PEPFAR's chances of becoming a plus-one

The fight over reauthorizing a once-bipartisan international HIV/AIDS program escalated Monday with seven sit-in protestors arrested on the hill. But lawmakers are growing less optimistic about a full-reauthorization, as champions scale back aspirations and search for a way to break a deadlock triggered by Rep. Chris Smith (R-N.J.) before a $6.9 billion funding lapse.

Smith, who penned the program's last five-year authorization, is refusing to back an identical bill because he believes PEPFAR has been indirectly funding abortions ever since President Biden rolled back the Trump-era Mexico City Policy. While most GOP lawmakers are antiabortion, fewer buy into that argument: the bill's Senate co-sponsor Lindsay Graham said last week he hadn't "seen any evidence of it."

"I'm open-minded, but you've got to show me that's the case," he told STAT's John Wilkerson. Graham added that the House proposal — requiring the Biden administration to reinstate the Mexico City Policy — "is not realistic."

Also not realistic: A five-year reauthorization (Menendez says maybe three), or a standalone bill. "Had we acted early on, I think we could've and we should've" hit those marks, its Senate sponsor Bob Menendez said. "At this point…we're looking for a vehicle."

Of course, it's not the only multibillion-dollar health program looking for a ride this month. If the HHS assistant secretary for preparedness and response wants to keep working, lawmakers also have to agree on a new version of the Pandemic All-Hazards Preparedness Act.

nutrition policy

Industry seeks to flavor nutrition panel with their own

Alex Hogan/STAT

The food industry has worked hard to infuse a national nutrition panel with friendly researchers who've touted the benefits of their products, STAT's Nick Florko reports. The 20-expert group hashes out the latest nutritional science for a biennial report that regulators use to tweak national dietary guidelines.

The National Potato Council, for example, nominated one of the researchers behind an industry-funded study showing eating french fries each day doesn't result in more weight gain than eating a comparable amount of almonds. The National Coffee Association put forth an academic who said coffee consumption is tied to lower risk of certain cancers. The soy industry nominated a prominent vegan.

The researchers all hold positions at prestigious universities and several had endorsements from other groups. But the trove of normally-secret nominations obtain by Nick show the lengths food industry groups are going to as they push to shape nutritional guidelines. More from him here.

patent reform

Orange you going stop patent abuses?

The Federal Trade Commission will hold a virtual public meeting Thursday that will inform its work on drug patent policy.

Up for discussion is the Orange Book, a book of drug patents with an orange cover that was first published on Halloween. The cute name belies its impact on drug prices. If a patent is listed in the Orange Book, brand drug makers can sue generic competitors for infringement, which by law automatically blocks the FDA from approving cheaper generic versions of the drug for 30 months.

More than 20 years ago, the FTC began studying what it says are Orange Book abuses aimed at delaying generic competition. Only certain types of patents are allowed to be listed, but drug companies often list patents that should not be in the Orange Book. The FTC is considering whether to take a position that Orange Book abuses increase drug costs. Commissioners also are assessing whether listing patents that don't belong in the Orange Book constitutes an unfair method of competition.

medical devices

Can the FDA fix 501(k)?

The agency is updating a medical device approval pathway that has long been lambasted for letting risky devices fall through the cracks. Or at least, it's trying to.

A trio of 510(k) guidelines released last week would ensure device makers can't skip human testing if older versions of the device were recalled or have "unmitigated" safety concerns.

But no one is entirely pleased with the news. On the one hand, academics who have studied recalls argue the guidelines don't go far enough. On the other, industry representatives argue the proposals are "unfair" and even "inappropriate." STAT's Lizzy Lawrence dives into the debate.

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