News: Marks: Mandates ‘just don’t work’ in U.S.

Friday, December 6, 2024

Marks: Mandates ‘just don’t work’ in U.S.

Dec 06, 2024

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By David Lim and Lauren Gardner

With Daniel Payne and Ben Leonard

Driving the Day

Peter Marks testifies at a Senate hearing.

The FDA's Peter Marks says the FDA failed to gain public confidence in Covid vaccines at the beginning of the pandemic in part because of its insufficient communication with Americans. | Pool photo by Anna Moneymaker

MARKS: COVID LESSONS LEARNED — Lauren moderated a discussion Thursday with Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, and two former government officials — Jeremiah Kelly and Rachel Sherman — about the regulatory and communications lessons learned from Operation Warp Speed.

Marks, who led the early Covid vaccine development work, reflected on communications missteps and issues he sees with the U.S.’ avian flu response.

Winning the public: In the pandemic’s early days, government officials considered bringing in social scientists to communicate about the public need for Covid vaccines before they were available to help address any hesitancy, Marks said. But the effort never got off the ground, which he said was “a huge mistake.”

“We know more about the country, right? We know that mandates, they just don’t work,” Marks said.

Telling Americans that vaccines were safe and “95 percent effective” and would “stop this pandemic cold” didn’t prepare the public for side effects, Marks said.

“What we’ve learned is, we have to convince people based on the evidence in language that they can understand,” he said. “People could have probably understood, ‘Look, it’s not perfect, but a million deaths is a third of 3 million deaths’ … people can get that.”

Bird flu: Marks said the U.S. “missed an opportunity” to take greater measures to contain the spread of avian influenza, such as increasing surveillance, isolating cows and potentially developing a bovine influenza vaccine.

“Avian influenza and what’s happened so far to date in the response illustrates everything that probably didn’t go well during the Covid response,” Marks said.

“They’ve allowed virus to replicate around humans who might have human influenza now, now they’re walking to flu season, and a recombination event is not implausible,” he added.

Hep C momentum? Legislation to expand access to hepatitis C medication has received a favorable Congressional Budget Office score and could potentially be used as an end-of-year pay-for, former NIH Director Francis Collins said earlier at the event.

“I’ll have to be a little coy and not tell you the number, but it’s a really good number,” Collins said. “We are in a pretty good position to be able to be part of whatever this end-of-the-year health package ends up looking like. So it’s kind of a white-knuckle moment here.”

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Stay warm out there.

Send tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

In Congress

A masked researcher performs tests at a biotech start-up's laboratory

Legislation that would bar federal contracts with certain Chinese biotech companies is at a standstill in Congress, but lawmakers are working on a compromise. | Anthony Wallace/AFP via Getty Images

BIOTECH REVIEW DEAL — Lawmakers are floating a compromise to break an impasse on legislation that would hamper Chinese biotech firms’ ability to do business in the U.S., three people familiar with the negotiations told Ben.

The BIOSECURE ACT, which the House passed 306-81 in September, would halt federal contracts for companies partnering with specific Chinese biotech companies and calls out five specific firms.

Because the firms partner with U.S. pharmaceutical companies, supporters of the measure warn they could gain access to Americans’ genomic data, which the Chinese government could then access under the country’s intelligence laws. Named companies have denied their data could be compromised.

The proposal: POLITICO first reported that the potential compromise would allow the listed firms to undergo a review process to determine whether punitive measures should be imposed. One of the people familiar with the situation said Republicans offered the compromise to Democrats but haven’t won them over yet.

Rand Paul (R-Ky.), who will take over as chair of the Senate Homeland Security and Governmental Affairs Committee in January, opposed the bill on the grounds that it would advantage some biotech companies over others. And there’s also significant Democratic opposition. Seventy-nine of those who voted no in the House were Democrats. It’s unclear whether the move would appease skeptics like Paul or Rep. Jim McGovern (D-Mass.), ranking member of the Rules Committee.

At least one of the targeted firms continues to fight the bill, Ben reports.

“Any proposal that keeps the names in the bill still would have major constitutional problems as it lacks due process protections,” Complete Genomics said in a statement.

FDA FOOD FIGHT — Senators on the HELP Committee grilled FDA Commissioner Robert Califf on Thursday about his agency’s food and beverage regulations and how they impact rising rates of obesity and health issues, Daniel reports.

But one issue that didn’t come up much: “I hope I get asked about the weight-loss drugs,” Califf said about GLP-1s more than an hour into the Health, Education, Labor and Pensions Committee hearing.

Califf suggested the drugs could be important tools in intervening in foods he believes are addictive. But he acknowledged the need to address the root causes of the rise in obesity.

Califf made several pitches to lawmakers for the FDA’s future.

He nodded to a recent decision from the Supreme Court — likely the court striking down Chevron deference, which gave more latitude to agencies to interpret ambiguous laws — saying lawmakers might consider putting programs they want to see in legislation instead of leaving them to agencies.

He also asked for more funding.

“If we had a bigger budget,” he said, “we would have studied a lot more things.”

Califf demurred when asked about his plans after the FDA, per POLITICO’s Marcia Brown.

“I’m 73 years old. Golf is in my future,” Califf joked to reporters. “No, I’ll be around. I have some special projects I’m interested in pursuing.”

Industry Intel

TRUMP, RFK MEET WITH PHARMA — The leaders of Eli Lilly, Pfizer and the Pharmaceutical Research and Manufacturers of America dined with President-elect Donald Trump and HHS Secretary nominee Robert F. Kennedy Jr. at Mar-a-Lago on Wednesday night, three people familiar with the dinner granted anonymity to discuss it told POLITICO.

Axios first reported the meeting attended by PhRMA CEO Steve Ubl, Pfizer CEO Albert Bourla and Lilly CEO David Ricks, which one of the people said was set up “a while back.”

A PhRMA spokesperson declined to comment on the meeting. Pfizer and Eli Lilly did not respond to requests for comment.

PAYMENT PLAN FOR SICKLE CELL DRUGS — The two manufacturers of sickle cell disease gene therapies have signed on to participate in CMS’ Cell and Gene Therapy Access Model, a pilot program to test outcomes-based agreements to pay for the pricey treatments. Those agreements tie payments to whether the drugs improve the health of patients in Medicaid.

The list prices for Bluebird Bio’s Lyfgenia and Vertex Pharmaceuticals’ Casgevy are $3.1 million and $2.2 million, respectively. The one-time treatment courses are intended to be curative, though the companies don’t yet have lifetime data on patients.

States may apply through the end of February.

Pharma Worldwide

UNCOMFORTABLY FAMILIAR — A mystery disease has killed 71 people in the Democratic Republic of the Congo — already home to a deadly mpox outbreak — and sickened nearly 400, POLITICO’s Carmen Paun reports.

National authorities believe the pathogen is respiratory, based on the symptoms, but they’re awaiting testing results and don’t yet know the mode of transmission. Children under 5 have been the most affected.

The disease was first reported locally at the end of October, according to the Africa CDC, but the DRC government wasn’t notified until Dec. 1, meaning the illness has been spreading largely unchecked for weeks.

Pharma Moves

Nonprofit pharmaceutical company Civica announced four new hospitals joined an effort to combat shortages of generic sterile injectable drugs: Winona Health, Boulder Community Health, Stanford Health Care and Essena Health.

Document Drawer

The FDA issued draft guidance on its accelerated approval program for drugs and biologics that treat serious conditions.

U.S. Patent and Trademark Office withdrew a proposed rule that aimed to cut down on use of patent thickets — an action slammed by Sen. Peter Welch (D-Vt.) as “misguided and counterproductive.”

A single mutation could make it far easier for avian influenza to spread among humans, according to a new study published Thursday in Science.

WHAT WE'RE READING

Eli Lilly CEO David Ricks argued that it is critical that the FDA’s primary data review for drugs seeking approval is maintained during the Trump administration, The New York Times’ Aimee Ortiz reports.

Eli Lilly’s Zepbound outdid Novo Nordisk’s Wegovy for weight loss in a head-to-head study, the pharmaceutical company said, CNBC's Annika Kim Constantino reports.

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