Majority Leader Mitch McConnell announced the Senate would rename the law’s cancer program after Joe Biden’s late son. | John Shinkle/POLITICO Biden’s farewell gift: Cancer moonshot helps pass $6.3 billion research bill

Two months after the Obama administration promised a “moonshot” to accelerate the fight against cancer, Vice President Joe Biden summoned top health care lawmakers to a meeting in the Old Executive Office building.

Biden, whose son, Beau, died from brain cancer less than a year earlier, saw a path to fund the initiative in Energy and Commerce Chairman Fred Upton’s 21st Century Cures bill — a measure designed to boost funding for research on cancer and other diseases while making sweeping regulatory changes at the FDA that easily passed the House but was struggling to gain momentum in the upper chamber.


The two-hour March meeting with Biden, Upton and the bipartisan leadership of the House and Senate’s health care committees was the beginning of a rare Washington partnership that would ultimately save the health care legacies of Biden and Upton, as well as key Obama administration research programs — a bittersweet victory for a White House that will likely see much of its health care agenda unraveled by Republicans next year.

In exchange for the big boost in funding for the National Institutes of Health, Republicans won a regulatory rollback at the FDA designed to speed approval of drugs and medical devices which had long been sought by industry — and which liberal senators like Elizabeth Warren and Bernie Sanders slammed as a corporate giveaway that could erode consumer safety.

The $6.3 billion 21st Century Cures bill was approved by the Senate Wednesday in an overwhelming 94-5 vote and is now headed to the White House as one of the last pieces of legislation to be signed into law by President Barack Obama.

The 10-year funding bill made its way through Congress because of Biden’s imposing presence — and also because it is packed with substantial amounts of money for enough pet projects, including a batch of Medicare and mental health reforms, to keep disparate lawmakers on board. Relentless cheerleading for the project by Upton, (R-Mich.) and Rep. Diana DeGette’s (D-Colo.) also played a key role. The duo traveled the country with other lawmakers and leaders like NIH Director Francis Collins to sell the project directly to the public.

The vote let lawmakers close the year and the 114th Congress on a dramatic high, after a divisive election and ahead of the heated battles next year over the dismantling of Obamacare.

That drama was captured Monday night, when Biden took the rare step of presiding over the Senate for a procedural vote on the bill and Majority Leader Mitch McConnell announced the Senate would rename the law’s cancer program after Biden’s late son.

In hindsight, the March meeting assured that Biden’s cancer research project would be funded by Cures and set in motion a series of bipartisan compromises that were critical for final passage.

“We convinced him easily that we are already at second base and we are looking at the third base coach and he is waving us home,” Upton said. “We don’t have time to start over.”

Despite the March agreement to include moonshot funding, Cures still faced many obstacles.

Work stalled in the Senate in the early summer over disagreements about how to pay for it, while the FDA balked at the inclusion of what it saw as dangerous provisions to accelerate the development of regenerative medicines, such as stem cell treatments pushed for by McConnell. But buy-in from McConnell, who had polio as a young child, would be pivotal to ensure the bill would get to the Senate floor.

That’s when the “inner core,” as Upton described the key players from the March meeting, reengaged. The White House and Reps. DeGette and Frank Pallone (D-N.J.) and Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.) helped broker a critical compromise on regenerative medicine needed to satisfy McConnell and the FDA.

The key players also added a billion dollars in funding to states to combat the opioid epidemic as an enticement, particularly for Senate Democrats who were unhappy with the bill’s regulatory rollback, which could allow some drugs and medical devices to be approved faster, with less rigorous data on safety and effectiveness. For many on the left, this part of the law was seen as a boon for the drug industry at a time when soaring drug prices are sparking public outrage.

“Congress shouldn't be in the business of selling FDA favors to the highest bidder, risking people's lives to enrich political donors,” Warren (D-Mass.) said on the Senate floor last month. “Let's be clear. What the Republicans are proposing is corrupt, and it is very, very dangerous.”

The bill provides significant amounts of money for various programs: $1.8 billion for Biden’s cancer moonshot, $1.5 billion for Obama’s Precision Medicine Initiative aimed at tailoring treatments to people based on their genes and lifestyles, $1.5 billion for the BRAIN initiative, to advance scientists' understanding of the human brain to solve diseases like Alzheimer’s and $1 billion for anti-opioid efforts.

The catch was that while the regulatory rollback that so rankled some Democrats is guaranteed, the research funding is not. It will have to be appropriated each year. Even worse in Democrats’ eyes, it will be paid for in part by raiding more than $3 billion from Obamacare’s Prevention and Public Health Fund, which pays for anti-smoking campaigns and other preventive health efforts.

Biden and other supporters told concerned Democrats that the Obamacare money would disappear anyway with the repeal of the health law.

“We had the opportunity to lock in real progress on medical research, mental health, and opioids under President Obama, instead of letting these priorities depend on the whims of a Trump presidency — so of course we took it,” said a senior Democratic aide.

Alexander said the funding for opioids was as important as the money to combat cancer in getting enough votes for the bill.

“Almost every senator has the opioid epidemic on the front page of his or her newspaper,” he said.

“Opioid funding was the biggest driver for me,” said Sen. Sheldon Whitehouse (D-R.I.), noting his state has been one of the hardest hit by the crisis.

The vice president, who since Beau’s death at age 46 has made fighting cancer his raison d’etre, even more than running for president, loomed large throughout the process. The near unanimous vote was due in no small part to Biden’s relentless lobbying on the bill as it headed toward the Senate floor — he personally called or met with nearly 20 members of the Senate, including Republicans.

He rallied the patient and disease advocacy groups enthused by his moonshot initiative to advocate for passage of Cures.

“The vice president’s visibility on the cancer moonshot and the goals of the cancer moonshot was palpably part of the excitement that these groups brought to the table,” said a senior administration official close to Biden.

He also countered the liberal Democratic narrative that the bill was a giveaway to the drug and device industry by arguing that’s it difficult to help patients without helping the companies that provide them with the cures they need to survive.

In the end, it was a bill that few lawmakers outside “the inner core” really loved, but few voted against. Some Senate Democrats had the same concerns about pharmaceutical companies that Warren expressed publicly but they felt like they couldn’t vote against the bill because of Biden’s moonshot and the opioid epidemic funding, according to a senior Democratic aide.

The aide added that some lawmakers also viewed it as a parting gift to Biden, who is just days from retirement after a political career that ended when he chose not to challenge Hillary Clinton for the 2016 Democratic presidential nomination.

“I really understand the pain that Joe went through and to be able to do something in the name of his late son is an important part of closure when it comes to the grief that a parent faces,” said Sen. Dick Durbin, the No. 2 Democrat in the Senate.

Still, money problems threatened to derail the process. To overcome the Senate’s funding stalemate, House Republicans crafted an unusual funding mechanism for the bill in conjunction with House Speaker Paul Ryan, which got McConnell’s sign-off. It provides discretionary funding but fully offsets it with spending cuts to other programs. That means that appropriators have to sign off on the money every year.

To assure wary Democrats, the money will be set aside in a special account that cannot be tapped for other purposes without additional legislation. DeGette did her homework, ordering a report by the Congressional Research Service to ensure the arrangement was above board.

To further allay Democrats’ concerns, Ryan wrote a letter to Minority Leader Nancy Pelosi committing to provide the first year of the Cures funding in the year-end stopgap spending bill which funds the government through spring, Upton and DeGette said.

But funding problems remained. The Senate Finance Committee, which controls access to several funding streams, didn’t want to give any of those up without advancing its own agenda. Eventually, about 20 Finance bills were added to the measure and, in exchange, Finance let HELP pay for a significant part of Cures by selling off oil from the Strategic Petroleum Reserve.

Among the greatest concerns for the bill’s opponents was a provision that directs the FDA to consider “real world” evidence for approval of drugs and devices; a faster review of medical devices similar to one already available for drugs; and a measure that frees drug companies to talk with insurers about potential off-label benefits of their products.

Democrats negotiated changes to ameliorate some of those concerns, including eliminating a requirement that FDA issue guidance on off-label communications. A provision that would carve out certain industry payments to doctors and hospitals from a physician payment transparency program was also removed at the eleventh hour.

The addition of bipartisan mental health policies that would establish a new assistant secretary of mental health at HHS and authorize treatment and prevention programs but provide no new resources got additional lawmakers on board, and helped put the bill over the edge.

Alexander’s relationships with both Biden and Obama, both of whom he worked with in the Senate, helped propel the bill forward. Alexander and Obama first discussed the President’s genomic medicine initiative at a lunch in a Knoxville-area airport hangar after Obama invited him to fly to Tennessee aboard Air Force One. Alexander pledged to put the initiative in Cures.

Even with all the high-power backing, it came down to the wire.

“Boy, we had to drag this bill out of the ditch so many times,” DeGette said. Upton and DeGette “spent the entire Thanksgiving week on the phone with ourselves, with our staff, White House and the senators, making this happen. That’s what you have to do to pass a bill this big.”

One of the final pieces to fall into place before the House’s revised bill was released the day after Thanksgiving was the regenerative medicine policy.

A proposal pushed this spring by Sen. Mark Kirk (R-Ill.) and McConnell would have amounted to an end-run around FDA’s gold standard for approval by allowing new therapies to be marketed based only on initial safety data and preliminary evidence they might work.

Adding to Democrats’ skepticism, the push was backed by Ed Bosarge, a GOP mega-donor from Texas, whose company, Petrodome Energy, had donated $1 million to McConnell’s Senate Leadership Fund last year. Bosarge also owns Bosarge Life Sciences, which is developing such treatments.

The White House and FDA worked closely with McConnell to work out an alternative — including hashing out the details at a White House dinner between Obama, Senate Minority Leader Harry Reid and McConnell in late November. The final agreement got rid of the shortcut for these treatments, but allows them to go through FDA’s accelerated approval process if there’s evidence they could treat serious or life-threatening illnesses, or address other unmet medical needs.

In the end, the three years of political persistence, begun by Upton and carried forward by a broad cast of characters, paid off.

“I think it shows that if you can consult, consult, consult and don’t give up, and listen to your colleagues, that we can actually solve big problems here,” Alexander said.