Since its approval by the House of Representatives in July 2015, the 21st Century Cure Bill has stalled in the Senate for nearly a year. The Bill would allow “evidence from clinical experience” to be used as justification for the approval of new uses of existing drugs. The Bill also loosens restrictions on approving new antibiotics and narrows the mandate that patients must give informed consent.
Many critics believe the FDA uses outdated and inefficient regulation processes for approving new medications and medical devices, driving up the costs of medications for pharmaceutical companies and patients.
Agreeing on the fine details of the Bill has caused quite a stir from both sides. The Bill would provide the National Institute of Health with a much needed $8.8 billion in funds, but the Bill would also loosen FDA regulations for approving new medications and medical devices.
However, critics of the Bill are not ready to agree. A report issued by the National Institute of Health asked for clarification on what “evidence from clinical experience” really means.
The stakes are high for the 21st Century Cure Bill, and not just financially. If the FDA loosens its regulations on approving new medications and medical devices, this could potentially allow for harmful medications and devices to be approved.
While supporters of the Bill say the FDA is stifling medical advances, it’s important to note the current FDA approval process isn’t perfect and loosening restrictions may make existing problems even worse.
Devices like Inferior Vena Cava filters (IVC filters) or the Essure contraceptive device were on the market for years before it was discovered the devices could have serious and life-threatening side effects. But defective devices aren’t the only products that have slipped through the FDA approval process. Prescription medications like Risperdal were widely prescribed off-label to elderly patients and minors before receiving a black box warning by the FDA.
Harmful medications and devices like these have caused the Bill to stall in the Senate. Not wanting to expose patients to harmful devices or medications but trying to make life-saving medical advances more widely available is a fine line to walk, and it doesn’t appear the Senate will figure it out any time soon.