Speed vs. quality.
It’s an age-old debate that is now being heard as Congress sends the White House a $6.3 billion bill that primarily enhances medical research.
The 21st Century Cures Act was approved by the House of Representatives last week. It received Senate approval today, and President Obama has promised to sign it.
The legislation is 1,000 pages long, and it’s a lot to take in.
“I don’t think anybody can wrap their head around an omnibus bill like this,” Dr. George Demetri, an associate professor of medicine at Harvard Medical School and a member of the board of directors of the American Association for Cancer Research, told Healthline.
However, while there are plenty of supporters for the additional research funding the bill provides, there are critics who are opposed to the provisions that would allow the Food and Drug Administration (FDA) to more quickly approve new drugs and treatments.
They see those changes as a gift to the pharmaceutical industry.
“When American voters say Congress is owned by big companies, this bill is exactly what they are talking about,” said Sen. Elizabeth Warren (D-Massachusetts) in a speech on the Senate floor.
What the bill provides
About $4.8 billion of the $6.3 billion the Cures Act provides will go to the National Institutes of Health (NIH) over the next 10 years.
This money would go toward research on diseases such as Alzheimer’s, cancer, and traumatic brain injuries.
“This is going to be a game-changer,” House Speaker Paul Ryan (R-Wisconsin) said at a news conference last week. “It will fundamentally transform the way that we treat and cure diseases in this country.”
“We’re voting to put vital innovations in biomedical research within reach, potentially saving countless lives,” Rep. Diana DeGette (D-Colorado) told USA Today.
Demetri welcomes the funding, but he also expresses concerns about the short-term nature of this one-time infusion of money.
“I like funding science,” he said, “but good research relies on reliable, stable funding.”
Demetri said the medical community needs to educate the public on why this type of funding needs to be sustained over the long term.
“We are not finishing the sentence,” he said.
About $1.8 billion of the research funding will go toward the “cancer moonshot” initiative headed by Vice President Joe Biden.
This part of the bill will also establish a mental health and substance abuse “policy laboratory” for prevention and treatment of those ailments.
It will also require insurers to cover mental health the same way they cover other medical costs.
“It’s nice to see the feds taking note of this,” Dr. Jason Jerry, an associate professor of medicine at the Cleveland Clinic Lerner College of Medicine, told Healthline.
Beyond the $4.8 billion in NIH money, the bill also provides $1 billion in funding to combat the opioid addiction crisis. It’s estimated 14,000 people die in the United States every year from overdoses involving prescription drugs.
Jerry, who is a board-certified psychiatrist specializing in addiction, sees this as a crucial component of the bill.
“We are in dire need of increasing funding in this area,” he said.
Not everyone is enamored with the funding, though.
The conservative Heritage Action for America has posted a column on its website, urging a “no” vote on the Cures Act.
They say the NIH and FDA don’t need additional funding, and Congress has no business adopting a complex 1,000-page bill during a lame duck session.
“Backroom negotiators have turned the Cures into a Christmas tree, loaded with handouts for special interests, all at the expense of the taxpayers,” the organization states.
Drug approval process
The most controversial part of the Cures Act, however, might be in the final $500 million of funding.
That money goes to the FDA to speed up approvals for new drugs and new devices.
Among other things, the provisions would allow the FDA to use data summaries instead of more detailed studies to approve existing drugs for new uses, according to a story in the New York Times.
It would also allow the agency to approve drugs for life-threatening infections based on test results from a smaller-than-normal group of patients, the Times reported.
The measures would also allow the FDA to approve some regenerative medicine treatments that use adult stem cells without clearing all the usual regulatory hurdles.
Michael Werner, executive director of the Alliance for Regenerative Medicine, told USA Today that the new system will put the United States on equal footing with other countries already using these types of treatments.
The pharmaceutical industry sees the FDA changes as necessary and lifesaving.
“[We] applaud Congress’ tireless commitment to accelerating the development of new treatments and cures for patients. We believe that the 21st Century Cures legislation will enhance the FDA’s ability to adapt to cutting-edge technologies utilized by America’s biopharmaceutical companies to bring new medicines to patients and their healthcare professionals,” Andrew Powaleny, senior communications manager for the trade association PhRMA, said in a statement to Healthline.
Critics, however, are worried the provisions will put drugs on the market before they’ve been thoroughly tested.
Warren said the pharmaceutical industry “hijacked the Cures bill,” leaving only a “fig leaf of funding” for the NIH and the opioid crisis.
Demetri said he isn’t worried that unsafe drugs will hit the market. He has faith that the FDA won’t approve such medications and that doctors wouldn’t prescribe them.
However, he said he is concerned that drugs that aren’t all that effective might get approval.
Nonetheless, he is still in favor of getting rid of the “no value-added steps” the FDA now has to go through.
Jerry said there are cases where a quicker drug approval process will be beneficial.
As an example, he mentioned children with Dravet syndrome who’ve been awaiting approval of medication for their condition.
On the other hand, Jerry is concerned about new pain-killing opioids getting quick approval.
As an example, he cites the 2014 FDA approval of extended-release hydrocodone.
“We do not have a shortage of narcotics in this country,” Jerry said. “We don’t need to rush narcotics through the process.”