Women seek­ing the abor­tion pill mifepri­s­tone dur­ing the pan­dem­ic will be able to or­der it through the mail and will no longer have to go in­to a clin­ic in per­son, act­ing FDA com­mis­sion­er Janet Wood­cock wrote Mon­day in re­sponse to a se­ries of con­cerns from the Amer­i­can Col­lege of Ob­ste­tri­cians and Gy­ne­col­o­gists and the So­ci­ety for Ma­ter­nal-Fe­tal Med­i­cine.

Mifepri­s­tone is a drug that can end a preg­nan­cy that is less than 10 weeks along, and has cre­at­ed a whirl­wind of po­lit­i­cal and le­gal ques­tions re­lat­ed to this in-per­son re­quire­ment.

In an­nounc­ing the change, Wood­cock said that based on a re­view of the med­ical lit­er­a­ture, there does not ap­pear to be “in­creas­es in se­ri­ous safe­ty con­cerns (such as he­m­or­rhage, ec­topic preg­nan­cy, or sur­gi­cal in­ter­ven­tions) oc­cur­ring with med­ical abor­tion as a re­sult of mod­i­fy­ing the in-per­son dis­pens­ing re­quire­ment dur­ing the COVID-19 pan­dem­ic.” She al­so not­ed that the re­quire­ments of the drug’s risk eval­u­a­tion and mit­i­ga­tion strat­e­gy still need to be met.

This means that many pa­tients in need of ter­mi­na­tion of ear­ly preg­nan­cy will be able to ac­cess safe, ef­fec­tive mifepri­s­tone by mail, rather than hav­ing to risk avoid­able COVID ex­po­sure to them­selves and their clin­i­cians. 2/

— ACOG Ac­tion (@ACO­GAc­tion) April 13, 2021

Mifepri­s­tone has been en­snared in le­gal chal­lenges re­lat­ed to this in-per­son re­quire­ment for ac­cess­ing the drug since the pan­dem­ic be­gan.

The Supreme Court in Oc­to­ber did not al­low the for­mer Trump ad­min­is­tra­tion to re­strict ac­cess to mifepri­s­tone via this in-per­son re­quire­ment but said low­er courts should con­tin­ue hear­ing on­go­ing ar­gu­ments.

But Jus­tice So­nia So­tomay­or, joined by Jus­tice Ele­na Ka­gan, ex­plained how FDA and HHS waived in-per­son re­quire­ments for sev­er­al oth­er drugs dur­ing the pan­dem­ic, in­clud­ing con­trolled sub­stances like opi­oids, but still re­quired women to go in­to health care clin­ics to ob­tain mifepri­s­tone.

“Be­cause the FDA’s pol­i­cy im­pos­es an un­nec­es­sary, un­jus­ti­fi­able, ir­ra­tional, and un­due bur­den on women seek­ing an abor­tion dur­ing the cur­rent pan­dem­ic, and be­cause the Gov­ern­ment has not demon­strat­ed ir­repara­ble harm from the in­junc­tion, I dis­sent,” So­tomay­or wrote.

Droves of House Democrats in Washington and members of the European Parliament have now glommed onto a major push by India and South Africa at the WTO to abolish all IP around Covid-19 vaccines.

At first blush, waiving this IP sounds like an easy win: More Covid-19 vaccines made locally for more people means more lives saved. Simple enough, especially as low-income countries have received just a tiny fraction of the world’s vaccine allotment so far.

Almost 10 years have passed since its first FDA approval and Regeneron’s macular degeneration injection Eylea continues to pile up sales to the tune of about $5 billion per year, or more than half of Regeneron’s annual revenues.

Those billions are not expected to go anywhere anytime soon thanks to competition, even as Novartis subsidiary Sandoz announced Monday that it’s beginning a Phase III trial for an Eylea biosimilar in 460 patients across 20 countries.