The Food and Drug Administration Safety and Innovation Act (FDASIA), the Senate's iteration of a package of user fee legislation and other regulatory reforms, advanced in the Senate on 21 May, moving the legislation one step closer to passage.
On 21 May, a "motion to proceed to consideration of measure," was passed, allowing the bill to advance for final debate and markup. A final vote on FDASIA is expected to occur between 23-25 May.
The legislation was delayed on 17 May after disagreements emerged over which amendments to the bill would be allowed. A benefit to that delay is likely to be the inclusion of a lot-level track and trace system, reports The Pink Sheet Daily.
The system would be phased in over the course of several years, but does not yet include a timeline for implementation, likely leaving much of the development of the system in the hands of the US Food and Drug Administration (FDA).
"The bill language is broadly similar to the industry proposal, and even incorporates the term "RxTEC" to describe the kind of information that should be encoded on products," explained The Pink Sheet Daily.
Meanwhile, Senate Majority Leader Harry Reid has called for FDASIA to be passed as soon as possible, reports The Hill.
"The FDA bill, which will prevent drug shortages and make life-saving medicines available more quickly, must not become another victim of this partisanship," said Reid. "I hope Republicans seize this opportunity to be cooperative rather than combative."
The Senate is scheduled to reconvene at 10:00 am on 22 May to resume consideration of FDASIA, otherwise known as S. 3187, with a vote expected to occur after 2:15 pm.
If the bill is passed by the Senate, a similar bill-the FDA Reform Act-would still need to be passed in the House of Representatives, after which time the bills would need to be combined into a single piece of legislation. That piece of combined legislation would need to be voted on again in both the Senate and House before going to the President to be signed into law.
Bill Status Summary - the Food and Drug Administration Safety and Innovation Act
The Pink Sheet - Lot-Level Track And Trace System Outlined In Senate Manager's Amendment To PDUFA Bill
The Hill - Reid calls for bipartisan truce on FDA bill this week
The Hill - Reid advances FDA billRegulatory Focus - User Fee Bill Delayed in Senate as Cloture Vote Forced