Egg Recall, Drug Approval Time Raise Questions About FDA Resources

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Nutrition / Diet;  Public Health;  Pharma Industry / Biotech Industry
Article Date: 03 Sep 2010 - 5:00 PDT



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The recent salmonella outbreak/egg recall is raising questions about whether the FDA is fulfilling its regulatory role, PBS' NewsHour reports. "For the past few years, it's been one food safety scare after another. There was E. coli-laced spinach, salmonella-tainted peppers. ... There have also been problems with drugs. The ingredients in a contaminated blood thinner came from China. And whether the tainted products are from abroad or the United States, it's the Food and Drug Administration's job to make sure they're safe for American consumption. The FDA has received some new money from Congress to police food and drugs, $141.9 million last fiscal year alone just for food safety."

Margaret Hamburg, commissioner of the FDA, however, says the agency lacks the necessary resources to do its job. Online pharmacies present a particular challenge. "While there have been very few reported cases of people becoming sick or dying from taking unapproved or counterfeit drugs, the FDA is concerned because the trade is growing so fast" (Bowser, 9/1).

Meanwhile, The Wall Street Journal reports on a doctor in Belgium who, after drug companies were unwilling to help fund clinical trials for a possible treatment, began injecting himself with a vaccine previously tested only on dogs and rats. "The reason for this desperate measure: Dr. [Stephane] Huberty suffers from myasthenia gravis, a rare neurological condition. It is one of more than 5,000 'orphan' diseases, so called because there are so few sufferers that most pharmaceutical companies are reluctant to invest in cures. ... Taking unapproved drugs is also the last resort for thousands of patients who are desperate to get access to new biological, stem-cell and vaccine technologies that are being invented much faster than regulators can certify them." The FDA "oversees a laborious approval process that requires drug developers to conduct four phases of trials, involving thousands of patients. It can take as long as 10 years to get a drug approved." Self-treatment by doctors has a long and sometimes-checkered past (Miller, 9/2).

This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org.

© Henry J. Kaiser Family Foundation. All rights reserved.



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