News & Analysis as of

Over The Counter Drugs (OTC) Birth Control

Seyfarth Shaw LLP

Guidance Issued on Contraception and Other Medical Services Under Health Plans

Seyfarth Shaw LLP on

The IRS recently published two notices which describe the tax treatment of amounts paid for condoms and expand the list of preventive care benefits permitted to be provided by a high deductible health plan (HDHP) without...more

Mintz - Health Care Viewpoints

2023: Another Year Chock Full of Challenges for FDA

At the start of 2022, we reflected on what the Food and Drug Administration (FDA) had accomplished during the preceding 12 months and the challenges that could be ahead for the agency during the impending year, especially...more

Mintz - Health Care Viewpoints

FDA Warns “Natural” Birth Control Company: Three Takeaways from the NOV Letter

A little over a year after the Dobbs v. Jackson Women’s Health Organization decision, the Food and Drug Administration (FDA) continues to be at the forefront of addressing reproductive health concerns. An example of this...more

Mintz - Health Care Viewpoints

First Nonprescription Birth Control Pill Approved for Marketing by FDA: A Milestone for Reproductive Health

As we previously reported, Perrigo Company’s subsidiary HRA Pharma submitted an application to the Food and Drug Administration (FDA) in the summer of 2022 to switch an existing prescription-only progestin birth control pill...more

Foley & Lardner LLP

Reproductive Health: Over the Counter Birth Control Pill Supported by FDA Advisory Committees

Foley & Lardner LLP on

At the May 9-10, 2023, Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee, U.S. Food and Drug Administration (FDA) advisers voted that the...more

Cozen O'Connor

The State AG Report – 11.10.2022

Cozen O'Connor on

Here are last week’s curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •AG Bonta Sends Letters to Plastic Bag...more

Cozen O'Connor

Multistate AG Coalition Urges Approval of Nation’s First OTC Birth Control Pill

Cozen O'Connor on

Twenty-one AGs submitted a letter to the FDA urging the agency to approve HRA Pharma, SA’s pending application for Opill, which, if approved, would become the country’s first ever birth control pill available without a...more

Mintz - Health Care Viewpoints

Will a Nonprescription Birth Control Pill Be FDA’s First Approval under its Long-Awaited “ANCU” Proposed Rule?

Unintended downstream consequences are likely to abound in the wake of the June 24, 2022 Dobbs decision that overruled Roe v. Wade, as Mintz attorneys have addressed in other contexts here and here Those looking ahead have...more

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