The Dry Eye Zone

Rebecca's Blog

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Public comments to the FDA re: LASIK redacted

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 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.
RebeccaComment