My latest in @thehill -
“Making America Healthy Again isn’t just about discovering new ways to be healthy. It’s about creating conditions that allow innovation to reach patients.”
The Washington Health Innovation Council congratulates Dr. Heidi Overton on her nomination to lead the FDA. She inherits an agency with real momentum, including the first agency-wide AI deployment in the federal government, a priority voucher pilot that has cut certain review timelines from months to weeks, and new development pathways for rare diseases and cell and gene therapies.
Our members innovate in medtech, biotech, and diagnostics need predictability from the FDA: clear pathways, timely feedback, and expedited review capacity that matches the pace of the science. As Secretary Kennedy and his team have emphasized from day one, chronic disease remains the defining health burden in this country, and the tools to address it increasingly exist. Legacy processes, transparency gaps, and what HHS leaders have called an over-reliance on "medical groupthink" remain real challenges across HHS agencies.
We look forward to working with Dr. Overton and the FDA team. No agency is more important to the mission of improving the health of American adults and children.
Jack Kalavritinos, Founder
Washington Health Innovation Council
Significant development flying under the radar screen of most health policy observers. The expected major reduction in time to market for innovations and access for patients in greatest need will be dramatic.
Montana’s is the most expansive “right to try” effort in the country. Which states, or tribal governments, will be next?
@kbrownsirk@goodwinlaw@JamesPPinkerton@RepGusBilirakis
https://t.co/ivTOA5pYTl
Check out Jack Kalavritinos’ piece. The article outlines the power of using trade leverage - vs other methods- to support innovators and patients and reduce the medicine price gap between EU healthcare consumers and Americans.
“Importing foreign reference prices does not level the playing field. It lowers the floor for everyone, including patients in allied countries who eventually benefit from drugs discovered and developed here,” @Jkal1985 explains.
Excellent interview -
We look forward to putting a spotlight on her organization at one of our upcoming WHIC forums. We have focused on Parkinson’s multiple times and need to dig deeper into Alzheimer’s diagnostics and treatments, such as these amazing blood test tests and Medicare reimbursement issues.
I appreciated participating in the very timely press event on the Capitol grounds supporting passage of the Great American Health Plan legislation and growing support to include it in a Reconciliation 3.0. Kudos to Rep @EricBurlison, his House colleagues, the range of stakeholders including the @WHICINNOVATES who showed up and pledged their support.
@GreatAmerHealth@A1Policy
We were honored to be part of this important event today at the U.S. Capitol.
The time is now for Congress to act and make history in Reconciliation 3.0.
@GreatAmerHealth@RepEricBurlison
We were honored to be part of this important event today at the U.S. Capitol.
The time is now for Congress to act and make history in Reconciliation 3.0.
@GreatAmerHealth@RepEricBurlison
"Third-party litigation financing of lawsuits filed in the U.S against companies and innovators has become a booming industry that views the nation’s courts as a marketplace for high-return investments instead of a way to deliver justice."
https://t.co/LrxthP7eF7
The Washington Health Innovation Council convened last week at for the Washington Summit on Deep BioSensing, Wearables Policy, and AI-Driven Diagnostics.
Leaders from the FDA, industry, patient advocacy, investment, and healthcare policy shared a timely discussion on the future of technology in healthcare, and the impacts innovation is already having on legislation.
Fantastic Bold Bets summit today at the Willard focused on a range of healthcare issues and a top-tier set of speakers
Kudos to @SCClemons, Widehall and sponsors @EliLillyandCo, @BDandCo@HDAconnect
Strong lineup of industry and current and former senior Administration health policy gurus.
And great spending time with @WHICINNOVATES colleagues and friends.
Especially enjoyed the powerful comments from the White House, HHS and CMS officials: Calley Means, Chris Klomp and John Brooks.
Also Garth Graham with @googlehealth Derek Isay with @EliLillyandCo and Chris Vurry with @ouraring.
🚨 BREAKING: @DrOzCMS announces 160 new prescription drugs are being added to https://t.co/iJahz0rH9p — taking the total to over 750 drugs available to the American public at MASSIVE savings.
A new, experimental medication nearly doubled overall survival rates for patients with advanced pancreatic cancer, according to the results of a study published Sunday. https://t.co/mSXIUnRJEU
Excellent and very timely piece by Kris Brown.
Excerpts:
Unfortunately, much of the post-Covid public discussion around vaccines has drifted toward a simplistic notion that mRNA platforms alone represent the future of pandemic preparedness. They do not.
mRNA technologies undoubtedly have important uses. But they can also be expensive to manufacture, dependent on sophisticated cold-chain logistics, and operationally difficult to distribute rapidly across lower-resource regions where many hemorrhagic fever outbreaks emerge.
Public-health infrastructure in remote parts of Central Africa does not resemble Manhattan, London, or Palo Alto.
https://t.co/qpWS5f8QDD
This article by our very own @themiaheck is an important follow-up to a series of discussions that took place at our Golden Age of AI Innovation in Lifesciences.
Mia asks an important question regarding prior authorization and then lays out the policy landscape:
“Prior authorization in U.S. healthcare is finally being modernized. Fax machines are being replaced with APIs, electronic approvals, and real-time decision systems. But almost no one is asking the harder question: what happens when the same infrastructure that speeds approvals also scales AI-driven denials?”
Marty, you took on entrenched interests, challenged the status quo, and never lost sight of the American people we serve. You pushed forward critical reforms and helped advance our mission to Make America Healthy Again. I’m grateful for your courage and your friendship. Wishing you the very best in your next chapter.
I also want to thank Kyle Diamantas for stepping in as Acting Commissioner — his leadership has already delivered remarkable wins on the MAHA food agenda, and I have full confidence in his continued work. We have an outstanding team at FDA, and the work continues without pause. The search for a new Commissioner is already underway, and we will move forward with urgency.