Researchers from Harvard University in Boston and the London School of Economics in the U.K. wrote a research letter published Oct. 18 in JAMA Internal Medicine arguing that this massive spending by Medicare is wasteful and puts patients’ health at risk.
The authors blamed the wasteful spending on the FDA’s practice of granting accelerated approval to certain cancer drugs and then later requiring postmarketing trials to confirm the drugs are effective, according to Endpoints News. They called on the FDA to improve the accelerated approval process and require timely postmarketing trials and to move faster to revoke approvals when trials show a drug isn’t effective.
One of the authors, Huseyin Naci, PhD, an associate professor of health policy at the London School of Economics, told Endpoints News he would recommend the accelerated approval pathway be reserved for “a clearly defined set of circumstances,” and that new guidelines be developed to determine which drugs should be eligible for the accelerated approval pathway.
Read the full article here.
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