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.
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.
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.