CDRH FY 2006 Budget Authority Would Be $165 Mil., With $56 Mil. For Field
This article was originally published in The Gray Sheet
Executive Summary
FDA enforcement activity will receive 70% of the $6 mil. increase President Bush is requesting for the medical device program in fiscal 2006
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CDRH funded in full
House passes the "Agriculture, Rural Development, Food & Drug Administration and Related Agencies Appropriations Act for FY 2006" (HR 2744) June 8, meeting the President's $221 mil. request for CDRH, which would fulfill the estimated MDUFMA funding target, assuming the enactment of "trigger-fix" legislation later this year (1"The Gray Sheet" Feb. 14, 2005, p. 3). Total FDA allotment of $1.5 bil. represents a $36 mil. increase over last year, but falls $14 mil. short of the President's request. An amendment proposed by Rep. Maurice Hinchey (D-N.Y.) and passing via a 218-210 vote would prohibit FDA from granting waivers to advisory panel participants harboring an apparent conflict of interest. Companion legislation is scheduled for mark-up by the Senate Appropriations/Agriculture, Rural Development & Related Agencies Subcommittee June 21 and by full committee June 23...
California compliance law
Assemblywoman Lois Wolk (D-Davis) drops efforts to obtain legal council opinion regarding the applicability of SB 1765 to device makers and will wait to see how the law is implemented (1"The Gray Sheet" April 25, 2005, p. 3). The law, signed in September 2004, requires adoption of compliance programs in accordance with PhRMA and OIG guidelines, beginning July 1. However, "some [device] companies are looking at this and saying that with the provision of substantial compliance and with proper documentation...you could potentially follow the AdvaMed code," AdvaMed Exec VP Blair Childs stated at the association's Emerging Growth Company Conference June 9 in Minneapolis...
CDRH funded in full
House passes the "Agriculture, Rural Development, Food & Drug Administration and Related Agencies Appropriations Act for FY 2006" (HR 2744) June 8, meeting the President's $221 mil. request for CDRH, which would fulfill the estimated MDUFMA funding target, assuming the enactment of "trigger-fix" legislation later this year (1"The Gray Sheet" Feb. 14, 2005, p. 3). Total FDA allotment of $1.5 bil. represents a $36 mil. increase over last year, but falls $14 mil. short of the President's request. An amendment proposed by Rep. Maurice Hinchey (D-N.Y.) and passing via a 218-210 vote would prohibit FDA from granting waivers to advisory panel participants harboring an apparent conflict of interest. Companion legislation is scheduled for mark-up by the Senate Appropriations/Agriculture, Rural Development & Related Agencies Subcommittee June 21 and by full committee June 23...