FDARA Passed by Senate, Senator Johnson Gets Vote on "Right to Try"

August 3, 2017
The Center for Biosimilars Staff

The Senate today passed the FDA Reauthorization Act of 2017 (FDARA) in a roll call vote.

The Senate today passed the FDA Reauthorization Act of 2017 (FDARA) in a roll call vote.

The bill, which reauthorizes user fees for biosimilar product applications, among other provisions, will ensure funding for the continued operations of the FDA. The Senate voted on the bill following Senate Majority Leader Mitch McConnell’s (R-Kentucky) Tuesday filing of a cloture motion (limiting consideration of a pending bill to 30 additional hours) on the bill to proceed.

Despite the fact that the FDARA had broad, bipartisan support and had been passed by the House on July 13, the Senate’s consideration of the bill was delayed by contentious debate over Republican efforts at healthcare reform. The act also faced pressure from Senator Ron Johnson (R-Wisconsin), who had vowed to block the legislation’s passage unless it included an amendment comprising his “right-to-try” legislation.

However, Inside Health Policy reports that sources close to the Senate say that Johnson agreed not to hold up the timely passage of the FDARA in exchange for the swift consideration of his legislation in a separate vote. The Senate passed Johnson’s bill, the “Trickett Wendler, Frank Mongiello and Jordan McLinn Right to Try Act of 2017,” just hours before the vote on FDA reauthorization. Johnson’s sponsored legislation will allow patients who are terminally ill to access experimental treatments that are under investigation, though not yet approved, by the FDA.

While Senator Johnson eventually supported the bill, Senator Bernie Sanders (I-Vermont) cast the sole vote in opposition. Sanders, who had demanded that the FDARA include provisions for the importation of cheaper drugs from other countries, had previously voted against advancing the bill out of committee.

Now that the FDARA has passed both houses, it faces one last potential hurdle: the Trump Administration. On July 12, the White House released a statement asserting that Congress should provide for 100% of FDA program funding through user fees. While the statement indicated that the administration was in support of the goals of the act, it remains to be seen whether that support will extend to the fee structure agreed upon by Congress.

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