The most important healthcare bill to pass in 2016 that has flown completely under the radar!
For years Congress had talked about modernizing the Food and Drug Administration’s (FDA) approval process. Critics claim the current process for approving drugs and medicinal instruments is out-of-date and cause arbitrarily delays to potential life-saving drugs. While both parties agree that modernizing the FDA’s approval process is a good idea, however Republicans and Democrats look to be at odds in how to actually make that happen.
Enter the 21st Century Cures Act, a $6.3 billion bill passed last Thursday by Congress that would create fundamental changes in how drugs are approved in the US. So what’s in the bill? Let’s take a closer look with our 10-Point Expert!
Point 1: Those in the medical community – including patients – have always complained about the FDA’s approval process for approving drugs and medical devices to be slow and arcane. Generally speaking, both Democrats and Republicans agree that the FDA’s approval process has to be modernized, however both parties have traditionally been at odds in how to tackle that problem. In the past, Congress has tried to pass laws to streamline the FDA’s approval process, but it ended up not going anywhere. Recently however, the 21st Century Cures Act passed Congress in hopes of finally tackling the FDA’s approval problem.
Point 2: The 21st Century Care Act is a 996-page bill that looks to modernize the FDA’s drug approval process by tackling three main factors: (1) help streamline the FDA’s approval process, (2) give more funding to experimental drugs/device research, and (3) get drugs from research trials to the market faster.
Point 3: There are also other riders to the 21st Century Cures Act as well, specifically funding going to state programs that treat opioid abuse and to existing programs that provide mental health treatment. In the bill, $1 billion in state grants would go to fighting opioid abuse and addiction, with the majority of the money going towards state programs that provide treatment. As for mental health services, they would get additional hundreds of millions in funding.
Point 4: Another big benefactor of the 21st Century Care Act are medical research groups. In the current iteration of the bill, the National Institute of Health would receive an additional $4.8 billion over 10 years. The money is meant to help researchers, medical centers, and universities – through the use of research grants – to study cures and treatments for various diseases and genetic ailments.
Point 5: The bill also pushes federal agencies and healthcare providers to modernize their records by creating electronic health records and new data collection procedures. Even though software and IT companies looked to be rewarded for their considerable amount of lobbying money ($35 million) towards the bill, most everyone agrees that a push towards modernizing medical records is a much needed move.
Point 6: The biggest beneficiary of the 21st Century Care Act however are drug and medical device companies. By having the bill streamline the FDA’s approval process, the medical industry looks to save billions in costs! Because of this, various groups are split over the bill’s current language.
Point 7: Detractors of the 21st Century Care Act say the bill is less of a compromise with the medical industry and more of a “government handout” to them. Those against the bill – like Democratic Senators Bernie Sanders and Elizabeth Warren – are quick to point out the massive lobbying effort from the medical industry which Kaiser Health News says to be around $192 million across 108 companies!
Point 8: Opponents of the 21st Century Care Act also include a litany of consumer and patient safety groups. Organizations like the National Center for Health Research look to be against the bill because it opens the door for potentially dangerous drugs or medical devices getting approval due to the streamlined approval process.
Point 9: At the same time, the bill has its supporters as well. Particularly patient groups have voiced strong approval for the bill saying it gives patients access to more treatments due to the FDA’s new approval process. They would also get more input in a drug’s development and approval, this in turn gives them more clout in the entire endeavor.
Point 10: As you can see, the 21st Century Care Act is a mixed bag when it comes to focusing on public health. While there are measures to modernizing the FDA’s approval process, put more money into medical research/treatment, and giving patients more power in their treatment decisions; on the flip-side it also could potentially approve unproven/dangerous drugs to the public. The 21st Century Care Act is a tough balance between regulation and modernization of the FDA’s approval process. Depending on whether you think that balance is skewed or not depends on who you fall within the bill’s language. Regardless, the bill looks to be turning into law with it passing in both the House and Senate, along with getting the backing of the Obama administration. If that is the case, then it would have major ramifications to US healthcare for years to come!
(Photo Credits: Pixabay.com, Dr. Phil’s YouTube Channel)