Who benefits from the 21st Century Cures Act?
After several years of negotiations, Congress has reached an agreement on the 21st Century Cures Act, a massive bill with a host of implications for healthcare spending.
The bill sailed through the House on November 30 with a 392 to 26 vote. A majority of the Senate voted to end debate on the bill Monday night. It passed the Senate yesterday (94-5) and will soon head to the president’s desk for signing
The 21st Century Cures Act has bipartisan support. On the surface, it appears to be a boon for research. It commits $4.8 billion in resources to the National Institutes for Health for cancer drug discovery and continues biomedical research initiatives targeted towards insidious diseases like Alzheimer’s. It also appropriates funding to address mental health issues as well as the country’s opioid addiction crisis.
“Simply put: 21st Century Cures is an innovative game-changer and a truly once-in-a-generation opportunity to bring our healthcare system light years ahead of where it is today,” says Rep. Fred Upton (R-MI), the bill’s primary sponsor in the House.
On the surface, this sounds like wonderful progress. Who doesn’t want to fund research that will find a cure for cancer? But this and several other must-pass measures were attached to the bill, which is close to 1000 pages long.
Critics such as Senator Elizabeth Warren (D-MA) and Bernie Sanders (I-VT) say the bill will do nothing to control skyrocketing drug prices and characterize it as a handout for the pharmaceutical industry.
Since the bill was introduced, 1,455 lobbyists, many representing pharmaceutical companies, have pushed for its passage. The drug industry’s lobbying group, PhRMA, spent $24.7 million alone. Rep. Upton, one of the bill’s biggest champions, made the top 20 list of Congresspeople in the last two election cycles who have received big donations from pharmaceutical firms and medical device makers.
Some also say the Cures Act undermines the FDA’s authority and ability to protect patients from harm. Michael Carome of the consumer interest group Public Citizen was quoted as saying: “This continues a trend of eroding standards at the Food and Drug Administration since the 1990s.”
The Cures Act weakens clinical trial regulations, allowing drug companies to use “real world evidence” rather than the traditional randomized trials to get new drugs through the approval process faster. This expedited pathway to market increases risk and may compromise patient safety.
The 21st Century Cures Act is a $6.3 billion bill. To help pay for it, $3.5 billion will be pilfered from a fund designated under the Affordable Care Act for preventative medicine.
Learn more: Public Citizen has outlined many of the bill’s concerning provisions.