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Rep. Elijah Cummings, the Maryland Democrat chairing the House Oversight Committee, put the pharmaceutical industry on notice this week when he launched an investigation into the industry’s drug pricing tactics. Until now, we didn’t know much more than the names of the 12 companies he sent letters to. But I dug around for more information ahead of the committee’s first hearing on the issue, on Jan. 29. Here’s what I learned:

  • Cummings is asking for a slew of information. STAT got the skinny on what’s in the letters, and it’s a lot. Representatives from two companies involved in the probe said he’s seeking 10 years worth of sales, revenue, pricing, rebate, discount, and commercialization data; research and development expenses; information on patents and indications; employee compensation and bonus information; information on each company’s interactions with federal agencies; and details of each company’s contracts with PBMs.
  • More drug companies are likely to be investigated. Cummings’ probe already encompasses the majority of the country’s largest drug makers, but he’s not done yet. “There’ll be more,” Cummings told me last week.
  • The probe will likely expand beyond drug makers. Illinois Rep. Raja Krishnamoorthi, the highest ranking Democrat on the Oversight health subcommittee, told STAT last week he believes Cummings will expand the probe. “There’s all kinds of middlemen and women in this and a lot of them make a lot of money,” Krishnamoorthi added.
  • Other committees are gearing up to investigate drug makers. Rep. Diana DeGette (D-Colo), the newly minted chair of the Energy and Commerce oversight subcommittee, told your author last week she plans to haul drug industry CEOs before her committee, and Sen. John Cornyn (R-Texas) broke the news Friday that the Senate Finance Committee will also lead its own investigation “into high prescription drug prices and questionable ‘rebates’ to pharmacy benefit managers that don’t directly benefit consumers.”
  • One key thing we still don’t know: The House Oversight Committee still hasn’t announced who is going to be called to testify in a little over a week. I posed the question to Cummings last week. His response? “It all depends.”

On its signature drug pricing pitch, the White House is out on its own

Republicans on Capitol Hill are willing to back President Trump on everything from his 4 a.m. tweets to his multibillion-dollar wall. But when my colleague Lev Facher and I asked them what they thought about his plan to tie what Medicare pays for drugs to what other countries pay, key members of the GOP weren’t exactly singing its praises. Of the dozen lawmakers we surveyed this past week, only one or two really expressed any positive ideas about it.

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“I applaud the president and what he’s trying to do, but at the same time I’m struggling a little bit on whether that’s really price controls,” Rep. Buddy Carter (R-Ga.) said.

Sen. James Lankford (R-Okla.), who sat through a meeting with HHS Secretary Alex Azar and several GOP colleagues about the proposal this week, had similar reservations.

“It was a free market group obviously, so any time you start talking about price management that’s a different type of conversation,” he said.

Added together, it’s not a great sign for the Trump administration, especially since those comments came after Azar spent the week on Capitol Hill trying to drum up support for the idea. If powerful lawmakers really don’t like the idea, they could kill it with legislation — or the threat of legislation — to rein in HHS’ authority. (Former Republican Sen. Orrin Hatch of Utah already called on his colleagues to do exactly that.)

Azar can’t necessarily count on Democratic support in the Senate, either. Though there’s a bunch of progressive Democrats ready to take even bolder steps on drug pricing, at least one pivotal Democratic Senate leader, Patty Murray of Washington, didn’t praise the international pricing plan.

“Looking at how we can reduce health care costs is really critical, but we have to make sure we are lowering patients’ costs and were not impacting the economy in the wrong way,” she told STAT.

Azar is slated to meet with Democrats on the Senate Finance Committee later this month. The top Democrat on that committee, Sen. Ron Wyden of Oregon, told STAT he’s still waiting for more details on how the idea would work.

“If you can divine from this administration any of the details with respect to how they would actually carry out such a policy, good on you because Congress hasn’t been able to,” Wyden told STAT.

Speaking of international prices: Is it even possible?

I read through more of the 2,000 comments on the proposal than I’d like to admit, and there were a few clear takeaways. I found only two groups unequivocally supportive of the administration’s plan: Patients For Affordable Drugs and Memorial Sloan Kettering’s Drug Pricing Lab. I was surprised to see even drug pricing advocates like AARP and Knowledge Ecology International raising some concerns with the idea.

A powerful — if obscure — group of congressional Medicare advisers known as MedPAC also dropped a bomb in its comment: It’s saying the idea may not even be feasible. Chief among MedPAC’s concerns: whether vendors will even be able to actually purchase drugs for the international reference price, and what will happen when they can’t. MedPAC also wants to know how HHS is going to calculate the international reference price given the increasing use of confidential rebates in others countries and the variability in how other countries measure their prices.

A number of groups had concerns that could be allayed by some tweaks to the proposal. And the administration is already emphasizing that it’s willing to work with its critics before formally moving it through the regulatory process. That’s why they started with a “notice” of the proposal and not a formal proposal itself, a senior HHS aide told STAT this weekend. “We wanted to hear from stakeholders what their concerns and suggestions would be. We are open to other ideas to fight foreign freeloading, so long as they preserve drug safety and keep the patient at the center.” (A reminder for readers: HHS wants to start moving the rule through the regulatory process by this spring.)

A surprise drug policy on the congressional agenda

There’s a lot of talk about drug pricing on Capitol Hill right now, but drug shortages are quickly becoming another top-tier issue for lawmakers. Reps. Anna Eshoo (D-Calif.), Diana DeGette (D-Colo.), and Sen. Chuck Grassley (R-Iowa) all have said they’ll use their respective committee leadership positions to tackle drug shortages.

Congress hasn’t taken up the issue in earnest since 2011, when lawmakers in both chambers held a series of hearings on it. The ultimate legislative solution — a requirement that drug makers notify the FDA of potential shortages — was very modest. It’s unclear whether Congress will coalesce around bolder policy options this time around, or even why the issue is suddenly getting so much attention.

There’s no shortage of ideas on how Congress can tackle the issue. (Zing!) Among the options: strengthening the existing notification requirement; requiring drug makers to disclose the location of their manufacturing facilities; directing national security agencies to assess the impact of shortages on national security; and allowing the Federal Trade Commission to review risks of shortages when considering drug company mergers.

A Democratic do-over on opioids?

Addressing the opioid crisis was one of the defining political issues of the last Congress — but some Democratic lawmakers feel Congress fell short with the Opioid Crisis Response Act that President Trump ultimately signed. And now that they control the House, lawmakers, Capitol Hill aides, and lobbyists tell STAT they’re gearing up for another push to overhaul U.S. addiction treatment.

While planning is still at the early stage, those individuals described a range of policy and messaging goals, including:

  • Elements of a $100 billion proposal from Sen. Elizabeth Warren (D-Mass.) and Cummings, including increasing treatment grants for nonprofits and public health departments
  • Calling opioid manufacturer CEOs before Congress to testify about drugmaker marketing practices — an idea pushed by new Energy & Commerce Committee member Rep. Annie Kuster (D-N.H.)
  • Further expanding access to mental health treatment via telemedicine, a proposal from Rep. Suzan DelBene (D-Wash.)

Lev Facher contributed reporting. 

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