8 Sep 2015

A Look at the “21st Century Cures Act” and FDA Review

Over the past few months, federal lawmakers have drafted legislation that, if approved, will speed up the review and approval process for new pharmaceutical and medical devices. Called the “21st Century Cures Act” (the Act) by the U.S. House of Representatives, the proposed law is now pending in the Senate. Although a faster review process may seem like a good thing at first glance, the Act has also drawn criticism from health advocates who claim an accelerated review process will compromise patient safety.

Increased Funding for the FDA and NIH

Major provisions of the pending law would deliver significant funding to the Food and Drug Administration (FDA) as well as the National Institutes of Health (NIH). If the Senate approves the Act, the NIH will get $8.75 billion in funding over the next five years. The FDA will also receive $500 million within a five-year span, with a portion of the funds earmarked for biomedical research.

Faster FDA Review Process

Another significant provision would ostensibly accelerate the FDA review process for new medical devices and prescription drugs, especially therapies and treatments still in the clinical trial stage that demonstrate promise of treating chronic and fatal diseases.

The Act’s supporters claim that streamlining the review process for innovative drugs and breakthrough therapies will help patients by removing roadblocks to getting beneficial drugs to the marketplace faster. Supporters also say that accelerating the FDA review and approval process will reduce research costs and lower prices for consumers.

However, the Act is not without its critics. Opponents to the new legislation state that speeding up the FDA’s review process will have a steep price: patient safety. Diana Zuckerman, the president of the National Center for Health Research, claims that accelerating the review process for new drugs shifts the burden of proof regarding safety from drug manufacturers to patients. Along with other health advocates, she claims that the Act may reduce costs, but it will be consumers who pay in the long run.

Georgia Personal Injury and Medical Malpractice Lawyer

If you or a loved one has been injured by a dangerous or defective medication or medical device, it’s important to act quickly. Contact my office today at (912) 265-9811 to discuss your case.

This article has been prepared by J. Alan Welch Law for informational purposes only and does not, and is not intended to, constitute legal advice. The information is not provided in the course of an attorney-client relationship and is not intended to substitute for legal advice from an attorney licensed in your jurisdiction.

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