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.