Senators look to streamline approval of new cures

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Senators are asking administration health officials on Tuesday for ideas on how to speed the discovery and approval of new medicines, as the House works toward a bill this week.

{mosads}Streamlining the Food and Drug Administration (FDA) approval process has been a focus in both chambers and both parties. Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.) have been working for months on their 21st Century Cures initiative, with a bill due to be released ahead of a hearing Thursday.

The Senate process is not as far along, but Sen. Lamar Alexander (R-Tenn.), the chairman of the Senate health committee, encouraged officials at a hearing on Tuesday to send ideas to his working group with Sen. Patty Murray (D-Wash.) for how to get new cures to the market faster.

He encouraged witnesses from the FDA and National Institutes of Health (NIH) to “create a red team for red tape.”

“Let us know, because this train is going to get to the station,” he added, noting cooperation with the Obama administration and the House. 

He said the committee would be reviewing their ideas over “the next few months.” 

Ideas discussed on Tuesday included clinical trial networks so each trial does not need to be set up separately, in a time-consuming fashion, as well as working on electronic data collection. Alexander pointed to the possibility of using experts outside the FDA to provide needed specialized knowledge. 

A point stressed by some Democrats, such as liberal Sen. Elizabeth Warren (Mass.), is the need for more NIH funding.

“To increase innovation, the NIH needs more resources,” she said. “We need to double down on support for NIH.”

Alexander raised the possibility of allowing the NIH to roll over its funding into subsequent years, 

FDA officials also pointed out that they have trouble retaining talented people because the private sector pays so much more. 

“We are the training ground for industry,” said Dr. Jeffrey Shuren, director of the FDA’s device center. “I train them, they are remarkable, and they leave and get salaries two or more times [the FDA rate].”

He said the turnover is an obstacle for the approval process when people leave in the middle of a review.

Closing the hearing, Alexander said he is looking for bipartisan consensus. 

“If we wanted to talk about ObamaCare or right-to-work laws, we could have a big fight on this committee,” he said. “Sen. Murray and I aren’t interested in having a big fight.”

Tags Elizabeth Warren Lamar Alexander Patty Murray
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