“We are bringing to reality the possibility of new breakthroughs to some of the greatest health-care challenges of our time,” Obama said. “It is wonderful to see how well Democrats and Republicans in the closing day of this Congress came together around a common cause. And I think it indicates the power of this issue and how deeply it touches every family across America.”
The 21st Century Cures Act had wide bipartisan support and has been held up as an example of what Congress can accomplish by working together. After a previous version of the bill stalled in the Senate for more than a year, a new version — cheered by the drug and medical device industry, patient advocates and universities — made a swift passage through the lame-duck session.
The measure’s critics — mainly consumer watchdog groups and health policy experts — have argued that the popular funding provisions mask a worrisome loosening of regulations at the Food and Drug Administration that could put patients at risk.
The bill contains several provisions that the White House has championed, including $1 billion for opioid abuse prevention and $4.8 billion for biomedical research funding, including Obama’s Precision Medicine initiative and the BRAIN initiative. A hefty chunk of that funding — $1.8 billion — is dedicated to cancer research, a part of the bill that was renamed the “Beau Biden Cancer Moonshot” in honor of the vice president’s late son, who died of a brain tumor. The bill also aims to strengthen mental health services and access.
While the setting for the ceremony, the White House’s South Court Auditorium, was relatively sterile, the personal testimony of both Biden and former West Virginia state senator David Grubb gave it a more personal, emotional feel.
Grubb’s daughter, Jessica, became addicted to heroin after being sexually assaulted her first year at college; in October 2015 he told the president during a town hall in Charleston, W.Va., that Jessica was sober and enrolled in a rehab program in Ann Arbor, Mich. But after undergoing surgery for a running injury in March, Jessica Grubb was released from the hospital with 50 pills of the painkiller OxyContin, despite the fact that her medical record identified her as a recovering heroin addict.
“That night, Jessie died,” recalled Grubb, who was visibly emotional at times during his remarks. “The loss of a child, no matter what the cause, changes a parent forever, and it has changed us.”
Grubb had appealed to Obama during that 2015 town hall to make more treatment centers available for those addicted to opioids, and he said he took comfort in the fact that the legislation would provide additional funding for such centers. “He said, ‘We’re working on it, and here we are.’ ”
Biden began his remarks by noting that he and his wife, Jill, had experienced the same sort of tragedy as the Grubbs, saying, “It’s a lousy club, but I’m proud of you.”
The bill, the vice president noted, shows that politicians “can still come together to do big, consequential things for the American people.”
“It’s going to help millions of people, millions of people,” he said.
Obama, who led the crowd in a standing ovation for the vice president, alluded to the fact that it was “a bittersweet day” in that the people onstage were rejoicing in legislative progress even as they recalled the people they had lost to disease and addiction. He noted that he has already outlived his mother, who died of cancer, by two-and-a-half years.
“And so it’s not always easy to remember, but being able to honor those we’ve lost in this way, and to know that we may be able to prevent other families from feeling that same loss, makes it a good day,” the president said. “It’s a good day to see us doing our jobs.”
To accelerate the development of new cures, the bill contains more controversial elements. The drug industry has argued that regulatory bottlenecks slow down the development of new medicines. To address that problem, the bill pushes for the use of new kinds of “real world evidence” to support some drug approvals, allows antibiotics makers to test their drugs in limited populations of patients and creates an expedited pathway for approving regenerative medicine.
Studies suggest that the United States is among the fastest countries in the world at approving new drugs. Critics argue that those changes might not result in more effective drugs — and could harm patients.
“All these pathways or provisions of the bill are intended to expedite approval of these products — and, if implemented the wrong way, can lead to substantial negative consequences for patients taking these products, when they are not proven to work and are potentially unsafe because they’ve been pushed through the regulatory process,” said Aaron Kesselheim, an associate professor of medicine at Harvard Medical School.
Tuesday’s event was likely Obama’s last public signing ceremony, and the fact that these traditional, symbolic observances have become so rare in Washington underscores the chasm that widened between the executive and legislative branch during the president’s second term. In a sign of how deeply invested lawmakers from both parties were in the bill’s passage, they crowded around him as he signed the measure with 12 separate pens.
Speaking to reporters on Monday, White House Press Secretary Josh Earnest said the paucity of signing ceremonies over the past couple of years is “an indication that there’s been very little passed by Congress under Republican leadership that’s worthy of a signing ceremony.” We’re “not going to have a signing ceremony for a post office naming,” he added.
“Now, what Republicans have done is they have passed a handful of bills that do nothing other than strip away Obama administration initiatives,” Earnest said. “And I think this underscores the intellectual vacuum at the center of the Republican Party right now.”
Don Stewart, spokesman for Senate Majority Leader Mitch McConnell (R-Ky.), noted in an email that the White House itself keeps a list online of all the bills Obama has signed, “And there are 126 pages!”