Major changes could be coming to the pharmaceutical industry in the wake of the 21st Century Cures Act being signed into law. Dubbed a ‘grab bag’ for pharmaceutical companies, patient advocacy groups and academic institutions alike, the revised 21st Century Cures Act will accelerate the discovery, development and delivery of new drugs and medical devices. Simply put — this is a major deal for the pharmaceutical industry.
"The 21st Century Cures Act provides more funding to the NIH (National Institute of Health) and to the FDA. The end goal is to promote faster approvals in the U.S. for drugs and devices that have a greater urgency within the patient population,” says Kelli Selness, a senior project manager for Randstad Life Sciences. “This does not mean there will be corners cut in the clinical research process. It means that pharmaceutical and biotech companies will be tasked with providing the [FDA] with the necessary data faster, and the agency will be looking to approve the drugs/devices faster.”
new bipartisan legislation
Provisions made to the Act allow for $4.8 billion in new, fully offset funding to the NIH for the advancement of the Precision Medicine Initiative, provides $1.8 billion to strengthen former Vice President Biden’s Cancer Moonshot initiative and allows for $1.5 billion in funding toward research into genetic, lifestyle and environmental variations of disease. Funding will also benefit the BRAIN initiative with an aim to improve understanding of diseases, such as Alzheimer’s, and provisions will address mental health issues as well as the opioid crisis in the country. Clinical trial requirements will be better simplified and pharmaceutical companies will no longer have to endure the lengthy and draining FDA approval process.
The Act covers a lot of additional ground, including:
- Supporting broader, more collaborative development, qualification and utilization of biomarkers, with the intention of assessing how a therapy is working, and in which patients, earlier on during the research process.
- Updating the way in which safety and efficacy data is accumulated and analyzed for clinical trials.
- Incentivizing drug development for pediatric diseases and medical countermeasures.
- Empowering the FDA to utilize flexible approaches in reviewing medical devices that represent breakthrough technologies.
- Streamlining regulations that are more clear and consistent for innovators creating health software and mobile medical apps, combination products, vaccines and regenerative medicine therapies.
- Providing the FDA with $500 million for regulatory modernization and to allow the agency to recruit and retain the best and brightest scientists, doctors and engineers.
Once all the pieces of the Act are in place, the streamlined FDA approval process is intended to help spur scientific innovation, keeping the U.S. at the forefront of medical progress around the world. In the face of increased workloads and the demand to meet these welcomed changes, the pharmaceutical industry is expected to create new job positions to meet their ambitious goals. “Compressed timelines means more resources needed, thus a greater demand for hiring. This is good news," says Selness.
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