Congress Takes 2nd Look at 21st Century Cures, Funding for Opioid Epidemic

Update: This story was originally published Nov. 28. The House approved the 21st Century Cures Act in a 392-26 vote on Nov. 30. The senate will vote on the bill in December. The original story is below.

The U.S. House of Representatives will vote on a massive health care reform bill Wednesday, Nov. 30. The 21st Century Cures Act would overhaul the prescription drug and medical device approval process and provide billions of dollars in funding for medical research.

The bill would include $5.3 billion to fund President Obama’s precision medicine and cancer moonshot initiatives, Food and Drug Administration reform and National Institutes of Health research. The House will also vote on a proposal to add $1 billion in funding to combat opioid and heroin abuse to the bill.

In a joint statement, Sens. Fred Upton, R–Mich., and Lamar Alexander, R–Tenn., said the bill was “an extraordinary opportunity to help almost every American family.”

The chairs of the Energy and Commerce Committee and the Health, Education, Labor and Pensions Committee have gained support from leaders in the House and Senate to ensure the bill will be approved by Congress before the new year. That would give Obama time to sign it before he leaves office.

“What we have in the 21st Century Cures Act is an innovation game-changer, a transformational bill to bring our health infrastructure light years ahead to best match the incredible breakthroughs that are happening by the day,” Upton and Alexander said. “And it is critical to remember that passing 21st Century Cures is the best way to ensure some of this funding occurs immediately in Fiscal 2017.”

The House approved an earlier version of the bill in July 2015, but negotiations over several aspects of the legislation fell apart in the Senate. That version would have reformed the FDA approval process and provided more than $9 billion in funding to the NIH and the FDA.

Critics of the 2015 bill argued that the FDA’s approval process was already one of the quickest in the world, and many senators disagreed over where the money would come from. The previous and current versions of the bill would create funding by selling oil from the government’s Strategic Petroleum Reserve.

Republicans released the revised version of the bill on Nov. 25, the day after Thanksgiving.

The details of the major provisions include:

  • $4.8 billion for the NIH, spread out over the next decade for cancer research and precision medicine initiatives
  • $1 billion in grants for states to combat opioid abuse during the next two years
  • $500 million for the FDA, spread out over the next decade to speed the drug and medical device approval process
  • $14 million to adjust states’ coverage of a variety of health care services
  • $12.5 million for states to maintain databases of mental health facilities

The bill has been one of the most heavily lobbied pieces of legislation since the Affordable Care Act. More than 1,455 lobbyists representing 400 organizations have attempted to sway lawmakers to support or oppose the bill, according to Kaiser Health News.

Opponents of the current bill urged Congress not to pass it without measures to control drug prices. The rising cost of prescription drugs was a talking point during the 2016 election, and several drug manufacturers have been suspected of price gouging.

In 2015, Obama offered preliminary support for several aspects of the 21st Century Cures Act, but he voiced concerns about pieces of the bill regarding sources of funding, extending the length of patents for drug companies and weakening the FDA approval process.

The president hasn’t indicated whether he’d sign or veto the revised bill, but it is likely his last opportunity to secure funding for several of his major health initiatives.

Democrats Urge Congress to Authorize $1 Billion in Opioid Funding

In July 2016, Congress passed the Comprehensive Addiction and Recovery Act with $181 million in funding to prevent and treat drug addiction. However, Obama and Democrat leaders have complained that the law didn’t provide enough money to fund all of the efforts it authorized.

In October, the Democratic staff of the Senate Committee on Finance said the law was an “empty promise.” Committee Chair Ron Wyden, D–Ore., urged lawmakers to authorize additional funding.

Last week, four Democratic senators renewed that request in a letter sent to Senate Majority Leader Mitch McConnell, R–Kent., and Minority Leader Harry Reid, D–Nevada.

Sens. Tammy Baldwin, D–Wisc., Jeanne Shaheen, D–N.H., Ed Markey, D–Mass., and Joe Donnelly, D–Ind., wrote that Congress had not provided sufficient funding to implement CARA.

“It is past time for Republicans and Democrats to come together to provide emergency funding and increase investments in prevention and treatment services for opioid use, misuse, and use disorders,” the senators wrote. “Until we do, our job is not done and our communities will continue to hurt.”

In 2016, Shaheen and Baldwin cosponsored the Expanded Access to Treatment and Recovery Act which would have authorized $920 million in funds dispersed over two years to expand state treatment efforts.

Both CARA and the original version of the 21st Century Cures Act received overwhelming bipartisan support, but senators remain in disagreement over the latter bill.

Since Republicans revealed the revised version of the bill, Democrats have continued to negotiate changes to the legislation. The parties reached a compromise on funding after the presidential election, but many Democrats still oppose accelerating the FDA approval process.

While many Republican leaders are optimistic that the law will be approved after reaching several compromises, it remains unclear whether enough senators will vote to pass the legislation when they vote in December.

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