Congress at war over third coronavirus package – Politico

With help from David Lim

House and Senate divided on coronavirus drug payments and testing requirements.

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New York begins trials for two potential treatments, heralded by Trump.

Gileads antiviral gets a rare disease nod ensuring 7 years of market exclusivity.

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CONGRESS AT WAR OVER THIRD CORONAVIRUS PACKAGE A new rescue plan from House Speaker Nancy Pelosi would, among other things, require insurers to eliminate co-pays on coronavirus treatments and bolster test reporting.

While Pelosi's draft bill has no chance of being enacted, it provides a laundry list of the kind of measures Democrats are pushing as talks over a historic stimulus package hit a rough patch in the Senate. Heres how the Senate Republican plan and Pelosis differ on pharma and devices:

Paying for drugs. While health plans would have to fully cover coronavirus treatments at no extra expense, theyd be reimbursed for their patients cost-sharing. But in addition to waiving treatment costs, Pelosis bill also orders plans to leave out certain barriers to accessing medicines, like prior authorization requirements, that could slow down use of coronavirus-targeting drugs.

House Democrats had struggled to get drug affordability language into the first stimulus package in the face of GOP opposition. The Senate version shields patients from out-of-pocket payments for tests but does not make the same assurances for medicines. Nothings been approved for Covid-19 yet, so its unclear what the bill for treatment would even be.

Tracking tests. The House bill would require states and local governments, labs and health systems to report real-time data coronavirus testing results. Democrats also want specific details from severe outcomes to be reported a step public health researchers say is needed to have a better understanding of how the disease is affecting different patient populations.

It is unclear if the House bill provides $5 billion in funding that commercial labs have sought. The Senate version did not contain such money, much to chagrin of groups like the American Clinical Laboratories Association.

ANTIBIOTIC MEASURE DROPPED FROM SENATE VERSION Meanwhile, a provision to boost payments for much-needed antibiotics has been dropped from the Senate GOP stimulus package, aides and lobbyists confirm. A corresponding measure was not in the House bill.

Conversations are ongoing, but its looking pretty grim, said one policy expert close to negotiations. The provision, drawn from the bipartisan DISARM Act, S. 1712 (116), would have boosted Medicare payments for antibiotics.

Proponents of the measure say its not just about bolstering the beleaguered antibiotic industry, which has been wracked by bankruptcies and mergers. The ongoing pandemic is about a virus but many people who contract a virus actually end up dying from secondary infections, especially if they are in the hospital on a ventilator that can be susceptible to bacteria, argued the policy expert.

Is that the case with coronavirus? Too early to say, the experts say. But a few research papers are starting to give us that smoke.

TRUMP TOUTS NY TRIALS President Donald Trump is hanging big hopes for defeating the coronavirus on a drug trial starting soon in New York, touting the potential benefits of an experimental combination that is only in the early stages of research.

That therapy probably is looking very, very good, and the trial could start as early as Tuesday, Trump said at a Monday night press briefing on the coronavirus.

Two clinical trials are set to begin in the state as early as this week, Gov. Andrew Cuomo announced Monday morning ahead of the president's briefing.

Cuomo and Trump have clashed in recent weeks over the federal response to the pandemic and states needs, but Trump on Monday pointed to New Yorks upcoming trials as evidence that swift progress was being made against the virus that has infected nearly 40,000 people in the country so far. New York, now considered the U.S. epicenter of the outbreak, has reported nearly 21,000 known cases.

We are dealing there well together, Trump said of Cuomo on Monday night, later adding that the governor has been working very hard."

One trial would combine the antibiotic zithromax and the decades-old drug hydroxychloroquine, originally developed to fight malaria. The president has named-checked the drug in recent press conferences as a promising option for treating patients who contract the virus, despite research being in the early stages.

Bioethicists and policy experts have warned against overpromising on chloroquine, which is also used against lupus and arthritis, because it's not yet clear how effective it is against the coronavirus and its side effects could be serious.

The second trial could begin as early as this week to test infusing a serum from recovered Covid-19 patients into current patients to boost their immunity to the virus, Cuomo said.

The plasma technique, first used in the 1890s, is still occasionally employed in critical situations Chinese scientists have used it in the current pandemic as well. But it has had a mixed record: In a trial using plasma against the Ebola virus, 31 percent of participants died, compared to 38 percent who died while receiving only supportive care, with researchers reporting that the technique "was not associated with a significant improvement in survival."

CORONAVIRUS A RARE DISEASE? Apparently so, according to an FDA decision Monday to designate Gileads experimental antiviral remdesivir an orphan drug. The designation gives Gilead seven years of market exclusivity and a 25 percent tax credit if it makes it to market. But Covid-19 has already infected 375,000 people worldwide and at least 39,000 people in the U.S., with no signs yet of abating. Some governors have warned that 40 percent to 60 percent of people could be infected if certain measures are not taken hardly the definition of rare.

The designation, in fact, does not take projected figures into account so even though public health experts expect many more domestic cases, coronavirus is still a rare disease, for now. And the FDA cannot rescind the designation just because case load grows over 200,000, its benchmark for the classification.

The intellectual property NGO Knowledge Ecology International quickly slammed the decision. "Everyone wishes this was a rare disease, but unfortunately, it isnt, and the testing will certainly confirm that shortly," the organization wrote in a statement.

House Democrats also might not be thrilled. The House Committee on Oversight and Reform last year grilled Gilead CEO Daniel ODay over the drugmakers patents and prices for HIV medicines. Some argued that the government should ignore the exclusivity on patents on a prevention drug, Truvada, that they said federally funded scientists at the CDC had a role in developing.

INSULIN GOES BIOLOGIC Grandfathered biologic drugs officially transitioned to a new regulatory pathway on Monday, a move aimed at opening the door to more affordable insulin as well as certain fertility drugs, human growth hormone and other substances.

New versions of insulin will now be classed with vaccines and therapeutic proteins and can be fast-tracked when shown to be similar to or interchangeable with FDA-approved biologics. There is no true generic insulin on the market now, partly because the conventional pathway made it difficult to make identical products.

FDA published a final rule Feb. 20 outlining the application process for the new pathway for biological products. In a release Monday, FDA deputy commissioner Amy Abernethy and drugs chief Janet Woodcock called it a historic day and a landmark moment.

FDA IS WARNING CONSUMERS ABOUT FAKE TESTS The agency says that while it is working with developers on coronavirus tests that may include at-home sample collection, there is no FDA-approved at-home test to date, and consumers should be wary of any product making such a representation.

Fraudulent health claims, tests, and products can pose serious health risks, FDA Commissioner Stephen Hahn said in a statement Friday.

PUBLIC HEALTH LABS GET SWAB REFRESH The labs are receiving more than 200,000 swabs from the Strategic National Stockpile in response to a supply crunch for basic testing materials, Scott Becker, the CEO of the Association of Public Health Laboratories, told POLITICO on Sunday.

A backlog of samples to be tested for coronavirus at commercial labs will be resolved by mid-week, Vice President Mike Pence told reporters Sunday.

Pence also said the administration would give all commercial labs guidance to prioritize in-patient testing, so that patients who have been checked into hospitals for the coronavirus or coronavirus-like symptoms could be tested more quickly.

MEETING THE VENTILATOR DEMAND CPAP devices can be converted into ventilators during the coronavirus outbreak, FDA said in guidance over the weekend.

The policy allows hospitals to repurpose existing products to meet major shortages in the United States during the coronavirus outbreak.

ResMed Chief Medical Officer Carlos Nunez told POLITICO that modifications to its in-market CPAP machines to support more advanced modes of respiratory aid requires careful assessment to ensure risk is acceptable.

We have an opportunity to convert the manufacturing resources typically used for PAP devices to support manufacturing bilevel and non-invasive ventilation devices that are more suited to the care of COVID-19 patients, Nunez said. The company is in the process of doubling its normal manufacturing levels for invasive-capable and non-invasive ventilators.

Ventilators normally used in other environments, such as ambulances, could be used for long-term care, the guidance says.

Still, groups including the American Hospital Association and state leaders like Cuomo argue the federal governments actions are inadequate and that Trump should use the Defense Production Act to compel manufacturers to boost supply of ventilators, personal protective equipment and testing supplies.

We cant just wait for companies to come forward with offers and hope they will, Cuomo tweeted Monday. This is a national emergency.

HOW DO YOU DOLE OUT IN A PANDEMIC? Two articles in the New England Journal of Medicine on Monday examine the question of how to ethically allocate scarce medical resources and ventilators during the coronavirus pandemic.

Rationing is already here. In the United States, perhaps the earliest example was the near-immediate recognition that there were not enough high-filtration N-95 masks for health care workers, prompting contingency guidance on how to reuse masks designed for single use, the medical ethicists wrote. They also note that hard decisions about which patients get intensive care beds and ventilators during a severe outbreak are on the horizon.

STATES STRATEGIZE ON TESTING New York is shifting its remote testing away from worried well residents and New Yorkers experiencing mild Covid-19 symptoms to prioritize the sick, the de Blasio administration said Sunday. The city canceled a remote testing site at Pier 88 the same day and shut down one of the public hospital systems sites in the Bronx on Monday, Amanda Eisenberg reports.

Meanwhile, Mayor Bill de Blasio said that NYC Health + Hospitals is about 10 days away from reaching its capacity for Covid-19 patients. He also warned of looming equipment shortages.

I think were about 10 days away now from seeing widespread shortages of really fundamental supplies, from ventilators, surgical masks the things that are absolutely necessary to keep a hospital system running, de Blasio said during an interview on CNN. And we have seen next to nothing from the federal government at this point.

Meanwhile in Florida, a small battalion of University of Florida researchers will be at The Villages, a sprawling retirement community north of Orlando, where they will administer 400 to 500 coronavirus tests daily to eldery patients even asymptomatic Gov. Ron DeSantis said Monday.

ANGRY STATE LEADERS PUSH BACK ON MASK SHIPMENT CLAIMS Governors, mayors and front-line health care workers confronting rising numbers of critically ill coronavirus patients said Sunday they have not received meaningful amounts of federal aid including the shipments of desperately needed masks and other emergency equipment that administration officials say they have already dispatched.

Several Democratic governors are demanding a more coordinated national response to get supplies as fast as possible to where they are needed most critically, Alice Miranda Ollstein reported. But Trump hit back at the governors' televised pleas, tweeting Sunday that they "shouldn't be blaming the Federal Government for their own shortcomings." He told the governors the federal government's role is to be there "to back you up should you fail, and always will be!"

HHS OIG put out a fraud alert Monday warning the public of coronavirus schemes like telemarketing calls seeking personal details such as Medicare information.

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Congress at war over third coronavirus package - Politico