Sludge Watch ==> Drugs in effluent and sludge - FDA fails to monitor adequately

[Maureen Reilly]

What's behind woes at the FDA?



By Ricardo Alonso-Zaldivar

Tribune Newspapers: Los Angeles Times

Published October 5, 2006





WASHINGTON -- The federal Food and Drug Administration has been in the 
spotlight because of problems in two of its most important areas of 
responsibility: making sure the food supply is uncontaminated and that 
prescription drugs are safe.



The recent outbreak of E. coli infections linked to California-grown spinach 
has exposed weaknesses in federal food safety regulation. FDA and FBI agents 
on Wednesday searched a Natural Selection Foods plant in San Juan Bautista 
and a Growers Express plant in Salinas to learn whether the two produce 
companies followed proper food safety procedures, The Associated Press 
reported.



Separately, a panel of the Institute of Medicine has found serious gaps in 
the way the FDA monitors prescription drugs to catch rare but potentially 
deadly side effects.



Q: How can one federal agency have such problems?



A: The FDA's regulatory responsibilities are vast, while its budget and 
staff have been squeezed in recent years. And when something goes wrong with 
an FDA-regulated product, people often are harmed, sometimes killed.



Q: Did the FDA abuse its power by warning consumers not to eat any fresh 
spinach when the search for contamination is focusing on only a few fields?



A:   A warning against eating any fresh spinach might be a blunt instrument, 
but FDA officials said they had to take sweeping action quickly because 
initially they couldn't be sure how widespread the problem might be. And the 
early cases included one death.






Q: So why didn't the FDA prevent the E. coli contamination?



A: Spinach and other farm produce aren't as closely tracked and regulated by 
the government as meat and poultry, which are overseen by the Department of 
Agriculture. The FDA's system for ensuring that farm produce is safe rests 
on voluntary adherence to good agricultural practices by growers, packers 
and shippers.



Although meat plants have an on-site inspector, producers regulated by the 
FDA can expect to see an inspector once every 5 to 10 years, on average.



Q: Will the government now put an inspector in every spinach field?



A: No, but FDA officials have indicated that some kind of closer regulation 
might be needed.



Q: What about prescription drugs? Doesn't FDA approval mean that a 
medication is "safe and effective?"



A: What it means is that a drug is safe and effective as far as the FDA 
knows from data available at the time of approval.



The Institute of Medicine panel found that the FDA devoted too much energy 
and resources to studying drugs before approval and not enough to monitoring 
the medications once they were on the market.



The panel also said the FDA needs to increase the number of scientists who 
follow post-approval safety.





Q: Is there any link between the FDA's drug and food safety problems?



A: There seem to be two links: lack of leadership and lack of resources.



The agency has been under acting commissioners for most of the Bush 
presidency. Andrew von Eschenbach is seen as a capable leader, but his 
confirmation by the Senate is up in the air. An acting chief can keep the 
wheels turning but generally lacks the clout to make major changes.



As for resources, an internal FDA analysis found that funding for its food 
and drug safety responsibilities hasn't kept pace in the face of rising 
personnel costs in recent years.





Chicago Tribune

http://www.chicagotribune.com/news/nationworld/chi-0610050066oct05,1,3756197.story?coll=chi-newsnationworld-hed