In an increasingly combative Congress, the 21st Century Cures Act stands out as a rare bipartisan effort. With at least 88% of legislators in both parties in the House and Senate in favor of it, it was one of the last acts signed into law by President Obama.
The House Energy and Commerce Committee first introduced the act in May 2015 and became its first cosponsors. The final product contained 312 pages of provisions that will help to discover, develop, and deliver innovative new cures and treatments for pervasive health issues. Overall the act authorizes $6.3 billion in funding for various initiatives.
One provision in the law authorizes $4.8 billion over 10 years in additional funding for the National Institutes of Health. Specific programs that will receive funding include the Precision Medicine Initiative, Brain Research through Advancing Innovative Neurotechnologies Initiative, cancer research, and research into adult stem cell regenerative medicine.
The Food and Drug Administration will receive $500 million over 10 years to help streamline and speed up the approval process for medication and medical devices. Also, $1 billion has been earmarked for grants to states to fight opioid abuse.
A new task force will also begin advising the Health and Human Services Secretary on improving safe, effective medications and therapies for pregnant and lactating women. This is especially important since most medications cannot be ethically tested on pregnant women.
In addition to funding discovery initiatives, the 21st Century Cures Act also contains requirements for best practices in certain parts of the pharmaceutical industry moving forward. The collection of patient experience data by the pharmaceutical industry will be standardized as dictated by the FDA. Moreover, the Department of Health and Human Services will evaluate whether real-world evidence of a drug’s efficacy can be used in lieu of post-marketing study requirements. Pharmaceutical companies also must disclose to the public their policies for compassionate use for drugs used to treat serious conditions.
Another interesting tenet of the law involves health information technology standards; HHS must defer to standards developed in the private sector for the best way to securely exchange health information electronically. Healthcare providers must also be educated on how they are allowed to use and share patient health information. This can affect pharmacists as they seek to verify patients’ health information in dispensing prescriptions.