The federal split on Covid booster policy

By David Lim and Lauren Gardner

Presented by the Partnership for America’s Health Care Future

With help from Katherine Ellen Foley and Sarah Owermohle

— Democrats in Congress are working to whittle down their drug pricing plans as moderates exert their influence.

— Health advisers in and around the Biden administration are sparring over U.S. Covid-19 booster policy.

— Federal survey finds more than 2 million youth vape regularly and flock to disposable, flavored products.

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Every American deserves access to affordable, high-quality health coverage and care to help them get healthy and stay healthy. Let’s build on and improve what’s working in health care – not start over with an unaffordable, new government-controlled health insurance system like the public option or by opening up Medicare to younger Americans. Learn more

FISSURES EMERGE IN BIDEN ADMIN OVER BOOSTER POLICY — Two camps have emerged among President Joe Biden’s health advisers: One that wants to boost the public in a bid to prevent as many mild to moderate Covid-19 infections as possible, and one that wants to give extra doses only to those at greatest risk for severe illness and death. The debate is happening just ahead of the winter months, when Americans will start spending more time indoors — possibly seeding even more outbreaks, POLITICO’s Erin Banco reports.

The former group, which includes chief medical adviser Anthony Fauci, argues that boosting more of the general population is beneficial because even mild infections can cause viral spread and keep workers off the job for weeks. Eric Topol, a professor of molecular medicine at Scripps Research, also argued that the high efficacy of the vaccines two weeks post-inoculation offers the best protection from long Covid, which can affect even vaccinated individuals, though the extent to which is unclear.

In the other corner — composed mainly of rank-and-file scientists at the CDC and FDA and their advisory panels — those experts say the data is not definitive on the long-term benefits of boosters, not to mention the risks to younger people. They also warn boosters wouldn’t necessarily prevent all mild breakthroughs.

While the U.S. still lacks solid data on boosters’ benefits and risks, the issue has become emotionally fraught as the pandemic drags on. “I don't think that the federal government should be in the business of telling people what is valuable to them,” said emergency physician Leana Wen. “I don't need the federal government telling me that I shouldn't care about infecting my young, vulnerable family members.”

HHS: THAT’S NOT WHAT HIPAA IS — The Biden administration on Thursday reminded the public that the Health Insurance Portability and Accountability Act is not a valid reason for individuals to not disclose if they are vaccinated against Covid-19.

“The Privacy Rule does not prevent any individual from disclosing whether that individual has been vaccinated against COVID-19 or any other disease,” the HHS notice states. “The Privacy Rule does not apply to individuals’ disclosures about their own health information.”

QIAGEN GETS $3.4M CONTRACT TO EXPAND TEST PRODUCTION — Qiagen announced Thursday it received a $3.4 million contract from the Pentagon to expand its production of Covid-19 tests that are run on its NeuMoDx PCR testing systems at a Michigan site. By March the company expects to make 16 million tests per year, up from 10 million.

ICYMI — Pfizer and BioNTech submitted their Covid-19 vaccine data on kids 5 to 11 to the FDA this week. And a CDC study found that a third dose of Pfizer’s or Moderna’s shots largely produce mild side effects.

DEMS SCALE BACK DRUG PRICING PLANS TO WOO MODERATES — Top congressional Democrats acknowledged this week that something’s got to give on their ambitious drug pricing proposals to get moderate members on board with their social spending package, POLITICO’s Alice Miranda Ollstein and Megan Wilson report. Changes on the table include dropping language allowing the government to directly negotiate drug prices for private insurance plans, making fewer drugs subject to such bartering under Medicare and moving the benchmark for those prices away from those paid in other developed countries, they write.

Three of the centrist House Democrats who bucked leadership in voting against the plan in the Energy and Commerce Committee in September told Alice and Megan that panel leaders have assured them changes are being made to the legislation. That outcome would be a win for the pharmaceutical industry, which would like to see the proposal disappear but would take a weakened end-result given Democrats’ unilateral control in Washington, D.C.

AMERICANS WANT DRUG PRICE NEGOTIATION — … Even if many lawmakers don’t. Americans support letting the government negotiate drug prices above all the other major priorities in the infrastructure and social spending packages now before Congress, according to a new POLITICO-Harvard poll.

But the drug pricing plan could be in peril as some centrist Democrats spar with Speaker Nancy Pelosi over the scope and details. Democratic leaders are now considering scaling back a House leadership-backed proposal or dropping it entirely from the $3.5 trillion social spending package.

Health priorities are top of mind. Asked to choose among 20 policy priorities, 39 percent of respondents picked direct government price negotiations with drug manufacturers first, followed by increased federal spending to prepare for pandemics, more resources for long-term and home-based care, and expanding Medicare to include dental, vision and hearing care.

The health priorities also cut across party lines, with Democrats and Republicans alike ranking drug price negotiation high.

HHS RESCINDS TRUMP-ERA INSULIN PRICING REG — HHS this week announced it rescinded a Trump-era regulation that aimed to set limits on what patients pay for certain drugs like injectable epinephrine and insulin at federally qualified health centers.

“HHS has concluded that the 2020 Rule created excessive administrative burden for health centers, which in turn would have resulted in reduced resources for health center patient services,” the rescission notice states. “HHS has determined that the overall impacts of the administrative burden outweigh benefits to patients from the reduction in prices of insulin and injectable epinephrine.”

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FDA ISSUES DRAFT GUIDANCE ON USING REAL-WORLD DATA FOR DRUG REGULATION — The Food and Drug Administration on Wednesday released draft guidance for industry on using real-world evidence, including electronic health records and other medical records, to evaluate novel therapies, Katherine reports. These kinds of real-world data show insight that clinical trials can’t, like how well drugs work in patients with additional conditions or how they fare after being on the drugs for long periods of time.

Drafting away: FDA also issued draft guidance for reporting safety concerns for investigational drugs and devices , assessing pharmaceutical quality in non-sterile manufacturing settings and weighing the risks and benefits of new biologics.

AGENCY MOVES — Amy Ramanadham will become acting associate director for drug safety operations today, replacing the retiring Terry Toigo. She joined the office in 2012.

WANTED: VACCINE ADVISER — FDA’s Office of Vaccines Research and Review is looking for a senior adviser, per this job notice posted this week. Sorry, non-HQ denizens — the gig is “open to current permanent OVRR employees only.”

BURR: ‘FDA LARGELY ROSE TO THE OCCASION’ — The FDA is not short on critics lately, but don’t count Senate HELP ranking member Richard Burr (R-N.C.) among the harshest questioners of the agency at the tip of the spear of the Covid-19 response.

The powerful lawmaker lauded the FDA’s use of its emergency use authorities, close collaboration with industry and prolific publishing of regulatory documents during the Covid-19 pandemic in a report published Thursday. But the agency should better prepare to speed tests to market more rapidly next pandemic, work to make the medical product supply chain more resilient and work through a large backlog of inspections to ensure products are safe and effective, he wrote.

“To build on the successes achieved during the COVID-19 response, Congress should codify and improve FDA’s capacity to accelerate the development and review of medical countermeasures for future public health threats,” the policy paper states.

A message from the Partnership for America’s Health Care Future:

BUTTERFIELD, BILIRAKIS BILL AIMS TO BOOST CANCER TEST COVERAGE — Two lawmakers are making a bipartisan push to require Medicare, Medicaid and the Children’s Health Insurance Program to provide coverage of molecular cancer diagnostics when individuals are diagnosed with cancer. The new bill, H.R. 5377, introduced by Reps. G.K. Butterfield (D-N.C.) and Gus Bilirakis (R-Fla.), also would require HHS to run a national education campaign to raise awareness of the role of genetic testing and counseling.

MORE THAN 2M TEENS VAPE REGULARLY, FEDERAL SURVEY FINDS — The National Youth Tobacco Survey, an annual study conducted by FDA and CDC, found that 11.3 percent of high school students and 2.8 percent of middle school students used e-cigarettes at least once in the past 30 days, Katherine reports. Those figures translate to 2.04 million kids and teens regularly using e-cigarettes.

Data from 2020 and 2019 showed that nearly 3.6 million kids and 5.4 million kids, respectively, vaped regularly. However, study authors note that because this survey was conducted online, and not in-person, due to the pandemic, 2021’s survey can’t be compared to previous years.

Reactions: The two sides of the vaping debate took the news differently: Groups fighting tobacco use in children said the survey revealed that vaping is still a significant problem among U.S. youth — particularly because some of the most popular vapes are disposable, flavored ones. Some of these products use synthetic nicotine, which means they fall outside of the Center for Tobacco Products’ purview due to a technicality.

Vaping industry advocates, however, see the survey results as a good thing — but were still defensive: "All stakeholders in this debate should be pleased to see youth vaping fall for the second year in a row," said Greg Conley, an attorney and president of the American Vaping Association. He added that “the youth usage data shows that [disposable] products have become much more of an issue than the ones FDA has spent the last month banning."

But but but: Some fear these results may be artificially low. "We have to be extremely cautious in interpreting the data," said Matthew Myers, the president of the Campaign for Tobacco-Free Kids. "The data this year may not reflect what we'll see when kids return to school, both in terms of what they report, and in terms of whether peer pressure pushes the numbers back up."

The waiting game: FDA still hasn’t made a decision on some of the largest e-cigarette manufacturers, even though its court-ordered deadline was Sept. 9. “We're having serious conversations about whether to go back to court to ask the court to require FDA to provide the court with a status report and a timeline for acting,” Myers said.

THREE MORE E-CIG MANUFACTURERS APPEAL FDA’S ORDERS TO TAKE PRODUCTS OFF THE MARKET — The companies Magellan Technology, Bidi Vapor and My Vape Order challenged FDA’s marketing denial orders for their e-cigarette products this week, following Turning Point Brands' lead. The number of companies asking courts to overturn FDA’s orders “could easily balloon to dozens in the next few weeks,” said Desmond Jenson, a lawyer at the Public Health Law Center at the Mitchell Hamline School of Law who focuses on commercial tobacco policy, as the FDA continues to issue marketing denial orders.

INTERNATIONAL TRADE COMMISSION SIDES WITH BAT GROUP IN PATENT CASE — The ITC ruled Wednesday that Philip Morris International and Altria infringed on two patents owned by British American Tobacco. As a result, Altria can no longer import its heated tobacco product, IQOS, into the U.S. IQOS is one of two products to receive FDA clearance as a modified risk tobacco product.

FDA RELEASES INDEPENDENT REPORT EXAMINING MDUFA IV — A report by Booz Allen Hamilton assessing FDA’s execution of its commitments under MDUFA IV found the agency generally met the agreement with the exception of the publication of draft guidance laying out the content of premarket submissions for software contained in a medical device. The agency says it intends to issue that draft guide before the end of 2021.

FDA CLEARS ‘FIRST MAJOR’ CT SCAN ADVANCEMENT IN YEARS — FDA announced Thursday it cleared Siemens’ Naeotom Alpha CT imaging device — a step Laurel Burk, assistant director of the agency’s diagnostic X-ray systems team, described as the “first major new technology for computed tomography imaging in nearly a decade.”

“The device uses the emerging CT technology of photon-counting detectors which can measure each individual X-ray that passes through a patient's body, as opposed to current systems which use detectors that measure the total energy contained in many X-rays at once,” the FDA said in a statement.

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‘SURPRISE’ BILL BAN ON DECK — The Biden administration is finalizing a key element of its ban on surprise medical bills, laying out new procedures for how insurers and providers should settle pay disputes for out-of-network care, POLITICO’s Adam Cancryn reports.

That multi-tiered process is aimed at shielding patients from dealing with unexpected (and often pricey) charges — forcing hospitals and doctors to instead battle it out with insurance companies. And it represents the core of a long-sought prohibition on surprise bills that was repeatedly complicated by lobbying from all corners of the health industry over who would ultimately bear the cost of care.

CDC EXPLORING VACCINE VERIFICATION TECH FOR EMPLOYEES — The CDC is gathering information on vaccine verification technology to help track whom among its workforce is getting Covid-19 shots, POLITICO’s Darius Tahir reports. The request for information may be a sign of a thaw at the federal level toward vaccine verification technology, commonly referred to as vaccine passports.

DEA: MORE COUNTERFEIT PILLS CONTAINING FENTANYL, METH — The Drug Enforcement Administration this week issued a public safety alert warning of an “alarming increase in the lethality and availability” of counterfeit prescription pills containing fentanyl and methamphetamine.

SANOFI JOINS MRNA VACCINE ARENA, BUT NOT FOR COVID — French vaccine manufacturer Sanofi announced Tuesday that its Phase I/II trial for an mRNA Covid-19 yielded positive results . Yet the company declined to pursue a Phase III trial for this candidate due to concerns that the market would be overly saturated by the time it was done. Instead, it used the results to justify a pivot to the development of more mRNA candidates — the first one will be for influenza, with clinical trials planned for 2022.

Thomas Glocer has been appointed as independent lead director at Merck.

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

New FDA guidances on gene therapies — The FDA this week published two new guidance documents that explain how companies can qualify for significant tax benefits under the Orphan Drug Act and efficiently test different versions of gene therapies, respectively.

In the first guidance , the FDA explains how it will assess whether two products are the “same,” since a gene therapy can only qualify as an “orphan” drug product if it is not the “same” as another available treatment approved by the FDA. The agency will typically consider two otherwise identical gene therapies as different if they contain different “transgenes” (the modified genetic material) or use different “vectors” (typically modified viruses which help to administer the transgene).

In the second guidance , the FDA recommends how companies should test multiple versions of the same gene therapy product in early-stage trials. FDA recommends that a sponsor submit a separate application, known as an Investigational New Drug application, containing relevant data for each modified gene therapy.

A message from the Partnership for America’s Health Care Future:

Government-controlled health insurance systems - like the public option and Medicare at 60 - could increase costs for patients and threaten access to the quality care Americans rely on.

Lawmakers should build on and improve what’s working in health care where private coverage, Medicare and Medicaid work together, not start over by creating unaffordable, new government health insurance systems. Get the facts.

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David Lim @davidalim Lauren Gardner @Gardner_LM

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