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# Cures Act Promises FDA $500 mil. More, Heads to Senate
- URL: https://www.fdaweb.com/cures-act-promises-fda-500-mil-more-heads-to-senate/
- Published: 2016-12-01T12:00:00.000Z
- Updated: 2026-09-14T21:51:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137464

FDA could see a $500 million funding boost over the next 10 years after the House passed the [21st Century Cures Act ](http://docs.house.gov/billsthisweek/20161128/CPRT-114-HPRT-RU00-SAHR34.pdf?ref=fdaweb.com)in a 392-26 vote Wednesday (11/30) night. The bill now heads to the Senate and could be voted on as early as next week. The White House has signaled its support after voicing some reservations.  
  
“With today’s overwhelming bipartisan vote, we took a giant leap forward on the path to cures, saidEnergy and Commerce Committee chairman **Fred Upton** (R-MI) and Rep. **Diana DeGette** (D-CO), co-authors of the bill. “21st Century Cures is the innovation game-changer that patients, their loved ones, and the nation’s researchers and scientists so desperately need.”

An analysis of the legislation by the Alliance for a Stronger FDA notes that an FDA Innovation Account will be set up to pay for the activities that will be required of the agency. The account will ultimately contain $500 million. “Because the amounts in the Innovation Account will be pre-funded by the revenue and savings contained in the larger bill, these monies will be set aside solely for FDA’s use and they will not count against the budget ceilings that otherwise restrict the growth in non-defense discretionary programs,” the group says. “Nonetheless, the monies will need to be appropriated from the account, otherwise FDA does not receive the funding. There is no guarantee that the appropriations committees will choose to appropriate these monies.”

 Also, the Alliance says that the responsibilities given FDA are comparable to the original House Cures bill, but the funding amount has decreased from $500 million over five years to $500 million over 10 years. “While this will not be adequate for all of the new activities required by the legislation, it is more funding than the Senate version of Cures, which would have provided no new additional funding for FDA. Over the past five years, Congress has given FDA increases in its budget authority (BA) appropriation, but they have been far smaller than the growth in FDA responsibilities... With the enactment of 21st Century Cures, the gap between FDA funding and FDA responsibilities is likely to grow larger.”

Overall, the bill provides $6.3 billion in additional funding to accelerate discovery, development, and delivery of new cures and treatments. It would provide $4.8 billion to the National Institutes of Health, including: $1.4 billion for President Obama’s Precision Medicine Initiative to drive research into the genetic, lifestyle and environmental variations of disease; $1.8 billion for vice president Biden’s “Cancer Moonshot” to speed research; and $1.6 billion for the BRAIN initiative to improve the understanding of diseases like Alzheimer’ and speed diagnosis and treatment. Additionally, FDA would get $500 million to fund the expected additional duties, and $1 billion in grants would go to states to combat the opioid crisis. After the House acts, the Senate has said it will vote on the bill before the end of December.

The Cures Act would help bring drugs and devices to market more quickly and at less cost, [lawmakers say](https://energycommerce.house.gov/news-center/press-releases/21st-century-cures-bill-released?ref=fdaweb.com), by making “needed reforms to the FDA, including: expedited review for breakthrough devices, increased patient involvement in the drug approval process, a streamlined review process for combination products that are both a drug and device, and freedom from red tape for software like fitbit or calorie counting apps.”

Such a wide-ranging piece of legislation does not come without controversy and many stakeholders are worried the measure will weaken FDA approval standards and increase risks to public health. “While many harmful provisions have been improved or removed since the 21st Century Cures Act passed the U.S. House of Representatives last summer, there are still many provisions in the renegotiated bill that remain problematic for public health,” Public Citizen cautioned. According to the group, Section 3022 on “real world evidence” would require FDA to develop a program to evaluate its potential use. The sources of real world evidence include ongoing safety surveillance, observational studies, registries, claims, and patient-centered outcomes research activities. “This will weaken the standards for FDA review and approval of supplemental new drug applications(sNDAs) and lower the bar for the type of evidence needed to meet post-approval requirements,” the group says.

Senator **Elizabeth Warren** (D-MA) [said she will not vote](http://www.warren.senate.gov/?p=press%5Frelease&id=1307&ref=fdaweb.com) for the legislation because Senate Republicans reneged on a promise that the bill would have a significant investment in medical research and they let “Big Pharma” hijack the bill. “This final deal has only a tiny fig leaf of funding, for NIH and for the opioid crisis,” she said. “And most of that fig leaf isn't even real. Most of the money won't really be there unless future Congresses pass future bills in future years to spend those dollars.”

The day before the vote, the House Rules Committee [denied a request](https://www.fdaweb.com/house-passes-cures-act-sans-device-reporting-measure/) by Rep. **Louise Slaughter** (D-NY) to add an 11th-hour amendment to the 21st Century Cures Act ([see earlier story](https://www.fdaweb.com/house-to-vote-on-cures-act-this-week-senate-vote-later/)) that would have added an extra layer of adverse event reporting in order to improve medical device safety. Reps. **Michael Fitzpatrick** (R-PA) and Slaughter introduced the [Medical Device Guardians Act](http://www.fdaweb.com/download.php?file=TEXT%5FMedical%5FDevice%5FGuardians%5FAct.pdf) earlier this year as advocates for patients allegedly harmed by power morcellators and the Essure birth control implant. Under the measure, the Food, Drug, and Cosmetic Act would be amended to require physicians and physician’s offices to be treated as covered device users that are required to report on certain adverse events involving medical devices. As such, a covered user would be protected from having their reporting to the agency used against them in a civil case.

Fitzpatrick made his stand and did not vote in favor of the legislation. “I voted against the bill because it fails to protect patients against dangerous medical devices. For two years, I’ve sought medical device reform in Congress to raise awareness and advance legislation that protected patients and altered FDA processes and procedures to allow for maximum innovation and safety,” said Fitzpatrick.“Congress ignored the patients harmed by faulty, dangerous medical devices and what is more disappointing, we were denied a hearing.”

Rep. **Jan Schakowsky** (D-IL) also voted against the bill. “I am a strong supporter of biomedical research,” she said. “One of the most troubling aspects of this legislation is that it would loosen the standards under which \[FDA\] prevents dangerous drugs and medical devices from reaching consumers. That is yet another giveaway to the pharmaceutical and medical device industries. We need to make the FDA’s standards stronger — not weaker. As we speak, 13 faulty models of St. Jude’s defibrillators are being recalled for a malfunction that has caused deaths and serious harm to its users. One of those users is a beloved member of my staff, who was forced to undergo yet another dangerous surgery to remove the faulty implant. These lethal devices came to the market after the FDA ‘accelerated’ their approval, and did so without substantial clinical data. We are loosening the FDA’s standards to benefit corporations at the cost of human lives. This is absolutely unconscionable.”

The White House [announced its support](https://www.whitehouse.gov/sites/default/files/omb/legislative/sap/114/saps34s%5F20161129.pdf?ref=fdaweb.com) of the legislation 11/29, saying there are some provisions in the bill that raise concerns, “but that have been modified from previous versions to help address concerns, such as provisions that allow for the marketing of drugs to payors for off-label uses. In addition, a number of effective dates will be challenging to meet, especially without additional administrative funding. The requirement to sell additional inventory from the Strategic Petroleum Reserve, when added to the sale requirements of the Bipartisan Budget Act and the FAST Act, continues a bad precedent of selling off longer term energy security assets to satisfy near term budget scoring needs. That said, this legislation offers advances in health that far outweigh these concerns.”