Abortion Pills Offered Nonprescription By E-Commerce Firms FDA Warned
One active ingredient in unapproved drugs sold by two e-commerce operations, identified by FDA as Rabold and AidAccess.org, is mifepristone, also known as RU-486 in the only drug with the ingredient approved for an indication of medical termination of early pregnancy, Danco Laboratories' Mifeprex. Firms' websites offer sales of products without requiring customers to submit prescriptions.
You may also be interested in...
US FDA sends warning letters to online businesses operating a total of 465 websites selling unapproved Rx drugs for indications including breast cancer, chicken pox and pain relief. Warning letters were part of Interpol's annual Operation Pangea against online sales of illegal medical products; this year, US and 115 other countries made 859 arrests worldwide and seized $14m in potentially dangerous pharmaceuticals.
HRA Pharma started recruiting in April for an actual use trial, using oral contraceptives with norgestrel 0.075 mg, and expects to complete its study in April 2019, according to clinicaltrials.gov's database. Advocacy group Ibis Reproductive Health, which is working with HRA on an NDA for an OTC oral contraceptive, called the start of the study a "pivotal moment" in moving birth control drugs out of Rx-only.
High court declines to intervene in dispute over Arizona law that would restrict use of abortion drug; court also denies Roche petition for review of Boniva patent ruling.