Biotech in­dus­try lead­ers want the drug de­vel­op­ment world to stand up and en­sure em­ploy­ees have ac­cess to abor­tions af­ter a draft rul­ing last week re­vealed the na­tion’s high­est court might over­turn a near­ly five-decade-old rul­ing, known by two names: Roe v. Wade.

“We have to make noise, for one thing, which is ef­fec­tive, but al­so en­cour­age peo­ple to take some sort of ac­tion,” Paul Hast­ings told End­points News. Last week, the Nkar­ta CEO and BIO chair called on his fel­low biotech com­pa­nies to help pay for trav­el ex­pens­es for em­ploy­ees in states hin­der­ing ac­cess to re­pro­duc­tive health.

Ama­zon, Levi Strauss, Uber, Lyft, Yelp and oth­er com­pa­nies have al­ready done so.

“We’re in the busi­ness of pro­vid­ing health­care for peo­ple, and so we want to be in the busi­ness of ad­vo­cat­ing for peo­ple so that they have rights to health­care. This is not an is­sue that is not a biotech is­sue. It’s front and cen­ter,” Hast­ings said. “We spend our lives com­ing up with ther­a­pies for peo­ple. Re­pro­duc­tive rights may not be a fan­cy biotech drug, but it’s cer­tain­ly a health­care ser­vice that is ab­solute­ly de­pen­dent up­on by half of our pop­u­la­tion, and we need to fight for that. And that is our busi­ness. That’s my opin­ion.”

Oth­er in­dus­try lead­ers have echoed Hast­ing’s call, in­clud­ing Ed­i­tas Med­i­cine VP Michaela Levin and RA Cap­i­tal man­ag­ing part­ner Pe­ter Kolchin­sky.

Pe­ter Kolchin­sky

“The least com­pa­nies can do is fol­low Ama­zon’s and Nkar­ta’s ex­am­ple. Pulling to­geth­er let­ters like what we did for Ukraine takes some time so it made sense for Paul to con­vey a shared sen­ti­ment more quick­ly un­der his own name, but were it a let­ter, it would no doubt have had many sign­ers,” Kolchin­sky told End­points in an email.

Asked if the in­dus­try would look to com­pile a co­or­di­nat­ed let­ter like it did in re­sponse to the war in Ukraine, Hast­ings said “a lot of peo­ple” would like­ly sign it but with abor­tion be­ing a “hot-but­ton item,” 1,000 dif­fer­ent re­cip­i­ents means 1,000 ed­its “be­cause every­body has a dif­fer­ent take on this.”

Hast­ings, whose start­up is lo­cat­ed in Cal­i­for­nia, said he doesn’t have to wor­ry about his em­ploy­ees’ ac­cess to re­pro­duc­tive rights be­cause of where Nkar­ta is perched. But he wor­ries about oth­er states.

“We need to re­mem­ber that the pow­er that we have in num­bers is as­tro­nom­i­cal, even in Texas, even in Flori­da,” Hast­ings said.

Biotechs should be cog­nizant of where they set up shop.

Kolchin­sky said, “It’s pru­dent for com­pa­nies to take a state’s po­si­tion on women’s re­pro­duc­tive rights in­to ac­count when de­cid­ing where to ex­pand in­to. As a board mem­ber and in­vestor, I would ex­pect them to.”

Hast­ings, who has been an ad­vo­cate for gay rights as one of the most vis­i­ble LGBTQ+ ex­ec­u­tives through his post as BIO chair, said he wor­ries about the po­ten­tial im­pli­ca­tions if the Supreme Court sticks to its draft rul­ing. This in­cludes abor­tion, con­tra­cep­tion, gay mar­riage, vot­ing rights and more, he said.

From his of­fice at Nkar­ta — in the mid­dle of the biotech’s lab — Hast­ings has talked about the Supreme Court news with his col­leagues, some of whom have been “dev­as­tat­ed” and have said they’re dis­cussing the is­sue with their fam­i­lies around the din­ner ta­ble.

“There’s so much noise out there right now with all these dif­fer­ent things with Ukraine and with this, what’s go­ing on in Flori­da and Texas, that peo­ple af­ter a while they get burnt out from all the noise, but we can’t; we’ve got to stay in front of this stuff.”

Ahead of the San Fran­cis­co launch event for LGBTQ-fo­cused in­dus­try or­ga­ni­za­tion OUT­bio last Thurs­day, Hast­ings said he ex­pect­ed the Supreme Court draft to be a “con­ver­sa­tion in the room.”

“That’s one place to get this con­ver­sa­tion start­ed,” he said.

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.