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Arena Pharmaceuticals, Inc. Message Board

  • jasonstoneinn jasonstoneinn Mar 27, 2013 10:59 PM Flag

    Possible Reason Behind DEA Delay

    FDA assesses about one-third of new drug applications (NDAs) to see whether they warrant additional scheduling review by the DEA, noted Douglas Throckmorton, deputy director of the Center for Drug Evaluation and Research (CDER), at a February 2012 seminar on controlled substance regulation sponsored by the Food and Drug Law Institute (FDLI). CDER's Controlled Substance Staff (CSS) determines whether DEA should evaluate the product further, which can lead to a complex scheduling process after FDA approves the NDA.

    DEA review delayed marketing 11 months after FDA approval in 2008 of Eisai's sedation medication Lusedra (fospropofol). DEA scheduling "is a big black box for industry," according to Eisai regulatory policy executive Ginny Beakes-Read, with no timelines for its actions and recommendations.

    Belviq was approved on June 27, 2012... today was exactly 9 months since approval... Q1 2013 launch in now out of the question... the longer the DEA takes, the more it seems that they might be "hung up" on something in the public comments, and the less likely it also seems that they will be granting Eisai a waiver for advancement of the Effective Date.

    ARNA longs would like to blame the delay on corruption or governmental inefficiency-- but the reality is that the process is extremely detailed and prone to extensive legal review. Mansbach's comment concluded by saying that CIV (Schedule 4) for lorcaserin was a "conservative, but defensible" position-- an interesting choice of words in retrospect. Another anonymous poster also brought numerous additional concerns out, including the fact that a CIV designation would not require mandatory FDA review of all future DTC ads for Belviq. Only a Schedule 2 or a REMS would require this. Could this DTC issue be the unresolved issue???

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    • Lorcaserin scheduling may be the first drug ever to be changed from the initial DEA staff recommendation because of public comments. There's a first for everything, and if the public comment period is to have any meaning then something like this had to occur at some point. If public comments are never seriously considered in the drug scheduling process why bother having them at all? Lorcaserin scheduling is democracy at its best where all the people's voices are heard, yet some of you are calling it corruption. Shame in you! Power to the people! I stand with Reza Ganjavi on this point.

    • edimartino Mar 28, 2013 9:59 AM Flag

      Nice try but I can now buy more with your confidence building OPINION.

    • This is the only reason.......the DEA has gotten a mandate from the Justice Department to concentrate on the law enforcement side to combat illegal prescription drug's, pill mills, and the realm of illegal activity involved in prescription drug abuse. This activity has taken their human resources to focus on that issue placing new drugs applications on a lower tier of attention. The DEA is in no hurry to follow past protocol time frames for approval of drug applications due to lack of resources. In other words, they function poorly to accomplish those task under their official directive. Wait, it will come soon.

      Sentiment: Buy

    • I'll make it easy for you. The FDA is more corrupt than any other Government Agency, Look and see how many dangerous drugs they put on the market only to pull them years later after people have been dying. Someone hasn't made their payment to the Person in charge of Belviq. Don't be so nieve. And don't expect good news any time soon.

    • I don't really see that in the chronology for fospropofol at the FDA and DEA. It took a long time before DEA dealt with it, but I don't see it. The issue may have had something to do with it being a anesthetic agent, not something the general public would touch, but administered by very few people who could abuse it. It did not have an extended post comment period. It took 3.5 months between the proposed scheduling and final order. This can be found at regulations dot gov

      FDA AdComm hearing on 5/7/08
      FDA approval on 12/15/2008
      DEA Proposed Schedule IV 7/16/2009
      End public comments on 8/24/2009
      Final rule dated 11/5/2009

      Thus, it is my belief that any delay by the DEA is unlike that for fospropofol. Instead the ARNA delay occurred after public comment. Thus, what is in the public comments that is unusual? No new science issues were alleged, thus the science issues were dealt with by the FDA and unlikely to be the issue. New fraud and stock manipulation claims were made, some claiming they had evidence. DEA is part of the Dept Justice and Obama is keen on nailing white collar wall street crime. Put 2 and 2 together and that is the most likely reason for the delay.
      Thus, my only solace during these insane short attacks is that some of them may be heading behind bars in the near future and their friends may help put them there.

      Sentiment: Strong Buy

      • 2 Replies to reasonable_risk1
      • And, when citing Mansbach, you, and the DEA must consider the source. They know that he's against ARNA, and trying his best to create any kind of doubt.

        Who wants to take too many pills that will yield a migraine headache? This is not an abusable drug.

      • @ risk1 - Funny while I agree with your general sentiment, the "Obama is keen on nailing white collar wall street crime" makes me laugh...vis-à-vis HSBC, Corzine, Mozilo, SAC etc. All are in jail right?

        Actually the DOJ is vindictively focused on whistleblowers and the A. Swartz, S. Aleynikov, B. Manning types (i.e. citizens/people that are bring to light malfeasance that is close to core.. accountability has been lost, so I highly doubt that the DEA/DOJ is looking into "claimed" illegal activity related to this.

        Sentiment: Strong Buy

    • Why should it be? The FDA already recommended schedule IV and the DEA said it agreed.

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