A 996-page bill that seeks to speed up the approval of new medicines and medical devices is expected to head to the House for a vote Wednesday, amid criticism that the complicated legislation is being rushed through without sufficient scrutiny.
Called 21st Century Cures, the legislation earmarks $6.3 billion for biomedical research, opioid abuse prevention and support for the agency that oversees the safety of drugs. It also contains multiple provisions that aim to ease the requirements for drugmakers seeking approval from the Food and Drug Administration to sell their products.
The bill has had broad bipartisan support, but consumer advocates have criticized the bill, saying that there are major trade-offs that could weaken the FDA’s regulatory power and potentially put patients in harm’s way. And some legislators, including Sen. Elizabeth Warren (D-Mass.), say the regulatory changes in the bill amount to a giveaway to the pharmaceutical industry.
The legislation has been supported by drug and medical-device companies and patient groups, and has been the subject of intense lobbying. According to the Center for Responsive Politics, more than 1,400 lobbyists have pressed for the bill on behalf of clients, including drug companies and universities, that could benefit from an increase in federal biomedical research funding.
A spokesman for the FDA said the agency does not comment on pending legislation.
A previous version of the bill sailed through the House more than a year ago but has been stalled in the Senate. The new version, unveiled by House and Senate leaders over the holiday weekend, contains changes intended to smooth its passage through both houses.
Rep. Fred Upton (R-Mich.) and Sen. Lamar Alexander (R-Tenn.) together introduced the final version of the bill over the Thanksgiving weekend, and in a joint statement they called it “an innovation game-changer, a transformational bill to bring our health infrastructure light years ahead.”
Funding medical research
There are popular provisions sprinkled through the legislation, including an additional $4.8 billion in funding for the National Institutes of Health over 10 years, $500 million for the FDA over a decade and $1 billion for opioid abuse prevention over two years. Its proponents are touting the support it will bring for initiatives such as Vice President Biden’s cancer moonshot and President Obama’s precision medicine initiative.
In a speech Monday afternoon on the Senate floor, Warren called the funding for NIH and opioid abuse prevention a “tiny fig leaf of funding” that masks provisions that benefit the industry.
“Why bother with a fig leaf in the Cures bill? Why pretend to give any money to NIH or opioids?” Warren said. “Because this funding is political cover for huge giveaways to giant drug companies. There are more examples than I can count.”
The funding is less than many had hoped; the original bill called for $8.75 billion over 5 years for NIH. The bill authorizes $1.8 billion “to support cancer research” over five years — the Obama administration’s “cancer moonshot” program, though the legislation doesn’t use that phrase. The funding would begin with $372 million for the current fiscal year, far less than the $700 million or so that the administration said it was seeking a few weeks ago. Still, cancer-research advocates were relieved that the legislation contained money for the initiative and said that they hoped to build on it in the future.
Jon Retzlaff, managing director of science policy and government affairs at the American Association for Cancer Research, called the $372 million “a down payment for a historic effort,” adding that the anti-cancer campaign will require “robust, sustained and predictable annual funding increases” over the next several years.
Senate Majority Leader Mitch McConnell (R-Ky.) has called the bill the most important legislation before Congress this year.
“Cutting back on bureaucratic red tape, advancing lifesaving research and tackling the scourge of cancer would move our country forward and help millions looking for more than hope, but a chance at long, healthy lives,” McConnell said.
But Sen. Charles E. Grassley (R-Iowa) said Monday that he objected to a provision that would water down transparency requirements that require doctors relationships with drug and device companies are disclosed. The bill would exempt doctors from disclosing when drug companies paid for continuing medical education.
“With taxpayers and patients paying billions of dollars for prescription drugs and medical devices, and prices exploding, disclosure of company payments to doctors makes more sense than ever,” Grassley said.
Sen. Bernie Sanders (I-Vt.) called it a “bad bill” and criticized the legislation for “corporate giveaways” with no relief on drug prices.
Speeding up drug approvals
The drug approval process has been criticized as bureaucratic by politicians and by the pharmaceutical industry. But an FDA study of novel drugs approved in 2015 found that two-thirds of them were approved in the United States first, before they were approved in any other country.
Critics of the bill argue the bottleneck in developing new cures is not the approval process, but rather that scientists and doctors do not yet know how to cure many diseases. They note that the FDA already has considerable flexibility to approve drugs based on preliminary evidence that a drug is working. Earlier this year, the agency made the controversial decision to approve a drug for rare, fatal Duchenne muscular dystrophy, despite advisers’ recommendations against it and no evidence that it had a clinical effect.
“The maintenance of a vibrant pharmaceutical and drug products market depends on the FDA regulators standing guard and implementing their work the best they can,” said Aaron Kesselheim, an associate professor of medicine at Harvard Medical School. “But there’s substantial flexibility in that, and I think a lot of provisions in this bill stretch that flexibility … to the point where it becomes quite concerning.”
Critics said some of the most troubling aspects of the original legislation have been removed, but they flagged some new concerns. For example, the bill opens the door for the FDA to ease the requirement for the level of evidence when approving a drug that has already been authorized for other diseases and conditions. Some drug companies have paid big fines for promoting drugs for unapproved uses, so easing follow-on approvals without the same level of evidence raises concerns.
“In our view, that’s dangerous; it creates a double standard for FDA approval for drugs,” said Michael Carome, director of the health research group at Public Citizen, a consumer advocacy organization. “The level of evidence to show that a drug is safe and effective should be the same for every marketed use.”
Ellen Sigal, founder and chairperson of Friends of Cancer Research, a nonprofit organization, praised the bill and the rare bipartisan collaboration. She disputed critics who said the legislation would accelerate FDA approvals for drugs and devices by sacrificing standards.
“There’s nothing in this bill that suggests that standards are being lowered,” she said, adding that “there was substantial input from the FDA on this, as well as from the White House and patient groups. We would not support it if there was a lowering of standards.”
Vinay Prasad, a hematologist at Oregon Health and Science University said that in his field, cancer, the FDA has been approving drugs at a rapid pace. Despite preliminary evidence that they are working, many treatments have not yet been shown to prolong people’s lives. He compared the changes aimed at speeding up drug approvals to trying to run a faster mile by buying a new stopwatch.
“We really want transformative drugs,” Prasad said. “These kinds of changes to regulation … just lower the bar for non-transformative drugs — to let them fly by.”
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