Fol­low­ing the Supreme Court’s his­toric de­ci­sion on Fri­day to over­turn Amer­i­cans’ con­sti­tu­tion­al right to an abor­tion af­ter al­most 50 years, At­tor­ney Gen­er­al Mer­rick Gar­land sought to some­what re­as­sure women that states will not be able to ban the pre­scrip­tion drug some­times used for abor­tions.

Fol­low­ing the de­ci­sion, the New Eng­land Jour­nal of Med­i­cine al­so pub­lished an ed­i­to­r­i­al strong­ly con­demn­ing the re­ver­sal, say­ing it “serves Amer­i­can fam­i­lies poor­ly, putting their health, safe­ty, fi­nances, and fu­tures at risk.”

John Roberts

Doc­tors and physi­cian groups around the globe sim­i­lar­ly sound­ed alarm bells over the dra­mat­ic move, even as it was ex­pect­ed months ear­li­er. Jus­tices vot­ed 6-3 in fa­vor of over­turn­ing Roe v. Wade, with three of the jus­tices ap­point­ed un­der Pres­i­dent Don­ald Trump join­ing in the ma­jor­i­ty.

Chief Jus­tice John Roberts al­so vot­ed with the ma­jor­i­ty but said he would’ve tak­en “a more mea­sured course” than an out­right re­peal.

In their dis­sent­ing opin­ion, the three lib­er­al jus­tices wrote, “To­day’s de­ci­sion strips women of agency over what even the ma­jor­i­ty agrees is a con­test­ed and con­testable moral is­sue. It forces her to car­ry out the State’s will, what­ev­er the cir­cum­stances and what­ev­er the harm it will wreak on her and her fam­i­ly.”

Physi­cians of­fered sim­i­lar sen­ti­ments in pub­lic state­ments.

“Ex­pe­ri­ence around the world has demon­strat­ed that re­strict­ing ac­cess to le­gal abor­tion care does not sub­stan­tial­ly re­duce the num­ber of pro­ce­dures, but it dra­mat­i­cal­ly re­duces the num­ber of safe pro­ce­dures, re­sult­ing in in­creased mor­bid­i­ty and mor­tal­i­ty,” the NE­JM said in its ed­i­to­r­i­al.

Ster­ling Ran­sone

Ster­ling Ran­sone, pres­i­dent of the Amer­i­can Acad­e­my of Fam­i­ly Physi­cians, sim­i­lar­ly said he was “dis­ap­point­ed and dis­heart­ened” by the de­ci­sion to strike down these long­stand­ing pro­tec­tions.

“Al­low­ing each state to pass their own laws re­gard­ing ac­cess to re­pro­duc­tive health care, in­clud­ing abor­tion ser­vices and con­tra­cep­tion, ex­ac­er­bates in­equities in the health care sys­tem,” Ran­sone said in a state­ment. “These laws dis­pro­por­tion­ate­ly af­fect those pa­tients who are in un­der­rep­re­sent­ed groups and un­der­served ar­eas, which al­ready puts them at in­creased risk of ma­ter­nal death.”

Near­ly half of the 50 states could po­ten­tial­ly pass bills ban­ning abor­tions, which would fol­low years of in­creased re­stric­tions around abor­tions across the South and Mid­west.

The FDA, mean­while, per­ma­nent­ly lift­ed its in-per­son dis­pens­ing re­quire­ments for abor­tion pills in De­cem­ber. Abor­tions with mifepri­s­tone ac­count for about 40% of all abor­tions in the US.

While some may ar­gue that states could put fur­ther lim­i­ta­tions on the use of mifepri­s­tone, lawyers ar­gue that such state-to-state lim­i­ta­tions could be chal­lenged, par­tic­u­lar­ly by phar­ma com­pa­nies.

“If a court were to say a state could ban cer­tain drugs, the im­pli­ca­tions for the phar­ma­ceu­ti­cal in­dus­try are huge. Go­ing to get a [new drug ap­pli­ca­tion] with the FDA is not some puny process, right? It takes hun­dreds of mil­lions of dol­lars and some­times decades of re­search. Com­pa­nies en­dure those costs and time be­cause they think it’s go­ing to lead to a na­tion­wide li­cense to sell a prod­uct. If all of a sud­den states can ban prod­ucts, you can imag­ine com­pa­nies be­ing pret­ty up­set,” Greer Don­ley, an as­sis­tant pro­fes­sor at the Uni­ver­si­ty of Pitts­burgh School of Law, told Bloomberg re­cent­ly.

U.S. At­tor­ney Gen­er­al Mer­rick Gar­land al­so made clear in a state­ment on Fri­day that states would not be able to ban the use of the abor­tion pill:

And we stand ready to work with oth­er arms of the fed­er­al gov­ern­ment that seek to use their law­ful au­thor­i­ties to pro­tect and pre­serve ac­cess to re­pro­duc­tive care. In par­tic­u­lar, the FDA has ap­proved the use of the med­ica­tion Mifepri­s­tone. States may not ban Mifepri­s­tone based on dis­agree­ment with the FDA’s ex­pert judg­ment about its safe­ty and ef­fi­ca­cy.

Mass­a­chu­setts pre­vi­ous­ly sought to ban the use of a par­tic­u­lar opi­oid (most re­cent­ly pulled from the mar­ket) af­ter it won FDA ap­proval, but that ban was over­turned in court.

but can they ban it as part of a gen­er­al ban on abor­tion, NOT fo­cused on its safe­ty or ef­fi­ca­cy? Does­n't look from the quote as tho the AG is opin­ing on that, hard­er but more im­por­tant, ques­tion. https://t.co/OYU­UaoKjMH

— Hank Greely (@Han­kGreelyL­SJU) June 24, 2022

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.