Last Wednesday the House passed with a vote of 392 to 26, a medical innovation bill known as the 21st Century Cures Act, aimed at curing diseases, with the measure securing bipartisan support after months of negotiations.
The bill’s goals are to speed up the Food and Drug Administration’s approval of new drugs while also investing new money in medical research.
The package also includes a range of other healthcare priorities, including $1 billion over two years to fight the epidemic of opioid addiction and $1.8 billion for Vice President Biden’s cancer “moonshot.”
The cures legislation also includes a mental health portion that seeks to reorganize and improve accountability for government mental health programs.
The Senate is due to take up the cures bill sometime before leaving town next month. In the Senate the bill will probably face a bumpier path. Sens. Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.) have blasted it as a giveaway to pharmaceutical companies.
Still, enough Democrats are expected to support the measure to get it approved.
“This bill, which expedites the approval of drugs and devices, includes literally billions of dollars in additional spending for health research so that we can find the cures and the answers to what patients are demanding today,” said House Energy and Commerce Chairman Fred Upton (R-Mich.), the measure’s main sponsor.
The White House gave the measure a boost on Tuesday night by announcing that it “strongly” supports passage, pointing in particular to the opioid funding and the funding for the cancer moonshot.
The liberal detractors in the Senate have made the point that the new research funding, which is helping to bring some Democrats on board in support of the bill, is not mandatory funding, meaning it is not guaranteed. Still, the $4.8 billion over 10 years is set aside in a separate fund and not subject to the usual budget caps.
Sanders and Warren have come out strongly against the bill calling it a give away to the pharmaceutical companies, in part by lowering the FDA’s regulations for approving their new drugs, while doing nothing to deal with the hot-button issue of high drug prices.
There have also been critics of the bill because of the fear that in speeding up the FDA’s approval process, it would lower safety standards and endanger patients.
The biggest sticking point about this is that the bill would allow for ideas like sometimes using “real world evidence,” rather than more rigorous and time-consuming clinical trials, in drug approvals. I am not sure what this actually means and how it would be interpreted and put into practice.
The mental health portion of the legislation establishes a new assistant secretary for mental health in the Department of Health and Human Services as well as a chief medical officer. The sponsor’s of the bill argue that these positions will bring more accountability and medical knowledge to the Substance Abuse and Mental Health Services Administration, an agency that has been criticized over time as being ineffective.
The bill also authorizes grants for areas like suicide prevention.
The bill does not lift any of the restrictions on Medicaid paying for care at mental health facilities, which would have cost billions of dollars.
It would have been nice to have the bill at least begin to tackle the high costs of certain medications. We also would have liked the bill to remove the restriction Medicare and Medicaid have in negotiating drug prices. This alone could bring a wind fall of savings into these programs.