Age restriction on emergency contraception lifted
On April 5, a US District Court judge ruled that the emergency contraception (EC) pill Plan B One-Step must be made available over-the-counter to all girls and women, regardless of their age. This ruling, made by Judge Edward R. Korman, was in response to a 2011 move by Health and Human Services Secretary Kathleen Sebelius.
On April 5, a US District Court judge ruled that the emergency contraception (EC) pill Plan B One-Step must be made available over-the-counter to all girls and women, regardless of their age. This ruling, made by Judge Edward R. Korman, was in response to a 2011 move by Health and Human Services Secretary Kathleen Sebelius.
The US Food and Drug Administration (FDA) recommended in 2011 that the “morning after pill” be made available to women and girls of all ages without a prescription. But Secretary Kathleen Sebelius overruled this recommendation.
At that time President Obama supported this decision, stating, “the reason [Secretary Sebelius] made this decision was she could not be confident that a 10-year-old or an 11-year-old go[ing] into a drugstore, should be able-alongside bubble gum or batteries-[ … ] to buy a medication that potentially, if not used properly, could end up having an adverse effect.” He also commented, “I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine.”
But in his April 5 decision, Judge Korman rebuked Secretary Sebelius, writing that her decision was “arbitrary, capricious, and unreasonable” and that “the motivation for the Secretary’s action was obviously political” and “the reasons she provided [as to why she overruled the FDA’s recommendation] are so unpersuasive as to call into question her good faith.”
He further stated, “The obstructions in the path of … adolescents in obtaining levonorgestrel-based emergency contraceptives under the current behind-the-counter regime have the practical effect of making the contraceptives unavailable without a doctor’s prescription.”
The American College of Obstetricians and Gynecologists (ACOG), the American Academy of Pediatrics (AAP), and the Society for Adolescent Health and Medicine (SAHM) all applauded the ruling to lift the age restriction. “The College has long supported making EC available over the counter without an age restriction, so this is welcome news to us and to young women,” said James T. Breeden, MD, ACOG president, in a joint press release issued by ACOG, AAP, and SAHM.
“EC is a safe, effective way to help prevent unintended pregnancy after a contraceptive failure, unprotected sex, or sexual assault,” he added. “We believe all EC products should be available over-the-counter.”
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
Listen
ICER Finds Insurers Struggled to Provide Fair Access for Obesity Drugs
December 19th 2024The Institute for Clinical and Economic Review assessed the formularies of 11 payers, covering 57 million people, to determine access for drugs that the organization had reviewed in 2022 for cost-effectiveness.
Read More
