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.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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Mi­rati’s drug sitra­va­tinib flops PhI­II in com­bo with Op­di­vo for cer­tain lung can­cer

Mirati Therapeutics’ path to a second drug approval will likely have to wait. The San Diego biotech company said Wednesday that its investigational lung cancer drug failed a Phase III trial testing it in combination with Bristol Myers Squibb’s Opdivo.

The drug, sitravatinib, and Opdivo weren’t better than the chemo drug docetaxel at keeping patients alive, Mirati said in a press release. The spectrum-selective kinase inhibitor missed the primary goal of overall survival in patients with second- or third-line advanced non-squamous, non-small cell lung cancer.

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FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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Teresa Bitetti, Takeda's president of the global oncology business unit

Take­da wins pri­or­i­ty re­view for $400M col­orec­tal can­cer drug, li­censed from Hutchmed in Jan­u­ary

Takeda and Hutchmed scored a priority review Thursday afternoon for a colorectal cancer drug, the companies announced.

The experimental drug in question is fruquintinib, previously approved in China in 2018 to treat metastatic colorectal cancer. Takeda and Hutchmed are aiming to bring fruquintinib to the US and other countries outside China in the same indication, and the FDA set its decision date for Nov. 30 of this year.

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Pur­due Phar­ma nabs court ap­proval for $397M sale of con­sumer health unit

A federal bankruptcy judge on Tuesday approved Purdue Pharma’s $397 million sale of its consumer health unit to a subsidiary of Arcadia Consumer Healthcare.

The news comes as Purdue awaits the court’s approval of a proposed settlement worth more than $10 billion to resolve civil claims over its role in the opioid epidemic, which claimed more than 564,000 lives between 1999 and 2020. The company filed for bankruptcy in 2019 amid mounting lawsuits alleging deceptive marketing of its highly addictive painkiller Oxycontin.

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