It was a sweeping victory for those who support the 21st Century Cures Act, which claims to “modernize and personalize health care, encourage greater innovation, support research, and streamline the system”. It would help drug and medical device companies win swifter government approval of their products, boost disease research and drug-abuse spending (opioids included) and revamp federal mental health programs. The bill envisions spending $6.3 billion over the next decade and was passed by the House of Representatives on November 30th by a vote of 392-26.
According to The Washington Times, the bill will be funded with $3.5 billion from Obamacare’s prevention and public health fund. There will still need to be other legislation written and passed in order to regulate the spending of these funds. Currently, we do not know how this may effect our non-profit sectors of public health.
VOX news reports that the 996-page bill will have provisions that will weaken the regulator’s authority and potentially compromise patient safety. Currently, only rigorous clinical trials would support the approval from the FDA but under the new bill, drug makers can submit observational studies or safety monitory data for approval.
Although this would limit the ability of the FDA to review and analyze data, it would certainly speed the approval process. Senators, Bernie Sanders and Elizabeth Warren, spoke out against the bill. “It’s time for Congress to stand up to the world’s big pharmaceutical companies, not give them handouts,” Sanders stated. Passing the bill would seem to benefit the pharmaceutical industry greatly but it may also benefit patients.
In streamlining the approval process, this bill suggests that patients will then have quicker access to much needed drugs. In addition, the bill will include incentives for young scientist to encourage growth and innovation as well as supporting V.P. Joe Biden’s “moonshot” effort to find a cure for cancer. Still, even with a great number of potential benefits, consumer-rights groups have concerns the plan would unsafely lower approval standards for drugs.