F.D.A. Did Not Intervene to Curb Risky Fentanyl Prescriptions
A fast-acting class of fentanyl drugs approved only for cancer patients with high opioid tolerance has been prescribed frequently to patients with back pain and migraines, putting them at high risk of accidental overdose and death, according to documents collected by the Food and Drug Administration.
The F.D.A. established a distribution oversight program in 2011 to curb inappropriate use of the dangerous medications, but entrusted enforcement to a group of pharmaceutical companies that make and sell the drugs.
Some of the companies have been sued for illegally promoting other uses for the medications and in one case even bribing doctors to prescribe higher doses.
About 5,000 pages of documents, obtained by researchers at the Johns Hopkins Bloomberg School of Public Health through the Freedom of Information Act and provided to The New York Times, show that the F.D.A. had data showing that so-called off-label prescribing was widespread. But officials did little to intervene.
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