Conservatives Step Up Fight Against IRS Funding Boost

By Yuval Rosenberg

Under Fire, FDA Sharply Narrows Recommended Use of Biogen's New
Alzheimer’s Drug

The Food and Drug Administration on Thursday dramatically
narrowed its recommended usage guidelines for Alzheimer’s drug
Aduhelm, suggesting that only patients with milder forms of the
disease should take it. The change follows sharp criticism of the
agency’s decision last month to approve the treatment for all
Alzheimer’s patients — and it could greatly reduce both the number
of patients eligible to receive Aduhelm and the potential costs of
the drug to Medicare, which is expected to pay for most
prescriptions.

The original prescribing information, which said that the drug
could be appropriate for anyone with Alzheimer’s, meant that about
six million Americans could get it. The revised label recommends
that the drug be given to patients with mild cognitive impairment
or mild dementia, a smaller group that matches the population in
drugmaker Biogen’s clinical trials. Under the new label, some 2
million Americans reportedly may be eligible.

The new label also says, “There are no safety or effectiveness
data on initiating treatment at earlier or later stages of the
disease than were studied.”

The original “accelerated” approval of Aduhelm had set of waves
of criticism given that the benefits of the drug
remain uncertain and that its list price — $56,000
a year — meant that covering the drug could add billions of dollars
in costs to Medicare. Doctors may still prescribe the drug
off-label for patients with more advanced Alzheimer’s, but the new
label could allow Medicare to restrict access to early-stage
patients, lowering the potential cost.

“We don’t expect the new Aduhelm label to impact peak sales for
this product,” SVB Leerink analyst Marc Goodman said in a note to
clients, according to
The Wall Street Journal. But it “should help
narrow the patient population that seeks treatment and make it
somewhat easier for physicians to ‘say no’ to many patients that
shouldn’t be candidates for usage in the first place” and “help the
payers for the same reason,” he added.

Changing a drug’s prescribing label drug so soon after its
approval is highly unusual. Biogen and the FDA described the change
as a clarification, but some doctors said that Thursday’s change
only raises more questions about the FDA’s process, and many
suggest that the revisions should have been more extensive.

The New York Times
reports: “Many experts say that the drug’s label
should not only narrow the use of Aduhelm to mild stages of the
disease, but should also require two other strict conditions of the
clinical trials: that eligible patients have evidence of high
levels of a key protein, amyloid, in their brains, and that people
with certain medical conditions (called ‘contraindications’) should
be prevented from taking the drug, or at least designated as a
high-risk group, because it can cause brain swelling and brain
bleeding.”

Business and Labor Join Forces to Lobby for Infrastructure
Deal

A group of business and labor organizations including the U.S.
Chamber of Commerce, the Business Roundtable, the AFL-CIO and North
America’s Building Trades Unions announced Thursday that they
support the $1.2 trillion bipartisan infrastructure proposal
outlined by the White House and Senate negotiators.

“We urge Congress to turn this framework into legislation that
will be signed into law, and our organizations are committed to
helping see this cross the finish line,” the newly launched
coalition said in a
statement. “Enacting significant infrastructure
legislation, including investments in our roads, bridges, ports,
airports, transit, rail, water and energy infrastructure, access to
broadband, and more, is critical to our nation and will create
middle-class family sustaining jobs. Don’t let partisan differences
get in the way of action – pass significant, meaningful
infrastructure legislation now.”

Other interest groups in the coalition include the
National Association of Manufacturers, the National Retail
Federation and the American Society of Civil Engineers.

“The alignment of business and labor organizations that
are more known for being at odds with each other underscores the
urgency surrounding the infrastructure package,” Bloomberg’s Jennah
Haque
notes.

Conservative Groups Step Up Fight Against IRS Funding
Boost

A host of conservative interest groups are mobilizing in
opposition to a plan to sharply increase funding for the IRS — a
key element of the financing for the bipartisan infrastructure
deal.

The infrastructure framework negotiated by the White House and a
bipartisan group of senators includes $40 billion to beef up the
IRS as part of an effort to offset costs by collecting more revenue
— less than the $80 billion President Biden originally wanted, but
a substantial increase nevertheless. The negotiators estimate that
the tax agency could generate an additional $140 billion with the
increased funding by focusing on taxes that currently go
unpaid.

According to The Washington Post Thursday, a set of conservative
groups including the Committee to Unleash Prosperity, FreedomWorks
and the Conservative Action Project are preparing a campaign to
influence Republican lawmakers, with the goal of eliminating the
additional funding for the IRS.

Why it matters: “A successful effort could imperil
bipartisan support for the $974 billion infrastructure package,”
the Post’s Jeff Stein, Tony Romm and Yeganeh Torbati
say.

The bottom line: The bipartisan
infrastructure plan faces any number of hurdles, and organized
opposition to increased IRS funding will make it that much harder
for the package to advance. Still, 11 Senate Republicans have
expressed support for the plan thus far, and it’s not clear yet
that the anti-funding group will prevail.

Debt Limit Deadline Will Be Hard to Predict: Report

The limit on the size of the U.S. national debt has been
suspended since July 2019 but is scheduled to come back into force
on August 1. If Congress does not act to address the situation, at
some point in the following weeks or months the government will be
unable to meet all of its obligations — a day referred to as the X
Date.

On Thursday, the Bipartisan Policy Center said that absent
congressional intervention, it expects the government to reach the
X Date in the fall but added that current conditions make it
especially difficult to predict the deadline with any
precision.

“The challenges of accurately forecasting the pandemic’s
lingering effects on the economy and the ongoing federal response
mean we may not have a clear picture until September, at which
point Congress could have just weeks to act,” Shai Akabas, the
think tank’s economic policy director, said in a
statement.

Given the uncertainty, lawmakers “should act sooner rather than
later” to maintain the nation’s full faith and credit, Akabas
added.

No plans in place: In the past, when faced with
constraints imposed by the debt limit, the Treasury has deployed
what it calls extraordinary measures to keep payments flowing.
Crucially, Treasury officials said in May that they expect to have
about $450 billion in cash in hand on August 1, which BPC estimates
will last until the fall — at which point lawmakers would be forced
to act in a hurry.

House Budget Chairman John Yarmuth (D-KY)
told Roll Call last week that lawmakers do not yet have
a plan on how to approach the issue. One option would be to use the
still-developing budget proposal in the House to declare that the
debt has been raised through next year; the Senate would then need
to pass legislation confirming the increase and President Joe Biden
would need to sign it.

Another option would be to use the reconciliation process to
raise the debt, but that could be risky given the uncertain
timeline involved.

The bottom line: Treasury Secretary
Janet Yellen warned in June that failure to act on the debt limit
could produce “catastrophic” results. Thursday’s announcement from
the Bipartisan Policy Center could add some degree of urgency to
lawmakers’ efforts to raise or resuspend the debt limit before they
leave town in August for their summer recess, which extends into
mid-September.

Number of the Day: Global Covid-19 Deaths Top 4 Million

The death toll of the Covid-19 pandemic topped 4 million this
week, according to data from Johns Hopkins University. “It took
nine months for the virus to claim one million lives, and the pace
has quickened since then,” The New York Times
notes. “The second million were lost in three and
a half months, the third in three months, and the fourth in about
two and a half months.”

Most experts say the actual number is almost certainly higher
than the officially reported 4 million. The U.S. leads the world in
deaths with more than 600,000, followed by Brazil and India. “The
numbers may not tell the complete story, and yet they’re still
really staggering numbers globally,” Jennifer B. Nuzzo, an
epidemiologist at Johns Hopkins University’s Bloomberg School of
Public Health, told the Times.

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