For the outgoing 55-year-old President Barack Obama, this is an unusual day. On December 13, under the influence of Vice President Biden and the main legislators, he finally signed the "21st Century Healing Act" at the White House, and the content of the bill will be officially written into the law.
The Biomedical Innovation Act aims to curb drug abuse, deepen awareness of diseases such as dementia and cancer, and accelerate the development and approval of new drugs. Previously, the US Senate and the House of Representatives unanimously passed the Senate with 94 votes in favor and 5 votes against. The US House of Representatives passed the nearly 1,000-page bill with 329 votes in favor and 26 votes against.
The 21st Century Healing Act invested $1.8 billion in the cancer “moon landing plan†and received strong support from Vice President Biden. His son, Beau, also died of brain cancer in 2015. Biden said: "This bill will inject new urgency into the fight against cancer, and will enable millions of Americans to bring new treatments and improve their lives through research." The US 21st Century Healing Act is a big winner, or it will speed up the approval of new drugs for new indications.
The bill will also cost $1 billion to prevent the abuse of opioid prescription drugs and other addictive drugs, such as heroin, over the next two years. In addition, the bill will invest $3 billion for Obama's "brain plan" ($1.56 billion) and "precise medicine" ($1.4 billion) to promote research on diseases such as Alzheimer's disease.
The bill also simplifies the FDA approval process for drugs and medical devices. For example, when measuring the approval of existing drugs for new uses, it must rely on data summaries and “real world evidence†rather than strong clinical trial evidence, FDA is now The “patient experience†and previous condition data must be considered during the review process. For those breakthrough medical technologies, the approval process will be accelerated.
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