Bouquets to Senator (Chairman) Kennedy who said the user fee system â€œdemonstrates the failure by Congress to give FDA the funds it needs to do the job that the American public counts on it to do.â€ And that Congress should â€œcorrect this failing, so that FDA does not have to rely excessively on user fees for its basic budget.â€
Brickbats to Senator Mikulski who believes there is a â€œperception that FDA is politicizedâ€ because of events like Dr. Susan Woodâ€™s resignation as the Officeâ€™s Director, and recent reports that Dr. von Eschenbach intends to cut the Officeâ€™s budget by 25%.
And bouquets to Commissioner von E for â€œclarifyingâ€ that reports about a proposed 25% cut in the Officeâ€™s budget are â€œmisperceptions.â€ He stated that he has â€œno intention to reduce FDAâ€™s commitment to womenâ€™s health.â€
Bouquets (along with the Dan Troy Prize for First Amendment Sensitivity) to Senator Richard Burr who pointed out that S. 484â€™s two-year ban on DTC for certain products â€œwill probably not meet a constitutionality test.â€
And brickbats to Senator Sherrod Brown who shrugged off the relevance of the US Constitution by commenting that heâ€™s not sure if there are constitutional issues related to limiting DTC advertising.
(Note to Drugwonks readers â€“ we are sure.)
We award our final bouquet to Mark McClellan who pointed out to the committee that that FDA â€œneeds the manpower, technical skills, and technical support to carry out their increasingly complex oversight requirements effectively.â€ And that â€œwe should aim for nothing less than world class data for evaluating drugs through their lifecycle.â€
FYI -- Complete witness testimony is available at: