Race on to speed OK of new drugs, devices

In a rare show of cooperation that could speed up the development process for new drugs and devices, the secretary of Health and Human Services has made working with the GOP a top priority.

Urged on by President Obama, Secretary Sylvia Mathews Burwell has told Sen. Lamar Alexander, chairman of the Senate Health, Education, Labor and Pensions Committee, and the panel’s top Democrat, Sen. Patty Murray, that the department is all in with working to modernize the drug and device development process to fix the bottleneck.

In an interview with Secrets, Alexander, a Tennessee Republican, said he talked to the president about it recently and was given “more than a hint” that cooperation was planned.

“I talked to the president about this. The next week I got a call from Secretary Burwell and she has made it clear to her staff, to Sen. Murray and me that this is a priority of the administration.”

However, cautious about past promises to make music together, Alexander said in the end it is up to the president to agree on any deal. “The question is, can we do business with the president?”

Alexander’s panel, and the key House committee involved, are moving forward on plans to speed up the drug and device development process, made easier with modern and speeded up research. The House Energy and Commerce Committee have already set up a program called 21st Century Cures and Alexander plans a similar effort by year’s end.

In the meantime, his panel has produced a voluminous report on the issue that most Americans are familiar with: It takes too long for drugs and devices to be developed, tested and approved.

Alexander said that he would like to shorten the current 8-10 year period from discovery to application for Food and Drug Administration approval. He also wants to tighten the approval period.

He pointed to the efforts to develop an Ebola vaccine as a good model. There Burwell accelerated clinical trials of experimental drugs, but it will still take years to prove they are safe.

Maybe just as important as the cooperation are Burwell’s efforts to keep in touch with Alexander and congressional Republicans — and Democrats — on issues both have interests in. Alexander said that Burwell, he and Murray, a Washington Democrat, have quarterly breakfasts and Burwell was hosted by his panel this week for a “wine and cheese hour” where discussion of speeding up drug and device development was “a major subject.”

Paul Bedard, the Washington Examiner’s “Washington Secrets” columnist, can be contacted at [email protected].



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