Cue the ​“Pomp and Circumstance”

By Juliana Keeping, communications manager

The Prescription Drug User Fee Act provides roughly half the Food and Drug Administration’s budget to review the pharmaceutical industry’s requests for marketing approval — and it’s up for reauthorization this year.
 

What’s Happening: On Tuesday, the House Committee on Energy & Commerce subcommittee on health marked up the bill. Notably, prompted by the FDA’s controversial approval of the Alzheimer’s drug Aduhelm, the bill includes policies with bipartisan support that strengthen the accelerated approval pathway. As this reauthorization moves forward, Congress has the opportunity to strengthen these provisions further to ensure the Accelerated Approval Program delivers what it was intended to: access to promising therapies now with the promise of future confirmatory evidence of direct patient benefits. The full committee is expected to take up the bill next week.
 

Why it Matters: In June 2021, the FDA approved Aduhelm — an expensive new drug to treat the early stages of Alzheimer’s disease — despite evidence of severe clinical harms and without any evidence of clinical improvements in patient cognition. It quickly became a flashpoint in the national debate about the tradeoffs between low-quality evidence and high prices.

In this year’s FDA user fee reauthorizing legislation, the House included some commonsense guardrails to ensure timely completion of confirmatory trials. Drugs granted accelerated approval must undergo additional confirmatory trials to verify and confirm the drug’s direct clinical benefit. However, there is no strong financial incentive for these so-called confirmatory trials to be conducted in a timely manner as they are required to be by law, and as a result they are often delayed. Recent studies have confirmed this, finding that even when a drug fails to demonstrate its desired clinical benefit in confirmatory trials, the FDA rarely exercises its statutory authority to withdraw the product from the market. The FDA must ensure that these confirmatory trials put patients over profits.
 

Congress can improve this legislation by automatically withdrawing accelerated approval drugs from the market in the absence of confirmatory evidence, requiring additional rebates be paid to Medicare and Medicaid on accelerated approval drugs until confirmation of direct patient benefits, and preventing the slow creep of lower quality evidence.
 

What’s Next: As this bill moves forward to full committee consideration next week, we applaud the committee’s ongoing efforts to ensure this reauthorization strikes an appropriate balance between promoting innovation, creating access, and ensuring the safety and efficacy of drugs on the market. We hope that needed reforms continue to be central to this bill as it moves through the legislative process.

By Evan Mintz, communications manager

On Thursday, the National Association of Counties and its partners held a virtual event to reintroduce its Data-Driven Justice (DDJ) initiative, including new tools and learning opportunities that local governments can use to better serve those who frequently come into contact with justice and health systems. 

What’s Happening: DDJ was first launched under the Obama administration as an attempt to better use data and share information across government silos to help identify and serve the most vulnerable who routinely cycle through systems without getting lasting support. 

Why it Matters: These familiar faces in the health and justice systems drive a significant amount of public resources. For example, Miami identified a core population of less than 100 people who spent nearly 40,000 collective days in jail, emergency rooms, hospitals, and mental health facilities over four years at a cost of $13.7 million. Overall, an estimated 64% of the people in local jails across the country suffer from mental illness, and 68% have a substance use disorder. 

What’s Next: Arnold Ventures supported the testing of DDJ strategies at three pilot sites: Johnson County, Iowa; the City of Long Beach, California; and Middlesex County, Massachusetts. These sites crafted their own solutions to better serve the familiar faces in public services and published their own reports on lessons learned — in addition to AV’s overarching playbook on implementing DDJ and helping those in crisis. The National Association of Counties’ new Familiar Faces Initiative will provide resources to more counties to continue this work. 

Related: Data-Driven Justice Program Releases Final Reports

The Pulitzer Prizes were announced this week, and criminal justice issues dominated the topics covered by award winners. A free press is critical to holding public institutions accountable, from law enforcement agencies to legislators to the hidden systems that entrench intergenerational poverty. The best of these pieces “deploy tremendous narrative power to deliver the intimate human news that should be at the heart of all our debates around incarceration, poverty, and injustice,” said Pulitzer Board Member Viet Thanh Nguyen, a novelist and professor at Columbia University. 
 

A special shout-out to The Marshall Project, an AV grantee, for its recognition as a finalist in national reporting for its coverage of government agencies taking benefits intended for children in foster care.

Criminal Justice

• This letter from Justice Action Network to U.S. Senate leaders urging them to bring the EQUAL Act to the floor for a vote. More than 50 of the country’s leading organizations signed the letter.
   
• In an op-ed from the NewsOne, Pastor Michael McBride and LIVE FREE Executive Director Dr. Antonio Cediel argue that the issue of gun violence is a public health crisis.
   
• State representatives in Oklahoma are decrying the lack of comprehensive data focusing on criminal justice issues such as pretrial incarceration, efficacy of diversion programs, and trends in initial charging. 
   
• A report from The Education Trust finds that men incarcerated in Texas prisons have access to more than triple the number of higher education programs than women do. The disparity is highlighted in this story by The 19^th. 
   
• NBC reports that the U.S. firearm homicide rate in 2020 was at its highest level in more than 25 years, according to data from the Centers for Disease Control and Prevention.
   

• More than 107,000 Americans died of drug overdoses last year, setting another tragic record in the nation’s escalating overdose epidemic. 
   
• A recent story in The Washington Post exposes a cache of more than 1.4 million records that illustrate how aggressively opioid manufacturers have marketed its product to doctors. 
   
• Health Affairs Forefront is hosting a blog series that looks at the challenges faced by America’s “dual-eligible” population. 
   
• MedPage Today outlines how organ procurement organizations are trying to block overdue Congressional action by misrepresenting their data.

 
Higher Education

• Many educational certificate programs don’t lead to better-paying jobs, but colleges are pushing back against a proposal to remove federal funding for them, finds The Hechinger Report. Read FREOPP’s return on investment analysis for higher education to learn more about gainful employment.
   
• The nonprofit IHEP is working with colleges to help re-engage students to get to graduation day, Forbes reports.
   
• John Katzman comments in Inside Higher Ed that the Government Accountability Office's report on online program managers (OPMS), which act as a third party vendor for schools to recruit and admit students into online degree programs, outlines only the start of a necessary critical eye on this sector.
   
• MDRC, in partnership with SHEEO, TICAS, and the Education Trust, released its newest brief in the College Completion Strategy Guide entitled Career Pathways: A Strategy to Boost College Completion and Economic Mobility.

 
Charitable Giving

• Data from the DAF Research Collaborative is shedding light on the funding habits of donor-advised funds (DAFs) — and the news strengthens the call for reform. The collaborative found that DAF sponsors in the U.S. — which hold, invest, and manage nearly $160 billion — are giving away much less money than what was previously reported. 

 
Contraceptive Choice and Access

• Among low-income women, 23% of contraceptive users said they would use a different method, and 39% of nonusers said they would begin using a method, if cost were not a deciding factor, according to a new study by Guttmacher published in Contraception: X.
   
• The Washington Post reports that Sens. Patty Murray (D-WA) and Ron Wyden (D-OR), said they were opening an investigation into complaints that health plans are denying patient requests for birth control and forcing them to pay out of pocket. 
  
  Related: Read our story on how some health insurance companies are breaking the law.

Journalism

• The Knight First Amendment Institute, supported by AV, has forced to light opinions issued by the Office of Legal Counsel, an influential office often called the Supreme Court of the executive branch. 

• We know times are bleak, but our hearts are warmed by Patron the bomb-sniffing dog receiving a medal from Ukrainian President Volodymyr Zelenskyy.
   
• Congress is holding its first open hearing about UFOs in 50 years. We may finally discover the truth!
   
• A passenger in Florida landed a plane with absolutely no flying experience. Never too late to learn a new trick, especially when your pilot is suddenly no longer available.