Senate Passes 21st Century Cures Act

WASHINGTON — The Senate passed the 21st Century Cures Act, sweeping legislation that aims to bring treatments more quickly from the lab bench to patients’ bedsides on Wednesday afternoon in a vote of 94-5.

“As a result of a lot of strong bipartisan work, we are sending a bill now to the president’s desk that will invest in tackling our hardest to treat diseases, put real dollars behind the fight against the opioid epidemic and make badly needed changes to mental health care in our country,” said Sen. Patty Murray (D- Wash.), Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee, just before the vote.

“I’ve heard often from those whose loved ones are suffering from Alzheimer’s, addiction, and other debilitating diseases,” wrote President Obama in a press release shortly after the vote, citing Vice President Joe Biden’s own tragic loss of his son Beau Biden.

“Their heartbreak is real, and so we have a responsibility to respond with real solutions,” Obama wrote, adding that he looked forward to signing Cures as soon as it reaches his desk.

The “Cures” bill authorizes a total of $6.3 billion for funding basic science, streamlining the FDA’s review process, and addressing the opioids epidemic. The bill also incorporates a handful of mental health reforms, aimed at improving care coordination, strengthening mental health parity laws, and promoting evidence-based treatments and therapies.

Murray thanked HELP Committee Chairman Lamar Alexander (R-Tenn.), who offered his own appreciation to his colleague and to those on both sides of the aisle.

Earlier this week Alexander called the bill’s provisions to invest in regenerative medicines “a game-changer” for stroke patients, those with heart disease or retinal disease and dubbed the entire package “another Christmas miracle” — referencing President Obama’s nickname for the 2015 rewrite of the “No Child Left Behind” education bill.

But not everyone was cheering: Public Citizen called the bill an early Christmas present for the pharmaceutical industry.

But the watchdog group didn’t sound only sour notes: in a prepared statement Michael Carome, MD, director of the group’s health research arm, claimed credit for helping to eliminate “provisions that would have 1) opened a gaping hole in the Physician Payments Sunshine Act for educational gifts made by industry to physicians; 2) increased medication prices and cost taxpayers an estimated $12 billion over 10 years; 3) encouraged hospitals to overuse the newest antibiotics, thereby contributing to the harmful spread of antibiotic resistance; and 4) allowed medical device manufacturers to make changes to high-risk medical devices without U.S. Food and Drug Administration oversight.”

Battling Opioids

Several Senators focused on the bill’s response to the opioids epidemic, emphasizing the current lack of resources and the slim capacity of many treatment facilities.

“When people with substance use disorder are turned away this means they remain on the streets, desperate, often committing crimes to support their addiction and at constant risk of a lethal overdose … Make no mistake this legislation will save lives,” said Sen. Jeanne Shaheen (D- N.H.) speaking from the floor on Tuesday.

Her colleague, Sen. Harry Reid (D- Nev.) said that the bill was “weak” in parts and “we could have done better,” but was also excited to see dollars for opioids.

“There should be far more, and it should be given a different way than we have it here, but it’s money,” he said. “And we have people … dying as a result of this scourge that’s sweeping America … So, that part of [the bill] is excellent.”

But the harshest critics of “Cures,”as the bill has been dubbed were unmoved by this sentiment.

Those opposing the bill included Sen. Bernie Sanders (I- Vt.), Sen. Jeff Merkley (D- Ore.), Sen. Ron Wyden (D- Ore.), Sen. Elizabeth Warren (D- Mass.), and Sen. Mike Lee (R- Utah)

The final breakdown for the bill is as follows:

  • $4.8 billion for the National Institutes of Health
  • $1 billion in state grants to help respond to the opioid crisis
  • $500 million in additional support for the FDA

Of the money allocated to the NIH over a 10-year period, the bill earmarks $1.8 billion for Vice President Joe Biden’s “Cancer Moonshot” project, — renamed “The Beau Biden Cancer Moonshot” — $1.6 billion for the BRAIN initiative, and $1.4 billion for President Obama’s Precision Medicine Initiative.

The Beau Biden Cancer Moonshot

The FDA’s funding would be geared towards bolstering research and staff, and like its sister agency, funds would be delivered over a decade, whereas the opioid grants will be administered over 2 years.

As Biden presided over a vote for cloture on Monday night, Congress offered an amendment to rename the Cancer Moonshot Initiative in memory of his son, Joseph “Beau” Biden III, who died from brain cancer in 2015.

“I think it fitting to dedicate this bill’s critical cancer initiatives in honor of someone who’d be so proud of the presiding officer [Biden] today: his son Beau,” said Senate Majority Leader Mitch McConnell (R-Kentucky).

That amendment passed without debate.

Winners and Losers

However, a second proposed amendment brought by Sen. Bernie Sanders (I -Vt.) did, receive pushback.

“I have been fighting the greed of the prescription drug industry for decades and as far as I can tell the pharmaceutical industry always wins. They win but the American people lose,” he said in a floor speech on Tuesday.

His legislation would allow Medicare to negotiate with drug companies and that would enable Americans to import their medications from other countries. Sanders stressed that both provisions had been endorsed by President-elect Trump during his campaign.

“Think about what you can do to pave the way for Mr. Trump coming in,” he said attempting to bait Senate Republicans who did not bite.

Full Speed Ahead

“One way to be sure and not get the work done we’re doing today is to add another topic,” said Sen. Roy Blunt (R- Missouri) who objected to Sanders’s amendment. “If everything’s a priority, nothing’s a priority.”

Sanders also criticized Cures for cutting $1 billion from Medicare and Medicaid programs and another $3.5 billion from the Affordable Care Act’s Prevention and Public Health Fund and for not giving enough funding to the NIH. Sanders said that if the bill passed it would still only grant the agency $7 billion less than it received in 2004, accounting for inflation.

The depletion of the ACA’s controversial fund also irritated the American Academy of Family Physicians, the group sent a letter to House leadership last week highlighting its disappointment, according to a press statement. The AAFP also noted that “the legislation stops well short of appropriately funding the important mental health and addiction provisions that are included.”

Mental Health

Echoing, Murray, Sen. John Cornyn (R-Texas) praised the bill’s mental health provisions noting that many families struggle to help their adult children who have mental health problems.

“Often there’s additional tools that need to be available to family members when they find that their loved one is getting sicker and sicker and not being compliant with their medication and potentially becoming a danger to themselves or to the community at large,” he said speaking from the Senate floor.

Cornyn noted that legislation will improve states and local government’s access to tools to help evaluate the healthcare needs of those in prison, so they can be helped. The bill also encourages the development of crisis intervention teams.

Though she voted for the bill, Sen. Debbie Stabenow (D- Mich.) urged Congress to “complete the job,” by delivering full-funding to community mental health centers.

The American Psychiatric Association applauded Cures saying it would improve the access and quality of care for people with serious mental illness, and those with substance use disorders.

“The bill will toughen enforcement of existing parity laws, helping to ensure that mental health care services are covered just like other health care services,” said Maria Oquendo, MD, PhD, president of the APA in a press release.

While Murray argued that another advantage of passing Cures now is to “lock-in” important investments ahead of the next administration, much of the actual funding in the bill will require Congress to appropriate or unlock dollars from various sources each year, such as sales from the federal Strategic Petroleum Reserve.

Approximately 420 organizations lobbied for the Cures bill, according to the The Center for Responsive Politics, including Blue Cross/Blue Shield, Roche, Amgen, and the Pharmaceutical Research & Manufacturers of America, the industry’s major trade association.

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