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21st Century Cures Act Is an Easy Pill to Swallow

Legislation Could Be a Boon to Biotech

Who said the government’s always divided? By a largely bipartisan vote, the House (392 to 26) and the Senate (94-5) approved the $6.3 billion 21st Century Cures Act to fund various health and life science initiatives. President Obama signed the bill into law days after it left the Senate. The funds will be divided among various programs and agencies.

NIH

The Nation Institutes of Health (NIH) will receive $4.8 billion over the next 10 years to research cures for a variety of diseases; $1.8 billion of which will go to preventing, detecting and curing cancer. Funds will also be allocated to a precision medicine initiative that “customizes” drugs based on a patient’s lifestyle and genetic makeup.

FDA

The Food and Drug Administration will receive $500 million over the next decade to add research staff and help streamline and quicken the approval process for drugs and medical devices. One such method will entail making it easier for previously authorized drugs to be used for other diseases, also known as off-labeling; another is giving the FDA more leeway in the use of stem cells.

States

States will receive $1 billion in funding over the next 2 years to tackle mental health issues and the growing problem of opioid addiction. Opioid-related deaths in the U.S. have quadrupled over the past 17 years.

Opponents

Some legislators and consumer advocacy groups opposed the bill because they feel that standards may weaken oversight of clinical drug trials and medical device manufacturers, thus increasing risk to end-users. They also called into question the safety and efficacy of making it easier to off-label medications.

The 21st Century Cures Act will be funded, in part, by money from the Affordable Care Act.

Steven Kreit, Partner-in-Charge of our New York Commercial Audit and Assurance Practice and Life Sciences and Technology Groups in New York, serves industries including life sciences, technology, pharmaceuticals, media, manufacturing and distribution.

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