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.

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.

Over the past few months, oncologists have been talking a lot about the ASCO conference. Not surprising considering its import and the study data presented, but what may be less expected is the second most talked about topic of health equity.

That’s according to data from The Harris Poll and the new expert network the researcher is building out. While the company has been doing deep data dives into specific health issues or conditions for pharma clients, it’s now monitoring influencer networks of therapy area specialists to find out what experts are really thinking about.

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.