House to Vote on Cures Act This Week; Senate Vote Later
The U.S. House of Representatives has scheduled an 11/30 floor vote on a revised 21st Century Cures bill that includes $6.3 billion in additional funding to accelerate discovery, development, and delivery of new cures and treatments. The measure 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, 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.” Many stakeholders are worried the measure will water down or lower approval standards and increase risks to public health.
“Congress should not rush to pass the nearly 1,000-page 21st Century Cures Act that was hammered out late Friday,” cautions Public Citizen. “There needs to be an adequate amount of time to thoroughly review the legislation and understand the public health consequences. 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.”
According to Public Citizen, 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.
Another section on Summary Level Review would allow FDA to rely upon “qualified data summaries” to support approval of a supplemental application for an FDA-approved drug for a “qualified indication,” if there are existing data demonstrating the safety of the drug. “This will weaken the standards for FDA review and approval of sNDAs,” Public Citizen says. And a section on breakthrough devices would create an overly-broad category and pressures the agency to “rush approval of these devices, potentially leading to poor decisions,” it warns.
For more information about the 21st Century Cures Act, click here. For a section by section description of the bill, click here.