One-Third Of New Drugs Had Safety Problems After FDA Approval

Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a “black box” warning on side effects or warranted a safety announcement about new risks, Dr. Joseph Ross, an associate professor of medicine at Yale School of Medicine, and colleagues reported in JAMA on Tuesday. The study included safety actions through Feb. 28.

“While the administration pushes for less regulation and faster approvals, those decisions have consequences,” Ross says. The Yale researchers’ previous studies concluded that the FDA approves drugs faster than its counterpart agency in Europe does and that the majority of pivotal trials in drug approvals involved fewer than 1,000 patients and lasted six months or less.

It took a median of 4.2 years after the drugs were approved for these safety concerns to come to light, the study found, and issues were more common among psychiatric drugs, biologic drugs, drugs that were granted “accelerated approval” and drugs that were approved near the regulatory deadline for approval.

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Rep. Cori Bush Introduces Bill to Decriminalize Possession of All Drugs

Apair of House Democrats introduced legislation on Tuesday that would decriminalize possession of all drugs at the federal level for personal use and begin the process of prioritizing a public health approach to drug use over punishment and policing. These are the necessary first steps, advocates say, for ending the war on drugs 50 years after it was first declared by President Richard Nixon.

Representatives Cori Bush (D-Missouri) and Bonnie Watson Coleman (D-New Jersey) introduced the Drug Policy Reform Act, which would eliminate federal criminal penalties for possession of any drug for personal use, including marijuana, cocaine, opioids, various psychedelics and other drugs banned under the Controlled Substances Act. The bill aims to begin repairing some of the damage to communities and the lives of individuals caused by the drug war, which has contributed heavily to mass incarceration and other forms of state violence that have fallen hardest on low-income communities and people of color.

“The economic stability of our carceral state depends on this misguided and racist policy, and we are here to say, no more, it’s time that we end this destruction,” Bush told reporters on Tuesday, adding that, as a nurse in St. Louis, she saw how criminalization and stigma harms people who use drugs. “Imagine what we could do if we built systems of care that treated and supported people…that is the world we should build.”

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