All FDA Interview Requests Denied

At FDA, for the past five years all my interview requests have been denied
or deflected to written questions submitted and cherry-picked by various
PIOs for selective written answers without time (due to my deadlines) for
follow-up questions. I have been told that FDA Press Office policy is to
evaluate requests for interviews according to the extent of readership the
journalist commands. Thus, NBC News and the Wall Street Journal would be
more likely to get the interview than I would with my few-thousand readers.

Granted an off-the record interview with the FDA commissioner, Margaret
Hamburg, I was astounded to see the agency's top PIO sitting with a
tape-recorder at the table. He told me afterwards that agency recordings are
routinely made on such occasions and they are kept for "internal purposes"
for varying periods of time. I found the experience intimidating, as
insurance should I not keep my commitment to be off the record.

When I asked the then-new director of FDA's Center for Devices and
Radiological Health for an interview about his expectations for the job and
how his prior experience fitted him for it, I got a call from the agency's
Press Office informing me that he was too new to FDA to be interviewed by
the press. Whose decision that was I never found out.

Jim Dickinson, Editor
FDA Webview/FDAReview/FDA Update 

FDA and NIH Not Talking About Critical Program

ClinicalTrials.gov is considered by many to be critical to the transparency and effectiveness of medical research.  It’s a database at which many clinical trials are supposed to be registered.

But last year a review said most studies that are supposed to report, don’t.

NIH and FDA said the numbers aren’t that bad but they have not released analysis indicating what the numbers are.

Meantime, the agencies have not published the rules Congress called for in 2007 legislation to enhance enforcement. Last year NIH told Congress it anticipated the rules would be out by the end of the year.

Now NIH and FDA aren’t answering questions. In January public information officers refused to let me speak to anyone over the course of eight contacts I made with them. An NIH official adamantly refused to tell me anything on the phone and an FDA official did not return my calls, sending refusals through the public information officers.

FDA public information officers said, “From our perspective it would be inappropriate to discuss or speculate on a process that is incomplete,” and, “Regulatory actions take time.”

Kathryn Foxhall

Freelance health reporter

Washington, D.C., area

CDC Refuses Reporter Permission to Speak to Experts After More than 20 Requests Over Five Weeks

The Centers for Disease Control and Prevention denied me permission to speak to any expert on male circumcision over a five-week period in October and November 2011 during which I made more than 20 requests.

 My audience was tens of thousands of physicians.

The CDC website indicated the agency had been working on the circumcision recommendations for well over two years.

After numerous contacts, I emailed Kevin Fenton, director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, with questions including:

---Are the subject matter experts prohibited from speaking to the press on this topic? Why can't my audience get an update on the status of the recommendations and the process from a subject matter expert? I've been told it's premature to talk about the issue. How can anything that is the public's business ever be premature?

I never received answers from Dr. Fenton and was never allowed to speak to a subject matter expert.

Kathryn Foxhall

Freelance health care reporter

Washington, D.C., area