The Good, the Bad, and the Brown.

Some brickbats and bouquets from the March 14 HELP hearing, “Drug User Fees: Enhancing Patient Access and Drug Safety” ...

Bouquets to Senator (Chairman) Kennedy who said the user fee system “demonstrates the failure by Congress to give FDA the funds it needs to do the job that the American public counts on it to do.” And that Congress should “correct this failing, so that FDA does not have to rely excessively on user fees for its basic budget.”

Brickbats to Senator Mikulski who believes there is a “perception that FDA is politicized” because of events like Dr. Susan Wood’s resignation as the Office’s Director, and recent reports that Dr. von Eschenbach intends to cut the Office’s budget by 25%.

And bouquets to Commissioner von E for “clarifying” that reports about a proposed 25% cut in the Office’s budget are “misperceptions.” He stated that he has “no intention to reduce FDA’s commitment to women’s health.”

Bouquets (along with the Dan Troy Prize for First Amendment Sensitivity) to Senator Richard Burr who pointed out that S. 484’s two-year ban on DTC for certain products “will probably not meet a constitutionality test.”

And brickbats to Senator Sherrod Brown who shrugged off the relevance of the US Constitution by commenting that he’s not sure if there are constitutional issues related to limiting DTC advertising.

(Note to Drugwonks readers – we are sure.)

We award our final bouquet to Mark McClellan who pointed out to the committee that that FDA “needs the manpower, technical skills, and technical support to carry out their increasingly complex oversight requirements effectively.” And that “we should aim for nothing less than world class data for evaluating drugs through their lifecycle.”

Amen.

FYI -- Complete witness testimony is available at:

http://help.senate.gov/Hearings/2007_03_14/2007_03_14.html

Enjoy.