The quest to speed up the introduction of new drugs and cures moved to the Senate on Tuesday. But a committee meeting that began with senators agreeing on the need for cures to progress more quickly turned into a Democratic defense of the Food and Drug Administration and the National Institutes of Health.
Sen. Lamar Alexander (R-Tenn.), who chairs the Senate Health, Education, Labor and Pensions Committee, positioned the committee hearing as the beginning of a yearlong process to produce Senate legislation to complement ongoing efforts in other parts of government. Dr. Francis Collins, director of the National Institutes of Health, and outgoing FDA commissioner Dr. Margaret Hamburg appeared at the hearing.
The House is currently working on its 21st Century Cures package, which has a number of bills intended to stimulate medical innovation through deregulation and policy changes. Meanwhile, the administration is touting President Barack Obama's precision medicine initiative.
The committee has formed a working group intended to coordinate their efforts toward producing a bill, Alexander said.
While Alexander was careful to state that the hearing “is not just about FDA,” Hamburg and some Democratic committee members defended the agency anyway.
Sen. Elizabeth Warren (D-Mass.) said that the Legislature was playing a "dangerous game" if it wanted to curtail the FDA's capabilities or lower FDA standards of review.
Hamburg touted the agency's efforts in approving new drugs, stating that 2014 was a 20-year high in new drug approvals, for example. As such, she warned against making an incorrect diagnosis that blamed the FDA for slowness in drug approvals. Hamburg also advocated for increased funding flowing to the agency, which would allow it to hire more quality scientists.
“Lowering FDA's standards will not increase innovation,” Warren said. Lowering or removing standards might result in a flood of unsafe new products. “The goal isn't new products—we don't want another Vioxx—but the goal is innovative products.”
Instead, Warren favors increasing the NIH's budget, which virtually all hearing participants agreed was too low. The lack of new funding for NIH was an obstacle leading to House Democrats' withdrawal of support from the 21st Century Cures legislative package in January.
Collins, meanwhile, was pressed mostly on administrative burdens that medical researchers are yoked to. Alexander cited a study by the National Academies of Sciences stating that 42% of researchers' time is spent on administrative tasks, and asked what the agency was doing, or could be doing, to ease those burdens.
In response, Collins pointed out that his agency had standardized the biography forms that scientists were expected to submit with applications.
Hamburg defended her agency's performance regarding duodendoscope safety. Issues with cleaning the scopes have contributed to outbreaks of antibiotic-resistant bacteria.
She stated that it wasn't until late 2013 that the agency discovered an outbreak emerging from a duodendoscope that had been properly cleaned. Previously, only isolated adverse event reports had emerged, and agency investigations suggested that cleaning procedures had not been followed in those instances.
The agency had previously publicly discussed issues with cleaning the surgical tools, including during a June 2011 workshop.
Still, Hamburg said, the agency was pressing forward to understand what to do about the problem and would hold an advisory panel meeting on the subject.
Follow Darius Tahir on Twitter: @dariustahir
