After more than two years in political limbo, President Barack Obama signed a sweeping bipartisan health care bill Tuesday that will expand medical research, invest in mental health care, battle opioid abuse, and give the U.S. Food and Drug Administration (FDA) more discretion over evaluating drugs and devices for approval.
The 21st Century Cures Act, which plans $6.3 billion in spending over the next 10 years, was hailed by supporters on both sides of the political spectrum as a step in the right direction for cancer research and health care.
“This legislation will improve the lives and health of countless Americans,” said American Psychological Association President Susan McDaniel in a statement after the Senate passed the bill. “It will increase access to effective, evidence-based care, particularly for those with serious mental illness.”
Nearly $5 billion will go to the National Institute of Health to support a cancer research “moonshot” initiative supported by Vice President Joe Biden, a project to map the human brain, and an effort to create new technologies from genetic data collected by a million American volunteers.
The FDA will also undergo changes that would allow the quicker passage of drugs and medical devices.
“The legislation includes pro-patient, science-based reforms which enhance the competitive market for biopharmaceuticals and drive greater efficiency in drug development,” said Stephen J. Ubl, CEO of the pharmaceutical industry’s lobbying firm Pharmaceutical Research and Manufacturers of America (PhRMA), after the bill passed the House in November. “It also increases FDA’s regulatory capabilities to foster the timely review and approval of new treatments for patients.”
Critics of the bill have expressed concerns over what the FDA’s deregulation will mean for the public and the influence the pharmaceutical industry has had in shaping the legislation.
Act Heavily Lobbied by Big Pharma
Since it was first introduced to the House of Representatives by Rep. Fred Upton on May 19, 2015, the bill has undergone massive changes. At 996 pages, the final form of the bill is 600 pages longer than the original version.
Over that time span, the 21st Century Cures Act became one of the most lobbied health care bills ever. More than 1,400 lobbyists worked to shape the legislation through behind-the-scene efforts.
Many organizations and consumer advocacy groups opposed the bill on a number of disparate provisions and wanted changes before the act passed.
“Whether or not it provides any funding for the NIH, the bill has a high cost to patients, because the bill weakens the scientific requirements of the Food and Drug Administration (FDA) for new medical products,” wrote the National Center for Health Research on its site. “Many would be approved that are less effective and less safe than those already available to patients – and they would cost more, too. This has the potential to hurt millions of patients.”
But no organization had as much sway in the bill as the pharmaceutical industry.
According to Kaiser Health News, 58 pharmaceutical companies, 24 device companies and 26 biotech companies push through provisions that would benefit the industry. The groups spent more than $192 million on lobbying expenses on the act and other legislation.
Upton, the sponsor of the bill, received more than $500,000 in campaign donations from pharmaceutical and medical device companies, according to OpenSecrets. He was also the top recipient of pharmaceutical industry contributions in 2013-2014.
Pharmaceutical Companies Benefit Most
With all the money spent on lobbying, the pharmaceutical companies are the clear winners of the 21st Century Cures Act.
The act gives the FDA more discretion over the approval and evaluation process of drugs to allow a more efficient approval process. Critics are concerned that this could lead to unsafe medications hitting the market before thorough analyses have proven their effectiveness.
“All these pathways or provisions of the bill are intended to expedite approval of these products — and, if implemented the wrong way, can lead to substantial negative consequences for patients taking these products, when they are not proven to work and are potentially unsafe because they’ve been pushed through the regulatory process,” said Aaron Kesselheim, an associate professor of medicine at Harvard Medical School, in the Washington Post.
The bill allows the use of real-world situations, such as anecdotal evidence, to acquire information about drug effectiveness without conducting long clinical trials. The result may be data that’s unreliable and doesn’t account for different types of populations.
Many medical devices will also receive an expedited approval process through the FDA under the bill. A pilot program that enables devices that are deemed high risk but innovative quick approval is being expanded. These so-called breakthrough devices do not need to be proven clinically meaningful to be categorized under for expedited review and may cause more harm than good.
The true effects of the act on the health care of the public and the benefit to pharmaceutical companies will be revealed as more drugs and devices are approved under the new provisions. However, critics are disappointed with the bill and the influence of the pharmaceutical industry.
“At a time when Americans pay, by far, the highest prices in the world for prescription drugs, this bill provides absolutely no relief for soaring drug prices,” said Sen. Bernie Sanders in a statement about the bill. “The greed of the pharmaceutical industry has no limit, and this bill includes numerous corporate giveaways that will make drug companies even richer… It’s time for Congress to stand up to the world’s biggest pharmaceutical companies, not give them more handouts.”