NOVEMBER 8, 2018
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:
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?
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.
Nicholas Florko is a
Washington correspondent for STAT, reporting on the the intersection of
politics and health policy.
https://www.statnews.com/2018/11/08/8-burning-questions-for-pharma-as-washington-braces-for-a-health-policy-shakeup/?itx[idio]=8812325&ito=792&itq=440939b4-d0fc-45bc-8a9d-63c8065a0338
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