risky Drugs
Critics say this trend has resulted in an increased risk to the public, as drugs were approved through less rigorous approval processes.
In September 2017, a study published in The BMJ found one-third of all new drugs approved by the FDA since 1997 went through an expedited process, and those drugs were almost guaranteed to have an average of at least one serious label warning update per year.
In June 2015, The BMJ also published an analysis that warned about numerous discrepancies in data submitted to the FDA by medical device manufacturers seeking premarket approval for heart devices.
Those discrepancies often included the number of participants varying in the actual study from the number reported to the FDA, substantially different results from similar FDA studies, and many of which were never peer reviewed.
Since drug makers and medical device makers often aggressively market new products after they are approved, espousing the benefits of their new treatment options, large numbers of unsuspecting patients end up being unwilling test subjects, without any disclosure that the product they are using was not fully vetted to ensure it is safe and effective.