FDA could use more appropriations
FDA could absorb an additional $100 million in funding over that proposed by the Bush Administration for fiscal 2009, but not the full $375 million recommended by the FDA Science Board, Commissioner Andrew von Eschenbach tells the Senate Appropriations Committee at an April 15 hearing. "We could absorb the $100 million that you referred to, and do that quite rapidly and quite effectively," he told the panel. "As we would get closer and closer to the [$375 million] ... it would require greater stewardship to be sure we could implement those dollars as rapidly and effectively as we need to," he said. The administration's proposal provides a $51 million increase over 2008 in direct appropriations to FDA, bringing federal funding to $1.77 billion in FY 2009 (1"The Pink Sheet," Feb. 11, 2008, p. 4). "It may be our responsibility to fix OMB's mistake here. And you probably have more friends here than you might have at other places in town," Sen. Robert Bennett, R-Utah., told the commissioner. An amendment sponsored by Sen. Ted Kennedy, D-Mass., would increase FDA appropriations according to the Science Board's recommendations for a $375 million increase over fiscal 2008 in direct appropriations to FDA for 2009, and larger increases in each of the following five years (2"The Pink Sheet," March 3, 2008, p. 9)
More from Archive
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
More from Pink Sheet
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.