2005P-0323 Immediately remove Adderall and Adderall XR from the market for safety reasons
FDA Comment Number : EC4
Submitter : Mr. Dave Lowe Date & Time: 12/21/2005 04:12:06
Organization : Mr. Dave Lowe
Category : Individual Consumer
Issue Areas/Comments
This in regards to NDA 11-522 and NDA 21-303, which are for the drugs Adderall and Adderall XR. I wanted to make FDA aware of some problems with approved drugs Adderall and/or Adderall XR. The problems are the NDA's for both.

The Adderall XR NDA (21-303) public documents which led to it's approval have some problems. You only need look at the brief summary of a magazine ad to verify this, and indications that never should have been FDA approved.

If you reference just the Adderall NDA of 11-522, that has a supplement approved after having an unapproved supplement. The NDA withdrawn in the Federal Register in the 1970's when a weight loss drug. It was renamed and that NDA approved without adequete clinical trials, and would reference FDA to it's website.

As for Adderall XR, the basis for it's approval is based on two drugs, and does not even have all reviews required and 7 websites. Both Adderall and Adderall XR are used during the approval process Adderall XR. I previously posted in the Federal Register about differing and changing ratios on marketed Adderall and Adderall XR, however this is approved health concerns.

In preclinical testing for Adderall XR, Andrew Mosholder found the Adderall XR NDA approvable. That used both Adderall at a 3:1 ratio of mixed amphetmine salts, and Adderall XR at a 1:1 ratio and imported data from "limited data" from the Adderall NDA. If you have an Adderall XR advertisement in the form of a complaint at DDMAC like I filed for adults that FDA approved, simply look at Carcinogenisis/Pregnancy information and you'll see both drugs were used in just preclinical data at different ratios, and approved "with the known extrapolation of Adderall" and should not have happened. Investigations for both.

In a posted communication with FDA received on 5/5/1999 in petition 2005P-0420, the sponsor was asked to open two IND's and did. The Adderall XR NDA uses both what are commonly called Adderall and Adderall XR in investigations for approval. That would be both Adderall ER and Adderall IR which is now marketed at the same ratio and different name. One NDA, one drug, one time, one name.

I believe if someone can open up either NDA, they will see major errors of a drug being approved, and the preclinical data alone is backed with the FDA logo. Humans were failed.

Thre is an obligation to protect America, and the approval process is not exempt. This should not have happened. With "issues" suddenly discovered in petition 2005P-0420 out of nowhere, a copy is sent to three offices of FDA like FDA knows this already. This includes the assitance of FDA in the destruction of documents when filing that petition and if it walks like a duck..

A Conflict of Interest complaint is on record with HHS about simply one clinical investigator from HHS that led to this approval, and a government employee owns stock in this drug company. HHS failed to act on that, a former NIMH employee who appears in Shire press relases when unapproved, with direct ties has to FDA. Look away from 2 indications th

How long has this been known by HHS, going to extremes? Only when Health Canada acts, does FDA care. They acted when American's were dead on your website, FDA in a reactionary public health advisory.

An FDA approved label covered under the 1971 Convention of Psychotropic Substances has been copyrighted from public view in that petition, violative of an international treaty.. Extremes. All approved labeling is available to the public, not just in Rockville.

Make a start at attempting to protect and pull this. Full disclosure, or continue ducking tough calls and others can inform as usual. All Adderall based products with clinical trials HHS paid for, violate informed consent under CFR and there is an obligation to act to protect human subjects in federally funded research. This doesn't matter to HHS, OHRP fails to acknowledge receipt, FDA will turn the cheek on that like everything else.