House Overwhelming Approves Sweeping Health Measure

(Editor’s Note :  The 21st Century Cures Act also includes language that would permit  groups of 50 or below to provide HRAs on a tax-free basis to employees to purchase individual coverage)

The House overwhelmingly passed a far-reaching measure on Wednesday to increase funding for research into cancer and other diseases, address weaknesses in the nation’s mental health systems and help combat the prescription drug addictions that have bedeviled nearly every state.

The bill, known as the 21st Century Cures Act, also makes regulatory changes for drugs and medical devices, which critics argue lower standards to potentially perilous levels.

Passage of the bill in the Senate next week appears likely, even though Senator Elizabeth Warren, Democrat of Massachusetts, has taken to the floor twice to criticize the bill as a windfall for drug companies, with too few safety provisions. “The American people are not clamoring for the Cures bill,” Ms. Warren said on Wednesday, calling it the sort of measure that explains “why people hate Washington.”

The bill, which passed 392 to 26, was the product of three years of work, largely in the House, with former and current officials from the Food and Drug Administration and National Institutes of Health — two of the biggest beneficiaries of new funding in the bill — as well as scientists, health care advocates and others. It aims to streamline the federal drug regulatory structure to keep up with advances in biotechnology and other forms of medical research.

“We have listened to every group out there,” said Representative Fred Upton, Republican of Michigan and the chairman of the House Energy and Commerce Committee, which shepherded the bill. “I think we have a pretty good bipartisan bill that’s going to meet everyone’s test of how legislation should be done.”

The bill authorizes billions of dollars in new funding for N.I.H. research, much of it directed for Alzheimer’s disease and cancer, including money for the cancer “moonshot” sought by Vice President Joseph R. Biden Jr., whose son died from complications of a brain tumor last year. The F.D.A. is expected to receive a half-billion dollars, in part to help expand its staff to speed up processes at that agency. States could tap into roughly $1 billion over two years to fight the opioid epidemic.

It also folds in another large piece of legislation designed to improve the nation’s mental health services.

Language that would have exempted some speaker fees from a requirement compelling doctors to report payments received from the pharmaceutical industry was excised at the last minute.

Democrats are unhappy with the way the bill is funded. It authorizes $6.3 billion in money taken from a preventive health care fund and other sources, but funding must be appropriated annually. Democrats wanted the funding to be automatic each year.

“We have assurances from Republicans that they want to spend this money,” said Representative Diana DeGette, Democrat of Colorado, who traveled around the country with Mr. Upton to build support for the bill. “I actually feel confident that the money will be spent on that because this is a goal that is shared by both parties.”

Critics of the bill say it lowers standards for drug and device approvals at the Food and Drug Administration, in exchange for a badly needed funding increase for the National Institutes of Health.

“I think this takes us backward,” said Susan Wood, an associate professor of health policy at George Washington University and a former assistant commissioner for women’s health at the F.D.A. “It was a trade-off that was never worth doing.”

Others argue that the bill falls short because it elevates measures of a drug’s success called surrogate end points that can be misleading — for example, if a drug shrinks a tumor but does not ultimately prolong life. “This legislation pressures the F.D.A. to rely more on surrogate end points instead of results that matter to patients, living longer or feeling better,” said Diana Zuckerman, president of the National Center for Health Research in Washington.

Ms. DeGette said that although the bill contained provisions she did not like, “there is nothing in this bill that the F.D.A. says would undermine safety or efficacy of drugs.” She and other Democrats said they would get no better a deal next year under President Donald J. Trump and a Republican-controlled Congress.

In talks among House Republicans, Mr. Upton said, “someone said, ‘Why don’t we let Trump have this victory?’

“But we can’t delay it for political reasons,” he continued. “Who knows what would have happened if we had to start from scratch next year?”

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