Democrats hit new crossroad in drug pricing talks

From: POLITICO Pulse - Monday Nov 15,2021 03:02 pm
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Quick Fix

— The challenges of drug pricing legislation aren’t over yet, as Democrats wrangle over how far they can take inflation fines.

— Central to talks is the looming threat of midterms that could arrive before the party delivers on any of its health care promises.

— And this week starts with sobering poll figures showing the president’s approval is sliding, even with recent progress on infrastructure.

WELCOME TO MONDAY PULSEICYMI Friday, the administration is finally naming an FDA commissioner. With David Lim and Alex Thompson, we sketched out how we got here. Send tips and Senate confirmation predictions to sowermohle@politico.com and acancryn@politico.com.

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Driving the Day

DEMS HIT NEW CROSSROAD IN DRUG PRICING TALKS — As House Democrats prepare to send the social spending package to the Senate this week, they’ve hit another roadblock: The way the plan would extend price controls beyond Medicare to private health coverage is stoking another battle over the package.

At issue is Democrats’ push to penalize drugmakers if they hike prices of medicine faster than inflation, a provision Republicans and the drug industry see as government overreach — and, they say, a violation of the Senate’s parliamentary rules for considering the bill because it’s a non-budgetary item, Alice Miranda Ollstein and Megan Wilson write.

Republicans are "likely to challenge everything and anything that looks or smells like [controlling] private markets,” said one pharmaceutical lobbyist, who asked not to be identified to speak candidly about the next steps. “That is their operating plan.”

The outcome could determine to what extent Democrats can make good on their pledge to rein in drug costs for all Americans — a promise some lawmakers view as central to keeping their slim congressional majorities in the midterm elections.

Drug industry lobbyists are urging Republican senators to scuttle the drug-pricing language with parliamentary challenges while looking for cracks in the Democrats’ ranks after the industry fought off more aggressive House attempts to impose drug price controls.

THERE ARE MIDTERM IMPLICATIONS … EVEN IF DEMS SUCCEED — The caucus is close to making good on long-held promises to lower prescription drug costs and make health care more affordable. But even if they settle these issues, voters won’t feel the effect until after the 2022 elections, Alice and Laura Barrón-López report.

The party is increasingly banking its midterm prospects on passage of the president’s domestic agenda in the coming weeks, convinced that it can help counteract concerns of inflation and inaction in D.C. But voters are not convinced right now, and infrastructure hasn’t moved the needle (more on that below...).

House Majority Whip Jim Clyburn (D-S.C.) told POLITICO that the party’s physical infrastructure bill that Congress recently sent to Biden’s desk isn’t enough, and pointed to the health provisions of the still-pending $1.75 trillion social spending bill as the types of measures that could win over voters.

“When people see the roads and bridges in their communities, when they see water systems being created ... and they see the $65 billion in broadband expenditures, that is a big, big deal,” he said. “But if you do that and do that only, what would you have done for prescription drugs? Nothing, that's in the other bill.”

“So Build Back Better has got to get done because the highest polling thing yet is the prescription drugs,” Clyburn added, referring to the name of the social spending bill coined by the White House.

Back to the inflation question. Backers fear both practical and political consequences if that drug pricing measure is stripped out — warning that pharmaceutical companies could hike prices for the roughly 180 million people on employer health plans or other private insurance to make up for the revenue they stand to lose from Medicare price negotiations and other provisions of the bill.

“I’ve insisted on [inflation caps] applying to the commercial sector,” Senate Finance Chair Ron Wyden (D-Ore.) told reporters. “What that means is that, not just for seniors but for millions of Americans, their drug prices wouldn’t go up more than inflation unless the companies are willing to pay a penalty.”

BIDEN DIDN’T GET AN INFRASTRUCTURE BUMPPresident Joe Biden’s approval rating is down to 41 percent, with 53 percent of respondents disapproving, according to a Washington Post-ABC poll out Sunday.

The issue for Biden: The poll was conducted Nov. 7-10, so after Congress passed the bipartisan infrastructure package poised for a shiny White House signing event today.

It gets worse: Nearly two-thirds of respondents said Biden has accomplished “not very much” or “little or nothing” so far in his presidency, worse than figures for Donald Trump, Barack Obama or Bill Clinton at similar points.

Education has forged ahead as a major issue for registered voters while perceptions of the president’s pandemic response — positive among voters early in his administration — are continuing to fade. Americans are now roughly divided on his response, with 47 percent approving and 49 percent disapproving.

There’s more: Just over half of respondents said they’d be likely to vote for Republican congressional candidates if there were an election right now, another sobering figure for Democrats ahead of next year’s midterms, the Post’s Dan Balz, Scott Clement and Scott Guskin write.

But respondents are still deeply divided on partisan issues, and roughly two-thirds say both parties are out of touch with voters’ priorities.

What’s next: Don’t expect the president’s $1.75 trillion social spending package to be passed soon. While the House is slated to consider the measure this week, Senate Majority Leader Chuck Schumer (D-N.Y.) said Sunday that his chamber will turn to the annual defense policy bill, the National Defense Authorization Act, first.

Schumer’s plan makes it all the more likely Congress will be working well into December to finish out Biden’s domestic agenda, POLITICO’s Burgess Everett writes. The Senate parliamentarian needs to go through the reconciliation bill before bringing it to the floor, making sure none of the language runs afoul of the bill’s protections from a GOP filibuster. Schumer said he hopes to finish that process this week.

 

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Around the Agencies

TOBACCO LAWSUITS THROW ROADBLOCK BEFORE MENTHOL BAN — The Food and Drug Administration this week will square off in a federal district court with anti-tobacco groups that say it has unreasonably delayed action to limit minty flavor in tobacco products, despite ample evidence of menthol’s toll on public health.

But while the menthol cigarette suit is just revving up, the agency’s effort to decide which e-cigarettes can stay on the market could force it to confront the menthol question much sooner, Katherine Ellen Foley writes.

The background: FDA has banned millions of fruity flavored e-cigs and vapes but has largely avoided action on menthol varieties — including products from some of the largest e-cigarette companies. A renewed legal fight over missing an e-cigarette regulation deadline could collide with the Biden administration’s plans to propose a wide-ranging ban on menthol tobacco products by April 2022.

It could also present an early challenge for Robert Califf, who was nominated Friday to lead the agency.

“The FDA has put itself in a position of having sort of a tension between its action on menthol cigarettes and other kinds of flavored tobacco products — most specifically e-cigarettes,” said Joelle Lester, the director of commercial tobacco control programs at the Public Health Law Center in St. Paul.

At a crossroads: An FDA spokesperson said the agency is developing a menthol policy and will finish its review of remaining e-cigarettes. But the agency has not made clear how it will handle the overlap between the two.

“Our commitment to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars is at the top of this Administration’s tobacco regulatory priorities,” said a spokesperson from FDA. “At the same time, our commitment to addressing youth use of e-cigarettes and other electronic nicotine delivery systems [e-cigarettes] is unwavering.”

ICYMI: MEDICARE BUMPS FEES, CITING ADUHELM — The potential cost of covering a pricey new Alzheimer’s drug will drive a sharp increase in premiums for Medicare Part B beneficiaries, Centers for Medicare and Medicaid Services announced Friday.

The standard monthly premium for Part B enrollees will rise to $170.10 next year, from $148.50, marking one of the biggest jumps in recent years. The annual deductible for beneficiaries will also rise to $233 from its current $203. Medicare Part B covers outpatient care.

It’s a “contingency reserve” for Medicare Part B’s trust fund in case the agency decides to cover Biogen’s Aduhelm — a controversial Alzheimer’s drug with a $56,000 annual price tag that the FDA approved early this year despite thin evidence of its effectiveness.

CMS has yet to determine whether Medicare will cover the drug. But in calculating the program’s finances over the next year, the agency needed to account for the possibility it will need to shoulder the cost, officials told reporters: “We have to plan for whatever contingency could happen because we only have one shot to get it right.”

 

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Around the Nation

HEALTH EXEC APPARENT WINNER OF FLORIDA SEAT — Sheila Cherfilus-McCormick, CEO of Trinity Health Care Services, was declared the preliminary winner of the Democratic primary to fill former Rep. Alcee Hastings’ seat late last week, winning by a razor-thin margin.

The primary was decided by less than 10 votes. The winner of the Democratic primary is all but guaranteed to win the safely Democratic seat. The special election will be held on Jan. 11.

 

BECOME A GLOBAL INSIDER: The world is more connected than ever. It has never been more essential to identify, unpack and analyze important news, trends and decisions shaping our future — and we’ve got you covered! Every Monday, Wednesday and Friday, Global Insider author Ryan Heath navigates the global news maze and connects you to power players and events changing our world. Don’t miss out on this influential global community. Subscribe now.

 
 
Names in the News

John Funderburk joins the Federation of American Hospitals as senior vice president of external affairs. He most recently was vice president for advocacy at the Alzheimer’s Association and worked at the American Medical Association as regional political director.

Josh Blumenfeld is joining Google as manager of government affairs and public policy for YouTube. He previously was managing director of global policy and advocacy and chief legal officer at Malaria No More.

A message from HCA Healthcare:

At HCA Healthcare, we believe excellence in healthcare starts with a foundation of inclusion, compassion and respect for all. Amidst the fight against COVID-19, HCA Healthcare’s commitment to addressing critical environmental, social and governance issues has not wavered, and our dedication to the communities we serve extends beyond our facilities.

In addition to our commitment to providing equitable care for patients, our robust diversity, equity and inclusion strategy supports colleagues in the work they do every day, creating opportunities for connection and dialogue and enabling us to better attract, engage and develop diverse talent.

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What We're Reading

A top editor at the medical journal Obesity received $1.2 million over seven years from companies involved in prescription weight loss treatments, raising questions about her conflicting interests, Stat News’ Ed Silverman reports.

The Austrian government implemented a nationwide lockdown for unvaccinated people starting at midnight Sunday, blocking any unvaccinated person 12 and older from leaving her home except for basic activities, Kirsten Grieshaber reports for the Associated Press.

Nebraska’s Lincoln Children’s Zoo said this weekend that three beloved snow leopards passed away from complications from Covid-19 , while other big cats have made a full recovery, continuing questions about animals’ reaction to the virus, Reis Thebault writes for The Washington Post.

 

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