President Barack Obama signed legislation Tuesday that increases funding for medical research, speeds up drug and device approvals, and battles prescription and opioid drug abuse.
The 21st Century Cures Act had spent more than two years in political limbo before it received widespread bipartisan support and passed overwhelmingly in the House and Senate.
“We are bringing to reality the possibility of new breakthroughs to some of the greatest health-care challenges of our time,” Obama said. “It is wonderful to see how well Democrats and Republicans in the closing day of this Congress came together around a common cause. And I think it indicates the power of this issue and how deeply it touches every family across America.”
The bill is worth an estimated $6.3 billion and will give the National Institute of Health (NIH) $4.8 billion for cancer research, new medical advances like brain mapping, and the Precision Medicine Initiative.
The nearly thousand page bill also includes major changes to how the U.S. Food and Drug Administration (FDA) regulates and approves drugs and devices. The agency will receive $500 million over the next 10 years to implement provisions for speeding up approvals while keeping the same safety standards in the past.
“The remarkable bipartisan, bicameral support for the 21st Century Cures Act proves that congressional lawmakers are serious about the need for scientific research, effective care-delivery, and the removal of barriers to scientific progress,” said Dr. Daniel Hayes, president of the American Society of Clinical Oncology, in a statement.
Big Pharma Benefits Most From Bill
Despite praise coming from both sides, many critics and advocacy groups are not pleased with the final outcome of the bill, claiming that patients are the biggest losers.
The NIH is set to receive nearly $5 billion to fund medical advances, but funding is not guaranteed. Not only will Congress have to vote each year to make the money available but a potential repeal of the Affordable Care Act could affect the 21st Century Cures Act.
But the real winners of the bill are pharmaceutical companies.
According to Kaiser Health News, the act was one of the most lobbied health care bills ever, with massive lobbying efforts by 58 pharmaceutical companies, 24 device companies and 26 biotech companies.
The result was changes to the FDA that would give the agency more discretion in the evaluation and approval process.
The United States is already one of the fastest countries in the world to approve new drugs, according to some studies. This bill will only make the approval process quicker, which some say might compromise the safety of patients.
“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.
A clause in the bill is designed to keep the FDA’s approval standards intact, but the addition of certain provisions may undermine those standards. The bill supports the use of “real-world situations” that would use sources other than clinical trials to get information on drug outcomes. Real world data may be less reliable and distort the benefits and risks of drugs.
The bill also affects the regulation of medical devices put out by pharmaceutical companies. One provision expands an ongoing pilot program that allows “breakthrough” devices with higher risks to get approved through priority review. While this could allow for more potentially important, life-saving devices to get to the public faster, the standards for breakthrough devices are not high and may come with more problems.
Risks of Less FDA Regulations
Another provision targeted by critics is the allowance for pharmaceutical companies to market off-label uses, or those unapproved by the FDA, to insurance companies. This would expand their market but also pose risks to the public.
“It is against the law for drug companies to market drugs for uses not approved by the FDA,” said Sen. Elizabeth Warren in a speech on the Senate floor last month before the bill passed with minor tweaks. “Some drug companies find this rule annoying – after all, they could make a whole lot more money selling a headache pill as a cure for everything from hair loss to cancer. But pushing treatments without scientific evidence that they work is fraud – fraud that can hurt people.”
Drugmaker Bristol-Myers Squibb recently agreed to a $19.5 million settlement with dozens of states over claims that the company marketed off-label uses for its antipsychotic drug Abilify in children and vulnerable elderly populations.
The combination of more lax regulations on pharmaceutical companies and quicker approval processes for drugs that don’t require long-term clinical trials to prove safety and efficacy could pose a huge risk to the public.
“People could die from using unproven treatments,” said Warren in her speech. “In fact, people have already died even during carefully controlled research experiments on these types of treatments. Congress shouldn’t be in the business of selling FDA favors to the highest bidder, risking people’s lives to enrich political donors.”