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June 22, 2016


What am I missing? If a brand can only sell the branded product under REMS, why would a generic be allowed to purchase and use the branded product in comparative studies (for biologics) but not have to handle the branded product under the same REMs conditions?

Brand companies were abusing REMS by preventing generic product developers from obtaining samples of the covered product to support their ANDA (e.g. show bioequivalence wrt the covered product) to get approval by the FDA. This would justify the purchase made by generic product developers.

On many instances Brand companies are delays the negotiation and development on commercially reasonable terms of a single, shared system of elements to assure safe use (necessary for the generic product developer to gain approval for its drug or licensing for its biological product).

So now by enactment of The CREATES Act, if an generic product developer prevails in a civil action brought under subpara (A), the court shall order the license holder to (with the approval of the Secretary) enter into a single, shared system of elements to assure safe use with the eligible product developer on commercially reasonable terms [or] the Secretary has waived the requirement for the covered product to be part of a system. [pg. 21-22]
Therefore the generic product developers can handle the branded product by different system only if the court & the Secretary permits.

Dear Nandkishor: do you know of any examples? Clearly the sponsors had some evidence that this was happening but it would be nice to understand how widespread the problem may be.

Thanks for the comment.

Dr. Noonan,

I am personally aware of ACCUSATIONS of such, but this is not as cut and dried as may be portrayed here.

From my personal experience, the "culprit" - or at the very least a huge factor - is the REMS laws themselves.

Kevin: I assume you're asking abt examples wrt REMS abuse.
In one of the recent case where Celgene hindered Mylan's all efforts to get samples of THALOMID and Revlimid. Celgene used REMS as an excuse to avert Mylan from getting the samples to conduct bio studies, even FDA determined that Mylan’s safety protocols were acceptable to conduct those studies. Consequently Mylan prevailed in a civil action when U.S.D.C. New Jersey ruled in its favor.
Celgene and Lannett’s were also involved in similar situation wrt THALOMID.


Do you have something more current than this: http://www.law360.com/articles/628588/3rd-circ-declines-to-hear-mylan-celgene-antitrust-fight

Thanks. It would be interesting to know if these types of apparent shenanigans are widespread. These drugs may be a special case, in view of the stringent restrictions on distribution due to their notoriously horrible side effects is administered to pregnant women.

If the hearings are informative and contain sufficient data I might be less skeptical about the need for this legislation.

Thanks again for the comments

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