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Disappointment with FDA’s Open Records Policy

Rarely do we express disappointment with the FDA. They do an extraordinary job keeping us safe. We never waivered in our support for the FDA in 2007 when Congress (and the public) blamed the agency for the deaths of 149 Americans who received adulterated heparin.

Americans receive billions of medication doses per year. With all those dosage units, some adulterated and mislabeled drugs will find their way into our medicine cabinets and hospitals. There are only so many FDA inspectors and certainly not enough to effectively do their job. With 80% to 85% of prescription drugs now being manufactured outside the United States, the FDA’s inspection coverage is spread even more thin.

Last week, Dr Reddy’s announced that it had received an FDA warning letter for quality control issues at three of its plants in India. The warning letter follows FDA inspections in November 2014, January 2015 and February 2015. At least one of those inspections resulted in a Form 483 Inspection Report. (We suspect all three inspections resulted in findings.)

The source of our knowledge? Public statements from Dr Reddy’s. Incredibly the FDA has not released any information about its actions. Nothing is available on their website as of this writing. Although the FDA maintains a Freedom of Information Act (“FOIA”) “Electronic Reading Room,” the FDA does not routinely post these critical documents!

The FDA’s explanation? They claim records are posted in their reading room “either (1) proactively at our discretion or (2) because they are "frequently requested" per the Electronic Freedom of Information Act Amendments of 1996.”

Instead of protecting the public, the FDA appears to be protecting big pharma. Although the records are still obtainable through a traditional FOIA request, it is difficult to request documents if you don’t know they exist. Since the FDA doesn’t publish its inspection schedule, it is impossible to know who is being inspected and when.

We are truly concerned about the conditions the FDA observed during their three inspections. Last year a Dr Reddy’s spokesperson issued a statement downplaying the Form 483 findings claiming they were not quality related. Now, given the warning letter we suspect that Dr. Reddy’s statements were untruthful.

Although the FDA may choose not to publish inspection findings and warning letters, concerned pharmaceutical industry workers and executives can still take action to protect the public. How? By filing a False Claims Act in federal court. That law empowers individuals with inside information to bring an action if adulterated or under / superpotency drugs enter the U.S. market.

Our hope is that more folks will step forward and help stop the spread of bad drugs from entering the marketplace.

Why would anyone want to do this? First, it is obviously the right thing to do. We have a duty to make sure that the products that are loved ones consume are safe and effective.

Another reason is the monetary award available from the U.S. government. The United States Justice Department and courts routinely pay people who come forward to report cGMP violations. The False Claims Act gives tipsters up to 30% of the penalties collected by the government. Awards are often in the millions of dollars and there is no need for U.S. citizenship.

There are very particular steps that must be followed in order to collect an award. We can help you with the process and at no charge to you.

Related topics: FDA (3)