Health Care

House panel easily approves bill to speed medical cures

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A House subcommittee on Thursday easily advanced a bipartisan measure aimed at smoothing the path for new medical cures.

The House Energy and Commerce health subcommittee sent the bill on to the full committee with a voice vote and no amendments. 

{mosads}A markup is expected next week. The 21st Century Cures bill has been gaining steam, and negotiators including Chairman Fred Upton (R-Mich.), ranking member Frank Pallone Jr. (D-N.J.) and Rep. Diana DeGette (D-Colo.) had kind words for each other Thursday. 

“All of us, Republicans and Democrats, and our leadership, have been very constructive,” Upton said. 

The bill is aimed at lowering barriers for FDA approval of new drugs and increasing funding for basic medical research at the National Institutes of Health (NIH). It includes $10 billion over five years in mandatory spending for the NIH, as well as yearly increases that will boost the agency’s budget by $5 billion by 2018, to help attract Democratic votes.

But how to offset the bill’s cost remains uncertain. Upton’s office says the bill will be fully paid for and more details on that will come next week. 

Democrats have also been pushing for more funds for the FDA, in addition to the NIH. DeGette said Thursday that if the FDA is not given more funding to aid in its approval of new cures “then we might as well not have the advances.”

There was some contention at the markup over a provision extending market exclusivity rights for drugs treating rare diseases for an extra six months.

Democrats have been pushing back on that language, arguing it might raise the price of drugs by reducing competition and is not necessary to encourage innovation. The length of time in the exclusivity provisions has been reduced since the original 21st Century Cures proposals. 

“I do not believe that companies need more exclusivity, but I’m grateful to the chairman for his willingness to consider my views,” Pallone said. 

Rep. Jan Schakowsky (D-Ill.) also raised concerns. 

“What will six months of exclusivity mean for patient access?” she said. 

“How will this affect spending by Medicare and Medicaid?” she added. “We simply don’t know, and that concerns me.”

Upton reiterated his timeline that the bill will be “enacted into law later this year.” 

But the Senate’s timeline could conflict with the lower chamber’s. Senate Health Committee Chairman Lamar Alexander (R-Tenn.) and ranking member Patty Murray (D-Wash.) are in the early stages of working on their own version of the bill. Senators say that the measure will not be ready at least until the fall. 

The House version aims to speed the approval of drugs through a number of measures, including by accepting broader evidence on a drug’s effects. It also encourages the use of “surrogate endpoints” in drug testing, which means tracking the progress of a biological measure instead of waiting for the full, definitive results, which can take much longer. It also creates a priority review program aimed at speeding the approval of breakthrough medical devices.

Critics, including recently departed FDA Commissioner Margaret Hamburg, have warned that the bill could speed up the process too much. 

“In the race for the newest treatment, we must remember the point that innovation doesn’t matter if the product doesn’t work,” she said in March during her final speech. 

Tags FDA Lamar Alexander NIH Patty Murray

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