Sunday, August 14, 2022
    HomeHealthThe Senate health committee finally marks up its user fee bill

    The Senate health committee finally marks up its user fee bill


    You’re studying the net version of D.C. Prognosis, STAT’s twice-weekly e-newsletter in regards to the politics and coverage of well being and medication. Join here to obtain it in your inbox.

    A one-man White Home personnel workplace

    When Francis Collins stepped down after practically 12 years as NIH director, he thought he’d lastly get some peace and quiet, he told me — an opportunity to spend extra time together with his spouse, the genetic counseling pioneer Diane Baker, and to commit extra consideration to his genomics analysis lab.


    His respite lasted about six weeks. Then got here a 7 a.m. name from Ron Klain, President Biden’s chief of employees. The evening earlier than, former White Home science adviser Eric Lander had resigned amid a workplace-abuse scandal, and Klain needed Collins to step in. It was, Collins mentioned, a request to which “you possibly can’t say no.”

    In an unique interview — his first in his capability as Biden’s science adviser — Collins crammed me in on the 4 main personnel searches he’s presently main: New administrators for NIH, ARPA-H, and the Nationwide Most cancers Institute, plus Biden’s subsequent science adviser (he calls that final appointment his “get-out-of-jail-free card.”) He additionally shared his tackle current criticism of NIH, the continued dependancy disaster, and political interference at federal science companies. Read more here.


    HELP — I want any individual (to reauthorize FDA consumer charges)

    The Senate HELP Committee convenes as we speak for a markup on the unfortunately-acronymed bill often called FDASLA, which might reauthorize the consumer charges that assist the Meals and Drug Administration and enact a variety of company reforms.

    A lot of the invoice isn’t significantly controversial. However there could possibly be some fireworks, particularly, on the difficulty of prescription drug importation. Sen. Patty Murray (D-Wash.) has thus far resisted a push from Sen. Bernie Sanders (I-Vt.) to incorporate main drug importation measures within the invoice. However a lobbyist shared a replica of an modification Sanders is anticipated to supply with me yesterday — and it features a scheme to facilitate imports from Canada, the UK, and different international locations deemed protected by the FDA. And a few committee Republicans have proven assist for drug importation prior to now, too. This might get fascinating!

    The supervisor’s modification shared by committee employees nonetheless consists of some modest reforms to the FDA’s controversial accelerated approval pathway and the requirement that the company transfer rapidly to approve over-the-counter listening to aids. The Home passed its own version of the bill final week, which takes a special method on accelerated approval.

    It’s scorching job summer season for well being care lobbyists

    A few of D.C.’s prime well being lobbyists and coverage wonks are ringing within the begin of summer season with some new gigs, Nick experiences. These strikes, particularly, caught his consideration:

    • Mike Mattoon, considered one of BIO’s prime lobbyists, is becoming a member of Acadia Prescribed drugs as its V.P. of presidency affairs.
    • Liz Richardson, who directed the well being care merchandise on the Pew Charitable Trusts, began Monday as a senior supervisor of public coverage.
    • Tim Robinson, the Home Power and Commerce Committee’s veteran chief counsel, is becoming a member of Tiber Creek Group, whose purchasers embody BIO and Anthem. He’s the second main E&C departure just lately: Jeff Carrol, the committee’s longtime employees director, left for Capitol Counsel final summer season.
    • And right here’s an enormous one: Keagan Lenihan, who served as chief of employees to Stephen Hahn, the previous FDA commissioner, has joined tobacco big Phillip Morris as its vice chairman of presidency affairs and public coverage.

    For those who’ve bought extra scoops for Nick, he’s at [email protected]

    Is the FTC strolling the stroll on hospital mergers?

    The Federal Commerce Commision made a splash final week when it introduced it was suing to dam not one however two main hospital mergers. And it follows a protracted stretch of President Biden and FTC chair Lina Khan talking a big game on cracking down on well being trade consolidation.

    However consultants describe final week’s lawsuits as “low-hanging fruit,” my colleague Tara Bannow writes, and argue that they don’t characterize a serious shift in how the nation’s prime antitrust enforcers view well being care mergers. “The complaints themselves are extra smoke than hearth,” one former FTC lawyer informed Tara. Read the rest here.

    PhRMA is descending on the WTO

    The pharmaceutical trade has put all palms on deck this week in Switzerland, the place international commerce negotiators are contemplating a proposal to quickly waive mental property rights for Covid-19 vaccines, my colleague Ed Silverman reports. The Biden administration shocked Washington and enraged the pharmaceutical trade when it endorsed the waiver a 12 months in the past in response to rich nations accounting for a dramatically outsize share of the worldwide vaccine provide.

    However the proposal hasn’t moved ahead. And now, the pharmaceutical trade says there’s no level in enacting the IP waiver this far into the pandemic, arguing that vaccine provide is now not a serious concern. However vaccination charges in a lot of Africa, Japanese Europe, and Central Asia stay far out of step with the remainder of the world. More here.

    What we’re studying

    SCOOP: Klobuchar, Porter name for FTC to analyze blood thinner worth hikes by Janssen, Bristol-Myers Squibb, STAT

    FDA says Moderna’s Covid vaccine for youths is protected and efficient, Washington Post

    Experimental ALS remedy receives approval in Canada, New York Times

    A Florida hospital system is suing a spiritual sharing ministry over unpaid medical claims, STAT

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