US House Committee Moves Forward Bill Reauthorizing User Fees for Rx Drugs, Generics, and Biosimilars

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-09-2017 09:30


In a vote of 54-0, the Energy and Commerce Committee of the US House of Representatives voted to advance the bill, The FDA Reauthorization Act (H.R. 2430), which reauthorizes user fees for prescription drugs, generic drugs, and biosimilars. The bill now goes to the full House for consideration.

The bill is a product of a bipartisan efforts, begun, in mid-April 2017, when members of the US House and Representatives and the US Senate proposed a discussion draft of the FDA Reauthorization Act of 2017

User fees for prescription drugs, generic drugs, and biosimilars are authorized every five years, and the current user-fee programs are scheduled to expire at the end of September 2017 and need Congressional authorization to continue.

The House bill also includes an additional amendment sponsored by Rep. Jan Schakowsky (D-IL) that encourages Congress and the Department of Health and Human Services  to commit to working on legislative and administrative actions that could lower the cost of prescription drugs and increase competition in the market.

The US Senate is also considering its version of the The FDA Reauthorization Act. In May 2017, the US Senate Health, Education, Labor and Pensions Committee voted to move forward a bill (S. 934) for reauthorization of user fees with certain amendments for consideration for the full Senate.

Source: US House of Representatives Energy and Commerce Committee


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