The House of Representatives passed a bill Friday that would raise funding for medical research at the National Institutes of Health, and allocate cash so the Food and Drug Administration could approve drugs more quickly.
Patient advocacy groups and the drug industry are both ecstatic. The bill gives drug companies more time to market some drugs exclusively — which means more money — and it could make it easier to get new drugs approved. Patient groups love it because it gives them a bigger voice in the drug approval process.
But not everyone’s happy about it. Some medical researchers say the bill, called the 21st Century Cures Act, will actually weaken FDA oversight over the drug approval process, and could help speed unsafe drugs to market. So do some consumer advocates.
"The bill is a bad deal for patients," said Vijay Das of the consumer advocacy group Public Citizen. "At its core, this legislation is a horse trade: In exchange for increased funding for the world-renowned National Institutes of Health, lawmakers added perks for the pharmaceutical and medical device industries. This is unacceptable."
The bill provides nearly $9 billion over five years to NIH, which just about everyone agrees is being underfunded. The current NIH budget is more than 20 percent below what it was in 2003.
"NIH has been underfunded for many, many, many years. They've lost purchasing power, they've lost the ability to keep people in science and to recruit people to science," Ellen Sigal, chair and founder of Friends of Cancer Research, told CNBC.
The bill, which now goes to the Senate for consideration, also authorizes $550 million over five years for the FDA to help speed up drug discovery and approval.
"It encourages patient groups and disease groups to work together on these issues to work, the FDA to work, the NIH to work with companies," said Sigal, an enthusiastic supporter of the bill.
"Because when you're dealing with these very rare diseases, you can't do that unless you work together so this bill encourages it," Sigal said. "It creates the ability for these amazing scientists both at the NIH and the FDA to travel, to go to professional meetings to collaborate, to hear about the best science.”
But Dr. Steve Nissen, who heads the cardiovascular division at the Cleveland Clinic, says it’s not strengthening the FDA.
"There are provisions to this bill that weaken the authority of the FDA, that lower the standards of evidence for the efficacy of drugs and reduce the ability of the FDA to protect the safety of drugs and medical devices," he said.
One provision that aims to speed approval would encourage FDA to use what are called surrogate endpoints to approve drugs.
For instance, statin drugs lower LDL or "bad" cholesterol. This is turn is believed to cut the risk of heart attacks and strokes. So if a drugmaker can prove a product lowers LDL, they can seek FDA approval to sell the product as a heart drug even if they haven’t directly shown the drug cuts deaths or cuts heart attack rates.
But Nissen also points out that using surrogates led to the widespread use of hormone replacement therapy to lower the risk of heart disease in women after menopause. "All the biomarkers went in the right direction," he said. But then clinical trials looking at what happened to women who took the drugs showed the hormones in fact raised the risk not only of heart disease, but of breast cancer.
"The bill, as it’s currently written, is not an appropriate way to regulate the FDA," Nissen said. "While I understand the desire to bring new therapies to market quickly, this is not the right way to do it."
Nissen says the powerful pharmaceutical lobby has helped turn the bill into a gift for drugmakers at the expense of patients.
Dr. Jerry Avorn and Dr. Aaron Kesselheim of Brigham and Women's Hospital and Harvard Medical School raised similar questions in a commentary they wrote for the New England Journal of Medicine.
"Some aspects of the bill could indeed enhance the development of and access to new drugs," they wrote.
"Embedded in the language of the 21st Century Cures Act are some good ideas that could streamline the development and evaluation of new drugs and devices; its call for increased NIH funding may prove to be its most useful component. But political forces have also introduced other provisions that could lead to the approval of drugs and devices that are less safe or effective than existing criteria would permit."
The National Center for Health Research is even more sharply worded.
"Congress says it will benefit patients, but to be a ‘cure’ a treatment should actually help patients, not just enrich stockholders," it says.
The group is also critical of the section allowing more patient input — the part that patient advocacy groups love. "This section encourages the FDA to lower its standards to even include anecdotes that the bill calls ‘clinical experience.’ Please remember that clinical experience resulted in tragedies such as birth defects from thalidomide and deaths from Vioxx,” it said.
Not all think-tanks hate it. The Bipartisan Policy Center praised the bill. “This bill will expand patients’ access to new treatments and therapies, support critical research, promote safe and effective drug and device development, advance biomedical innovation, and does so in a fiscally responsible manner,” it said.
The FDA and NIH must be silent — they can't wade into politics. The White House has expressed support, with a few reservations. But former FDA commissioners Dr. Margaret Hamburg and Dr. David Kessler have criticized the bill, also.
Public Citizen’s Das says there too much of a downside. "We should not hold NIH funding hostage in the false pursuit of scientific and medical breakthroughs while undermining safety and access to essential medicines and treatments," Das said.
CNBC'S Meg Tirrell contributed to this article
