A bipartisan coalition of lawmakers is rushing to finalize a new healthcare law that would overhaul the Food and Drug Administration (FDA) and earmark billions of dollars for medical research. The bill, called the 21st Century Cures Act, is also a huge win for lobbyists: 1,455 lobbyists, working on behalf of 400 different healthcare companies, medical device makers and research institutions weighed in on the 900 pages of regulatory tweaks and research grants.
The 21st Century Cures Act passed the House Wednesday by a vote of 392-26. The Senate is expected to take it up next week and President Barack Obama has indicated he will sign the bill when it comes to his desk.
The law combines more than $5 billion in funding for medical research and anti-addiction services, with significant changes in how the FDA regulates drugs and medical devices.
Originally conceived as a bill to boost research, the law has been revised and tweaked countless times to build bipartisan support. At the same time, pro-industry groups have used the bill as a vehicle to achieve their long standing legislative agenda: to reduce the regulatory burden of bringing products to market.
“The medical devices and pharmaceuticals have sprinkled all sorts of goodies in the bill,” Dr. Michael Carome, director of the consumer advocacy group Public Citizen's health research group, told International Business Times. While he applauds the push for more research funding, Carome said the final version of the bill is “a bad deal for patients” because it effectively makes it easier for drug companies and medical device manufacturers to get FDA approval for their products without demonstrating that consumer safety has been taken into account.
Supporters of the measure applauded the new research funding — including $1.8 billion for the popular “Cancer Moonshot” initiative — and characterized the bill as a much-needed reform for the FDA. “It’s going to be a game-changer,” House Speaker and Republican Wisconsin Rep. Paul Ryan said Wednesday. “It will fundamentally transform the way that we treat and cure diseases in this country.”
But Carome and other consumer advocates are particularly concerned with several provisions that make it much easier for pharmaceutical companies to bypass stringent testing requirements to market and sell drugs for multiple uses.
Currently, if a company wanted to sell a drug to treat more than one ailment, it must conduct randomized scientific trials showing the product does indeed work for each separate illness it's marketed for.
The 21st Century Cures Act lowers that threshold and tasks the FDA to adopt a “real-world evidence” standard — a far cry from the clinical trials the FDA has been requiring. Instead of conducting randomized, controlled experiments, a company would be required only to submit observational data from a set of patients already using the drug.
This “undermines the gold-standard of safety that’s supposed to be included in the review process,” said Carome.
The bill also frees pharmaceutical companies to work with insurance companies to promote off-label uses for their drugs and creates a new category of “breakthrough” medical devices which qualify for expedited regulatory approval. In some cases, it allows the industry to submit summaries of trial data when seeking FDA approval, instead of the entire raw data-set.
These regulatory changes are alarming to some experts who study the FDA’s review process.
Daniel Carpenter, a historian at Harvard who writes about the FDA, has called the new bill “the 19 Century Fraud Act,” and warned that relaxing FDA standards “threatens to take us back more than a century.” Dr. Reshma Ramachandran, co-chair of the 20,000-member National Physicians Alliance, is also a harsh critic of the bill. She argued in a recent op-ed that it could fundamentally “distort the meaning of ‘FDA approved.’” Supporters of the bill stress that the regulatory tweaks have the stamp of approval from Andrew Eschenbach, George W. Bush’s FDA commissioner, who has been consulting with congress over the law.
Carome, with Public Citizen, said the weaknesses in the bill are the direct result of industry lobbying: Over the last two years, lawmakers were subjected to one of the most intense lobbying blitzes of the Obama era, as the pharmaceutical and medical device industries worked to influence the final text of the bill. The frenzy was so intense, Politico reported early this month, that lobbyists have been privately referring to the bill as a “grab-bag” and “a Christmas tree.”
Kaiser Health News reviewed the lobbying records filed by the Pharmaceutical Researchers and Manufacturers of America, the trade group representing drug makers, and found the industry group spend up to $24.7 million lobbying on the bill. (On some of the lobbyists' disclosure forms, multiple healthcare laws are listed, and it was not clear how the industry's lobbyists divided their time.) The mega-drug maker AbbVie — which manufacturers Humira, one of the most lucrative pharmaceuticals marketed for multiple uses — spent up to $7.7 million. The U.S. Chamber of Commerce spent up to $136.5 million.
The bill also had support from the US. Oil and Gas Association — which spent $293,000 on lobbying — since some of the new funding for research would come from selling oil crude from the Strategic Petroleum Reserve.
The proliferation of lobbying struck a nerve with Massachusetts Democrat Sen. Elizabeth Warren, who along with Vermont Sen. Bernie Sanders is trying to lead a Democratic insurgency against the law.
"This is a bad bill, which should not be passed in its current form," Sanders said on the eve of the House vote. "It's time for Congress to stand up to the world's biggest pharmaceutical companies, not give them more handouts."
Warren railed against the measure on the Senate floor Monday: "Does the Senate work for Big Pharma that hires the lobbyists and makes the campaign contributions, or does the Senate work for American people who actually sent us here?"
Warren singled out the case of W. Ed Bosarge, a Texas stem-cell entrepreneur, who donated more than $3 million to GOP Senate Majority Leader Mitch McConnell’s Super PAC. Bosarge also hired lobbyists to persuade Republican senators to introduce provisions that would allow certain stem cell treatments to go to market before they’ve been proven effective.
Some, but not all of Bosarge’s requests were integrated into the final version of the 21st Century Cures Act. Some other industry-supported provisions, including a proposal that would have made it easier for doctors to hide payments they receive from pharmaceutical and medical device companies, were rolled back ahead of Wednesday's vote.
According to data from the Center for Responsive Politics, the lawmakers who introduced the measure are bankrolled by the healthcare industry. One of the bill’s original sponsors, Michigan Republican Rep. Fred Upton, collected more than half a million dollars from the industry over his last two campaigns. His co-sponsors, Pennsylvania Republican Rep. Joe Pitts and New Jersey Democratic Rep. Frank Pallone, both collected more than $300,000.
Upton, for his part, has said meeting with children suffering from spinal muscular atrophy convinced him to author the legislation. “We’ll find cures for these diseases that impact every family that is out there, whether it is cancer, lupus, Alzheimer’s, diabetes, you name it,” he said after the bill passed the House.
Carome was blunt in his assessment of the bill’s success: “The process for passing and crafting this legislation is corrupt,” he said. The most popular provisions — the additional funding for opioid treatment and medical research — don’t lock in a long term funding stream, Carome said, and could be eliminated under a Donald Trump administration.
“There's no guarantee that future Congress will appropriate that funding — a GOP-led legislature could very well cut it,” he said. “And in exchange for something this illusory, many lawmakers have agreed to permanently weaken some FDA standards in favor of the industry.”National