Drugmakers Question FDA Thinking On ‘Subjective’ New Inspection Powers

The FDA’s interpretation of what constitutes delaying or denying an inspection is far too subjective, and highlights the need for an appeals process for pharma companies flagged as obstructionist, drugmakers say in comments.

Violations outlined in recently published draft guidance on the issue could be interpreted differently from investigator to investigator, they said. Such violations include situations where a facility’s contact ignores the agency, postpones a scheduled inspection start time or fails to produce requested records, according to the July guidance, Circumstances that Constitute Delaying, Denying, Limiting or Refusing a Drug Inspection (WDL, July 15).

“The level of subjectiveness has the potential to lead to a disharmonized approach to inspection expectations and management,” Celgene wrote. “Is it possible to provide clarity or definitive times for examples of reasonable justifications so that both inspectors and companies are aware of what is expected?”

In cases where definitions in the draft guidance are disputed, Celgene asked for a “mechanism to resolve the dispute” prior to a determination and any associated consequences, which could include criminal penalties.

Merck also asked for an appeals process, referencing a provision that an investigator must not be left in a conference room without access to necessary documentation for “an unreasonable period of time.”

There is no definition for what constitutes “unreasonable,” Merck said. Sometimes a requested document could be stored off site and “it may take time to locate and retrieve records (in some cases over 24 hours),” the drugmaker added.

Other commenters took aim at a provision surrounding the taking of photographs by an FDA investigator. The guidance states that not allowing photography may be considered a limitation if “such photographs are determined by the investigator(s) to be necessary to effectively conduct that particular inspection” (WDL, July 29).

The Biotechnology Industry Organization commented that companies and the FDA often negotiate to allow photographs of certain areas. This helps protect intellectual property and trade secrets. The group asked the agency to amend the draft guidance to loosen its provision on photos by inserting language regarding “prior discussions” about photos. Celgene asked the FDA to provide a list of situations or scenarios where a company can expect an investigator to take a photograph.

The comment period on the draft guidance, docket no. FDA-2013-D-0710, is now closed. — Robert King