Free Newsletter
Acting FDA chief promises science, not politics
Want the skinny on the acting FDA chief straight from the horse's mouth? You're in luck. His first full day on the job, Dr. Frank Torti penned a "viewpoint" memo, which you can read--or listen to--on the FDA website. (Thanks to Eye on FDA for the link.) He begins with a sort of disclaimer: The job of Acting Commissioner is tougher than that of a permanent one, because agency staff tend to look askance at a temporary chief's orders. After all, an acting chief may not be acting for long.
But, Torti says, the FDA needs help--now. He asked Congress to help reshape the agency and provide the necessary resources and powers to get the job done. He emphasized the role of "scientific thought and process" in regulatory decisions, perhaps in response to those agency scientists who recently accused management of engendering a "culture of corruption" where science takes a backseat. And he specifically said that politics should have "no standing in regulatory decisions."
Promising pledges. But as Eye on FDA notes, with so much reform needed at the agency, the Obama administration needs to get a move on and appoint a permanent commissioner. Because whether his staffers listen and obey or not, Torti can't take on the kind of sweeping overhaul that a permanent commissioner can.
- read Torti's viewpoint
- check out the post at Eye on FDA
Related Articles:
FDA scientist Torti moves to the helm
Who will take over at the FDA, HHS?
FDA reform doesn't top Obama's list
FDA scientists plea for agency reform
Sweep the FDA clean, Stupak says
Kindler: Take politics out of the FDA
Comments
By Anonymous | Posted 2:40am | January 30, 2009
I would like an answer to this. Please.... Why is it that FDA calls in outside experts to get additional opinions on a new drug (A great idea) and then does not agree with INVITED EXPERTS WHEN THEY ARE UNANIMOUS in agreeing that it should be marketed. The product is already released in a few European countries (Sugammadex, Schering). FDA believes there are allergies with its use. All package inserts on virtually all products carry such a warning. If you are going to get an allergic reaction to any product or foodstuff, isn't it safer to get it in the O.R. with doctors at your side as opposed to getting it in a restaurant with no treatments or doctors available? If a product is the safest and reduces the effects of a muscle relaxant in 3 minutes so that a patient can be extubated and breath by him/her self? If allergic reaction is all that bothers FDA, then ALL products that carry the same caution should be recalled. When a patient has no history of allergies and gets a reaction from an antibiotic or some other drug or chemical in the O.R. I would think the doctors have a false sense of security before the operation starts. Sugammadex should be approved immediately. How many problems have occurred as a result of not negating the muscle relaxant and were they more severe than what can happen with Sugamadex? Are those important questions to ask? Please give me an answer.
Post new comment
Paid Research Reports
- The Specialty Pharma Market Outlook: Key players, new company growth models and emerging opportunities
- Investigating Clinical Trial Costs: Comparative analysis of trial cost components in key geographies
- Clinical Trial Recruitment Strategies: Optimizing patient recruitment and retention in late stage clinical trials
- Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies
- Stakeholder Opinions: Vaccines in Emerging Markets (Asia) - Opportunities in China, India, South Korea and Taiwan
- Big Pharma Performance Before, During and Beyond the Global Recession
SHARE
WITH: