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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Todd Zavodnick, Dermavant CEO

With top­i­cal ap­proval, Der­ma­vant looks to bring new stan­dard-of-care to plaque pso­ri­a­sis pa­tients

Dermavant CEO Todd Zavodnick has been plotting to upend the plaque psoriasis market for years now. And with the company’s first approval on Tuesday, he’s pulling the trigger.

The FDA on Tuesday approved Dermavant’s “cosmetically elegant” vanishing cream tapinarof, the first steroid-free topical medication in its class, now marketed as Vtama. And unlike other launches, which could take months, Zavodnick is ready to roll it out as early as next week.

Raymond Tesi, INmune Bio CEO

Man­u­fac­tur­ing con­cerns spur clin­i­cal hold on small biotech's Alzheimer's tri­al — shares plunge

The FDA is keeping an experimental Alzheimer’s therapy out of the US for now, placing a clinical hold on INmune Bio’s IND for a Phase II trial until it can provide additional information on chemistry, manufacturing and controls.

INmune Bio, which gets its name from the approach of leveraging the innate immune system to fight disease, said it was informed about the hold via email and expects more details in a later letter. In a brief statement, it said the agency was looking for more information about CMC “of the newly manufactured XPro1595.”

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