UPDATED: FDA Withdraws Final Rule After Receiving 'Significant Adverse Comment'

Posted 26 June 2012 | By

Sometimes it takes just a single powerful argument to derail an intended final rule. The US Food and Drug Administration (FDA) announced on 27 June its withdrawal of a final rule as the result of a "significant adverse comment."

The agency did not elaborate on the comment or its significance, but the intended final rule was published on 23 March 2012. Entitled, "Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments, Agencies, and Organizations," FDA argued it should no longer be compelled to post its ongoing agreements or memoranda of understanding in the Federal Register as the result of the documents being made available on its website.

The agency said the resources necessary to post the documents to the Federal Register were generating unnecessary printing costs, consuming agency time and resources and were otherwise unnecessary.

FDA currently maintains three separate webpages for its agreements: one for domestic agreements, one for academic agreements, and another page for all other agreements including those involving foreign entities.

At the time, FDA said it intended the rule to be final, but published a call for public comment. "If we receive any significant adverse comments, we will publish a document withdrawing the direct final rule within 30 days after the comment period ends," FDA wrote in the Federal Register in March.

The Regulations.gov website did not contain any submitted comments as of 26 June, though such comments are published several days after submission to the agency.

Update: In comments posted on Regulations.gov, medical device manufacturer Cook Group Inc. said it saw the publication of such MOUs as "vital aspects of FDA's mission" and requested the notices be published in the Federal Register.

Cook called attention to the standardized nature of the Federal Register relative to FDA's website. "FDA's website has no single place where it lists all newly-added information," explained Cook in its letter to FDA. "It also has no clear standard of what is noteworthy enough to be included in any of its various what's new' pages. In addition, there have been numerous occasions where FDA has updated its website and either the information has become difficult to find or the links no longer connect to the appropriate pages within FDA's website."

"By including the full text of the document in the Federal Register and publishing the document on the FDA website, FDA enhances its efforts to improve transparency while still reducing printing costs (by reducing the number of printed copies requested from the agency)," concluded Cook.

Read more:

FDA - Agreements and Memoranda of Understanding: Between Food and Drug Administration and Other Departments, Agencies, and Organizations; Withdrawal

Regulatory Focus - FDA Altering Policies on Publishing Memoranda of Understanding


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