An­ti-abor­tion groups file suit against FDA in Texas, de­mands agency re­voke ap­proval for abor­tion pill

Abor­tion op­po­nents sued FDA in fed­er­al court on Fri­day in a bid to have the agency re­verse its ap­proval of mifepri­s­tone, a drug ap­proved more than two decades ago and used in med­ica­tion-in­duced abor­tions.

Al­liance De­fend­ing Free­dom, a con­ser­v­a­tive le­gal ad­vo­ca­cy group that has been in­volved in past an­ti-abor­tion law­suits, filed the suit in the North­ern Dis­trict of Texas fed­er­al court Fri­day on be­half of four an­ti-abor­tion med­ical groups — the um­brel­la group Al­liance for Hip­po­crat­ic Med­i­cine, along­side three of its mem­ber groups: Amer­i­can As­so­ci­a­tion of Pro-Life Ob­ste­tri­cians and Gy­ne­col­o­gists, Amer­i­can Col­lege of Pe­di­a­tri­cians, and the Chris­t­ian Med­ical & Den­tal As­so­ci­a­tions. Plain­tiffs al­so in­clud­ed four doc­tors that had treat­ed pa­tients with the drug: Shaun Jester, Regi­na Frost-Clark, Tyler John­son and George Del­ga­do.

De­fen­dants di­rect­ed in the suit in­clude FDA com­mis­sion­er Robert Califf, deputy com­mis­sion­er Janet Wood­cock, CDER di­rec­tor Pa­trizia Cavaz­zoni and Xavier Be­cer­ra in his of­fi­cial ca­pac­i­ty as head of HHS.

In the 113-page com­plaint, the suit claims that the FDA lacked the au­thor­i­ty to ap­prove the drug, did not ad­e­quate­ly study the med­ica­tion and that the drug is un­safe. Mifepri­s­tone is a fre­quent­ly used drug, with the ma­jor­i­ty of abor­tions in the US con­duct­ed us­ing the drug. The FDA and oth­er health ex­perts have made clear that it’s safe.

The suit al­so added, “the FDA failed Amer­i­ca’s women and girls when it chose pol­i­tics over sci­ence and ap­proved chem­i­cal abor­tion drugs for use in the Unit­ed States. And it has con­tin­ued to fail them by re­peat­ed­ly re­mov­ing even the most ba­sic pre­cau­tion­ary re­quire­ments as­so­ci­at­ed with their use.”

At­tor­neys high­light­ed six cer­tain “agency ac­tions” that the fed­er­al reg­u­la­tor took to dereg­u­late chem­i­cal abor­tion drugs over the course of three decades — and the suit is ask­ing that the court holds those un­law­ful and va­cate those ac­tions. So far, those in­clude:

  • The ini­tial ap­proval of mifepri­s­tone was in 2000. The law­suit claims that the on­ly way the FDA could have got­ten it ap­proved is by de­clar­ing preg­nan­cy an “ill­ness” in or­der to use the ac­cel­er­at­ed drug ap­proval path­way
  • A pe­ti­tion de­nial in 2016. The FDA re­ject­ed a pe­ti­tion from two plain­tiffs in 2016 to with­draw its ap­proval of chem­i­cal abor­tion drugs. The at­tor­neys ar­gued that the pe­ti­tion ex­plained how the agency vi­o­lat­ed fed­er­al law by ap­prov­ing said drugs
  • A “ma­jor changes” amend­ment al­so in 2016, al­low­ing pa­tients to take the drug at sev­en weeks ges­ta­tion in­stead of 10 weeks, for ex­am­ple
  • a 2019 AN­DA ap­proval of gener­ic mifepri­s­tone
  • a 2021 non-en­force­ment by FDA lead­er­ship to stop en­forc­ing in-per­son dis­pens­ing of mifepri­s­tone and  tem­porar­i­ly al­low mail-or­der chem­i­cal abor­tions dur­ing the Covid-19 pan­dem­ic, and
  • a 2021 pe­ti­tion re­sponse. The FDA re­ject­ed a pe­ti­tion from two plain­tiffs that had to ask the FDA to re­store and strength­en a pre-2016 drug reg­i­men for chem­i­cal abor­tion drugs.

It’s worth not­ing that on­ly two of the plain­tiffs are lo­cat­ed in Texas — the um­brel­la group and Shaun Jester. The rest are lo­cat­ed or head­quar­tered in states such as Flori­da, Ten­nessee, Cal­i­for­nia, In­di­ana and Michi­gan.

Law pro­fes­sor Greer Don­ley told End­points News that from her per­spec­tive, the law­suit is fair­ly friv­o­lous.

Per Don­ley:

The claims es­sen­tial­ly are that the FDA abused its pow­er by us­ing the sub­part H au­thor­i­ty to ap­prove mifepri­s­tone, and that that was ev­i­dence that the agency had act­ed le­nient­ly. But the re­al­i­ty is that the agency used sub­part H so that it could reg­u­late the prod­uct much more strict­ly than any oth­er prod­uct it ap­proves, so that it could im­pose what we call like post-ap­proval re­stric­tions on the dis­tri­b­u­tion of mifepri­s­tone. And so this was the on­ly way the FDA could do that be­fore the REMS Statute came about in 2007…

I think that the fact that the plain­tiffs in this law­suit are try­ing to use that sub­part H au­thor­i­ty as ev­i­dence of le­nien­cy is iron­ic, be­cause, you know, the agency re­al­ly used that au­thor­i­ty so that it could try to be very con­ser­v­a­tive and re­al­ly lim­it the dis­tri­b­u­tion of this very safe med­ica­tion.

FDA told End­points that the agency does not com­ment on pos­si­ble, pend­ing or on­go­ing lit­i­ga­tion.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”