Senators Draft Bill to Expedite Drug Approval

Posted 27 March 2012 | By Alexander Gaffney, RAC 

A piece of legislation introduced this week by a bipartisan group of three Senators would "expedite US Food and Drug Administration (FDA) approval and provide more flexibility when a drug or treatment shows dramatic responses early in development, while still ensuring drug safety and efficacy," according to the Senators.

Sens. Michael Bennet (D-CO), Richard Burr (R-NC) and Orrin Hatch (R-UT) introduced the Advancing Breakthrough Therapies for Patients Act (ABTPA) on 26 March, saying they hope the bill will speed treatments to patients and avoid a process that is currently "slowed down by government red tape."

The bill would allow FDA to approve "innovative" clinical trials, including ones with shorter durations and fewer patients.

"Our bill provides the flexibility in approval mechanisms so home-run treatments that show great promise early on reach patients more quickly," said Bennet in a statement. "It also strikes a careful balance between providing regulatory certainty for developers of these breakthrough treatments and maintaining the level of drug safety and efficacy patients expect and deserve."

The bill is likely to be referred to the Senate Health, Education, Labor and Pensions (HELP) Committee for further review, study and markup.

Read more:

Statement - Hatch, Bennet, and Burr Introduce Bipartisan Bill to Bring Breakthrough Treatments to Patients More Quickly (The Bill)

BioCentury - Senate bill seeks to speed approvals of 'breakthrough therapies'

Pharmalot - Yet Another Bill to Speed FDA Drug Approvals  (The Bill)

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