Cures Act
Over the last two years the COVID-19 pandemic has forced us to change nearly every aspect of our daily routines in both our personal and professional lives. In the healthcare space we have been further challenged to find a treatment option to combat COVID-19 as quickly as possible. Members of the FDA had to rely on both old and new policies in order to assist pharmaceutical companies like Pfizer, Moderna and Johnson and Johnson to run trials to develop a vaccine that abided by safety and regulatory guidelines. Not only did a vaccine need to be formulated, it needed to be easily and readily available to the public in hopes of developing herd immunity to shield children, eldery and the immunocompromised individuals in our communities from a virus we knew very little about.
The 21st Century Cures Act was passed on December 13th, 2016 and played a part in helping accelerate the development of COVID vaccines. The act was designed primarily to help patients in need receive innovative medical product development faster and more efficiently. It authorized $500 million over 9 years to help the FDA with costs to implement the law. The act aligns directly with the FDA’s goal of involving patient perspectives in the development of drugs, products and devices to modernize clinical trial design as we discussed in our previous PharmaOut blog. The pandemic has stressed the importance of continuously investing in biomedical infrastructure so we are ready for variants of COVID-19 and other viruses that risk public health and safety. The Cures Act also goes a step further and aims to address the opioid crisis, improve mental health services and even ease regulatory issues associated with Electronic Health Information (EHI).
According to the FDA, the Cures Act has helped support programs like:
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The Regenerative Medicine Advanced Therapy, or RMAT, that offers a new expedited option for certain eligible biologics products.
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The Breakthrough Devices program, designed to speed the review of certain innovative medical devices.
The Washington Report recently highlighted the updated version of the 21st Century Cures Act, the Cures 2.0. It is currently in draft legislation to support medical innovation of diseases that are more difficult to cure. The act also aims to increase funding for pandemic preparedness and incentivize research of new antibiotics so we don’t experience the same delays we did when developing the COVID-19 vaccine.
As we make our way into the new year it is important to reflect on the challenges we have faced and overcome. The pharmaceutical and biotech industries must prioritize continuing to invest in medical innovation to produce therapies and treatments for diseases/viruses both new and old. With the help of the Cures Act, we have been able to roll out 2 doses and a booster to help protect against COVID-19 in record time. The Cures Act has greatly shaped the direction in which the pharmaceutical and biotech industry are headed and we look forward to the new advancements to come in 2022. We hope you have a happy and healthy New Year!
For more information on the Cures Act 21st Century deliverables please visit: https://www.fda.gov/
The PharmaOut team remains committed to doing our part to fight COVID-19 and help keep our families safe. Our team of expert recruiters and consultants have years of experience to assist our clients in successfully continuing their business with our staffing, consulting, HR and investigator meeting services. Please contact us if you would like to discuss how PharmaOut can be your strategic partner.