WASHINGTON—The 21st Century Cures legislative debate in the House is down to quibbles. The Health Subcommittee of the House Energy and Commerce Committee passed the bill, unanimously, by voice vote, to the full committee.
The full committee said it would take up the bill next week.
“This is a product deserving of the committee's support,” said Rep. Frank Pallone (D-N.J.), the ranking member of the Energy and Commerce Committee.
Pallone's support is notable. The legislative package is intended to boost biomedical innovation through additional funding, incentives and regulatory changes. The package's legislative momentum had been stymied in January, when Democrats withdrew their support from an early discussion draft over a lack of funding for the National Institutes of Health.
Pallone was reportedly the ringleader of the withdrawal, making his overall endorsement—despite some reservations—a milestone.
Pallone's critiques focused on two contentious areas. One was that the bill lacks additional funding for the Food and Drug Administration, which will bear additional review and regulatory burdens under the new bill. FDA officials recently testified that they already lack the resources to retain top scientists. That concern was echoed by several of Pallone's fellow Democrats.
Pallone also expressed concern about new exclusivity incentives introduced by the bill, but he noted that they are limited. For example, drug manufacturers would get six additional months of exclusivity for a drug with a new indication to treat a rare disease.
But, Pallone cautioned, “I do not believe companies need more protection from competition to invest in the development of novel and innovative drugs."
Other representatives described their own wish lists. Rep. Doris Matsui (D-Calif.), a longtime supporter of telehealth, said she wants to see more in the bill supporting that industry. That section of the current legislation does not expand Medicare reimbursement for telehealth services. This effort "is not the last you'll hear from us," Matsui said.
A few representatives on the subcommittee also expressed concern about the funding situation for young scientists. Rep. John Sarbanes (D-Md.) noted that researchers ages 65 or older receive twice as many NIH grants as those younger than 38.
There is, he said, “a real crisis among young researchers,” Sarbanes said.
Several members also endorsed the stiff interoperability penalties envisioned by the bill, but Rep. Tim Murphy (R-Pa.) said the data-sharing provisions could go further. Murphy, a psychologist, spoke about the need for better data-sharing with respect to opioids.
The current rules, Murphy said, mandate that a patient using methadone or other opioid dependence drugs has to sign a release for each instance the patient wants to share data regarding that prescription. And yet the consequences for getting an opioid prescription while on methadone or a comparable drug are grave.
“This can be fixed,” Murphy said.
Otherwise, Murphy—like every other member—praised the bill and his colleagues for their work on the legislation, which is gaining broad bipartisan support. “It's a good example of teamwork," he said.