Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
Jan 22, 2025 View in browser
 
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By David Lim and Lauren Gardner

With Robert King

Driving The Day

President Donald Trump holds up a signed executive order in the Oval Office.

Among the many executive orders President Donald Trump signed Monday was one overturning a Biden order aimed at lowering prescription drug prices. | Pool photo by Jim Watson

TRUMP PULLS BACK BIDEN DRUG PRICING EO — The Trump administration’s first drug pricing action — rescinding a Biden executive order encouraging Medicare to help lower prescription costs — is befuddling drug pricing experts.

“It is perplexing why Trump would have included receding this drug cost executive order on Day One,” said Larry Levitt, executive vice president for health policy at KFF. “It at least sends a signal that Trump may not be serious about addressing drug costs.”

But it is unclear when the action will have a material impact, Robert reports, namely whether the removal of the executive order would impact any of the models — which can help reward providers who deliver high-quality and coordinated care — are in various stages of development.

In October 2022, former President Joe Biden issued an order directing the Center for Medicare and Medicaid Innovation to create several payment models to lower prescription drug costs. The agency announced three models in February 2023.

One model encouraged Medicare prescription drug plans to offer a co-payment for certain inexpensive generic drugs capped at $2 a month per drug. Another called on state Medicaid agencies to jointly create outcome-based agreements with manufacturers for pricey cell and gene therapies. The model is intended to ensure the price that states pay is based on the drug having its desired effect on improving patient health.

A third model would reduce Medicare funding on drugs cleared by the FDA under accelerated approval, which speeds up the endorsement of medications that fill an unmet need.

CMMI is taking applications for the cell and gene therapy model until Feb. 28. The center has yet to implement either of the other models.

“I don’t think the executive order would necessarily stop these models,” Levitt said. “The really big question is what Trump will do with the Inflation Reduction Act and government negotiation of drug costs.”

Speaking of which: CMS released the list of the next 15 drugs subject to price negotiations on Friday, three days before the Biden administration’s end.

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In the Courts

A medical staff member prepares the Pfizer-BioNTech Covid-19 vaccine.

Former HHS Secretary Xavier Becerra is being sued over a serious adverse effect a patient had after getting a Covid vaccine. | Jae C. Hong/AP

SUIT PUSHES VICP COVERAGE FOR COVID SHOTS — A law firm specializing in vaccine injury complaints has sued Xavier Becerra on behalf of Paul Brundage, who says he developed a blood-clotting disorder after being vaccinated against Covid-19. His lawyers argue that Becerra missed the deadline when he was HHS secretary to add Covid vaccines to the vaccine injury table, one of the steps necessary to ensure people who had serious reactions to the shots are compensated.

While the lawsuit filed Thursday didn’t prompt any last-minute moves from HHS, one attorney behind it said she hopes the next secretary will reassess the status quo.

Background: The Countermeasures Injury Compensation Program, created by a George W. Bush-era pandemic law, is intended to award payments to those who experience serious injuries or death from a “countermeasure” — a vaccine or a drug, for example — created in response to a public health emergency. The program covers Covid vaccines and treatments like monoclonal antibodies.

It’s separate from the Vaccine Injury Compensation Program, a no-fault alternative to the traditional torts system for shots the CDC recommends for children and pregnant people.

That program, funded by a 75-cent excise tax on vaccine doses administered, has volume and staffing issues but is regarded as a necessary bulwark against vaccine hesitancy. Meanwhile, lawmakers and attorneys have criticized the CICP for compensating a fraction of the thousands of Covid claims filed.

HHS and Congress: The CDC officially recommended Covid vaccines for inclusion in its annual immunization schedules beginning in 2023.

By law, HHS had two years from that point to add any newly recommended shot to the VICP. But a recommendation also requires action by Congress to apply the excise tax to that product; until then, the vaccine won’t yet be eligible for claims.

Anne Carrión Toale, a partner at mctlaw who represents the plaintiff, said lawmakers “historically” enact the excise tax before HHS adds a vaccine to the injury table but noted that the order of actions shouldn’t matter.

“If all these Covid [vaccine-]injured people don’t start getting compensated, that’s not going to help vaccine hesitancy at all,” she said.

HHS didn’t respond to a request for comment.

AROUND THE AGENCIES

TRUMP ADMIN PAUSES HHS COMMS — The Trump administration has halted HHS outside communications and website updates, two HHS employees and four people familiar with the instructions granted anonymity to discuss the order told POLITICO.

The decision, which one of the HHS employees said is intended to avoid “surprises,” is not unusual with a new administration.

“It’s pretty typical,” said a former senior agency official granted anonymity to speak about the pause. “It’s pretty common in a transition that external communications or anything you would issue that is public facing would have higher level review and undergo a clearance process.”

The White House did not immediately respond to a request for comment.

ANOTHER NAME JOINING THE WHITE HOUSE — Don Dempsey, vice president of policy and research at the Better Medicare Alliance and a former OMB official, is expected to join the Trump Office of Management and Budget as an associate director working on health care programs, POLITICO’s Chelsea Cirruzzo reports.

Industry Intel

FDA EXPANDS LABEL FOR DEPRESSION SPRAY — The FDA on Tuesday approved Johnson & Johnson’s Spravato, a ketamine-derived nasal spray, as the first and only therapy for adults with major depressive disorder who haven’t responded well to at least two antidepressants.

The drug was previously approved for use with an oral antidepressant for treatment-resistant depression. The nasal spray is still indicated to be used with an antidepressant pill by adults with major depressive disorder that includes acute suicidal ideation.

Pharma Moves

IGC Pharma has appointed Virginia Gov. Terry McAuliffe as a strategic adviser.

Document Drawer

The Justice Department sued Walgreens on Friday, alleging the pharmacy chain knowingly filled millions of prescriptions for opioids and other commonly abused drugs without a legitimate medical purpose.

Sens. Elizabeth Warren (D-Mass.), Ron Wyden (D-Ore.) and Bernie Sanders (I-Vt.) urged President Donald Trump in a letter to not pause the Inflation Reduction Act’s Medicare drug price negotiations.

WHAT WE'RE READING

Advancing American Freedom, the advocacy group founded by former Vice President Mike Pence, is throwing everything at the wall in a bid to convince Republican senators to stop Robert F. Kennedy Jr., POLITICO’s Daniel Payne reports.

Three former FDA officials write in Stat about the features of the agency the second Trump administration should maintain so that it can continue to be regarded as the global “gold standard” public health regulator.

 

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