July 27, 2015
Last week, the U.S. House of Representatives voted overwhelmingly (344-77) to pass a bill known as the "21st Century Cures Act," which would boost federal funding for medical research and speed up Food and Drug Administration (FDA) approvals for many new drugs and medical devices.
The bill, HR 6, will give $8.75 billion to the National Institutes of Health (NIH) for research and another $550 million to the FDA over the next five years. A scaled-down bill has been introduced in the U.S. Senate and there are hopes that it will pass by the end of the year.
The bill will remove barriers to increased research collaboration, modernize the clinical trial process (including patient registries), provide incentives for the development of drugs for rare diseases, create an Innovation Research Fund, and assist the biomedical infrastructure to help the future development of drugs and devices.
It would be funded by selling oil from the nation’s strategic petroleum reserves.
One goal of the bill is to speed up the FDA approval process. Drug companies have long complained the FDA approval process is too rigorous and too slow, preventing them from bringing some less-profitable drugs to market. Critics of the bill say the FDA currently has strict safety standards for drug approval and this bill will loosen those standards.
One of the direct results of the bill would be to allow more flexibility in clinical trials in the development of new antibiotics. Legislators are convinced that the reliance on old drugs and the lack of new drugs have created a plague of untreatable "superbugs."
The bill would also change the FDA approval process for medical devices, redefining the evidence that can be submitted for consideration to include patient medical histories and articles published in peer-reviewed journals.
The measure has generally drawn praise from the medical community and patient groups. However, it has drawn criticism from some consumer advocates that say FDA approval changes would threaten to lower safety standards.
The California Medical Association (CMA) has been closely following this bill and will continue to work with the American Medical Association and Members of Congress as the bill moves forward.
In addition to the main provisions discussed above, there are a number of other health care related provisions in this bill. A provision of particular concern is a one that would allow Medicare Part D plans to create barriers for physicians when prescribing controlled substances to patients.
CMA also worked to insert a provision that requires Medicare to provide comparable cost information to seniors for the same services depending on the site of service. CMA has been critical of the fact that Medicare pays as much as three times more for the same service when it is delivered in the hospital versus a physician’s office.