FDA Had ‘Fox Guarding The Henhouse’ When It Came To Regulating Powerful Class Of Fentanyl
The agency entrusted enforcement of the drugs to the companies that were making them, documents show. "People were getting hurt — and the FDA sat by and watched this happen," Dr. Andrew Kolodny, an opioid policy researcher at Brandeis University, tells The New York Times. Meanwhile, under pressure, another pharmaceutical wholesaler agrees to boost oversight of its opioid distribution.
The New York Times:
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. (Baumgaertner, 8/2)
Stat:
Under Pressure, Cardinal Health Agrees To Boost Opioid Distribution Oversight
For the second time this year, a major pharmaceutical wholesaler has reached agreement with a coalition of institutional investors to bolster oversight of opioid distribution and board accountability. In this instance, the Cardinal Health (CAH) board agreed to create a committee to monitor the risks of distributing the addictive painkillers and provide investors with reports of two investigations into allegations of failed oversight. In addition, the wholesaler agreed to post detailed information about its policies and efforts on its website. (Silverman, 8/2)
And in other news on the national drug epidemic —
Bloomberg:
Allergan Sues Pfizer Over Damages In Opioid Litigation
Allergan Plc sued Pfizer Inc. to cover any potential damages that the drugmaker might be forced to pay as a result of the hundreds of lawsuits it faces over its alleged role in the opioid crisis. Allergan claims the allegations in the opioid litigation involve improper marketing and sale of sale of morphine drug Kadian in the years before it acquired the rights to it. Allergan, then known as Actavis Plc, acquired Kadian in December 2008 from a company that was later acquired by Pfizer. (Hopkins, 8/2)
Stat:
Poison Control Calls Spike For Unapproved Drug With Opioid-Like High
Calls to U.S. poison control centers about an unapproved antidepressant that has opioid-like effects have climbed dramatically since 2015, according to a new analysis published by the Centers for Disease Control and Prevention. Tianeptine is used as an antidepressant in Europe, Asia, and Latin America. It hasn’t been approved by the Food and Drug Administration. But it’s easy to buy the drug online as a diet supplement or research chemical and is sometimes abused, because it can give users an opioid-like high. (Thielking, 8/2)
Cincinnati Enquirer:
Parental Loss High In Cincinnati Are, With Opioid Crisis Partly Blamed
On Friday, Interact for Health, a nonprofit community health advocate and funder, released the results of the 2017 Child Well-Being Survey, taken by more than 2,700 parents and guardians in a 22-county swath of Southwest Ohio, Northern Kentucky and Southeast Indiana. It found: Nearly 15 percent of children in the area have a parent who has been jailed. That compares to 8 percent nationwide. (DeMio, 8/3)
