After many months of debate, the United States Congress finally passed a bill ostensibly aimed at improving medical research: the 21st Century Cures Act. Now a year has passed since the act was signed into law.
The consequences of the entire piece of legislation are very worrisome and may result in more, not fewer, dangerous drugs and defective medical devices being released onto the market. Here’s what you should know about the 21st Century Cures Act, its potential impact, and how it could affect you in the near future.
Effects on Medical Device Manufacturers
The big change that the 21st Century Cures Act is designed to “streamline” the FDA approval process by greatly increasing the speed at which devices and drugs may be granted approval for use in the United States.
The FDA has certain standards that must be met for any device to be brought to market—and for good reason. When medical devices fail, people get sick, hurt, and can even die. Yet the 21st Century Cures Act erodes those standards even further, potentially putting people at risk.
To date, under the previous system, there have been many warnings and recalls issued for a wide variety of medical devices, including:
- Hip and knee implants (DePuy, Stryker, and others)
- Surgical hernia meshes (Atrium C-Qur and others)
- Intrauterine or implantable birth control products (Essure, Mirena)
- Inferior vena cava (IVC) filters
- Left Ventricular Assist Device (LVAD) heart pumps
In one opinion article published in the New York Times, two physicians point out that these failures and recalls occurred under the FDA’s system prior to the Cures Act, which required only one clinical trial for certain high-risk medical devices to be approved. (New drugs seeking approval typically require two clinical trials.) Yet according to the authors, the 21st Century Cures Act removes even this requirement for a single clinical trial. Instead it may allow manufacturers to use data about safety and efficacy from sources other than clinical trials, such as individual case histories, to bring high-risk “breakthrough” products to the market faster—and with less testing.
Drug manufacturers aren’t left out in the cold with this legislation, either. The new law also relaxes standards on medications, and may allow certain classes of drugs to come to market after studies with fewer patients or shorter study times than were previously required. The bill also changes the way that the effectiveness of a new drug is gauged, by disregarding patient improvement. For example, if a medication doesn’t cause a tumor to shrink, but the tumor remains unchanged, that might just be “good enough” under the new law.
Benefits of the Act
It’s worth noting that there are some benefits to this legislation, mostly in the form of funding for advanced medical research. It devotes nearly $5 billion dollars towards the National Institutes for Health, including $1.8 billion in accelerated research for cancer, and nearly as much again to fight Alzheimer’s and other neurological disorders. It also boosts funding for the Food and Drug Administration, and it also provides grants for states fighting against the epidemic of opioid abuse sweeping the nation.
Get Legal Help For Your Defective Medical Device
If you believe that you have been hurt by a defective medical device or a dangerous drug, Wayne Wright LLP would like to hear from you today. We believe in seeking justice for those who have been injured due to the greed of medical device manufacturers and pharmaceutical companies, and we’re here to help you get the justice that you and your family deserve, too. You may be able to receive compensation for your hospital bills, physical therapy or rehabilitation, psychological therapy, lost wages due to time spent recovering, diminished earning capacity in the future, pain and suffering, and more.
You can be compensated for an injury caused by a dangerous drug or medical device even if the item has been approved by the Food and Drug Administration.
To arrange a free, no-obligation consultation with an experienced legal professional at Wayne Wright LLP, call us by phone, use the contact form to send an email, or click the live chat box on this page right now.