Scott Gottlieb: Trump’s shadow FDA commissioner during Covid-19?

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A barrage of drug pricing intel

Rachel and I have been chasing lawmakers and bugging congressional staffers and lobbyists all week to bring you the latest intel on the fate of Democrats’ signature drug pricing legislation. Here’s what we know:

The Senate is shooting for the stars — but there are some big obstacles

Senate Democrats want to expand their policy for penalizing drug makers that hike prices faster than inflation to the job-based insurance market, Rachel scoops. That’s on top of their already ambitious plans to tie what Medicare pays for drugs to what other federal health programs, like the VA, pay.

Whether those policies can actually get signed into law, however, is still unclear. STAT scooped last week that Sen. Tom Carper of Delaware believes that any plan that would cost drug makers $600 billion is too ambitious. And Politico’s reporting that Sen. Kyrsten Sinema of Arizona, who has voiced several objections to the overall package, also has concerns with the drug pricing provisions of the bill.

When pressed on Sinema’s objections Monday, Senate Finance Committee Chairman Ron Wyden said, “I think we can bring Democrats together.” He added that he has spoken to virtually all of the Democratic caucus on drug pricing “and I believe overwhelmingly, they believe it’s possible to get relief for consumers.”

Advocates are out for blood after moderates caught them off guard

Progressive groups were blindsided last week when moderates on the Energy & Commerce Committee voted against including Nancy Pelosi’s signature drug pricing bill in the larger spending package, Rachel and I explained in a story this weekend.

In response, those advocates are organizing protests around the country, and they’ve got a long list of targets, including some lawmakers you’ve probably never heard of, like Republicans Carlos Antonio Giménez of Florida and Michelle Steel of California. Per our discussions with those groups, the protests have two goals: to convince skeptical lawmakers to soften their stance against the drug pricing bill and to give House Speaker Nancy Pelosi the political cover to take a hardline stance against anyone who wants to water down the bill.

PhRMA, the Washington drug lobby, is the next target for a protest. Sen. Bernie Sanders is heading to their D.C. headquarters this morning, alongside several advocacy groups … and a “menacing puppet master controlling puppets” of Reps. Scott Peters, Kathleen Rice, and Kurt Schrader.

Scott Gottlieb: Trump’s shadow FDA commissioner?

Former FDA Commissioner Scott Gottlieb’s new book includes several eyebrow-raising anecdotes, like the fact that the CDC’s warnings in February 2020 prompted such anger in the Oval Office that federal health officials stopped announcing new Covid-19 mitigation measures for a full two weeks.

But I was particularly struck, as an FDA nerd, by the fact that Gottlieb briefed Trump multiple times in the early days of the Covid-19 pandemic — roughly a year after he stepped down as FDA commissioner.

Gottlieb personally met with Trump, at the president’s request, on March 13. But Gottlieb was greeted by senior White House officials who pleaded with him to “help in trying to convince the president that we needed to adopt some form of mitigation to slow the spread.” Gottlieb subsequently warned the president that “New York was on the brink of a major epidemic” and that mitigation steps like limits on large gatherings, as well as more accurate tests, were urgently needed. (Gottlieb said Trump had already seemed convinced that mitigation measures were needed by the time they had met.)

Gottlieb’s expertise in Covid-19 policy shouldn’t come as a surprise to anyone who has watched cable news in the last year and a half, but I couldn’t help but wonder: What must have Steve Hahn, the actual FDA commissioner, thought about his predecessor having such an influence on the White House despite no longer holding the FDA’s top job?

One interaction seemed particularly awkward for Hahn. Trump apparently called Gottlieb on March 18 to ask the former FDA commissioner’s opinion on hydroxychloroquine — while the actual FDA commissioner was in the room. Per Gottlieb’s telling, he and Tony Fauci expressed concern with Trump pushing the unproven Covid-19 treatment but Hahn “remained silent throughout the conversation.”

👀 indeed.

Battle of the drug pricing polling: Commence!

For weeks, pharmaceutical companies have tried to argue that allowing Medicare to negotiate drug prices isn’t nearly as popular as its proponents insist. Their arguments have relied primarily on a Kaiser Family Foundation poll that showed support for the policy diminished after hearing that it would limit access to drugs or lead to less research and development.

But advocates say a new poll from Hart Research Associates, sponsored by Protect Our Care, calls that assertion into question. In a survey of 1,200 voters, they found that roughly 60% believe that advocates’ various arguments for drug pricing reform are more convincing than those presented by drug companies. The poll also found that overall support for Democrats’ spending bill, including Medicare negotiation, was still supported by 69% of voters, including 44% of Republicans — even after being presented with PhRMA’s arguments.

Brian Newell, a PhRMA spokesman, called the new poll “a messaging exercise meant to build support for a policy that both Republicans and Democrats fear will lead to less access to life-saving medicines and fewer new cures and treatments.”

Is it finally time to consolidate all of the FDA’s approval special pathways?

One of the FDA’s biggest proponents for helping drug makers speed drugs to market thinks it may be time the FDA’s many fast-track programs finally be consolidated.

Rick Pazdur, the FDA’s Oncology Center of Excellence director, told me during a panel discussion on Monday that simplifying the process “is warranted and actually would be better for everyone.”

At least one industry expert, BIO’s Michelle McMurry-Heath, agreed with the suggestion. “I think it’s high time to look at simplification,” she said during the discussion, which was hosted by Friends of Cancer Research.

Pazdur also hinted that the FDA may need more authority to deal with companies who drag their feet on completing the follow-up studies that are required as a condition of accelerated approval. “We have to have some authority over this and this is one of the other areas that may need to be looked at,” he said.

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