By Rakesh Choudhary
On December 13th, President Obama signed the 21st Century Cures Act into law. While signing the Act, President Obama paid tribute to the bipartisanship since both the Democrats and Republics came together to make this bill a reality. He also lauded Vice-President Joe Biden, who had initiated ‘Moonshot Program’ as a fight against the disease after the death of his son due to brain cancer last year.
With over $6 billion in investment, the controversial law is expected to touch many American lives through its extensive coverage of various healthcare issues including opioid epidemic, mental health crisis and Cancer.
The Act provides $1 billion for an opioid epidemic to improve accessibility to treatment programs.
It also provides for training healthcare professionals and research activities. Further, it will fund $1.8 billion to accelerate cancer research through VP Biden’s Moonshot initiative. The law also addresses various mental health issues. Most importantly it requires insurance companies to treat mental health just like other medical treatment by the insurance companies.
FDA and Pharma industry
However, the most significant impact will be seen in the way the Food and Drug Administration (FDA) approves drugs and medical devices for commercial use. With the objective of quickly bringing drugs and devices for patient use, the law seems to do away with the stringent approval process. For e.g. it says FDA should consider “least burdensome” means of showing safety while reviewing new medical devices. Similarly, for approving new drugs, FDA should focus attention on “patient experience data” showing its impact on the disease. The Act even does away with full clinical trials in some of the cases. There is also a provision which waives requirements of “informal consent” of the patient in some circumstances.
The Act is a major lobbying victory for pharmaceutical industries. They were successfully able to keep price control on prescription drugs out of provision. While at the same doing doing away with the review and approval process. Patient advocacy groups also support the Act for they see a net societal benefit in the passage of the bill.
The law has its own share of critiques propounded by consumer watchdog groups, health policy experts and lawmakers.
Consumer watchdog groups and health experts are skeptical. Doing away with some of FDA’s approval processes to promote ‘patient focussed drug development’ may end up weakening FDA’s review process. Hence, exposing patients to unforeseen risk.
Some senators are critical that the law contains no provision to rein in the already soaring drug prices. There were already many benefits for pharmaceutical companies. Hence, they saw this Act as an opportunity to put a cap on drug prices. On 29th Nov, Bernie Sanders stated:
Despite criticism, rarely do we see a law with such wide-ranging implications with support from both sides of the table. There was a surprising consensus between Democrats and Republics. There was an alliance of pharmaceutical industries and consumers for the passage of the bill. Now that the 21st Century Cures Act has come into existence, it remains to be seen how this Act will be implemented by the FDA in reality.
Featured Image Courtesy: Harper’s Bazaar