With Zachary Brennan, David Lim and Lauraine Genota

— “We need science to be the place of trust.” What happened with the vaccine guidance.

Trump’s importation plan is here with savings TBD.

Science academies sound the alarm on political interference with Covid-19 vaccines.

It’s Friday, welcome back to Prescription Pulse. Happy birthday, Hatch-Waxman Act! H/t Zachary Brennan for the reminder. As always, send pharma tips and news to [email protected] or @owermohle. Loop in David Lim ([email protected] or @davidalim) and Zachary Brennan ([email protected] or @ZacharyBrennan)!

WHAT HAPPENED WITH THE VACCINE GUIDANCE? FDA Commissioner Stephen Hahn spent weeks preparing a proposal to set more stringent standards for emergency authorization of a coronavirus vaccine, hoping to boost public trust in the government’s biggest public health decision in decades.

But it hasn’t happened. President Donald Trump blew up FDA’s carefully laid plans, vowing to have final say over the process, reports Adam Cancryn.

The president this week suggested he may not sign off on the toughened guidance, sent earlier this week to HHS and the White House for review. The latest comments came amid repeated promises from Trump that a vaccine is just around the corner — contradicting his own experts on the timeline and the standards necessary for approval.

“We shouldn’t even be having this discussion,” a former senior HHS official said of the struggle for control over the vaccine process. “There are experienced career scientists at FDA who make these judgments every day for public health. This shouldn’t even be a White House issue.”

It speaks to larger issues of confidence. Just over half of Americans now say they would take a vaccine if it were available today, polling shows, a 21-point drop from earlier this year. That’s alarming from a public health point of view, since having fewer people take the vaccine dilutes its effectiveness.

“People’s short-term political agendas have incredibly long-lasting potential negative impacts,” a senior HHS official said of the impact on public confidence that a vaccine won’t be rushed. “We need science to be the place of trust.”

TRUMP’S IMPORTATION PLAN The Trump administration late Thursday finalized its plan to allow states to import drugs from Canada, but the scope is limited and the potential consumer savings is unknown, Zachary Brennan reports.

The final rule outlines how states can create two-year drug import plans that must be authorized by the FDA. Importers must test the eligible prescription drugs to make sure they are authentic.

The plan may help states to set up their own systems. It excludes certain drugs like controlled substances, IV drugs and pricey biologics. Others, like sterile drugs, are not excluded but the FDA will evaluate that as part of state proposals.

The FDA may decide not to authorize certain state proposals, the rule says, if the agency flags safety concerns; finds that a proposal “would not result in significant cost savings;” or if its resources are too limited to examine the proposals.

Savings TBD: Azar in his safety certification letter wrote that the program “will result in a significant reduction in the cost of covered products.” But the final rule says the agency is “unable to estimate the cost savings” because of a lack of information about the likely size and scope of states’ proposals, the specific eligible prescription drugs that may be imported, and the cost difference between imported drugs and those available in the U.S.

Canadian officials have warned that exporting drugs to the U.S. could cause shortages in their country and would not significantly lower costs for U.S. consumers.

FDA REQUIRES UPDATED WARNINGS FOR XANAX, OTHER BENZOS The FDA is requiring new warning labels for benzodiazepines, drugs that can treat anxiety and insomnia and include the popular anxiety drug Xanax. The updated labels warn of the potential for abuse, misuse and addiction, among other cautions.

In 2019, U.S. pharmacies dispensed an estimated 92 million benzodiazepine prescriptions, according to the FDA, and 38 percent of those were for Xanax. Patients taking a benzodiazepine for weeks or months can have withdrawal symptoms when the medicine is discontinued abruptly or the dose was reduced too quickly, FDA cautioned.

FDA LAUNCHES DIGITAL HEALTH CENTERThe agency’s long-awaited digital health center of excellence launched Tuesday — a step Commissioner Stephen Hahn says will help advance medical technology outside of traditional health care settings.

Bakul Patel, FDA’s director of digital health, will oversee the center within the Center for Devices and Radiological Health. The idea is to provide a central repository for the public, industry and FDA to discuss digital health policy and regulation, he said. The agency is holding two virtual listening sessions to gather input on the digital health center on Oct. 19 and Nov. 12.

FDA will continue to issue regulatory documents to support the digital health field even if it means getting additional clearance, Patel told POLITICO. The White House has been reviewing any regulatory guidance it deems noteworthy.

“We will continue to do what we have been doing,” Patel said. “Obviously, we have to make sure that the documents go out with the right level of eyes on it.”

SCIENCE ACADEMIES SOUND THE ALARM Leaders of the National Academy of Sciences and the National Academy of Medicine — two prominent groups of scientists who regularly advise the government — warned Thursday of “alarming” political interference in the coronavirus response.

Their rare statement came one day after President Donald Trump suggested that he might reject an FDA proposal to raise standards for emergency use of any coronavirus vaccine.

Reports of widespread political interference come at a key point in the pandemic, the science and medicine academy leaders warned.

“Our nation is at a critical time in the course of the COVID-19 pandemic with important decisions ahead of us, especially concerning the efficacy and safety of vaccines. Policymaking must be informed by the best available evidence without it being distorted, concealed, or otherwise deliberately miscommunicated,” Marcia McNutt and Victor Dzau, the respective leaders of the science and medicine academies, wrote.

Remember: The Academies are nongovernmental groups that advise the government. They are currently assessing how to fairly distribute a Covid-19 vaccine after a request from federal health officials to draw up a framework.

The expert panel assembled by the academies is considering priority population as well as health disparities, high-risk groups and potential viral hot spots.

AZ CEO: PHARMA WILL BE MORE TRANSPARENT ON VACCINES — Coronavirus vaccine developers are crafting a consensus on what additional data they can disclose from their clinical trials to increase transparency, AstraZeneca CEO Pascal Soriot said Thursday.

“We are discussing with other companies as an industry what kind of transparency we could offer without compromising patient privacy … but also without compromising the trial itself,” he said during a World Economic Forum event reported by POLITICO Europe’s Ashleigh Furlong.

It’s a careful calculation, Soriot said. If too much information about the trial is disclosed, it could compromise its blinded nature or infringe on patient privacy.

…His comments come after several pharmaceutical companies, including AstraZeneca, have disclosed their clinical trial protocols.

Also: J&J not a single shot? At the same briefing, Paul Stoffels, chief scientific officer at Johnson & Johnson, said that a second dose or a booster shot “will need to happen at certain points for long term protection.” It’s still not clear whether this would be needed, Stoffels said, but the J&J trial is set to study both a single shot and then a booster shot after two months — and possibly again at six or 12 months.

FDA AUTHORIZES FIRST POINT-OF-CARE ANTIBODY TESTThe agency said Wednesday that Assure, which received an emergency use authorization in July for lab-based antibody testing, can market its test for use in point-of-care settings. The expanded EUA still requires a prescription from a health care professional but now allows use of a finger-stick blood sample in places like a doctor’s office, hospital or urgent care setting.

“Until today, serology test samples were generally only able to be evaluated in a central lab, which can be time consuming and use additional resources to transport samples and run the test,” FDA Commissioner Stephen Hahn said in a statement Wednesday. “As more and more point-of-care serology tests are authorized, they will help conserve those resources.”

GILEAD SETTLES IN KICKBACK PROBE Gilead has agreed to pay $97 million to resolve claims that it illegally used a foundation to cover the out-of-pocket costs for thousands of Medicare patients taking Gilead’s pulmonary arterial hypertension drug, according to the Justice Department.

The pharmaceutical company’s action allowed it to boost revenue, the DOJ said. Drugmakers are prohibited by the False Claims Act from offering anything of value to induce Medicare patients to purchase the company’s drugs.

WHERE COULD A BIDEN ADMIN ‘MARCH-IN’ — The liberal think tank Center for American Progress recently resurrected the idea that if elected, Biden’s administration could use so-called “march-in” rights to lower the prices of medicines developed with government investments. The controversial move, which has never been done before, would likely come with a legal challenge, Zachary writes.

Bernstein biotech analyst Ronny Gal earlier this week called the idea “bad policy” as it “has very obvious downstream ramifications for the very productive academic-industry collaborations which allowed US biotech to flourish.”

NEW YORK, MICHIGAN GOVERNORS CALL FOR COVID RESPONSE INVESTIGATION — Cuomo and Michigan Gov. Gretchen Whitmer want Congress to investigate the White House’s coronavirus pandemic response, POLITICO’s Anna Gronewold reports. They write that President Donald Trump is responsible for the “inarguable fact that the United States has had the worst response to the COVID-19 virus of any nation in the world.”

They’re asking Congress to conduct an oversight investigation into the Trump administration’s response, including recent revelations that the White House blocked an HHS plan to ship masks to every household in April.

RUSSIA SAYS IT WILL PROVIDE 17 COUNTRIES WITH POTENTIAL COVID MED Russia’s sovereign wealth fund RDIF and its partner ChemRar Group have agreed to make the experimental COVID-19 drug avifavir available in additional countries, RDIF said in a press release on Wednesday.

Avifavir is an antiviral based on favipiravir, a Japan-based flu medicine, known as Avigan, that has shown promise in clinical trials, POLITICO Europe’s Laurenz Gehrke reports.

…The announcement came as Russia is striving to establish itself as front-runner in the fight against coronavirus, having green-lighted its vaccine Sputnik V as early as August, Laurenz writes.

BARD SETTLES WITH STATES OVER MESH MARKETING — C.R. Bard and its parent company BD agreed to pay $60 million split between 48 states and the District of Columbia to settle allegations it deceptively marketed transvaginal surgical mesh devices, California Attorney General Xavier Becerra and Washington Attorney General Bob Ferguson announced Thursday.

— GoodRx made its public debut Wednesday, with shares up 53 percent when the market closed, CNBC reported.

— A majority of Americans are worried about a coronavirus vaccine being released before it’s ready. FiveThirtyEight’s Maggie Koerth talked to experts about how to figure out when you can trust a vaccine. Read the four pieces of advice.

— Philadelphia thought it was going to participate in the pilot program to help develop the nation’s coronavirus vaccine distribution plan, but it seems the CDC just wanted to hear city officials’ ideas before the agency released its official playbook, WHYY reports.

— Hana El Sahly, the head of FDA’s vaccine advisory committee, recused herself from the panel’s review of Covid-19 vaccines because of her role as one of three lead investigators for Moderna’s late-stage COVID-19 vaccine trial, Reuters reports.

— A secret panel of experts, called the data and safety monitoring board, is tasked with reviewing data on the safety and effectiveness of coronavirus vaccines, and has the power to stop a clinical trial or fast-track it. KHN has more details.

The FDA has issued an alert about a voluntary recall of all unexpired albuterol inhalers manufactured by Catalent Pharma Solutions for Perrigo Pharmaceutical Company. Perrigo informed FDA it has received several thousand complaints about the product.

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