House Energy and Commerce Advances HR 6; Includes FDA Funding, Sequestration Relief and more
Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.
House Energy and Commerce Advances HR 6; Includes FDA Funding, Sequestration Relief. H.R. 6, the newly introduced version of 21st Century Cures, was marked up by the House E&C Committee this week. The manager’s amendment adopted by House E&C:
Contains $550 million over 5 years to support specified responsibilities* that H.R. 6 would add to FDA’s workload. The money, not subject to appropriations, would become available to the agency directly as a mandatory program.
Adopts language that would prevent sequestration of FDA user fees in the future, re-establishing that these are private, not governmental contributions and therefore should not be used for federal deficit reduction.
For more insights into the Committee action and next steps, check out this week's Analysis and Commentary.
Alliance Releases Statement on H.R. 6, Cures Legislation. The Alliance responded to media inquiries with the following brief statement: The Alliance thanks the Energy and Commerce Committee for providing more than half-a-billion dollars in funding for the FDA as part of the 21st Century Cures proposal. This money is substantial and truly welcome, and will help the agency fulfill the broad new responsibilities being placed on it, should the legislation become law. We are especially encouraged to see an authorizing committee consider the resource implications of the new responsibilities it is giving FDA.We are also pleased that the committee has proposed to exempt user fees from the sequester. User fees are special-purpose funds intended to achieve specific results, and were never meant for deficit reduction purposes.
FDA Announces July 13 MDUFA Meeting. FDA has scheduled July 13 for the first public meeting on reauthorization of the Medical Device User Fee Act (MDUFA). The MDUFA public meeting will take place 2 days before a July 15 Prescription Drug User Fee Act (PDUFA) meeting.
-----* The specified responsibilities that would be paid for by the Cures (FDA) Innovation Fund include development of data on natural history of diseases; support for the Council for 21st Century Cures; development and use of patient experience data to enhance structured risk benefit assessment framework; qualification of drug development tools); utilizing evidence from clinical experience; and grants for studying the process of continuous drug manufacturing.