FDA evolves

Don't think I would have miss out on this one! This is exciting news--Margaret Hamburg, FDA Commissioner of 8 weeks, is improving things around the office. But I won't rush into giving the FDA too much credit, because this timing seems perfect for personal and political reasons.

Hamburg noted, without much difficulty of course, that FDA enforcement during the Bush Administration was lax. aka. it sucked. It was heavily motivated by capitalism and corporatism, without consistently looking out for the common good of the people. Under Obama's presidency, Hamburg made it quite clear her process for change. She is opting for greater scrutiny on behalf of the FDA in the direction of companies, by eliminating lengthy wastes of time between actions. Her six steps are outlined as follows:

1) There will be 15 day deadlines following all company inspections
2) The warning letter process, following 15 day deadline, will be voided of revision by the Office of Chief Counsel (thus decreasing duration of response times)
3) State and local officials will deal more closely with FDA regulatory partners
4) Following distribution of warning letters, there will be quicker form of action
5) Observation of public health risks will cause immediate inspections and warning letters
6) Publication of warning letters to the world wide web following inspection

The seriousness of this change in FDA regulations will only be assessed following company responses, ie. how serious they take this change. Whether a personal motivation, on behalf of Hamburg whom has only been in commission for 8 weeks (and thus possibly attempting to gain advances), or not, this could evoke a VERY positive response from the American public. Don't be fooled, however. This does not change FDA relations with pharmaceutical and agricultural companies. When fiscal matters are invovled, there is no doubt that the FDA will follow its previous trend in bartering for personal benefits. No doubt, I am very interested to see what the outcomes are. The Obama administration promises change, and with health care reform being at the top of the list, this is an excellent place to begin.