Fast drug approvals based on weaker science
New drugs are being approved by the FDA at a faster clip, but the science behind them is weakening, according to a study published in JAMA. That means more drugs are available, but questions remain if they are effective.
Researchers from Harvard Medical School’s Program On Regulation, Therapeutics, And Law (PORTAL) analyzed how the regulation of prescription drugs has evolved from the 1980s to 2018. While new drugs are required under U.S. law to be tested before they are approved, legislation and regulatory initiatives have “substantially changed drug approval at the FDA,” wrote first author Jonathan J. Darrow, SJD, JD, MBA, faculty at PORTAL, and colleagues.
For one, the ability of the FDA to request or require additional studies from drugmakers after approval is weaker than the pre-approval phase, the researchers noted. And other laws and standards have changed over time, affecting drug testing, new approval standards and even the role of the FDA. Additionally, “pressure from patients to make drugs available more quickly” has contributed to the fast-paced approval process.
From 1990 to 1999, the mean annual number of new drug approvals was 34, more than the 25 from 2000 to 2009, but less than the 41 from 2010 to 2018.
Biologics saw a bigger jump. The median number of new biological product approvals went from 2.5 from 1990-1999 to 5 from 2000 to 2013 and up to 12 from 2014 to 2018. Generics saw the biggest increase––136 was the median annual number of generic drugs approved from 1970 until 1984, when the Hatch-Waxman Act was enacted. From 1985 to 2012, when the Generic Drug User Fee Act was enacted, the median was 284. From 2013 to 2018, the median reached 588.
Instead of relying on more drug testing for approvals, the FDA has allowed more surrogate measures, as well. The FDA also began taking fees to fund review processes, taking in $29 million in 1993 after Congress passed the Prescription Drug User Fee Act. The fees jumped to $908 million in 2018.
“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,” Darrow et al. wrote. “The FDA has increasingly accepted less data and more surrogate measures and has shortened its review times.”
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."