Following its Senate counterparts, the Energy & Commerce health subcommittee on Thursday advanced a bill to reauthorize the user fee agreements over the next five years for drugs, generic drugs, medical devices and biosimilars. All four amendments were agreed to, including one to increase generic drug competition and provide 180-day exclusivity for first generics where there’s a limited market, one on protecting the supply chain, one on improving the process for me...

Secretary of Health and Human Services (HHS) Tom Price is continuing to push the Senate to further increase the industry fees paid to the US Food and Drug Administration (FDA), which would upend the agreed-to amounts negotiated by FDA and industry for the next five years, and allow for further cuts to the agency’s congressional appropriations. Last week, the Senate Health, Education, Labor & Pensions (HELP) committee advanced a bill reauthorizing the user fee pro...

As part of a bid to bring down the price of pharmaceuticals in the US, Reps. Jan Schakowsky (D-IL), Keith Ellison (D-MN), Rosa DeLauro (D-CT) and 33 other House members sent a letter to President Donald Trump on Monday seeking a way forward to meet the promises he’s made on the campaign trail and since taking office. Among the suggestions is to attach drug price lowering provisions to the bill reauthorizing the US Food and Drug Administration (FDA) user fee agreem...

The Senate Committee on Health, Education, Labor & Pensions on Thursday advanced by a vote of 21-2 a bill that would reauthorize the pharmaceutical, medical device, generic drug and biosimilar user fee agreements that expire at the end of September. Two additional amendments were added to the latest version of the bill , one from Sens. Orrin Hatch (R-UT), Michael Bennet (D-CO), Richard Burr (R-NC), and Bob Casey (D-PA) on expanded access to drugs and one from Sens...

This article provides an overview of upcoming important changes to FDA's major user fee programs (PDUFA VI, MDUFA IV and GDUFA II) for Fiscal 2018–2022. It discusses new performance goals, additional commitments FDA has agreed upon with industry and how these changes could impact various types of industry submission strategies. 1-3 Introduction Prior to the passing of the Prescription Drug User Fee Act ( PDUFA ), FDA experienced backlogs in its drug approval proces...

Ahead of Wednesday’s Senate health committee vote on the five-year reauthorizations of the US Food and Drug Administration (FDA) user fee agreements, the committee has released an updated version of the legislation that includes several medical device bills discussed on the House side. The so-called manager’s amendment of the bill features the same drug, medical device, biosimilar and generic drug user fee agreements crafted over the past two years, as well as ne...

Next Wednesday, the Senate Committee on Health, Education, Labor & Pensions will vote on the five-year reauthorization of the four US Food and Drug Administration (FDA) drug, medical device, biosimilar and generic drug user fee agreements. The current, five-year agreements are set to expire 30 September 2017, though if Congress fails to act before its summer recess, thousands of FDA employees would receive layoff notices. The proposed reauthorizations, grouped ...

The US House and Senate appropriations committees on Monday released government spending bills through the end of this fiscal year, offering the US Food and Drug Administration (FDA) a boost in discretionary spending and user fee revenues. In total, the agreement on spending through 30 September 2017 contains $153.4 billion in discretionary and mandatory funding, which is $16.3 billion below President Donald Trump’s FY2017 budget request and $12.5 billion above the FY20...

With the deadline for reauthorizing the US Food and Drug Administration's (FDA) user fee programs rapidly approaching, members of the House Energy & Commerce Subcommittee on Health are considering a handful of device-related bills to include with the reauthorization package. On Tuesday, the E&C subcommittee will discuss four bills that look to make hearing aids more accessible to patients over-the-counter , overhaul FDA's inspection program for device establishments , ...

This article discusses key points and benefits of the Prescription Drug User Fee Act (PDUFA) for those filing a New Drug Application (NDA) and explains how PDUFA user fees have played an important role in expediting FDA's drug approval process. Introduction: Benefits Offered by PDUFA When planning a New Drug Application (NDA) or other type of marketing application, regulatory professionals must consider many things. These considerations include: when the data will com...

With an aim to avoid thousands of US Food and Drug Administration (FDA) employee layoffs, House and Senate committees on Friday released a draft bill to reauthorize the user fee programs for pharmaceuticals, generic drugs, medical devices and biosimilars from 2018 to 2022. Forged via negotiations between FDA and the various industries dating back to 2015, and racing to beat a September deadline, the bills sequentially increase the amount of user fees FDA can assess for r...

Representatives from the biotechnology, medical device and generic drug industries told members of the Senate Committee on Health, Education, Labor & Pensions on Tuesday that if the five-year user fee programs are not reauthorized, the US Food and Drug Administration (FDA) would likely see more than 3,000 job cuts. Those layoffs, if Congress and President Donald Trump fail to act before 1 August or Congress’ summer recess, would significantly curtail new medical product...