IVF deal showcases Trump's approach to drug pricing

The drug pricing deal for IVF drugs announced last week placed on full display the differences in how Republicans and Democrats approach the tasks of lowering drug prices and expanding insurance coverage.

In case you missed it, Daniel Payne and Lizzy Lawrence explained the structure of the multifaceted deal.

On drug prices, President Trump prefers bargaining with individual companies on custom-made deals, which could disappear with a new administration. The Democratic approach has been creating a law that directs career government employees to negotiate prices, bound by valuation criteria, regardless of who is in the White House.

The Trump administration's deal on fertility drugs combines the threat of massive tariffs with the reward of a priority review voucher from the FDA. It also allows Trump to take personal credit, including by branding the deals through TrumpRx.

Insurance coverage is another intriguing aspect of the deal. Democrats have tried to require insurance to cover fertility treatments and bar state restrictions on the procedure. Trump called for universal insurance coverage of IVF on the campaign trail, but fell back on the more traditional Republican approach of reducing regulations in the hopes that employers will voluntarily cover the costly service.

Allowing stand-alone IVF coverage similar to dental and vision avoids ACA actuarial and deductible requirements, lowering the cost of coverage. Time will tell whether that will be enough to prod significantly more employers to offer the benefit, and how helpful it will be to people trying to build their families.

drug reviews

Priority review vouchers as negotiating leverage

The FDA announced the first nine recipients of the Commissioner's National Priority Review vouchers, Lizzy reports.

Congress originally created priority review vouchers to encourage the development of drugs for neglected conditions by speeding up review times. The Trump administration is also using them to reward companies that lower prices or build domestic facilities, among other priorities.

fda

Hiring and drug review slowdown at the FDA

STAT built a tracker to keep up with the exits of senior staff at FDA, but the agency quietly released its own numbers on attrition on Thursday, according to Lizzy.

The FDA centers that oversee drugs and biologics have each lost a tremendous number of people compared to previous years. In the fiscal year 2025, the Center for Drug Evaluation and Research lost 1,093 people and the Center for Biologics Evaluation and Research lost 224, as first pointed out by AgencyIQ. In comparison, CDER gained 259 people and CBER gained 105 in fiscal year 2024.

Stakeholders continue to worry that brain drain at the FDA will impact the agency's work. A recent analysis from RBC Capital Markets found this is starting to be the case — there was a significant drop in drug approvals in the recently ended third quarter, more marketing applications were rejected than in previous months, and the agency delayed more reviews of those applications. Read more for the analysis by Ed Silverman.

cdc

RIFed, miffed, and confused

The CDC statisticians who run surveys on issues ranging from food to oral health to environmental exposures still seem to be laid off, Elizabeth Cooney writes.

An HHS spokesperson previously said those jobs were not eliminated, but Elizabeth has reviewed emails that these workers received stating they've lost their jobs. RIFed employees can't access work email, so they can't find out if they've been called back.

Or as Elizabeth so aptly puts it: "Confusion rules in one corner of the Centers for Disease Control and Prevention whose purpose is the pursuit of certainty."

medicaid

States grapple with Medicaid work requirements

The next 14 months will fly by if you're a Medicaid director trying to ready your state for work requirements, MassHealth Undersecretary Mike Levine said at the STAT Summit last week during a conversation moderated by Tara Bannow.

Many parts of the new Medicaid work requirements remain unclear, and states are already beginning to feel the deadline pressure, Isabella Cueto writes.

And while they await guidance, they're also preparing for the possibility of Congress axing work requirements, at least in their current form. "We build in an 'off' switch," Levine said.

orphan drugs

Increasing drug costs

While the administration brags about deals to cut drug prices, Congress' nonpartisan budget experts said a recent GOP law will cost taxpayers $8.8 billion over a decade in higher drug prices, up from the previous $4.9 billion estimate, according to Ed.

When Democrats passed the law that directs Medicare to negotiate drug prices, they exempted orphan drugs, which are used to treat rare diseases. That exemption only applied to drugs with a single orphan designation, discouraging companies from testing drugs for additional rare conditions.

But Republicans broadened the exemption in Trump's tax bill. And at the request of Democrats, the Congressional Budget Office updated its estimated budget impact to include three drugs for which Medicare has spent great sums of money. Read more.

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