F.D.A. Did Not Intervene to Curb Risky Fentanyl Prescriptions

F.D.A. Did Not Intervene to Curb Risky Fentanyl Prescriptions

When the narcotic pain reliever tramadol was approved by the F.D.A. in 1995, it allowed Ortho-McNeil of Johnson & Johnson to fund a steering committee to monitor drug abuse instead of classifying the drug as a controlled substance.

After two decades of mounting abuse, tramadol was reclassified as a controlled substance in 2014.

In recent years, drug companies have faced legal action for falsely advertising T.I.R.F.s. Cephalon paid over $400 million in fines for false marketing of its products, including its T.I.R.F. lollipops, called Actiq, to treat migraines.

The owner of Insys Therapeutics, which makes Subsys — and five prescribing doctors — were charged in a bribery scheme to boost off-label prescribing. McKesson, the distributor, paid a $150 million settlement for failing to report suspicious opioid orders.

Carolyn Markland of Jacksonville, Fla., wanted to be able to lift her grandchildren despite a degenerative spinal disease.

Her doctor prescribed a dose of the T.I.R.F. to her in July 2014. Ms. Markland suffered respiratory distress the following morning and died of drug toxicity, according to court documents.

Joey Caltagirone of Philadelphia was prescribed his first of almost 6,000 Actiq lollipops for migraines in 2005, when he was 30. He developed a lasting addiction, was prescribed methadone to curtail it, and died of methadone toxicity in 2014, according to court records.

Deborah Fuller, Sarah’s mother, is still struggling with the loss of her daughter.

“If she had died from disease, I wouldn’t be as angry,” she said. “But knowing how she died — and the manipulation that went on — I get angry. I just don’t know what to do with all that anger.”

(Original source)