martes, 14 de mayo de 2019

Is pharma's R&D spending a mark of shame or a point of pride?

D.C. Diagnosis
Nicholas Florko

First In STAT: CSRxP ups its fight with pharma over R&D 

The Campaign for Sustainable Rx Pricing is attacking pharma with a new study, first shared with STAT, that finds 10 of the largest drug makers spent on average 22% of their revenues on research and development in 2017 — a figure the group says proves pharma “is investing more boldly in profits, advertising and corporate overhead than in researching new cures.” The study also provides some interesting new data on how much drug makers spend on advertising and marketing, based on proprietary data from the firm GlobalData. STAT has all the details of the study here, but I wanted to highlight a few data points that caught my eye:
  • Pfizer banked $21 billion in profits in 2017, nearly triple what it spent on R&D that year. (A Pfizer spokesperson tells me that the company's reported profits were exceptionally high that year due to President Trump's tax law.)
  • Smaller biotech firms like Biogen and Gilead spent a smaller percentage of their revenue on R&D than big-name drug makers, like Merck and Eli Lilly.
Today’s study is the latest attempt by the coalition of pharmacy benefit managers, insurers, and hospitals to dispel the drug industry’s message that it’s a key driver of innovation. PhRMA General Counsel Jim Stansel’s drove home that point at last week’s hearing before the Senate Judiciary Committee over the drug patent system. Stansel argued: “The competitive market with appropriate IP protections is the engine that drives the innovative biopharmaceutical R&D ecosystem” and that “the biopharmaceutical industry invests on average six times more in R&D as a percentage of sales than all other manufacturing industries.” For my dispatch from that hearing, click here.

What has Joe Biden been doing for the last two years, anyway? 

The former vice president and new Democratic frontrunner — per early polling, at least — has devoted much of his post-White House energy to the Biden Cancer Initiative, a "culture change" organization devoted to accelerating cancer research and cures. 

But it's easy to see how Biden's legacy on cancer and health policy more broadly could play into a 2020 debate, too. Just a year after the passing of his son Beau, Joe Biden was the driving force behind the Obama administration’s Cancer Moonshot and the broader 21st Century Cures Act. His cancer nonprofit's board is stocked with political power brokers, and the organization's refusal to accept drug industry funding has been interpreted as a recognition of an anti-pharma climate among Democrats. STAT's Lev Facher has the full story here.

How do you cap Medicare expenses without blowing up the deficit?

There’s a growing consensus on Capitol Hill that Congress should pass a law capping how much Medicare beneficiaries are required to pay out of pocket for their drugs. It’s one of the few issues creating consensus between the White House and both congressional Republicans and Democrats. But there’s one problem: Creating such a cap would cost the government a small fortune. (One such policy, outlined in the president’s budget, would cost $14 billion over 10 years, according to the government’s own calculations.) 

That’s why I was particularly struck by a new plan, released Friday, from the Council For Affordable Health Coverage, a group that includes drug makers, middlemen, and insurers, for capping Medicare expenses without adding to the deficit. The group’s president Joel White told STAT there are four or five “levers” to ensure the proposal doesn't end up costing money. Most are changes to how Medicare deals with so-called catastrophic coverage — a period in which the federal government picks up a bigger chunk of the tab for seniors who’ve already spent more than $5,100 on drugs in a year.

White told STAT he has already met with leadership on the House Energy and Commerce, Ways and Means, and Senate Finance committees to pitch CAHC’s idea. But despite White’s advocacy, Democrats may be eyeing an easier — and far more swampy — way to achieve the same goal.

Multiple lobbyists told STAT that congressional Democrats are considering blocking, or at least delaying implementation of, the Trump administration’s proposal to end the rebates middlemen and drug makers negotiate and then banking those savings to pay for a slew of other drug pricing priorities, including capping Medicare expenses (if that proposal is ultimately finalized). The Congressional Budget Office recently estimated that the administration’s rebate rule would cost the government $177 billion over 10 years, meaning blocking or delaying such a proposal would give Democrats a sizable chunk of savings that could be used to pay for other drug pricing ideas. 

The FDA’s compounding foes take D.C.

The International Academy of Compounding Pharmacists, the Texas-based compounding association that has waged war with the FDA over the agency’s compounding policies, will hold its annual fly-in starting this Saturday, STAT has learned. The fly-in has two explicit goals: getting more lawmakers to sign on to a letter urging the FDA to rethink its agreement with states over regulating compounding, and gathering more cosponsors on a bill from Reps. Morgan Griffith (R-Va.) and Henry Cuellar (D-Texas) that would force the FDA’s hand on a number of hot-button compounding topics. The group will also hold a reception with Cuellar and a $1,000-per-seat fundraiser with Rep. Diana DeGette (D-Colo.), which the group is billing as an “opportunity to break bread in a small one-on-one setting with Congresswoman Diana DeGette (D-CO), to share your stories and challenges.”

Loyal D.C. Diagnosis readers are undoubtedly familiar with the long-simmering feud over the FDA’s compounding policies, but here’s a quick refresher: Compounding advocates, like IACP, have argued the FDA’s policies would harm patient access to critical drugs, while supporters of the FDA’s approach say those policies ensure compounding doesn’t become a lucrative, underregulated drug market. So your author couldn’t help but snicker when he was emailed an invite meant for IACP members with the subject line: “Would you give up a day to boost your compounding business?” 

Worth your time

"Let's keep the door open until someone tells us we can't": Eli Saslow's opus from Oklahoma underscores the plight of one small hospital and the broader, accelerating crisis in rural health care across the country. —Lev Facher

STAT's got a great and thorough look at the FDA's new policy about when a biosimilar can be considered "interchangeable" with a biologic — a nerdy but critical piece of the policy puzzle surrounding some of the country's most expensive drugs. — Erin Mershon 

I'd be remiss if I didn't get Caroline Chen's expose on the stem cell industry somewhere in this week's newsletter. All I can say is: Read it. All 6,000+ words. It's truly worth your time. — Nicholas Florko 

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