s Congress races to finalize the 21st Century Cures Act, Sen. Bernie Sanders said in a statement Tuesday that the legislation is a “bad bill” that should not be passed and criticized the pharmaceutical industry for seeking “handouts.”
The legislation has been touted as a way to advance medical innovation and, in particular, get more treatments to patients faster. But at issue is a fierce debate over the extent to which the legislation will do more to help — the public or drug and device makers. And Sanders issued some of the most blistering remarks.
“At a time when Americans pay, by far, the highest prices in the world for prescription drugs, this bill provides absolutely no relief for soaring drug prices,” he said in the statement. “The greed of the pharmaceutical industry has no limit, and this bill includes numerous corporate giveaways that will make drug companies even richer… It’s time for Congress to stand up to the world’s biggest pharmaceutical companies, not give them more handouts.”
His comments come amid furious jockeying over the legislation. House and Senate Republicans released the 996-page opus late last Friday — over a holiday weekend — and are racing to finalize a vote to be held on Wednesday. However, the legislation is generating notable pushback from some lawmakers and consumer groups.
Sanders is now the second prominent opposition leader to openly attack the legislation. Yesterday, Sen. Elizabeth Warren argued the bill would lower standards for approving new drugs and devices, among other things. She claimed the legislation was “hijacked” by industry and vowed she would not vote for its passage.
The Cures Act would give the states $1 billion to fight the opioid crisis, in addition to providing $4.8 billion for continuing three signature Obama administration research programs over the next 10 years: Vice Pres. Joe Biden’s Cancer Moonshot, the BRAIN Initiative, and the Precision Medicine Initiative.
An earlier House version of the Cures Act, which was passed last year, called for $8.75 billion in funding for the National Institutes of Health over five years. The current version of the legislation also includes $500 million for the US Food and Drug Administration, although this is well below the amount Democrats had sought.
The criticisms, however, were made in response to various provisions that critics say could eventually harm consumers, but benefit drug companies. “If you have approved drugs that don’t work or are dangerous, then you can have massive expenses to patients and their families and the health care system,” said a source familiar with Sanders’ objections.
As an example, the source pointed to language in the bill that would require the FDA to develop a program for evaluating “real world evidence” for supporting approval for a new indication for a drug. This could include ongoing safety monitoring, observational studies, registries, and patient-centered outcomes. This would allow the agency to approve added uses without relying on randomized controlled trials. These are considered to be the gold standard for determining whether a drug offers a benefit and help gauge the extent to which there are risky side effects.
Sanders also objects to a provision that would allow the FDA to approve antibiotics based on smaller clinical trials in smaller groups of patients. His concern, according to the source, is that safety problems may go undetected during testing and that approved antibiotics may be used inappropriately in larger patient populations in the real world.
There is also language to create an expedited review pathway for approving “regenerative medicine,” or stem cells, and rely on the use of surrogate endpoints and post-approval studies. A wealthy donor to Senate Majority Leader Mitch McConnell’s super PAC reportedly is an active investor in stem cell technologies.