House moves closer to choosing its leader

The House GOP picked Rep. Steve Scalise to be the next House Speaker. The next hurdle for the Louisiana Republican is getting at least 217 Republicans to vote for him on the House floor, which means he can lose only 4 votes from his own party – no Democrats are expected to vote yes.

It's not clear what's next, or when the vote might take place. But any new Speaker will have an impact on health care policy. As Rachel reported last week, Scalise has a long track record on the big health policy issues in Washington, even if he hasn't been closely involved in the nitty gritty. He backed his party's effort to repeal the Affordable Care Act and vocally opposed Democrats' law to let Medicare negotiate drug prices. Scalise also served for ages on the House Energy & Commerce Committee, which has broad jurisdiction over health care policies.

THE AGENCIES

NIH director nominee to get her day in committee

Mark your calendars: The Senate health committee will hold a confirmation hearing for National Institutes of Health nominee Monica Bertagnolli next week.

Committee Chair Bernie Sanders (I-Vt.) had refused to hold a hearing on Bertagnolli until the Biden administration promised more drug pricing reform. The deal that HHS struck with Regeneron on the company's Covid-19 monoclonal antibody satisfied Sanders enough to officially put it on the schedule.

We'll be watching for Bertagnolli to defend NIH's massive budget under siege from Republicans, who will likely devote a large part of their questions to research that she's never worked on. The cancer doctor, who leads the historically top-funded institute on the Bethesda campus, likely won't field questions about cancer as much as she will volley with lawmakers over infectious disease research and Alzheimer's disease progress. More on her nomination, here.

GENERICS

Drug shortage watch

One of the world's biggest generic drug manufacturers, Teva Pharmaceuticals, is headquartered in Tel Aviv, and the company is seeking to reassure its shareholders that the war between Israel and Hamas won't significantly impact its drug production. "Production in Israel constituted less than 8% of our total global production in USD," it said in a statement Tuesday.

Experts aren't expecting shortages of any drugs, either. Unlike in July, when a tornado hit a Pfizer plant in North Carolina and hospitals began panic buying some drugs not made at that facility, they said in Teva's case, hospitals probably don't expect many Israeli facilities to make many drugs for the U.S. market.

The U.S. Pharmacopeia, which keeps track of where drugs in the U.S. market are made, said Israeli facilities make at least four sterile injectable drugs that are sold in the United States. None of them are on the FDA's essential medicines or drug shortage lists.

Q&A

Operation Warp Speed for rare diseases

Reporters know there's no such thing as a dumb question, and FDA's Center for Biologics Evaluation and Research Director Peter Marks wants to engrain that in the thinking of drug company researchers, too.

In a Q&A with STAT's Jason Mast, Marks explains how the agency hopes to reinvigorate the field of gene therapy. It involves a pilot program that is not actually called Warp Speed. Instead it's the Support for Clinical Trials Advancing Rare disease Therapeutics (START). Less catchy, but also less likely to offend.

The pilot will allow companies to get agency feedback faster on drugs they're testing. Company researchers will be introduced to the FDA project manager in charge of their product review so the two sides can become "email buddies" and get answers to questions, even supposedly dumb ones, within days instead of weeks. Read more.

IN THE STATES

States are cracking down on drug prices, too

Right now, only Medicare gets to benefit from the lower drug prices that its new price negotiation program can eke out of drugmakers. Democrats tried to extend those prices to private insurance that employers provide, but that effort was thwarted by a legislative technicality.

Enter states. Pharmalot author Ed Silverman reports that seven states have created boards that set prices for drugs. Some states plan to use them to set prices for drugs that state and local governments cover for their employees, and some also plan to set prices in Obamacare plans, too. Read more.

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