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FDA Takes Over #Tylenol Plants – Whistleblowers Key to Safer Drugs

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:Original raster version: :Image:Food and Drug...
Last week CNN reported that the Food and Drug Administration (FDA) took control of three of Johnson & Johnson’s Tylenol plants located at:

  • Las Piedras, Puerto Rico
  • Fort Washington, Pa
  • Lancaster, Pa
Additionally, the FDA and the U.S. Department of Justice are pursuing criminal charges against two executives for failing to comply with federally-mandated manufacturing practices.

Johnson & Johnson’s reputation has been marred over the past couple years by a history of drug recalls and FDA violations at its manufacturing plants.  The Wall Street Journal provided a detailed list of the recalls in its Health Blog:

  • In January J&J said it would pull 43 million bottles of certain Tylenol, Benadryl, Sinutab and Sudafed products because they were made at the company’s Ft. Washington, Pa., plant at a time when equipment may not have been properly cleaned.
  • In December the company said it was recalling all lots of Rolaids Extra Strength Softchews, Rolaids Extra Strength Plus Gas Softchews and Rolaids Multi-Symptom Plus Anti-Gas Softchews following consumer reports of foreign-particle contamination.
  • In October, there was a recall of 127,000 bottles of Tylenol 8-Hour caplets due to a musty odor.
  • In August, J&J’s DePuy Orthopedics unit pulled two hip implants off the market because of an unusually high rate of replacement surgeries.
  • In late 2009 there were recalls of Tylenol Arthritis Pain Caplets due to that musty odor issue.
The public places its trust in drug companies to provide safe and affordable drugs.  It’s unacceptable for drug companies to betray the public’s trust by delaying a recall when the company has reason to know drugs were not properly manufactured.  The drug company plant worker, quality assurance manager, and executive each have a duty to report unsafe drugs immediately and before those drugs reach the medicine cabinets of the public.

Whistleblowers are the key to detecting unsafe drugs early and forcing the management of drug companies to recall those drugs.  We wrote a post in January about a classic example where the law worked: whistleblower Cheryl Eckard was awarded $96 million under the False Claims Act after reporting that her former employer, GlaxoSmithKline, failed to immediately recall drugs that were contaminated.  It’s impossible to know how many lives may have been affected positively by her prompt reporting.

Eckard was awarded millions, because Congress designed the False Claims Act to reward whistleblowers for the risks they take when reporting companies committing fraud against the federal government.  Since many prescription drugs and some over-the-counter drugs are purchased using government health care programs such as Medicare and Medicaid, drug companies defraud the federal government every time they knowingly sell unsafe drugs to the public.  The whistleblower is in the unique position to detect unsafe drugs early and prevent disaster.

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