General Health

New Health Bill Could Lead to Changes in FDA Approval Process

The 21st Century Cures Act may dramatically change the Food and Drug Administration's approval process for new medical devices and prescription drugs, allowing insufficiently-tested products to enter the marketplace. The bill also raises concerns about the potential for drug manufacturers to participate in off-label marketing.

The Senate recently voted to pass the 21st Century Cures Act, a complex health bill which aims to provide federal funding for multiple health-related causes, but that could also negatively affect the FDA’s approval process for new prescription drugs and medical devices. This health reform law is among the most heavily lobbied bills of our time, and will likely have far-reaching implications for the health of Americans for years to come. While the act is sure to have numerous positive benefits, many are concerned that the provisions made for the Food and Drug Administration could lead to an increase of inadequately tested drugs on the market.

What is the 21st Century Cures Act?

The Cures Act is primarily concerned with funding health initiatives. Over the next ten years, the Cures Act will allocate $6.3 billion to organizations including the FDA and National Institutes of Health (NIH). Chief among its goals are:

  • Enabling the NIH to finance cancer research, conduct Alzheimer’s research, and support President Obama’s Precision Medicine Initiative
  • Fighting widespread opioid abuse by giving states funding for opioid treatment programs
  • Allowing the president to appoint an assistant secretary for mental health and substance abuse
  • Accelerating the FDA’s testing and approval process for drugs and devices

How the 21st Century Cures Act Could Affect the FDA

Under the Cures Act, the Food and Drug Administration would receive about $500 million in federal funding. This money is intended to help the FDA to speed up its drug approval process and improve the use of technology in medicine. The FDA will be permitted to approve new drugs based on less clinical data. It will also be encouraged to give greater weight to patient experience data, which takes into account patients’ treatment preferences and how diseases and treatments affect patients’ daily lives. It is hoped that the bill will expedite pathways for getting life-saving drugs and devices to patients who could benefit from them, and place more emphasis on a patient’s desired treatment plan.

Concerns over Decreased FDA Standards and Off-Label MarketingA health care bill could change the FDA approval process for new drugs.

Opponents of the Cures Act, including consumer health advocacy groups and prominent senator Elizabeth Warren, fear that it will help pharmaceutical companies without doing much to support the FDA. A faster approval process may not mean a better process. Instead, it could result in fewer randomized clinical trials of drugs and allow manufacturers to release dangerous drugs and devices on the market without putting enough research into uncovering products’ potential life-altering side effects. Considering that drugs such as Benicar, Invokana, and Xarelto were released under the FDA’s current regulatory system before their severe side effects were discovered, it’s easy to understand why the bill’s opponents are troubled by the prospect of a less intensive approval process. 

Under the Cures Act, drug manufacturers can market off-label uses to insurance companies. In addition, they can make promotional claims unrelated to the FDA-approved conditions they are meant to treat. An example of off-label usage is found in the drug Zofran. Zofran was created to treat nausea in cancer patients, but was marketed to pregnant women experiencing morning sickness and caused birth defects in some infants. The provisions made in the 21st Century Cures Act could lead to similar situations in the future, and the benefits of getting medications to consumers sooner may be outweighed by the risks of unknown side effects.

What Lies Ahead

While speculations about the impact of the 21st Century Cures Act abound, no one can say for certain how the FDA will respond to this health bill or what effect that response will have on American health. It’s possible that the bill will accomplish just what its authors hoped, improving the health of thousands of Americans and providing them with access to breakthrough advances in drugs and medical devices rather than introducing insufficiently tested products to our markets. In either case, the best way to safeguard your health will always be by researching your prescription drugs and devices, staying informed about possible recalls and side effects, and paying close attention to any unexpected side effects you may be experiencing.