Public comments to FDA redacted

[Rebecca Petris]

According to Dickenson's FDA Review (this is subscription only but you can get a free trial subscription at fdaweb.com if you want to read the entire article - it's dated 8/26/2008):

Once labeled one of the most secretive government agencies for consumers, FDA seems to continue to shoot itself in the foot on the “transparency” front. Notwithstanding a regulation at 21 CFR 20.103 that says all public comments received by the agency are available for public disclosure, the agency has taken the unprecedented action of redacting the names, affiliations/locations and apparently random slabs of text from all but two of the 246 public comments it received after the 4/25 meeting of its Ophthalmic Devices Panel on LASIK safety.

Why? In an effort to find out, FDA Webview asked panel executive secretary Karen Warburton. She did not respond to two emails. We next asked acting Office of Public Affairs head Judy Leon, who replied: “Since your question deals with FOI process your best bet is to redirect your question to the Freedom of Information office.” So we asked FOI Division director Frederick J. Sadler, who also did not respond.

In addition to redacting all but two commenters’ names, affiliations and addresses, FDA also redacted device names and LASIK surgeons’ names and affiliations from the text of comments, as well as seemingly arbitrary other words and phrases....

For those of you who sent comments to the FDA for that meeting: If you wished and expected that your comments would be published in full, I recommend you contact the FDA and perhaps your congressperson about this.

[lboogie]

wow -- I don't know what to say................that is amazing. I browsed through a few -- many of them are positive accounts. I know mine sure was not positive!! Government just can't be responsible for this kind of stuff.

[YGB]

See the middle of page 7 in the following link that begins with "An anti-LASIK group has asked the FDA to ban LASIK."

http://www.fda.gov/ohrms/dockets/ac/...ts02%20pt1.pdf

I was initially surprised by how many happy LASIK patients wrote in but then it made sense when I realized that LASIK surgeons were soliciting their "happy" patients en masse to write in to the FDA. Most of the e-mail trails were redacted by the FDA but this one seemed to slip by.

[Rebecca Petris]

My letter is not there.

[mary kenny badami]

not sure that I understand what the fuss is about (boldface in the following phase is mine) . . .

of the 246 public comments it received after the 4/25 meeting of its Ophthalmic Devices Panel on LASIK safety

Most of what was "redacted" (= fancy word for erased or concealed) were names of patients and docs. As far as I can see, they did not remove the substantial content of the messages. And because I, like many other patients, managed to send in my comments before the meeting, my letter isn't up there either.

[Rebecca Petris]

I think the word "after" is a mistake in the article. There was a deadline well before the meeting for sending in comments and the letters that are in the PDF files online are dated early April for the most part. If you sent your letter before the deadline it should be there. These letters online are the same ones as were available in a binder for our perusal at the meeting.

I understand redacting the senders names (if I recall correctly we were told that would be the case) but what bothered me when I read the article was the redaction of additional information such as the brands of lasers used.

[Lucy]

These all seem to be dated April 8th and mention that their doctor told them/sent them a letter saying that Lasik was going to be banned and they should send their comments (good, of course) to the FDA. My letter was not there.

They probably even sent a template for the letter. I didn't count the letters, but there are only about 3 mentioning problems and the rest are all "glory letters." I'll bet dr offices were notified by fax/email that this meeting was taking place and they should have their patients sent in their input. Well, so all the techs in the office, their mothers and husbands write an email to the FDA about their wonderful lasik. Throw in a couple of lawyers, drs and police officers and you've got it covered.

I was surprised that no one lost a large amount of weight because they were so happy with their lasik. Also, if you've already had lasik, why do you care whether there is a "hearing" on it or not? You're already done and happy. Period. You have much wonderful living to do after this miracle.

Personally, I don't care if they ban (for example) gastro-bypass surgery. I spend zero time worrying about it. Now, if I had been a gastro-bypass patient, I would still not care if they banned it. I would be one of the happy campers and getting on with my wonderful life. (Example only-No, I have not had it.)

Apparently the writers were obviously led to believe the FDA meeting was to see if "Lasik" would be banned. I notice they removed most names, but left in a few prominent doctor/clinics where the results were "happy."

Mary K-B.....thanks for the professorial interpretation of redacted.

Lucy

[Teri]

my letter

I sent in an email after the hearing, and my letter's not there.

Also, it was not good for my morale to read all of those "The day I had Lasik was the best day of my life" letters people sent in.