Operation Warp Speed — now, the ‘CAG’— is here to stay

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Inside Biogen’s top secret campaign to get the FDA to approve Aduhelm 

Biogen launched a secretive two-year campaign, dubbed Project Onyx, to convince the FDA to approve its controversial Alzheimer’s drug, Aduhelm, my colleagues Adam Feuerstein, Matt Herper, and Damian Garde scoop in a blockbuster new story for STAT.

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At the center of that campaign was an effort by Biogen to win over the head of the FDA’s Office of Neuroscience, Billy Dunn. Biogen’s top scientist Al Sandrock met with Dunn in May 2019 for an off-the-books meeting shortly after Biogen announced it was halting trials of the drug, STAT reports. The meeting appeared to pay off: Dunn’s office prepared for the company an extensive road map laying out how Biogen might gain FDA approval, despite lackluster data.

The reporting is likely to inflame critics of the agency who have complained for years that the FDA acts more like a consultant to the drug industry and less like an impartial — or tough — regulator. The news will also give further fuel to critics like Public Citizen who have already called for the ouster of Dunn, and for the HHS Office of Inspector General to investigate the close collaboration between Biogen and FDA officials.

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Read STAT’s explosive new exclusive here.

It looks like Operation Warp Speed — err, , the ‘CAG’— is here to stay

I scooped Friday afternoon that Gus Perna, the former head of Operation Warp Speed is set to retire this summer. Perna’s departure isn’t the only major change at OWS we reported: A number of top DOD staffers left in recent weeks, and the initiative even has a new name: the Countermeasures Acceleration Group.

Despite the major changes, it looks like the CAG is here to stay, at least in some form. An HHS official told STAT Monday that the initiative will “formally transition into a permanent structure within HHS, so we can continue to rely on its important functions to respond to this pandemic as well as better prepare for future threats.” According to a DOD memo, the health department was due to take over responsibility for Perna’s role as chief operating officer of the initiative earlier this month. That transition does appear to be delayed: The HHS official confirmed that Perna remains chief operating officer. They referred further questions to DOD, which did not respond to an email.

Having trouble wrapping your head around just how much Aduhelm could impact Medicare? STAT can help.

My colleagues Rachel Cohrs and J. Emory Parker are out with a new story exploring just how big of an impact Aduhelm will have on Medicare spending. Their conclusion? Depending on the drug’s uptake, the impact will either be “big, huge, or catastrophic.”

The story includes an interactive data visualization that lets you see how the costs change when the size of the patient population changes — and even moderate uptake of the drug would cost Medicare more than the federal government spends on the Centers for Disease Control and Prevention. If every senior with Alzheimer’s takes the drug, it could cost nearly half the budget of the Department of Defense — or four million Tesla Model Xs, they write.

More here.

First in STAT: Coherus, Teva launch campaign to boost Made-In-America pharmaceuticals 

Four companies, including generic pharmaceutical giant Teva and biosimilar maker Coherus Biosciences, are launching a new coalition focused on pushing regulators to lure drug makers back to the U.S. with lucrative incentives like federal contracts and preferential placement on Medicare and VA formularies.

Members of the coalition met Monday with White House officials, according to David Sanders, the vice president of government relations at Coherus and the executive director of the new organization, who added that his company has already had “more than a half dozen meetings with White House and agency officials.”

While drug makers spent much of the Trump presidency fighting against that administration’s efforts to move manufacturing stateside, Sanders, a Republican, was optimistic about the Biden administration’s “smart” approach. He noted, for example, that the Biden administration’s own review of the drug supply chain suggested that the Centers for Medicare and Medicaid Services should review reimbursement policies to boost domestic production of medications.

“That’s what I wanted to see out of this administration,” he said.

North Carolina’s settlement with Juul doesn’t go far enough for one major anti-vaping advocate 

The attorney general of North Carolina, Josh Stein, announced Monday a $40 million settlement with e-cigarette maker Juul. The agreement, which is the first of its kind between the e-cigarette maker and a state attorney general, is widely seen as a bellwether for future settlements. Thirteen other states, including California and New York, have filed similar lawsuits against the company.

STAT spoke briefly with Matt Myers, the executive director for the Campaign for Tobacco Free Kids, who outlined a number of concerns.

He noted that a $40 million penalty was “not enough for Juul to feel sufficient pain,” and lamented that the settlement will actually prevent the public and the FDA from seeing a number of potentially incriminating Juul documents for at least a year. He also noted that the settlement, which bars the company from advertising using models under 35, “will continue to permit print and media marketing in ways that can be abused.”

Myers told STAT he hopes other attorneys general will look at the settlement with North Carolina as a “starting point.” He did add, however, that the settlement was “a positive step forward” and that he did not mean to be critical of Stein.

It looks like Operation Warp Speed — err, , the ‘CAG’— is here to stay

I scooped Friday afternoon that Gus Perna, the former head of Operation Warp Speed is set to retire this summer. Perna’s departure isn’t the only major change at OWS we reported: A number of top DOD staffers left in recent weeks, and the initiative even has a new name: the Countermeasures Acceleration Group.

Despite the major changes, it looks like the CAG is here to stay, at least in some form. An HHS official told STAT Monday that the initiative will “formally transition into a permanent structure within HHS, so we can continue to rely on its important functions to respond to this pandemic as well as better prepare for future threats.” According to a DOD memo, the health department was due to take over responsibility for Perna’s role as chief operating officer of the initiative earlier this month. That transition does appear to be delayed: The HHS official confirmed that Perna remains chief operating officer. They referred further questions to DOD, which did not respond to an email.

STAT stories you may have missed

Powerful House Democrats announced an investigation into Biogen’s pricing of a controversial new Alzheimer’s drug and the FDA’s decision to approve it.

Johnson & Johnson agreed to pay $230 million to settle a lawsuit alleging that the company helped fuel the opioid crisis.

Gilead is facing pressure to lower the price of a drug to treat a rare and life-threatening infection.

Buoyed by Biogen’s good news, Eli Lilly said Thursday that it will seek a fast U.S. approval for its drug to treat Alzheimer’s disease.

Janet Woodcock, the acting commissioner of the FDA, brushes off agency criticisms in a new interview with STAT.

Wyden, the powerful chair of the Senate Finance Committee, released his principles for his drug pricing project — and there’s a welcomed addition for small biotech companies.

ARPA-H is inching closer to reality.

This was the web edition of D.C. Diagnosis, STAT’s weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox.

Source: STAT