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Amber Racine
Amber Racine
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FDA – Too Slow To Protect Us?

4 comments

Earlier this year, the public learned that alcohol prep wipes, alcohol swabs and other products manufactured by H&P Industries Inc. and the Triad Group posed a significant risk to the public due to bacterial contamination. On Friday, despite previously standing behind their actions, the FDA admitted poor oversight over the companies.

It has been reported that the FDA knew of problems with contamination at the plants that manufactured these wipes, as well as other medical-related products, as early as July 2009. Yet, they inexplicably waited until January 2011 to request that Triad issue a voluntary recall, cease production and distribution.

After months of lax follow up, in April, the FDA finally requested that the U.S. Marshals raid the plant. The Marshalls seized an estimated $6 million worth of products to prevent their distribution. It is believed that many of these products may have been tainted with two dangerous bacteria that were reportedly the of cause deadly infections which were reported to the FDA. The FDA never sent the company a formal warning letter; a letter which is considered an official enforcement action and would have required a “prompt and thorough response” from the company.

Unfortunately, for many, it is shocking to even think that the FDA could fail to protect the public from a known potential health risk. As an attorney who handles pharmaceutical cases, it is a reality I face every day. The FDA has less than 13,000 employees that face the arduous and tremendous task of monitoring every nutritional product, medical device and prescription drug sold in America. By comparison, most individual drug companies will have upwards of 10,000 employees working to research, develop and promote their products; the Triad Group and H&P Industries Inc. are estimated to have approximately 200 employees at their Hartland, Wisconsin processing plant. The plain truth is that the FDA is often slow to act on reports of potential dangers to the public. Often, there are thousands of individual lawsuits filed before the FDA will take action – typically to require that the company provide a better warning or to recommend a “voluntary” withdrawal of the product.

As consumers, we need to take measures to protect ourselves. While it should be remembered that the FDA is there to help, the agency should not be viewed as an all-knowing, supremely powerful entity capable of thwarting every possible threat. Instead, we should be more realistic by taking action to protect ourselves. Most importantly, reporting adverse effects from food, medications and medical devices to the FDA and by lobbying our State representatives to encourage the FDA to take stronger and swifter actions to protect us.

4 Comments

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  1. Stephen says:
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    A look at the recall of hip and knee devices proves to me that the FDA is not doing a good job of ensuring that products are safe for public use. I was reading a blog

    http://spickwick.wordpress.com/21-2/

    that mentions how one implant went on the market without testing because there is a loophole in regulations. Even though studies show that it is a risky device, it still hasn’t been recalled.

  2. Amber Racine says:
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    Stephen –

    You are exactly right. Many devices and products enter the market this way. Another concern is that once the device or drug is on the market, it is the responsibility of the manufacturer (who is profiting from the sales of the product) to properly monitor the product and report adverse events to the FDA. This is why it is essential for the public to make sure that EVERY side effect experienced or harmful experience is reported to the Agency.

    As cliche as it may sound, lawsuits are often the inciting method to bring about product recalls.

  3. Mark says:
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    FDA is not here to protect us, they exist to protect Big Pharma and Big Agra from COMPETITION! If you sell tomatoes at the end of your driveway, expect a military like cadre of thugs to show up at you house and take you away. Now who are the terrorist?

  4. Amber Racine says:
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    Regulations are admittedly necessary to keep the industry “in check”, the problem is that the FDA gets the majority of safety information and complaints from the companies that are selling the drugs…clearly creating room for conflict and delays in providing warnings to the public. Add to that the lobbying power of these companies and you see the issues that prevent the FDA from moving more quickly to pull drugs from the market or add clear, black box warnings to their labels.