Biden admin tries to revive hunt for Covid-19 drugs — FDA cracks down on kratom — Labs argue FDA lacks authority over LDTs

By David Lim and Lauren Gardner

With Katherine Ellen Foley and Emily Martin.

— Biden admin tries to revive stalled hunt for Covid-19 drugs.

— Gottlieb, Giroir tussle after FDA cracks down on kratom.

— Clinical laboratories argue that FDA doesn’t have the authority to require premarket review of laboratory-developed tests.

It’s Tuesday, welcome back to Prescription Pulse. We’re still slack-jawed about these century-old lung samples being studied for 1918 flu virus mutations.

As always, also send tips to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) and Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).

SUBSCRIBE TO "THE RECAST" TODAY: Power is shifting in Washington and in communities across the country. More people are demanding a seat at the table, insisting that politics is personal and not all policy is equitable. The Recast is a twice-weekly newsletter that explores the changing power dynamics in Washington and breaks down how race and identity are recasting politics and policy in America. Get fresh insights, scoops and dispatches on this crucial intersection from across the country and hear critical new voices that challenge business as usual. Don't miss out, SUBSCRIBE . Thank you to our sponsor, Intel.

HOW VACCINES SIDELINED THE COVID DRUG HUNT — The federal government was so focused on finding effective Covid-19 vaccines it missed the opportunity to develop treatments for mild infections, report POLITICO's Sarah Owermohle and Katherine Ellen Foley. That’s a problem now in part because of slow vaccination rates worldwide, and because many experts think there will still be outbreaks of Covid-19 even after the pandemic ends.

Several top Biden administration health officials say that developing therapies for Covid-19 patients who don't require hospitalization is a top priority. But the Biomedical Advanced Research and Development Authority stopped funding research on early treatments earlier this month, partly because of tight budgets. An HHS official told us that BARDA could receive more funding through the American Rescue Plan, but past Covid-19 trials funded by the agency yielded mixed results.

The administration is now focusing on antivirals, which require years of research and billions of dollars of investment to develop. The Trump administration’s decision to prioritize Covid vaccine development soon after the coronavirus arrived meant development of new products would slip well past the worst of the pandemic.

One way to avoid this? Constant government funding—even in normal times. "No pharmaceutical company is going to develop a pandemic preventative therapy off the bat,” a senior health official said."

THE FATE OF SCHOOL COVID SCREENING PROGRAMS? IT’S COMPLICATED — The future of the Biden administration’s multibillion-dollar push to create Covid-19 screening programs in K-12 schools nationwide is murky amid falling infection numbers and rising vaccination rates.

More schools have returned to hybrid and in-person classes since Biden took office, but no one POLITICO asked could say what percentage of school districts across the country are regularly screening students and teachers for Covid-19.

An Education Department spokesperson said the department is “not tracking that level of detail.” A Centers for Disease Control and Prevention spokesperson said that "most states have offered or implemented testing programs in schools during the 2020-2021 school year," adding that a survey conducted by the publication EdWeek in February found that just 16 percent of school district leaders said they were testing students.

Education and health groups — including the Association of State and Territorial Health Officials, the Rockefeller Foundation and American Federation of Teachers — also said they do not have comprehensive nationwide data on how many districts have testing programs in place.

The Rockefeller Foundation on Monday released a roadmap for small businesses looking to implement Covid-19 testing programs of their own.

ACLA: HHS SHOULD LEAVE TEST POLICY TO CONGRESS — The American Clinical Laboratory Association argued in a letter to the Biden administration that the FDA does not have the authority to require premarket review of laboratory-developed tests, in line with a legal determination by the Trump administration.

The group’s letter on the hot-button issue, sent Friday, comes after House Democrats and the Pew Charitable Trusts separately pushed the Biden administration to reconsider the legal notice. Former HHS Secretary Alex Azar issued it last August over objections from top FDA officials.

The lab industry — which has long maintained LDTs should not be regulated as medical devices — wants Biden’s team to focus on advancing legislation that would overhaul the regulatory framework for both diagnostics and LDTs.

“Ever-shifting policy announcements and reversals would be detrimental to the laboratory industry’s efforts to provide a consistent supply of accurate and reliable COVID-19 tests and undermine the important public health role of LDTs on a host of other fronts, such as precision medicine,” ACLA President Julie Khani wrote to HHS Secretary Xavier Becerra.

STUDY: COVID ANTIBODIES MAY LINGER 10 MONTHS POST-INFECTION — A Labcorp study published Monday in the journal EClinical Medicine found that nearly 87 percent of people infected by the coronavirus maintained antibodies for a minimum of 10 months . The study of specimens from more than 39,000 patients between March 2020 and January 2021 showed the antibody positive rate stayed “mostly stable” that long after infection, though people under 65 recorded a “more sustained rate.”

KRATOM CRACKDOWN — FDA on Friday said that U.S. Marshals had seized more than 207,000 units of dietary supplements or bulk ingredients that are or contain kratom, a plant indigenous to Southeast Asia that produces narcotic-like effects when ingested. The agency has warned consumers for years against using products containing kratom, citing toxicity concerns and a general lack of information about its safety.

Former FDA Commissioner Scott Gottlieb launched a tweetstorm on the topic Friday evening, lamenting what he said was the Trump HHS’ efforts to block kratom from being scheduled. He briefly sparred with former Assistant Secretary for Health Brett Giroir, who tweeted the department rejected FDA’s recommendation because of “embarrassingly poor evidence” showing the substance is exacerbating opioid addiction.

FDA: MULTI-TARGET TESTS ARE IN SHORTAGE — The FDA on Monday formally added multi-target respiratory specimen nucleic acid tests that detect Covid-19 alongside other infections to its pandemic medical device shortage list. An FDA official told POLITICO the agency was unable able to include medical devices that had received emergency use authorization to the list. But now that a multi-target test has received marketing permission through the agency's De Novo classification pathway, FDA can be notified of related or anticipated shortage situations for that product type.

FDA KEEPS GDUFA REAUTHORIZATION TALKS UNDER WRAPS — Minutes posted from FDA’s May 6 Generic Drug User Fee Amendments reauthorization meeting provide little insight into the negotiations between industry and the agency.

“FDA and industry continued discussions around the proposals for setting a sound foundation for continued programmatic success and clarifying details around the drug master file and inspection proposals,” the entirety of the meeting description states.

HEALTH APPROPS ON DECK — House and Senate appropriators have scheduled a flurry of hearings this week on the Biden administration’s budget requests for NIH and the CDC. The House Labor-HHS panel will consider NIH’s fiscal 2022 request today at 10 a.m., with the Senate subcommittee following suit Wednesday morning. NIH Director Francis Collins and Biden medical adviser Anthony Fauci are among those slated to appear.

The House subcommittee will hear testimony on the CDC’s budget proposal Wednesday morning.

NEARING THE FINISH LINE — The Senate voted 52-43 Monday to end debate on Chiquita Brooks-LaSure’s nomination to lead the Centers for Medicare and Medicaid Services. Her confirmation is expected soon.

SUBSCRIBE TO WEST WING PLAYBOOK: Add West Wing Playbook to keep up with the power players, latest policy developments and intriguing whispers percolating inside the West Wing and across the highest levels of the Cabinet. For buzzy nuggets and details you won't find anywhere else, subscribe today.

Steven Selde on Monday joined the Association for Accessible Medicines as the director of the Biosimilars Council. He previously worked as the assistant director of government affairs for the Ambulatory Surgery Center Association.

AAM has also promoted Erik Komendant to senior vice president for government affairs. He had been the group’s vice president of federal government affairs.

GSK Consumer Healthcare and Vizient have joined the Buy Safe America Coalition, which backs efforts to curb organized retail crime and the sale of counterfeit goods.

SINGAPORE ALLOWS COVID-19 BREATH TEST — A breath test that can detect Covid-19 within a minute has received provisional authorisation from Singapore’s Health Sciences Authority, the National University of Singapore said in a statement.

The test is the first breath analysis system to secure the authorization in Singapore. It was developed by Breathonix Pte Ltd, a spin-off company from the university, which is now working to run a deployment trial on travelers at the Tuas Checkpoint between Malaysia and Singapore.

EU AIMS TO DONATE 100M VACCINE DOSES IN 2021 — EU Council President Charles Michel put forward new draft conclusions calling for the bloc to donate 100 million coronavirus vaccine doses by the end of the year, POLITICO EU’s Jillian Deutsch, Ashleigh Furlong and David M. Herszenhorn report.

Commission President Ursula von der Leyen also publicly urged the EU to help needier countries with any excess doses.

Senior officials and diplomats warned that there's still no agreement. Some expressed frustration the Commission was taking credit for vaccine pledges that are coming from member states. EU leaders were expected to further discuss donations at the Council summit on Monday night.

Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for the FDA.

Biosimilar user fee negotiations moving forward — A new batch of meeting minutes posted by the FDA late last week show that efforts to make improvements to the Biosimilar User Fee Amendments (BsUFA) program are focused on the creation of some new early feedback mechanisms, new and predictable timelines for the review of applications, commitments to release new guidance documents and the promotion of “best practices.” The BsUFA program is modeled on similar user fee programs for drugs and devices and is intended to provide the FDA with additional resources to hire dedicated staff and ensure a predictable, consistent review process for biosimilar products. It is currently set to expire in October 2022 and specific commitments are being negotiated between FDA and the biologics industry.

New funding for FDA’s off-label uses app — Last week the FDA announced it received a $9.2 million grant from HHS to expand its CURE ID application . CURE ID is a collaboration between FDA and NIH aimed at leveraging real world experiences from providers and health systems to collect data on the off-label use of drugs, specifically for new or “neglected” infectious diseases like Covid-19. The grant will fund the creation of an automated electronic health record data gathering tool and help FDA to partner with institutions to build CURE ID into their systems.

The CDC is looking into reports that a small number of teenagers and young adults may have developed myocarditis, or heart muscle inflammation, after vaccination for Covid-19, The New York Times reports.

Covid-19 cases in the U.S. now are occurring mostly in unvaccinated populations , The Washington Post reports.

The U.S. needs to build and maintain continuous manufacturing facilities for drugs and vaccines in case another novel pathogen spreads, former FDA commissioner Scott Gottlieb argues in the Wall Street Journal.

FDA published guidance for early planning for pediatric evaluation of certain molecularly targeted oncology drugs to address amendments made by the 2017 FDA user fee reauthorization package.

FDA published guidance with recommendations for the specific regulatory, quality, nonclinical, and clinical considerations in the development of bispecific antibodies.

Follow us on Twitter

David Lim @davidalim Lauren Gardner @Gardner_LM

Follow us

To change your alert settings, please log in at https://www.politico.com/_login?base=https%3A%2F%2Fwww.politico.com/settings

This email was sent to by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA

Please click here and follow the steps to .