LAT: Panel: FDA Needs More Clout to Monitor Safety (of medical devices)

[DeepModem Mom]

Panel: FDA Needs More Clout to Monitor Safety
By Ricardo Alonso-Zaldivar, Times Staff Writer


WASHINGTON -- Government regulators lack an effective system to monitor the safety of medical devices, which range from incubators for premature babies to surgical clamps and cardiac pacemakers, a scientific panel concluded in a report issued today.

The Food and Drug Administration, which is responsible for the safety of medical devices as well as drugs, needs additional legal authority from Congress and better internal procedures, according to an Institute of Medicine panel.

The institute is affiliated with the National Academy of Sciences, which provides the government with independent advice on scientific issues.

An FDA official said the report was constructive....

***

"This report exposes a fissure in the FDA's safety mission," Sen. Charles Grassley (R-Iowa), who has written legislation to reform the FDA's drug safety office, said in a statement. "These are the same kinds of problems we see with the review of medicines."...


http://www.latimes.com/news/nationworld/nation/la-071805fda_lat,0,2018065.story?coll=la-home-headlines

[Trillo]

1. Why is it always "more, more, more?"

They need "more" legal authority even after their proven failures with all the new and recalled drugs? Seems to me like those recalls indicts their processes as part of the corporatists' pharma-phenomenon.

Next step? They'll need more MONEY to enforce their EXPANDED authority.

Maybe they need LESS instead of MORE.

[Robbien]

2. The FDA under BushCo doesn't want to regulate anything

unless of course they can help out a company which supports BushCo by sabotaging one of its competitors.