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Is this a chance to comment to FDA on bioequivalency?


I’d like others to check this government link. Is this an opportunity to comment on a petition to change bioequivalence metrics so extended release methylphenidate drugs have to have the same release timing to be generics?

http://www.regulations.gov/#!docketDetail;D=FDA-2004-P-0151

There are several documents on the page with technical and legal information.

If you have experienced any difference between the “generic” Concerta manufacturers, this is important.

There are several documents on that page that probably should be looked at as they discuss the appropriateness of particular metrics. One of them has a “live” comment button!

I’m pretty good at reading this kind of information, but am hoping someone else can provide their take on what this is about. If this is really a chance to comment - we should spread the word.

Replies

Hi - I wish I could answer your question. From what I can see, it looks like all comments are closed for the various actions in that docket. Only one is still open, and it was filed in 2008. I took a look at the document contained in it, which looks to be a petition filed in 2004 by the company (McNeil and Specialty Consumer Pharmaceuticals). It seems to be saying what you’re saying, that they are wanting the FDA to allow Concerta to be produced as a generic.

It is possible to upload comments to that file - docket - whatever it is supposed to be called. You can upload documents as well. I have no idea if anyone is reviewing the comments, or if this is an open file. Hope someone else can shed some light on it for you!

Posted by Rosemary on Jan 12, 2014 at 8:37am

Short answer: yes. Realize this is strictly a legal maneuver to try and override patent protection on the drug. While J&J is not one of them, there are certain pharmas that specialize more in legal maneuvering than R&D.

Posted by ADDedValue62 on Jan 12, 2014 at 2:03pm

The ADD medications are not the only ones affected by this.  My arthritis medication went generic a number of years ago.  I refilled at the local pharmacy and was told that they were out of the generic and would have to use the brand name medication.  Because they were out of the generic, my co-pay was the same; however, when I took the medication, I had much longer relief of symptoms. I have run into this same problem with other medications, too.

Posted by Dianne in the Desert on Jan 12, 2014 at 11:05pm

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