After three years of debate, countless hearings, and pleas from patient advocates, lawmakers have approved legislation to speed new drugs to market and to authorize an additional $4.8 billion in spending for medical research, according to a report from STAT News. The House of Representatives passed the 21st Century Cures Act by a 392-to-26 vote. The bill now heads for a Senate vote early next week, which it is expected to pass.
The act includes numerous provisions for faster approval of prescription drugs and medical devices. While proponents claim that these measures will not lower safety standards, critics, including some former FDA officials and national consumer groups, disagree. They have argued that the FDA already moves faster than similar agencies in other countries.
The act also provides $4.8 billion for three signature Obama administration research programs over the next 10 years: Vice President Joe Biden’s “cancer moonshot;” the BRAIN Initiative; and the Precision Medicine Initiative. In addition, it would give states $1 billion to fight the opioid crisis, and would deliver an additional $500 million to the FDA.
Senator Harry Reid (D-Nevada), the minority leader, acknowledged that there had been “angst” over the legislation among his colleagues. Representative Rosa DeLauro (D-Connecticut), for example, said the bill would weaken regulations on medical devices, allow drugs to be approved with only limited evidence of their safety and efficacy, and rush the use of new and unproven antibiotics.
Moreover, Dr. Michael Carome, director of Public Citizen’s Health Research Group, pointed out that the act would allow the FDA to consider “real world evidence” when approving drugs and would allow companies to submit summaries of study data, rather than full clinical trial records.
“The summary data could hide important information about the safety and effectiveness from the FDA scientist reviewing the data,” Carome said. “I’m disappointed to see it. ’’
The Cures Act initially included a rollback of requirements for companies to report certain payments to doctors. That provision was deleted after protest by Republican Senator Charles Grassley of Iowa.