The Center for Reproductive Rights and other plaintiffs suing FDA say the agency’s plan to approve only Teva’s Plan B One-Step for universal OTC sales, but not less-expensive generic emergency contraceptives, would not provide sufficient access for all women.
The Center for Reproductive Rights and other women’s health care advocates will continue pressuring FDA to approve full OTC sales of all levonorgestrel-based emergency contraception, unsatisfied with a legal victory that clears a path for universal OTC access to just Plan B One-Step.
The Department of Justice, representing FDA in litigation over OTC access to emergency contraception, agreed in a June 10
Some FDA employees who were recently laid off by the Trump Administration are being called back to work, multiple sources confirmed to the Pink Sheet.
Proposed administrative order likely is first to prompt opposition from OTC industry or other stakeholders potentially delaying or deferring the agency’s expectation for moving its proposal to a deemed final order effective one year after it would be published.
Qnovia notes NRT inhalation product recently received investigational new drug clearance from FDA as agency and NIH say innovation needed smoking cessation to help improve rate of success for quitting the habit that kills around 500,000 US consumers annually.
The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”
