The Food and Drug Administration is soliciting comments from the public and stakeholders regarding making the agency more transparent, The FDA issued a press release that said in part:
“As part of the final phase of its transparency initiative, the U.S. Food and Drug Administration is seeking comment from the public and other interested stakeholders on how the agency can increase transparency in its interactions with regulated industry.”
The Press Release Continues:
“For this final phase, the FDA is particularly interested in comments from all interested parties on how the agency can make improvements in the following areas:
~ Training and education for regulated industry about the FDA regulatory process in general and/or about specific new requirements
~ The guidance development process
~ Maintaining open channels of communication with industry routinely and during crises
~ Providing useful and timely answers to industry questions about specific regulatory issues”
FDA periodically embarks on an effort to be more transparent to the public and to regulated industry. This time they are seeking public comment, which is a good thing. However, past efforts at transparency haven’t always born fruit. For example, when I was conducting inspections in the mid-90s the field organization, the Office of Regulatory Affairs, started distributing inspection reports, called EIRs for Establishment Inspection Report, to the inspected party under an initiative called a Field Management Directive: FMD-145. This effort has long fallen by the wayside and many clinical investigators and others in regulated industry don’t even know they can obtain their report. Here is a link to FMD-145:
The public also would like to know what types of source documents FDA expects to see for a clinical trial. Others ask what the definitions of common industry terms are, such as “trial master file.” So transparency is something FDA can improve on.
Final Compliance Determination:Most people are aware of the Form FDA 483, Inspectional Observations. This form lists the preliminary observations made by the FDA Consumer Safety Officer (field investigator) at the conclusion of an inspection. However this is not the final compliance determination of the agency. This will usually come in post-inspectional correspondence. FDA writes letters to most inspected firms, not just the Warning Letters that are posted on the internet.
There are many FDA 483s requested under the Freedom of Information Act (FOIA) that are floating around and discussed by regulated industry. However, it is the letter that FDA writes after the EIR is reviewed by a compliance officer that is the final compliance determination of FDA. Sometimes it is quite different from the original 483. These letters should be made available when a 483 is requested under the FOIA . On several occasions I have, to no avail, attempted to request “post-inspectional correspondence” from the overworked Freedom of Information Act technicians that redact FOIA requests from the public.
The final compliance determination is what FDA really thinks, and a lot of “regulation by rumor” would be cut down if FDA released these letters along with a Form FDA 483. Sometimes these letters are called “informational” or “untitled.” FDA should have a uniform method of requesting post-inspectional correspondence. It would be a valuable compliance tool.
Some Bright Spots
In FDA’s defense they are about the only regulatory agency in the world that will release a regulatory inspection report under a law such as the Freedom of Information Act. Just try getting an inspection report from a European, Asian, or other regulatory agency. FDA also posts redacted Warning Letters on their website. That is also unique. And FDA has programs like GCP Questions that try to answer basic regulatory issues. Here is a link to email answers to many inquiries to GCP Questions:
All in all FDA is one of the more transparent regulatory agencies in the world, something it doesn’t get much credit for. However, there is certainly room for improvement.
How To Comment:
Electronic comments may be submitted to:
Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md., 20852. All comments should be identified with docket number FDA–2009–N–0247.
Posted in the March 12, 2010, Federal Register, the request for electronic or written comments has a deadline of April 12, 2010.
Read the FDA Press Release: