Regulatory Focus™ > News Articles > FDA Proposes Changes to Make Disclosure of Animal Drug Information Less Convoluted

FDA Proposes Changes to Make Disclosure of Animal Drug Information Less Convoluted

Posted 14 March 2014 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has issued a final regulation which it says will allow it to increase the transparency of its veterinary drug approval decisions.

The 14 March 2014 announcement in the US Federal Register, a compendium of all regulatory decisions made by US government entities, aims to better work within an unusual statutory confinements.

Background

When a human pharmaceutical product is approved, the materials used to support its approval are generally available shortly after the publication of its approval decision on FDA's website.

The process for making approval materials available for veterinary pharmaceutical products, however, is altogether more difficult. Under the terms of the 1968 Animal Drug Amendments, FDA is required to publish the conditions and indications of use of a new animal drug (approved under a new animal drug application, or NADA) in the Federal Register.

Complicating matters, FDA regulations, last issued in 1974, require it to wait to disclose "certain data and information in an NADA file" in response to a Freedom of Information Act (FOIA) request until after it had been published in the Federal Register.

Then, in 1988, the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) requires FDA to publish a revised list of all new animal drug products approved once every 30 days, to include all NADAs approved during that 30-day period. That information is also contained within FDA's "Green Book," which contains all reference and generic animal drug products, as well as their patent and exclusivity information.

In short: Even if FDA has approved a NADA, the regulations as currently written delay a valid FOIA request for up to 30 days for no apparent reason. In a statement, FDA said this delay can actually be as long as two months in practice, though it wasn't immediately clear why.

New Regulation

That's where FDA's new direct final rule, Confidentiality of Data and Information in a New Animal Drug Application File, comes into play.

The new regulation would change the time when approval-related information contained in the NADA file will be publicly disclosed. FDA would then be able to update the Green Book within its 30-day statutory timeframe, it said-a requirement which had previously been ignored.

Consequently, FDA said scrapping the requirement to publish the information in the federal register first will allow it to speed up the release of information, similar to how information is now released for human pharmaceutical products.

In a statement, FDA said the change will "increase transparency of FDA's approval process by allowing for more timely public disclosure of approval-related information."

Regulatory Details

The key section of the Code of Federal Regulations that will be changed is 21 CFR 514.11(e)(ii):

(ii) For an NADA approved on or after July 1, 1975, a summary of such data and information prepared in one of the following two alternative ways shall be publicly released when the approval is published in the Federal Register.

(a ) The Center for Veterinary Medicine may at an appropriate time prior to approval of the NADA require the applicant to prepare a summary of such data and information, which will be reviewed and, where appropriate, revised by the Center.

(b ) The Center for Veterinary Medicine may prepare its own summary of such data and information.

The new section (e)(ii) is to read:

(ii) For an NADA approved after July 1, 1975, a summary of such data and information prepared in one of the following two alternative ways shall bepublicly released when the application is approved

The regulation was released as a direct final rule, which will be adopted so long as no adverse comments are received by FDA. If they are, FDA has released a companion to the final rule which will allow it to proceed as planned.

 

Confidentiality of Data and Information in a New Animal Drug Application File


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