Senate's User Fee Bill Largely Steers Clear Of Controversy

HELP Committee manager’s amendment lacks provisions on such hot-button issues as off-label drug promotion, REMS abuses and right-to-try legislation.

It appears as if Democrat and Republican lawmakers wanted to avoid any politically charged add-ons with the upcoming US FDA user fee program reauthorizations, as several topics that have received congressional attention were left out of the Senate Health, Education, Labor and Pensions (HELP) Committee’s manager's package.

The manager's amendment – released May 8 in advance of the committee's May 10 markup of the user...

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