The Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies on Tuesday voted to advance its draft FY2018 appropriations bill, which includes $2.8 billion in discretionary funding for the US Food and Drug Administration (FDA). The full Appropriations Committee is scheduled to meet Thursday to mark up the bill before voting to advance it to the Senate for consideration. While the funding levels in the bill d...

Editor's note: This article has been updated with the number of vacancies at CDER as of 8 July 2017. Looking to fill a "substantial" number of job vacancies, the US Food and Drug Administration (FDA) will soon pilot new hiring and recruitment procedures for its drugs and biologics programs. In a blog post Monday, FDA Commissioner Scott Gottlieb said the agency has struggled to keep pace with its staffing needs as it confronts increasingly complex and specialized produ...

Following the House of Represenatatives' passage of the bill to reauthorize US Food and Drug Administration (FDA) user fees on Wednesday, the White House doubled down on its earlier call to amend the agreements so that FDA is entirely funded by medical products industries. "The Administration urges the Congress to provide for 100 percent user fee funding within the reauthorized programs," the White House said in a statement . "In an era of renewed fiscal restraint,...

In a moment of bipartisanship, the US House of Representatives on Wednesday passed a bill via voice vote to reauthorize the prescription drug, generic drug, medical device and biosimilar user fee programs through 2022. Several representatives discussed the issue of expensive medicines on the House floor Wednesday, though none of the user fee programs address the issue directly. However, speeding the review of generic drugs could lower some high-priced brand name dr...

The US House of Representatives on Wednesday will take up a bill to reauthorize the US Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar and medical device user fee programs, and though the Senate has not yet scheduled a time to take up the bill, it is expected to before thousands of FDA employees are laid off. The bipartisan House user fee bill , which sailed through the Energy & Commerce committee unanimously last month, has be...

May and June 2017 have seen the most generic drug approvals since the US Food and Drug Administration (FDA) began tallying its monthly approvals, lending credence to FDA Commissioner Scott Gottlieb's pledge to speed approvals and lower drug costs. According to the activities report of the generic drug program , FDA approved and tentatively approved 96 generic drugs in May and 100 in June (a level FDA has not seen since December 2015 when 99 generics were approved and...

The US Senate and House of Representatives have given themselves a little more than 10 working days to finish a bill to reauthorize the US Food and Drug Administration (FDA) drug, generic drug, medical device and biosimilar user fee programs and get it signed by President Donald Trump before thousands of FDA employees will receive layoff notices. In the Senate, the bill advanced through the Health, Education, Labor & Pensions Committee almost unanimously in May. T...

As Congress looks to reauthorize the US Food and Drug Administration's (FDA) user fee programs, the Government Accountability Office (GAO) on Monday released a report saying that FDA should develop a plan for managing unspent fees collected from generic drugmakers. "Such a documented plan could aid Congress in determining the appropriate amount of user fees to be collected by the agency during the annual appropriations process and when considering a reauthorization of th...

The Congressional Budget Office (CBO) on Thursday released its cost estimate for the Senate's bill to reauthorize the US Food and Drug Administration's (FDA) user fee programs, saying the agency will need $1.2 billion in appropriations from 2018-2022 to implement changes brought on by the bill. The estimate is based on the version of the FDA Reauthorization Act of 2017 that was advanced by the Senate Committee on Health, Education, Labor & Pensions in May. Notably, t...

In preparation of its commitments under the second Generic Drug User Fee Amendments (GDUFA II) , the US Food and Drug Administration (FDA) on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs. Under GDUFA II, FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a complete and accurate pre-submission facility correspondence (PFC) two months ahead of their a...

The House Energy and Commerce Committee on Wednesday voted unanimously (54-0) to advance its bill to reauthorize the US Food and Drug Administration's (FDA) user fee programs for prescription and generic drugs, biosimilars and medical devices to the full House. The committee also adopted several amendments to the version of the bill, known as the FDA Reauthorization Act of 2017 , that came out of the health subcommittee on 18 May. And, in an effort to move the bill f...

This article examines the benefits for both FDA and the medical device industry derived from "user fees" authorized by the passage of the Medical Device User Fee Act (MDUFA 2002) and its subsequent reauthorizations. 1 Introduction The category "medical devices" encompasses a wide variety of products intended for diagnosing diseases or other conditions as well as the cure, mitigation, treatment or prevention of disease. 2 Among its responsibilities, the US Food and D...