Thursday, April 17, 2014
 

FOI Request

Clinical trial information

Requested by aaronsw on Dec. 10, 2010 for the Food and Drug Administration of United States of America and fufilled on Jan. 7, 2011

Status: Completed


From Aaron Swartz on Dec. 10, 2010:

To Whom It May Concern:

This is a request under the Freedom of Information Act. I hereby request the following records:

All clinical trial information, including the medical and statistical reviews of New Drug Applications.

As you know, the law requires that information on all industry-funded clinical trials be provided to the FDA prior to approval.

I also request that, if appropriate, fees be waived as I believe this request is in the public interest. The requested documents will be made available to the general public free of charge as part of the public information service at MuckRock.com, processed by a representative of the news media/press and is made in the process of news gathering and not for commercial usage.

In the event that fees cannot be waived, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.

Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.

Sincerely,

Aaron Swartz
Filed via MuckRock.com
E-mail (Preferred): requests@muckrock.com
Daytime: (617) 299-1832
For mailed responses, please address:
MuckRock
185 Beacon St. #3
Somerville, MA 02143

 
From MuckRock.com on Dec. 27, 2010:

Spoke with FDA on phone. They said the request must be narrowed to specific drugs in order to be processed.

FDA charges $46 an hour for search and review for this sort of request.

If a drug hasn't been previously released, it takes 18 - 20 months and is put in the complex FOIA processing queue.

If it has been previously released, it will likely take much less time and will be put in the simple queue.

Suggested browsing http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm for more information on specific drugs.

 
From Aaron Swartz on Dec. 27, 2010:

This is a modification to a previous request, the body of which appears at the bottom of this message.

We respectfully request the list or log that includes all names of drugs which the FDA has already processed and prepared for public release all the submitted medical and statistical new drug reviews.

We were told that requesting the medical and statistical reviews of these drugs would be processed in the "simple" queue.

Thank you!

 
From Food and Drug Administration on Jan. 4, 2011:

Request acknowledgement letter
Request acknowledgement letter
View | Download
An acknowledgement letter from the Food and Drug Administration.
 
From Food and Drug Administration on Jan. 7, 2011:

Final Response
Final Response
View | Download
The response to a request for a list or log that includes all names of drugs which the FDA has already processed and prepared for public release all the submitted medical and statistical new drug reviews. The response includes a reference to the requested information on the FDA's website.
 
  • Request acknowledgement letter
  • Final Response
 
About MuckRock

We make tools to keep our government transparent and accountable.

Want to Learn More?

Read our blog and join our mailing list.

Get in Touch

Email: info@muckrock.com