By fax to 240-276-3943 and by email
Daniel G. Schultz, M.D., Director
Center for Devices and Radiological Health
U.S. Food and Drug Administration
9200 Corporate Boulevard, Room 100
Rockville, MD 20850
Dear Dr. Schultz
This is a follow-up to our letter of March 17, 2009 (copy attached and also posted), a letter to which we have not received a reply. The main subject of the letter was the policy decision by CDRH to discontinue inspections of nonclinical laboratories – inspections covered by the Good Laboratory Practice regulation. We asked why the decision to discontinue inspections was not announced publicly – for example, by posting on the CDRH website a notice disclosing the proposed new policy, explaining it, and inviting public comment.
In our letter we described why public notice of the proposed policy was needed:
To us it seems obvious that public notice is required, if only for ethical reasons, when a change of this nature is contemplated by a federal regulatory agency. We see no justification for failing to inform patients who volunteer for clinical trials that an important safety regulation that helped protect volunteers in the past is no longer being enforced. Similarly, the physicians caring for these patients as well as those serving on IRBs [Institutional Review Boards] deserve to be told about the lack of enforcement.
The implantation of medical devices entails some risk, and for certain Class III devices the risk of injury or death is significant. That is one reason why patients or their surrogates must give informed consent to such procedures, especially when these procedures are a part of a clinical trial. Most physicians and many laymen know that in these circumstances, informed consent is not optional. The ethical and legal principles underlying informed consent are discussed on the FDA website.
In the letter we further described the possible effects of CDRH’s unannounced decision to stop GLP inspections:
. . . patients participating in clinical trials of medical devices as well as members of IRBs charged with protecting those patients should have been informed about CDRH’s decision to stop GLP inspections, but they were kept in the dark. Even now, many (perhaps almost all) these patients, physicians, and IRB members still have not been told about the new policy. Some of them would undoubtedly be dismayed to learn of the stealthy relaxation of safety standards.
We remain concerned that your policy decision to discontinue GLP inspections was not announced publicly – for example, by posting on the CDRH’s website a notice disclosing the proposed new policy, explaining it, and inviting public comment.
On further reflection, do you believe that CDRH’s decision to stop GLP inspections is relevant or irrelevant to the issue of informed consent of patients in clinical trials?
We again request a response to this letter. We would welcome the opportunity to meet with you if you think this would be helpful.
Project On Government Oversight
Ned Feder, M.D.
Project On Government Oversight
1100 G Street, NW
Washington, DC 20005
Attachment: Letter of March 17, 2009, from Danielle Brian and Ned Feder to Dr. Daniel G. Schultz
Copies: Commissioner Margaret A. Hamburg
Deputy Commissioner Joshua Sharfstein
Michael M. Landa, Acting Chief Counsel
 Letter of March 17, 2009, http://www.pogoarchives.org/m/science/pogo-schultz-cdrh-20090317.pdf
 As we informed you previously, the Project On Government Oversight published a report, “The FDA’s Deadly Gamble with the Safety of Medical Devices,” which was posted on February 18, 2009, on our website at http://www.pogo.org/pogo-files/reports/public-health/safety-of-medical-devices/ph-fda-20090218.html In the report we reviewed the history of the GLP regulation, the value of GLP inspections of nonclinical laboratories in helping ensure patient safety, the decision by CDRH officials to discontinue GLP inspections, and the objections of some CDRH personnel to this decision.
 See, on the FDA’s website, the Declaration of Helsinki of 1983 at http://22.214.171.124/search?q=cache:ziFxjETkaxsJ:www.fda.gov/oc/health/helsinki83.html+site:fda.gov+
This is a cached file. The original file (http://www.fda.gov/oc/health/helsinki83.html) has been removed from the FDA website.
See also the Belmont Report of 1979 at www.fda.gov/OHRMS/DOCKETS/AC/05/briefing/2005-4178b_09_02_Belmont%20Report.pdf For a statement by the FDA on informed consent, see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/