Senate Moves To Floor Phase For Innovation Bill; Postmarket Surveillance, LDTs Could Get Attention
This article was originally published in The Gray Sheet
The Senate HELP Committee passed more measures for its planned medical innovation bill, including one affecting FDA's issuance of guidances versus formal rulemaking, and another in support of the administration's Precision Medicine initiative at an April 6 markup. Leadership also promised later floor debate on laboratory-developed test regulations and a device postmarket surveillance bill.
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A combined House/Senate "21st Century Cures" package will get a vote in the House on Nov. 30, and soon in the Senate. The medical innovation package includes a breakthrough device pathway that, in its current form, would allow 510(k), as well as PMA and de novo, devices to participate. The bill also provides a modest $500m to help support a range of additional FDA device and drug pathway streamlining reforms. Meanwhile, it would authorize $4.8bn for the Precision Medicine Initiative, a BRAIN Initiative, and for cancer "Moonshot" research funds at NIH.
When Congress returns to work after the summer recess, the House and Senate medical innovation packages may gain momentum as legislators seek a “feather in the cap” for reelection campaigns, and House Energy and Commerce Committee Chair Fred Upton and Vice President Joe Biden look to cement legacies, say legislative analysts. Also, a Zika virus funding rider is expected be attached to a continuing resolution.
AdvaMed's new chief Scott Whitaker says industry doesn't want to sign onto a new "national evaluation system" for devices championed by FDA until it is convinced that the initiative will enhance, rather than hinder, premarket product development.