WASHINGTON — Will House Democrats set their sights on high drug prices over Russian election hacking? Should drug industry CEOs be checking their mailboxes for subpoenas? Is Bob Casey or Greg Walden the next Orrin Hatch? What about the next Claire McCaskill?

Drug industry executives are no doubt buzzing over many questions in the wake of the Democrats’ takeover of the House. Democrats made health care a central plank of their re-election drive, and they’ve made clear that they’ll leverage their new power to make lots of noise about the high cost of prescription drugs.

So for the drug industry, these next two years will be, to put it mildly, challenging. Based on STAT’s conversations with key players, here are eight burning questions whose answers will help determine how significantly Tuesday’s midterms will shake up health policy in Washington:

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Will Trump’s countless controversies distract Dems from taking on drug pricing?

The House Oversight Committee, which will lead the charge on investigating the Trump administration, is already sitting on 60 subpoenas that were denied by Republicans in the last Congress.

Those requests cover everything from questions of Russian hacking to management of the Medicaid website. It’s still unclear where drug pricing stacks up in that list of priorities.

And high drug prices are just one in a litany of Democrat’s health-care-related complaints. They want answers on everything from the Trump administration’s refusal to defend Obamacare’s protections for pre-existing conditions to its decision to require Medicaid recipients work in order to qualify for benefits.

Trump’s actions on drug pricing have also been more favorably received than some of the Trump HHS’ more controversial policies, and that could further knock drug pricing down on the oversight priority list.

Nevertheless, Democrats also know high drug prices is a winning issue — and that could mean bashing pharma rises to the top of Dems’ priority list.

“The number one target for health Dems is Donald Trump. Right behind him: pharmaceutical companies,” one Republican drug lobbyist told STAT.

Who’s next in line to get the Heather Bresch treatment?

One of the more dramatic congressional scenes for pharma came when Mylan CEO Heather Bresch was hauled before the House Oversight Committee in 2016 to account for rising EpiPen prices. Rep. Elijah Cummings (D-Md.) is hardly bashful about his distrust toward drug companies, and with his expected elevation to head that committee next year, other pharma CEOs might meet a similar fate.

Even before the election, Cummings said he wants to probe Allergan’s deal with an Indian tribe to shield the company’s pricey dry eye drug, Restasis, from generic competition. Cummings sent a letter to Allergan CEO Brent Saunders requesting a slew of documents regarding the arrangement. At the time, Cummings did not have the power to compel Allergan to hand over those documents or to require Saunders to come before the Oversight Committee. Come January, that could all change.

Cummings also has a history of asking drug companies to answer for their price hikes. In 2014, he sent letters to 14 generic drug makers demanding answers to why their prices had increased.

What will PhRMA do without Orrin Hatch?

After 40 years in the Senate, Sen. Orrin Hatch (R-Utah) will retire at the end of the year. Hatch has been an industry darling for decades and currently serves as the chair of the Senate Finance Committee, which has jurisdiction over Medicare and Medicaid. With Hatch gone, Republicans will have to find a new champion.

The most favored son of pharma this election cycle? A Democrat, believe it or not. Sen. Bob Casey (R-Pa.) collected $522,000 from the pharmaceutical and health products industries this cycle, according to a Center for Responsive Politics analysis of campaign disclosures through Oct. 26.

Like Hatch, Casey sits on both of the Senate committees in charge of overseeing health care. That said, some of his policies — like supporting drug importation — make him an imperfect replacement for his GOP colleague.

If Casey doesn’t fit the bill, Rep. Greg Walden (R-Ore.) might. He was the second largest recipient of pharma money this election cycle, per that same data set. And Walden’s position as chair of the Energy and Commerce Committee has made him a useful firewall against some of the most aggressive swipes at the drug industry.

Hatch’s departure becomes more consequential if Sen. Chuck Grassley (R-Iowa) decides to give up his position as head of the Senate Judiciary Committee to chair the Finance Committee.

Throughout his career, Grassley has been more combative toward the drug industry than Hatch ever was. He has sponsored a number of bills taking on the industry, including bills banning pay-for-delay deals and cracking down on gaming of the Food and Drug Administration’s safety systems — many of which could more easily move if Grassley takes the Finance Committee gavel.

Can Democrats make nice with Trump on drug pricing?

In the hours since the midterms, Republican and Democratic leaders have expressed a willingness to work together to bring down the price of prescription drugs. But it’s unclear how deep that bipartisan goodwill runs — especially as Democrats increasingly turn their attention on taking on President Trump in the run-up to 2020.

A lingering question is whether Democrats in Congress will coordinate with the Trump administration on drug pricing policy — or whether they’ll pursue their own notions and then challenge Trump to sign them into law.

“You can’t simultaneously be beating somebody and then say, ‘Hey, let’s go have fun again, let’s hold hands,’” one Republican lobbyist said. “I think they’re going to be working in parallel, but not in concert.”

It’s also unclear where Democrats currently stand on some of Trump’s more sweeping ideas for bringing down drug prices, like eliminating drug rebates and pegging the price of high cost drugs to what other countries pay.

As the governing party in the House, Democrats will be asked to take a stand on some of these more controversial ideas.

Democrats likely won’t have to vote on many of these ideas, given that they’re being pursued administratively. But budget experts at Washington think tanks told STAT that it would be politically smart for Democrats to codify some of the proposals that save the government money so that those savings can be used to offset other pricey must-pass legislation.

Will Joe Grogan find himself on the hot seat?

Cummings has already signaled his interest in probing whether one of Trump’s top drug pricing advisers, former Gilead lobbyist Joe Grogan, violated ethics rules. Now that Cummings will likely have subpoena power, Grogan’s ties to his former employer could be more closely examined.

In July, Cummings requested a slew of Grogan-related documents, all of which centered around potential conflicts of interest regarding CAR-T therapies developed by Novartis and Grogan’s former employer Gilead.

Grogan, a mild-mannered policy wonk, has been a tempting target for consumer groups like Public Citizen due to his ties to industry. He also wields outsized influence over Trump’s drug pricing agenda in his current role as the head of health programs at the Office of Management and Budget.

Have opioid manufacturers dodged a bullet?

The toppling of Sen. Claire McCaskill (D-Mo.) on Tuesday was a blow not just to Democrats, but to those hoping to see Congress conduct aggressive oversight of manufacturers seen as having exacerbated the country’s addiction crisis. McCaskill had conducted numerous investigations into the marketing practices of companies including Teva, Insys, and Mallinckrodt.

With McCaskill gone, it’s not clear who — if anyone — will take the baton. The House Energy and Commerce Committee did hold hearings investigating the role of drug distributors in the opioid crisis, and requested documents this summer from a number of opioid manufacturers. But the top Democrat on the committee’s oversight arm, Rep. Diana DeGette (Colo.) announced Wednesday she was running for a post in Democratic leadership. It’s also not clear whether opioids will remain a priority issue for Congress after President Trump signed a long-awaited opioids bill into law in October.

Will Nancy Pelosi brazenly take on drug companies?

Before the election, STAT reported that Nancy Pelosi had put the drug industry on notice that her elevation to the speakership would mean the end of the drug industry’s winning streak in Washington. With Tuesday’s election, she’s one step closer to holding the speaker’s gavel. But would she deliver on that threat?

Pelosi’s stance toward pharma has the support of the more progressive wing of her party. The more far-reaching a drug pricing bill, the more support it seems to have in Congress. One hundred Democrats, for example, have co-sponsored the Medicare Negotiation and Competitive Licensing Act, which would allow Medicare to negotiate directly with drug companies, and would strip those companies of their patent rights if they refuse to negotiate in good faith.

While Democratic leadership, Pelosi included, has embraced letting Medicare negotiate drug prices, they have shied away from more controversial ideas, like seizing a company’s drug patents.

The leaves the question: Will Pelosi warm to those more radical ideas?

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Scott Gottlieb is so beloved that even the press can’t find much to critique except his sock choice. Will that change?

So far, Democrats have had a hard time digging up dirt on FDA Commissioner Scott Gottlieb. But now lawmakers may try to leverage against Gottlieb the growing public health crisis related to youth use of e-cigarettes.

Democrats have called on the FDA to be more aggressive, and have slammed the agency for pushing back key regulatory deadlines for e-cigarette makers. But Gottlieb hasn’t been publicly called to account for increasing rates of e-cigarette use — with the exception of a number of government funding hearings earlier this year.

Rep. Frank Pallone (D-N.J.) who is expected to head the House Energy and Commerce Committee, has been particularly critical of the FDA’s response on e-cigarettes. Pallone has sent multiple letters to Gottlieb over the past two years requesting more information on the FDA’s strategy for stemming the tide of youth tobacco use.

As chairman of the Energy and Commerce Committee, Pallone also would have the authority to subpoena Gottlieb, should he want to dive deeper into the tobacco controversy.

Lev Facher contributed reporting. 

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  • The question RE. Pharmaceuticals ‘hiding’ patents behind a claim of an “Indian tribe’s” ‘sovereign Indian nation’ is easily put to rest…permanently! Demand an answer to this question. It is a simple question. So simple, it is hard:
    “Where is the proclamation ratified by the voters of the United States to amend the United States Constitution to make the health, welfare, safety and benefits of a select group of U.S./State citizens distinguishable because of their “Indian ancestry/race?”

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