On December 13, 2016 President Obama signed H.R.34 and so, the 21st Century Cures Act became law. Sponsored by Rep. Suzanne Bonamici* (D-OR) and co-sponsored in a bipartisan manner, many say this is the biggest legislation of Obama’s presidency, after the Affordable Care Act. However, just like the Affordable Care Act, the bill has its detractors.
H.R. 34 first was introduced on January 6, 2015, “to accelerate the discovery, development, and delivery of 21st century cures, and for other purposes,” as the bills synopsis states. The 21st Century Cures Act addresses mental (neurological) disorders, such as Alzheimer’s, trys to find a cure cancer and pays special attention on America’s current opioid epidemic. Though many articles do not mention that H.R. 34 specifically supports tbi research, an overview of the bill shows that of the $6.3 billion allocated to medical research, $1.5 billion are alloted to the Brain Research Through Advancing Innovative Neurotechnologies Initiative (BRAIN Initiative). (As I note in a previous article, BRAIN is associated with tbi research.) “Congressman Frank Pallone, Jr. (D-NJ), ranking member on the House Energy and Commerce Committee, applauded President Obama for signing the 21st Century Cures Act into law… [as he says] the 21st Century Cures Act will advance medical research, fund the fight… towards mental health reform. As a leader in medical innovation, New Jersey and [medical] institutions… stand to benefit from 21st century cures investments in medical research.”
Beyond research, though, the bill focuses on pharmaceuticals. It is with this that many take issue. Currently, the FDA has to approve the efficacy and safety of all medications or medical devices before they go on market. Going through the government’s red tape can take years. “Under the Cures Act, companies will be allowed to submit observational data and ‘in house’ registry data as evidence for the safety and efficacy of a new product.” The bill’s proponents attest that this will significantly reduce the cost of medication, thereby promoting research and development. Detractors, like myself, worry that getting rid of the “safety and efficacy” red tape may mean less safe and ineffective drugs.
*Another bill, also called the 21st Century Cures Act (H.R. 6), was introduced by Rep. Fred Upton (R-MI) on May 19. 2015. In Uptons words, “21st Century Cures is an innovative game-changer and a truly once-in-a-generation opportunity to bring our healthcare system light years ahead of where it is today.” The last action on this bill was on July 13, 2015, when it was referred to the Committee of Health, Education, Labor, and Pensions by the Senate. (Word-for-word, H.R.34 and H.R.6 have the same synopsis, so they essentially seem to be the same bill.)