Careers

Diversity

With 18 offices, from New York to Los Angeles and Seattle to Orlando, we live and work in communities all over the U.S., collaborating across locations, disciplines and even borders. Our experienced, highly ranked lawyers serve businesses wherever they are and wherever they want to go.

Offices

About Us

Pages

Professionals

Thought leadership: blogs, podcasts, videos, publications, events and news

Insights

Services

Pro Bono

Am Law 100 firm with practices in Business, Digital Assets and Data Management, Intellectual Property, Labor & Employment, Litigation and Tax.

Home | BakerHostetler

The Cloakroom with Peter Roskam

The Cloakroom with Peter Roskam: 36th Annual Legislative Seminar – Senator Tim Kaine, D-VA

Tax Planning for International Families in an Age of Uncertainty (Tax Notes)

Updates and News from the BakerHostetler Life Sciences Industry Team

DOJ Policy Shifts May Resurrect De Facto ‘China Initiative’ (Law360)

<h5>Key Takeaways:</h5>  <ul> 	<li>The FDA has finalized a rule permitting abortion pills to be sold at certified retail pharmacies.</li> 	<li>Mifeprex and its approved generic can now be dispensed by certified pharmacies or by or under the supervision of a certified prescriber.</li> </ul>  On Jan. 3, the Food and Drug Administration (FDA) finalized a rule allowing more retail pharmacies to dispense abortion pills upon completion of a certification process. The FDA finalized the changes after reviewing supplemental applications from manufacturers of the drug mifepristone requesting modification of the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program. Under the modified Mifepristone REMS Program, Mifeprex and its approved generic can be dispensed by certified pharmacies or by or under the supervision of a certified prescriber. The Mifepristone REMS Program continues to require the Patient Agreement Form and certification of healthcare providers who prescribe mifepristone.  The FDA first approved mifepristone in 2000 to terminate pregnancies of up to seven weeks’ gestation and in 2016 extended this to 10 weeks’ gestation. Mifepristone blocks the hormone progesterone, which is needed for a pregnancy to continue. Mifepristone, when used together with another medicine called misoprostol, is used to end a pregnancy through 10 weeks’ gestation (70 days or less since the first day of the last menstrual period).  The submitted REMS modification documents and materials are available on the FDA website linked <a href="https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm">here</a> and more information regarding mifepristone can be found on the FDA <a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation#The%20January%202023%20REMS%20Modification">Q&A webpage</a>.  Authorship Credit: Amy Fouts (partner) and Claire Bass (associate)

FDA Approves Abortion Pill for Sale by Retail Pharmacies

Featured Insights

Related Services

Featured Insights