UPDATED: Industry Stakeholders, FDA "Agree in Principle" to Double MDUFA Fees
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Posted: 1 February 2012
By Alexander Gaffney
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Several news organizations are reporting that parties are close to a deal in the negotiations over the Medical Device User Fee Act (MDUFA). The agreement between the US Food and Drug Administration (FDA) and stakeholders from the medical device industry would double the user fees industry currently pays to FDA in return for a faster and more predicable approval pathway, reports Bloomberg and Reuters.
The MDUFA legislation charges medical device manufacturers fees to submit their products for FDA approval, which in turn allows FDA to hire more review staff to review products expeditiously. Under the 2007 iteration of MDUFA, FDA needed to submit a new MDUFA proposal to congress by 15 January 2012.
Multiple sources from the talks confirmed that the amount paid by industry would double from $287 million in fees over the last five years to roughly $595 million over the coming five years.
In return for the fees, FDA will reportedly improve the speed and reliability of the device review process, hire an outside consultant to evaluate its review system and will meet with manufacturers in the middle of the device review process to give “companies more time to respond to questions,” reports Reuters.
The Medical Device industry has long complained about last-minute FDA requests for more data, but there were disagreements during MDUFA negotiations over what those additional meetings and resources would cost FDA.
The news that negotiators have reached an agreement comes not a moment too soon. The House Energy and Commerce Committee is scheduled to hold a hearing on the legislation on 15 February. FDA Center for Devices and Radiological Health Director Jeffery Shuren is scheduled to testify at that hearing.
Once hearings on the MDUFA legislation are completed, the legislation — the existing iteration of which expires in September — faces a constricted Congressional window.
Congressmen typically leave Washington, DC, several months early during an election year to return to their respective districts and campaign. The current congressional calendar has both the Senate and House of Representatives leaving town on 3 August and not returning until 10 September. The House is only scheduled to be in session for eight days in September, and the Senate for only eleven days.
The presence of the Republican and Democratic national political conventions in late August and early September, respectively, also raises the prospect that the must-pass legislation could be subject to a heated political climate by September. Political earmarks, addendums and brinksmanship between the House and Senate could also complicate the legislation’s passage.
UPDATE: FDA is confirming the agreement in a statement posted on their website.
"The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program.The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon."