WHAT IS THE 21ST CENTURY CURES ACT?
The 21st Century Cures Act was just passed by the House and Senate and will likely be signed by President Obama in the next few weeks.
This legislation gives funding to the NIH for a variety of research. The bill includes $1 billion in funding for opioid abuse prevention and $4.8 billion in research funding, a big chunk of that being designated for cancer research. Mental health
The bill also changes the route to approval for certain medications. Drug makers argue that their research and development cost isn't worth the lengthy process to gain drug approval. The accelerated approval pathway is thought to help approve medications for life threatening diseases (such as cancer and CNS
disorders). By allowing for intermediate endpoints, drugs will be on the market sooner and thus, beneficial to patients in a more timely manner instead of waiting for trials with clinical endpoints that are too difficult or take too long to measure (ex. memory loss in Alzheimer's).
There are many advocates for this bill but there are some critics too. The critics warn that the looser FDA requirements may put patients at a safety risk. However, the bipartisan support for this bill is giving some hope to people on what Congress can accomplish when they work together.
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