Laura Helbling

Director of Research at Prevision Policy; Senior Writer for The RPM Report Covering pharma and biotech regulation and policy.

[LenaSun @bylenasun]

Breaking: White House delays CDC pick. Duties of CDC Director fall to NIH director Jay Bhattacharya, who has been acting cdc director. Me @rachel_roubein @ddiamond

https://t.co/YTwbJAx4PW

[Sarah Karlin-Smith @SarahKarlin]

Its not just that these aren't the lowest prices anywhere...many companies seem to be strategically only offering "deals" on products where they've abused the system to keep cheaper competitors off market for decades. https://t.co/6CjiyVwUyD

[Max Bayer @maxonwifi]

Attributable to a federal health official, this week's ACIP meeting is postponed following the court ruling just now against Sec. Kennedy's overhaul of the federal vaccine schedule and his ACIP appointments.

[Friends of Cancer Research @CancerResrch]

Amy Abernethy, Co-Founder of Highlander Health, will join Michael McCaughan of Prevision Policy for a Fireside Chat at our upcoming “Application of ECAs in Oncology Drug Development" meeting on April 7. Register today to join in-person or virtually: https://t.co/OYj7PlwF8x.

[Sarah Despres @sarahdespres]

One year (and change) into @SecKennedy tenure at HHS a lot has changed in the federal approach to immunization. @drJoshS and I break it down.

The 4 Pillars of Childhood Vaccine Policy—1 Year Later https://t.co/ln8HXXrZLv

[Sarah Despres @sarahdespres]

It’s interesting that @US_FDA chose to redact the entire “path forward” section of the memo. Also, where are the underlining data and any an analyses performed by FDA staff? It’s so irresponsible of @DrMakaryFDA not to put that information into the public. Radical transparency.

[Alexander Gaffney @AlecGaffney]

More than 3 months after it was publicly reported, too. Strange timing and a reminder that the fatality data still aren't available.

(The full memo, available via BioCentury: https://t.co/2NruoeC7GN)

[Ramsey Baghdadi @Ramsey_Baghdadi]

Feels like that ship sailed but love the connection. Maybe Janet Woodcock returns in caretaker mode to where it all started!

[Rep. Jake Auchincloss 🟧 @RepAuchincloss]

The FDA commissioner & his CBER director are breaking the law. Under GOP gavels, the Energy & Commerce Committee has done nothing to stop it. The simple first step is a hearing.

[Zach Brennan @ZacharyBrennan]

On Prasad’s last few weeks as CBER chief:
1. It was absurdly inappropriate to bring a large group of reporters together and rail on a pending application “on background”
2. The walk back of the Moderna RTF was a bad unforced error. He could’ve just overruled staff again, following a review
3. Fingers crossed he comes back to Twitter

[Rep. Jake Auchincloss 🟧 @RepAuchincloss]

This 'senior official' was Vinay Prasad. Disclosing trade secret information without legal authorization is a prohibited act under the FDCA & a criminal violation under the Trade Secrets Act.

[Adam Feuerstein ✡️ @adamfeuerstein]

Hint: You might learn something more about the "senior FDA official" in this $QURE piece.

https://t.co/ceDE0TXjdI

[Matthew Herper @matthewherper]

@docrodwong @AppleHelix Adcomms aren’t perfect, but having covered them since Vioxx, they can come pretty close.

[Ramsey Baghdadi @Ramsey_Baghdadi]

Remarkable!

[Sarah Despres @sarahdespres]

Impt thread that describes the real world challenges of this new vaccine schedule—challenges that @hhs didn’t consider in their closed door process —at least they aren’t referenced in any of the docs released today. Sad.

[U.S. Senator Bill Cassidy, M.D. @SenBillCassidy]

As a doctor who treated patients for decades, my top priority is protecting children and families. Multiple children have died or were hospitalized from measles, and South Carolina continues to face a growing outbreak. Two children have died in my state from whooping cough. All of this was preventable with safe and effective vaccines.

The vaccine schedule IS NOT A MANDATE. It’s a recommendation giving parents the power. Changing the pediatric vaccine schedule based on no scientific input on safety risks and little transparency will cause unnecessary fear for patients and doctors, and will make America sicker.

[Dan Diamond @ddiamond]

Bill Cassidy — who voted to confirm RFK Jr — says his move to roll back vaccine recommendations “will make America sicker.”

[Alexander Gaffney @AlecGaffney]

FDA appears to have named Angelo de Claro as the new Acting Director of its Oncology Center of Excellence.

Marks the first time the center has ever been led by anyone other than Rick Pazdur.

It's still not clear if de Claro will lead it long term.
https://t.co/6T0GNfFuup

[IDSA @IDSAInfo]

ACIP is comparing the US childhood vaccine schedule with those of other countries. Why is the US schedule different? We explain.

[Ashish K. Jha @ashishkjha]

Senator Cassidy is right

The CDC director should ignore the vote of the discredited ACIP and leave the vaccine schedule for Hep B unchanged