Good Monday morning — and welcome to our first Early 202/Health 202 collaboration(!).

Below, Pelosi says Democrats are close to a deal on their economic package and FDA finds Pfizer’s coronavirus vaccine is highly effective for kids. But first:

PhRMA is working furiously to kill Democrats' drug pricing dreams

For months, the pharmaceutical industry has waged a multimillion-dollar lobbying campaign designed to keep Democrats’ sweeping drug price proposal out of their massive child care, health-care and climate change bill, The Early 202's Theodoric Meyer and your host report. 

Democrats' slow progress on the drug bill is in part due to effort by the Pharmaceutical Research and Manufacturers of America, the industry’s powerful trade group.

  • PhRMA spent more than $22.4 million lobbying on drug pricing and other issues in the first nine months of the year, according to recent disclosure filings. And it has run TV ads warning the proposal will mean that “politicians … decide which medicines you can and can’t get.”

The House’s signature proposal would — for the first time — allow the federal government to directly negotiate with drugmakers for lower prices in Medicare on some medicines. Proponents of the plan argue it's a crucial tool to reduce high drug prices.

But the plan faces pushback from several more moderate lawmakers who contend it could stifle the advent of new breakthrough drugs. Sen. Ron Wyden (D-Ore.), the chairman of the Senate Finance Committee, has been hashing out a proposal that can get all the members of his caucus on board — but no plan has yet been made public.

Behind the scenes

Much of PhRMA's push has been focused on lobbying a handful of Democratic lawmakers who’ve expressed concerns about the proposal, according to lobbyists familiar with the efforts.

But on Thursday, Stephen Ubl, PhRMA’s president and chief executive, sat down for the first time this year with Rep. Richard Neal (D-Mass.), the chairman of the House Ways and Means Committee, which advanced the House drug-pricing proposal last month, according to a committee aide. 

  • “Neal emphasized the need for serious measures that will lower costs for patients,” the aide wrote in an email.

It’s not clear exactly what prompted the meeting. Ubl has met with Wyden only once this year, in July, according to a Senate Democratic aide, and there’s been relatively little communication at the staff level. 

Brian Newell, a PhRMA spokesman, said only that the trade group has had “constructive engagement with various policymakers” in an effort to “lower costs for patients, while protecting choice, access and future innovation.”

PhRMA

Wide-ranging effort

Ubl and pharmaceutical company executives also met in September with Susan Rice, who heads the White House’s Domestic Policy Council, according to a person familiar with the matter. But PhRMA appears mainly to have focused its efforts on lawmakers with concerns about House Democrats’ proposal. They include three House Democrats who opposed drug-pricing language in committee last month, along with Sens. Tom Carper (D-Del.), Kyrsten Sinema (D-Ariz.) and Robert Menendez (D-N.J.).

  • Menendez declined to say where he stood on specific policy changes the Senate is exploring on the drug pricing provisions. “I said to Ron, you got to show me the whole package, and then we’ll see where we’re at,” Menendez told The Health 202, referring to Wyden.

Some of the lawmakers who appear wary of the House proposal represent states or districts where pharmaceutical and biotechnology companies are major employers.

  • “This is like if you were coming after the auto industry,” said one Democratic lobbyist who represents the industry, speaking on condition of anonymity to talk candidly. “How would Michigan react?”

PhRMA has said it supports efforts to lower prescription drug prices but has argued that House Democrats’ proposal would cost jobs and slash how much money the industry could spend on research developing new drugs. 

  • As it fights the proposal, PhRMA has added more Democratic lobbyists to its already deep bench, including Eben DuRoss, who was previously the Democratic Senatorial Campaign Committee’s finance director and also worked on the 2016 campaign of Sen. Catherine Cortez Masto (D-Nev.).
  • The trade group also hired Chris Putala in June as an outside lobbyist. Putala is a former Biden Senate aide who had never lobbied on health care issues before this year, according to disclosure filings. Disclosure filings show that he’s lobbied the White House and the Senate on PhRMA’s behalf.

But will a deal be reached?

It's likely lawmakers will ultimately hash out a compromise that doesn’t go as far as House Democrats’ language, those on Capitol Hill and lobbyists have said. 

Reps. Scott Peters (D-Calif.) and Kathleen Rice (D-N.Y.), both of whom opposed the House plan in committee, talked with White House staffers on Friday about a potential way forward, according to two people familiar with the matter, but no deal has been finalized.

But one rival plan — a bill led by Peters and a third lawmaker who voted against the plan in committee, Rep. Kurt Schrader (D-Ore.) — has drawn criticism from other Democrats who favor a tougher approach and the drug industry, which says it goes too far. 

  • “While we appreciate there are Democratic lawmakers who want to find a more responsible path forward, this proposal falls short of the balanced approach patients need to lower their drug costs,” PhRMA spokesman Newell told Theo.
  • He said Peters and Schrader’s bill would still impose “government price setting on some of the most innovative treatments covered by Medicare” and “punitive measures to impose price controls and retroactive penalties on medicines even if the prices paid by insurers and health plans have fallen.”

But Peters said he thought compromise was possible.

  • “My understanding is that a lot of senators are interested in figuring out something that might pass, and so we’re talking to a lot of offices about our bill,” he said.

Patients for Affordable Drugs Now, an advocacy group

On the Hill

Pelosi says Democrats are on the cusp of a social spending deal

Democrats appear to be in the final stages of crafting an agreement on the massive economic package, with Pelosi estimating 90 percent of the bill had been agreed upon. 

  • “I think we’re pretty much there now,” Pelosi said on CNN’s “State of the Union” yesterday, though she didn’t specify a final spending number.
  • Biden hosted Sen. Joe Manchin (D-W.Va.) and Senate Majority Leader Chuck Schumer (D-N.Y.) at his home in Delaware on Sunday to continue negotiations, The Post's Amy B Wang reports.

The health provisions of the social spending bill have been the subject of fierce debate as Democrats try to pare down the package by over a trillion dollars to gain unanimous support from their caucus. For instance: Biden floated scaling back a proposal to add dental benefits to Medicare last week in the face of opposition from Manchin.

Coronavirus

The FDA appears to pave the way for shots for kids ages 5-11

Food and Drug Administration advisers are expected to vote Oct. 26 on whether to recommend Pfizer’s coronavirus vaccine for children aged 5-11. (Reuters)

A Food and Drug Administration review found the benefits of the Pfizer-BioNTech vaccine outweighed the risks for kids between the ages of 5 and 11, The Post’s Carolyn Y. Johnson and Laurie McGinley report. The review is the first independent evaluation of company data, and extending the vaccine to this age group would achieve a key goal of public health experts.

Here’s what’s left before vaccines for kids are allowed:

  • Tomorrow: Advisers to the FDA will meet to discuss vaccines for children.
  • Within a week: A decision from FDA regulators could come.
  • Nov. 2 and 3: Advisers for the CDC are slated to meet to recommend the vaccine’s use.
  • The first week of November: If authorized, the vaccination campaign for 28 million newly eligible kids could kick off.

Reproductive wars

Supreme Court to hear oral arguments on Texas’s abortion law next month

The justices declined to block a law in Texas that bans abortions once a fetal heartbeat has been detected, but the court granted an expedited review of the case, rearranging its docket to hear arguments on Nov. 1.

  • “Friday’s decision to keep the law in place but put the cases on a fast-track seemed to be a compromise worked out in advance. Because it involves a procedural matter on how to challenge the law, rather than the law’s merits, a resolution could be reached more quickly compared with other cases the court hears,” The Post’s Robert Barnes reports.

In other health news

  • Some Americans living abroad are still waiting to get their first shot, even as their friends and family back home are getting third shots, The Post’s Dan Diamond reports.
  • Some recipients of the Johnson & Johnson vaccine rushed on Friday to get a booster shot, The Post’s Katie Shepherd and Lena H. Sun report. Many were relieved at the prospect of getting an additional shot after data suggested that the single-dose of the J & J vaccine was less effective than the Moderna or Pfizer-BioNTech regimens.
  • U.S. communities that want to share their vaccines with other countries are being told by the White House that they can’t, The Post’s Kevin Sieff and Dan Diamond report. White House officials say it’s because the vaccines are property of the United States, and that means the federal government is liable for their use.
  • Biden met privately with former FDA commissioner Robert Califf on Friday, a sign that the cardiologist may be poised to assume the top FDA position again, Politico’s Adam Cancryn and David Lim report. Sources familiar with the matter told Politico that the meeting represents the final step ahead of a formal decision.

Ten companies in developing countries are strong candidates for making mRNA vaccines

That’s the finding from a New York Times investigative report that analyzed which companies have the existing facilities, human capital and regulatory systems that would allow them to ramp up production of the gold-standard mRNA shots, The Times's Stephanie Nolen reports. 

It’s a conclusion that appears to contradict claims by the chief executives of Moderna and Pfizer, who argue that it makes no sense to license their mRNA technology in developing countries because the process is so complex and time-consuming it would not be worth the effort to establish production in other facilities.

Experts told The Times that the development and production of mRNA vaccines require fewer steps and ingredients than traditional vaccines and that the technology for the vaccines could be delivered in a ready-to-use modular kit.

Second opinion

Sugar rush

Thanks for reading! See y'all tomorrow.