The Secret Life of (b)s

The Secret Life of (b)s

By | 2018-05-03T16:09:42+00:00 May 3rd, 2018|Biopharma / Pharma, CGMP, FDA Inspections, Food, Form FDA 483, Medical Devices|

I recently discovered a gap in my education. Like you, I’ve seen my share of redacted 483s and EIRs. Those redactions are marked with a “(b)” followed by a number in parentheses. I’m normally a curious person, but it never occurred to me that those letters and numbers had a meaning.

I had an aha (and color me red) moment when I received my first Freedom of Information Act (FOIA) response from the FDA. They included a cover letter, which I had never seen before.

That cover letter explained the secret life of (b)s!

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The (b)s are exemptions under FOIA 5 U.S.C. section 552. In other words, the (b)s should be redacted before releasing the record to the public. The two most common ones you’ll see are (b)(4) and (b)(6). Pick nearly any document in the store, and you’ll find both of those.

  • (b)(4) protects trade secrets and commercial confidential information. You’ll typically see this used to redact things like company and protocol names (but not always!)
  • (b)(6) protects personal privacy. You’ll often (but again, not always) see people’s names get redacted with (b)(6). The higher up you are in the organization, the less likely it is your name will be redacted.

Less common are (b)(5) and (b)(7). These are typically used in Establishment Inspection Reports (EIRs) – by the time information is rolled up into a 483, (b)(4) and (b)(6) seem to be sufficient for redaction purposes.

  • (b)(5) “permits the withholding of inter-agency or intra-agency communications records which are part of the deliberative process and pre-decisional.” (See this EIR to Dr. Howard M. Gross)
  • (b)(7) protects “records or information complied for law enforcement purposes.” In some cases, FDA invokes (b)(7) to withhold an entire document (as in the case of the EIR for the FEB 2016 inspection of Dr. John Gabriel). The (b)(7) redaction has 6 subcategories, 4 of which I’ve seen used so far:
    • (A) – disclosure “could reasonably be expected to interfere with enforcement proceedings” (See the EIR for Dr. Arthur Riba)
    • (C) – disclosure “could reasonably be expected to constitute an unwarranted invasion of personal privacy.” (See the EIR for Dr. Nicole A. Shonka)
    • (D) – disclosure “could reasonably be expected to disclose the identity of a confidential source.” (See the EIR for Dr. Shaker Dakil)
    • (E) – disclosure “would disclose techniques and procedures for law enforcement investigations or prosecutions or would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law.” (See the EIR for Dr. Henry A. Frazer)

There you have it. The secret life of (b)s. (Apologies to Sue Monk Kidd.)

Originally posted on Colgin Consulting, Inc.

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