Janet Woodcock, acting FDA commissioner (Al Drago/Bloomberg via Getty Images)

FDA per­ma­nent­ly lifts in-per­son re­quire­ments for dis­pens­ing abor­tion pills

Since the pan­dem­ic be­gan, the FDA has al­lowed women to ac­cess the abor­tion drug mifepri­s­tone via the mail, mak­ing it eas­i­er for them and en­sur­ing that they don’t have to go to a clin­ic to re­ceive the pills.

The FDA’s tem­po­rary change be­came per­ma­nent on Thurs­day af­ter­noon, with the FDA an­nounc­ing that the REMS on mifepri­s­tone (brand name Mifeprex) and its gener­ic ver­sions must be mod­i­fied by re­mov­ing this in-per­son dis­pens­ing re­quire­ment.

“Re­mov­ing the in-per­son dis­pens­ing re­quire­ment will al­low, for ex­am­ple, dis­pens­ing of mifepri­s­tone by mail via cer­ti­fied pre­scribers or phar­ma­cies, in ad­di­tion to in-per­son dis­pens­ing in clin­ics, med­ical of­fices, and hos­pi­tals as cur­rent­ly out­lined in the Mifepri­s­tone Rems Pro­gram,” the FDA said.

The per­ma­nent change is a win for abor­tion rights groups in a time when there may be some big changes com­ing around Roe v. Wade, with the Supreme Court weigh­ing in on a ma­jor chal­lenge.

An­ti-abor­tion groups raised ques­tions about the safe­ty of the change from FDA. And the agency, while ac­knowl­edg­ing that it hasn’t iden­ti­fied any new safe­ty sig­nals, has re­ceived re­ports of se­ri­ous ad­verse events in women who took mifepri­s­tone. As of June 30, there were re­ports of 26 deaths of women as­so­ci­at­ed with (not nec­es­sar­i­ly caused by) mifepri­s­tone since the prod­uct was ap­proved in Sep­tem­ber 2000. A sum­ma­ry re­port of those FDA da­ta is here.

Act­ing FDA com­mis­sion­er Janet Wood­cock pre­vi­ous­ly not­ed in April that based on a re­view of the med­ical lit­er­a­ture, there weren’t “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 re­main­ing re­quire­ments of the drug’s REMS still need to be met.

The new­ly up­dat­ed REMS makes clear that mifepri­s­tone must be pre­scribed by or un­der the su­per­vi­sion of a cer­ti­fied health­care provider who meets cer­tain qual­i­fi­ca­tions, the health­care provider must ob­tain a signed form from the pa­tient af­ter coun­sel­ing and pri­or to pre­scrib­ing mifepri­s­tone, and the phar­ma­cies that dis­pense mifepri­s­tone must be cer­ti­fied.

Ac­cord­ing to the Guttmach­er In­sti­tute and the CDC, abor­tions with mifepri­s­tone ac­count for about 40% of all abor­tions in the US, and 339,640 med­ica­tion abor­tions were pro­vid­ed in non-hos­pi­tal fa­cil­i­ties in 2017, a 25% in­crease from 2014.

Mifepri­s­tone is ap­proved by the FDA, in a reg­i­men with miso­pros­tol, to end a preg­nan­cy through 70 days, or about 10 weeks ges­ta­tion.

The Supreme Court is weigh­ing in on a Mis­sis­sip­pi law — which it’s like­ly to up­hold, as all six Re­pub­li­can-ap­point­ed jus­tices sug­gest­ed that they would up­hold it — that bans abor­tion af­ter 15 weeks of preg­nan­cy. Ac­cord­ing to the New York Times, on­ly 4% of abor­tions hap­pen af­ter 15 weeks.

“With Roe v. Wade hang­ing by a thread, it is es­pe­cial­ly ur­gent that the fed­er­al gov­ern­ment do every­thing in its pow­er to ex­pand ac­cess to this med­ica­tion,” Ju­lia Kaye, a staff at­tor­ney for the Amer­i­can Civ­il Lib­er­ties Union, told the Wash­ing­ton Post.

Illustration: Assistant Editor Kathy Wong for Endpoints News

How Pur­due's $272M ad­dic­tion pay­out fund­ed a new home for its dis­card­ed non-opi­oid re­search

Don Kyle spent more than 20 years working for Purdue Pharma, right through the US opioid epidemic that led to the company’s rise and eventual infamy. But contrary to Purdue’s focus on OxyContin, Kyle was researching non-opioid painkillers — that is, until the company shelved his research.

As the company’s legal troubles mounted, Kyle found an unlikely way to reboot the project. In 2019, he took his work to an Oklahoma State University center that’s slated to receive more than two-thirds of the state’s $272 million settlement with Purdue over claims that the drugmaker’s behavior ignited the epidemic of opioid use and abuse.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

President Joe Biden at the State of the Union address with Vice President Kamala Harris and House Speaker Kevin McCarthy (Patrick Semansky/AP Images)

The drug pric­ing pres­i­dent: Biden warns of ve­to for any IRA re­peal at­tempts

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Rupert Vessey, Bristol Myers Squibb head of research and early development

Up­dat­ed: R&D tur­bu­lence at Bris­tol My­ers now in­cludes the end of a $650M al­liance and the de­par­ture of a top re­search cham­pi­on

This morning biotech Dragonfly put out word that Bristol Myers Squibb has handed back all rights to its IL-12 clinical-stage drug after spending $650 million to advance it into the clinic.

The news arrives amid a turbulent R&D stage for the pharma giant, which late last week highlighted Rupert Vessey’s decision to depart this summer as head of early-stage R&D following a crucial three-year stretch after he jumped to Bristol Myers in the big Celgene buyout. During that time he struck a series of deals for Bristol Myers, and also shepherded a number of Celgene programs down the pipeline, playing a major role for a lineup of biotechs which depended on him to champion their drugs.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

FDA Commissioner Robert Califf on Capitol Hill, Feb. 8, 2023 (Drew Angerer/Getty Images)

FDA com­mis­sion­er floats ideas on how to bet­ter han­dle the pan­dem­ic

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”

Utpal Koppikar, new Verily CFO

Ex­clu­sive: Ver­i­ly wel­comes Atara Bio­ther­a­peu­tics vet­er­an as new CFO

Verily, Alphabet’s life sciences outfit, has plucked a new CFO from the ranks of Atara Biotherapeutics, the company announced on Wednesday.

Utpal Koppikar joins Verily after a nearly five-year stint as CFO and senior VP at Atara, though his résumé also boasts roles at Gilead and Amgen.

The news follows a major reshuffling at Verily, including several senior departures earlier this year and a round of layoffs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 159,000+ biopharma pros reading Endpoints daily — and it's free.

Singer Nick Jonas is back at work for Dexcom, this time for its new G7 glucose monitor.

Dex­com's spokescelebri­ty Nick Jonas re­turns to Su­per Bowl in new glu­cose mon­i­tor com­mer­cial

Dexcom is going back to the Super Bowl with its pop singer and patient spokesperson Nick Jonas. Jonas takes center stage as the lone figure in the 30-second commercial showcasing Dexcom’s next-generation G7 continuous glucose monitoring (CGM) device.

Jonas’ sleight-of-hand tricks populate the commercial — he pinches his empty fingers together and pops them open to reveal the small CGM — even as he ends the ad, saying, “It’s not magic. It just feels that way.” Jonas then disappears in a puff of smoke.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 159,000+ biopharma pros reading Endpoints daily — and it's free.

Richard Francis, newly-appointed Teva CEO (Novartis via Facebook)

New Te­va CEO Richard Fran­cis repri­or­i­tizes to 'get back to growth'

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

Drag­on­fly chief: Bris­tol My­ers shouldn’t blame IL-12’s clin­i­cal per­for­mance for de­ci­sion to scrap the deal — eco­nom­ics played a key role

Bristol Myers Squibb says the IL-12 drug they were developing out of Dragonfly Therapeutics was scrubbed from the pipeline for a simple reason: It didn’t measure up on clinical performance.

But Bill Haney, the CEO of Dragonfly, is taking issue with that.

The early-stage drug, still in Phase I development, has passed muster with Bristol Myers’ general clinical expectations, advancing successfully while still in Phase I, he says.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Sanofi is renewing its #VaccinesForDreams campaign with more stories, such as Juan's in Argentina (Sanofi)

Sanofi re­news so­cial cam­paign to re­mind that vac­cines let peo­ple ‘Dream Big’

Sanofi is highlighting people’s dreams — both big and small — to make the point that vaccines make them possible.

The renewed “Dream Big” global social media campaign’s newest dreamer is Juan, a teacher in the Misiones rainforest in Argentina whose story is told through videos on Instagram and Sanofi’s website with the hashtag #VaccinesForDreams.

The campaign ties to Sanofi’s broader umbrella initiative “Vaccine Stories” to promote the value of vaccines and drive awareness of the need for improved vaccination coverage.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 159,000+ biopharma pros reading Endpoints daily — and it's free.