The Bulletin - An Unusual Alliance on Health Care

News Article

By Jennifer Steinhauer and Sabrina Tavernise

By the standards of the modern Congress, Reps. Fred Upton, R-Mich., and Diana DeGette, D-Colo., have no business writing health care legislation together.

Upton, the buttoned-up chairman of the powerful Energy and Commerce Committee, is one of the House Republicans' go-to representatives on dismantling the Affordable Care Act. DeGette, a member of the Democratic leadership who leans decidedly left of center, counts herself among the central champions of the health care law.

But the two lawmakers, friends since they met in a prayer group nearly two decades ago, have spent the last 18 months -- sometimes with a spouse or dog in tow -- sitting together through hundreds of hours of meetings with doctors, health advocates and policy experts; traveling to each other's districts and to policy conferences around the country; and enlisting colleagues coast to coast to hold town hall-style meetings, all with the goal of developing a sweeping measure to help cure diseases.

"Every family is impacted by disease; they just are," Upton said. "My wife has lupus, my dad has diabetes, my mom's a cancer survivor. And I'm no different than anyone else."

On Friday, their bill -- which would spur biomedical innovation, change the way federal health officials approve drugs and medical devices, and increase funding for the National Institutes of Health -- passed the House overwhelmingly, 344-77.

The compromise was so strong that lawmakers even agreed on a highly unusual way to pay for it: by ordering the Obama administration to sell enough oil from the nation's strategic petroleum reserve to cover the cost. The reserve is supposed to be for national energy emergencies and has been tapped on occasion to soften price shocks; it is not meant to serve as a piggy bank.

The far-reaching measure drew praise from many physician and patient groups, and criticism from some consumer advocates who said the changes threatened to lower safety standards. But it was also a rare bipartisan compromise, hard fought with intense disagreements, largely over the role of pharmaceutical companies.

But it ended in significant accommodation, with strong Democratic support and praise for many of its provisions from the Obama administration. A similar bill is under consideration in the Senate, where lawmakers hope to have legislation by the end of the year.

"This is kind of a throwback to the way people used to do business around here," DeGette said.

The impetus for the bill, known as 21st Century Cures, was what the drafters said was a plodding and outdated regulatory process at the Food and Drug Administration, the federal agency in charge of drug approvals. In announcing the legislation in April, Upton and DeGette called the federal drug and device approval process "the relic of another era."

The agency countered that it approved drugs far faster than other developed countries and that about two-thirds of drugs approved in 2014 were done so under expedited processes, assertions that researchers corroborated.

The FDA has strict standards for what kind of information is required for drug approvals. Most approvals are based on the outcomes of highly controlled clinical trials, considered the gold standard in science, though some consumer advocates say the agency has been under pressure in recent years to relax its standards.

The bill's central aim was to quicken the pace of drug development by reducing what the drafters said were regulatory hurdles, and many of its provisions will deeply affect the FDA.

An early version of the bill was deeply alarming to some groups, including the FDA and producers of generic drugs, because it would have fundamentally rewired the approval system in ways officials thought risked patient safety, and would have given brand-name drugs more time on the market without generic competition. But the bill changed substantially.

"In the previous version, there was language that would have undermined standards for safety and efficacy," said Dr. Janet Woodcock, the director of the agency's Center for Drug Evaluation and Research. "We were very happy that our suggestions were incorporated."

In the end, drafters adopted softer language, telling the FDA to study how quicker-to-gather data, like information from doctors' practices or disease registries, might be used to approve new uses for drugs.

The bill also tells the FDA to take suggestions for ways to measure a treatment's effect without waiting to determine if a patient's health has improved -- for example, a scan showing that a tumor has not gotten bigger, instead of a more conclusive health outcome like survival. But it stopped short of requiring that these methods be used.

The FDA seemed satisfied with that approach, but critics, including some doctors and the editor of JAMA Internal Medicine, a prestigious medical journal, said it could open the door to lower drug approval standards.

Some of the most direct changes concerned antibiotics, the miracle drugs of the 20th century that are losing their effectiveness because of overuse. For years, development has lagged, and the new law tries to remedy that by offering incentives in some cases, like more flexible clinical trials with smaller numbers of patients.

Critics said that would lower safety standards, but Woodcock argued that the problem was urgent; that the population afflicted with hard-to-treat "superbugs" was small; and that in the risk-benefit calculation involved in any drug approval, regulators and patients were willing to take a few more risks.

The bill also changes the way medical device approvals work, allowing the use of evidence like patients' medical histories and articles in peer-reviewed journals. Critics said this would lower standards.

Upton and DeGette had scores of meetings with health care experts and lawmakers, who would each plow through a giant binder and suggest changes to the bill. At least 50 House members offered ideas, they said. They and other members made scores of trips around the country to meet with families and health advocates.

The bill would give $8.75 billion to the National Institutes of Health, which lawmakers believe has been starved, and $550 million to the FDA over the next five years, a provision researchers said would help remedy shortfalls imposed by mandatory spending limits.

DeGette said that she had found herself seated next to Francis Collins, the NIH director, this year and that he had told her, "If we hadn't had massive cuts to NIH, we probably would have a vaccine for Ebola."

Paying for the new measure was one of the most significant hurdles to its passage, because critics feared that tapping the petroleum reserve would set a dangerous precedent.

But even on that, there was agreement.

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