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FDA is Broken Puts Americans at Risk

Posted by Jane Akre
Tuesday, December 04, 2007 1:27 PM EST
Category: Major Medical, Protecting Your Family
Tags: Defective Drugs, Medical Devices and Implants, U.S. Food and Drug Administration (FDA)

FDA Broken


* Read the FDA report, "Science and Mission at Risk"

* See the FDA home page 

The report is enough to make anyone afraid. 

The Food and Drug Administration, (FDA) so often portrayed as the final safety net that ensures the safety of the American food and drug supply, is broken according to a new report.

The 56-page report by an expert panel titled "FDA Science and Mission at Risk,"  basically concludes that under funding at a time of expanded responsibility has put American lives at risk.

For example, the FDA is losing inspectors who oversee the safety of our food supply. So far about 600 over the last four years.  Just two inspectors oversee pet food safety. The FDA staff has been cut 14 percent over the last dozen or so years.

The agency's computer system is so old that technicians must be brought out of retirement to fix it because new IT department's haven't seen the antiquated system. And then there are those who don't even have a computer. Oftentimes inspectors have to rely on handwritten notes to compile inspection reports.

Who is to blame- not the FDA says the report, but Congress which repeatedly cuts the FDA's budget while requiring more responsibility for the agency. 

Gail Cassel, co-author of the report tells ABC News that, "The wheels are coming off. In fact, I would say they're off. They're already off."

The agency was created in 1938 as the Federal Food, Drug and Cosmetic Act at a time when its role was simpler.

Since then the "demands on the FDA have soared" says the report specifically in the number of new products that need review, the complexity of those products and the globalization of industries.

The drug industry has gone from cellular to molecular to gene-based technologies while the FDA procedures for drug review remain largely unchanged over the last half century.

Today the agency regulates $1 trillion in consumer products from pet food to pharmaceuticals, food to cosmetics and toiletries. 123 new statutes have been added since 1988 while the agency lost $300 million due to inflation. 

Cassell is vice president for scientific affairs at Eli Lilly & Co. She and other representatives  from Genentech and Wyeth drug companies prepared the study for FDA Commissioner Andrew Von Eschenbach at his request last year. 

The FDA is requesting a $2.1 billion dollar budget for 2008 with $250 million going to food safety.

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