It's insulin CEOs' turn in the hot seat

Sen. Bernie Sanders has used his perch at the top of the Senate health committee to mount a campaign against the pharmaceutical industry's drug pricing practices, and insulin makers are next on his list

Even though insulin makers recently voluntarily lowered their prices for some insulin products (which may have worked to their own advantage), Sanders is still calling the CEOs of large insulin manufacturers to testify in a hearing aimed for next month, my colleague John Wilkerson and I scooped yesterday. This follows Sanders' grilling of Moderna CEO Stéphane Bancel in March over the company's Covid-19 vaccine pricing policies.

Get the full story here, including responses from Eli Lilly, Sanofi and Novo Nordisk on the prospect of their executives testifying.

Capitol hill

Markup delays, wonky bills, and new CBO scores, oh my!

As my colleague John predicted in D.C. Diagnosis earlier this week, the Senate health committee's markup of health care policy has slipped from its initial timeline of next week. But we talked with 17 lobbyists and Senate staff to get you the latest, wonkiest details on what's under consideration.

Lawmakers pushing insulin cost reforms are revisiting their proposals in light of drug makers' decisions to lower their prices, a few generic bills are coming into focus, and we've got the blueprint that the committee could work from if they pursue regulations of PBMs. Read all the details here.

reproductive rights

Pharmaceutical industry comes to FDA's defense

The pharmaceutical industry is escalating its opposition to a Texas' judge's decision to suspend the Food and Drug Administration's approval of an abortion pill.

A grassroots biotech and pharmaceutical industry advocacy push that started as an open sign-on letter now has turned into an amicus brief in support of the FDA. Signatories include companies such as Pfizer and Gilead, the Biotechnology Innovation Organization, and individuals including BIO Board Chair and Nkarta CEO Paul Hastings and biotech investor Peter Kolchinsky.

While the industry's largest trade group, PhRMA, didn't sign on, the group on Wednesday put out a blog post that is notably more pointed than its initial statement. PhRMA's General Counsel Jim Stansel wrote that the group has "serious concerns with any court substituting its opinion for the FDA's expert approval decision-making" and that PhRMA will "continue to explore all policy and legal options to ensure the FDA's approval authority is protected."

biotech

FDA staff wanted to reject Sarepta's gene therapy

Reviewers at the FDA were leaning toward rejecting Sarepta Therapeutics' gene therapy for Duchenne muscular dystrophy until a high-ranking agency official intervened, according to three people familiar with the matter.

As STAT's Adam Feuerstein and Jason Mast report, staff at the FDA's gene therapy division had reached a preliminary conclusion that Sarepta's application did not pass muster for a speedy approval. That led Peter Marks, a top FDA official and advocate for faster approvals, to step in and direct staff to schedule a public hearing on gene therapy, the people said.

That was Marks' second intervention in the review of Sarepta's gene therapy: Last year, he cleared Sarepta to submit its medicine for accelerated approval after learning reviewers were planning to tell the company its application didn't even meet the criteria to undergo an official FDA review, according to people familiar with the matter. Read more.

This item appeared in STAT's daily biotech newsletter, The Readout. Sign up here.

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