A $16 billion Covid budget mystery

How much money does the federal government still have set aside for the Covid-19 response? It depends who you ask, I write in a new story this morning.

A government watchdog published a report last month showing that HHS had a remaining $20.6 billion from laws funding various Covid-19 response activities at the end of January. But the White House has been sending information to Congress saying there's only $4.5 billion left.

That's a gap of more than $16 billion — an amount nearly twice the size of the FDA's annual budget. And the total matters, as the Freedom Caucus is eager to rescind any money they can categorize as leftovers. Read more about the difference, and what we know about where the unspent money is.

drug pricing

Patients' voice in Medicare negotiations

Patients with health issues are already wading through bills, treatment plans, and scheduling chaos. They shouldn't be expected to sift through dozens of pages of paperwork to weigh in on Medicare's drug negotiation process, too, the National Organization for Rare Disorders plans to tell Medicare during a comment period that ends in mid-April..

Medicare does want to take patients' needs into account when it starts negotiating drug prices, but the information collection form it quietly released earlier this month is dense, geared toward manufacturers, and difficult for patients to understand, NORD says. The patient feedback part of the form doesn't even start until page 39.

"For our community, it would be a challenge to prioritize this type of thing," said Heidi Ross, the group's vice president, for policy and regulatory affairs. Instead, the group is advocating for proactive listening sessions similar to what the FDA runs.

CYBERSECURITY

A new mandate for device makers

A little-noticed provision slipped into Congress' end-of-year government funding bill created a brand-new requirement for makers of medical devices to prove to the FDA that their products are safe from cyberattacks, my colleague Lizzy Lawrence writes.

The law went into effect on Wednesday, and the FDA has $5 million to implement it. The new rule will force manufacturers to grapple with cybersecurity risks before going to market, which didn't always happen before.

ON THE HILL

Califf takes the licks so FDA staff don't have to

FDA Commissioner Rob Califf got an earful Wednesday about infant formula, food safety, e-cigarettes, and supply chain security when he testified before a House appropriations subcommittee. The panel's chair, Rep. Andy Harris (R-Md.), also managed to get some jabs in about a drug used off label to block puberty in transgender youth.

Democrats focused on the impact Republicans' proposed budget cuts would have on the agency, while Republicans tended to ask about parochial interests. But both sides asked about tobacco regulation (Dems want the FDA to do more, while Republicans fear unintended consequences.) Both parties also badgered Califf about infant formula.

"FDA continues to be passive and reactive when it comes to infant formula inspection activities, which surely everyone at the agency knows infant formula is, and has been, in the spotlight," Harris said.

LOBBYING

The drug pricing revolving door

John Barkett, who was until December a drug pricing policy adviser in the Biden White House, is now a managing director at the Berkeley Research Group. Barkett worked on the Inflation Reduction Act during his time at the White House and he'll now be advising health plans, healthcare providers, life sciences companies, and healthcare investors in his new role.

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