FDA Drops Access Restrictions On Generic OTC Emergency Contraceptives
This article was originally published in The Pink Sheet Daily
In a recent letter to drug firms, FDA rejects Plan B One-Step manufacturer Teva’s requests to restrict sales and labeling of generic equivalents. Labeling for the generics will not prevent consumers under 17 from buying the products nor require retailers to ask consumers for proof of age.
You may also be interested in...
Smart Women’s Choice promotes its namesake brand topicals with claims including “One hundred percent hormone-free, completely safe, natural birth control that cannot fail when used as directed and causes no harmful side effects,” FDA warning says.
Judge ordering permanent injunction against Confidence USA on a complaint filed in 2019 questioned FDA's calculations for requiring the firm to recall and destroy all products it had distributed since February 2018.
Boston University researchers recommend allowing pharmacists to dispense buprenorphine without prescriptions to expand access among the 2m consumers with opioid use disorder and help reduce the estimated 130 overdose deaths each day in the US. "It is important to attempt to address the opioid epidemic in new, effective, and safe ways. Increasing access to buprenorphine, a relatively safe medication, without a prescription could prove helpful for treating persons with OUD," say Payel Jhoom Roy and Michael Stein.