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View Diary: Pharmaceutical company hikes price of preemie birth preventive (82 comments)

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  •  not even pro-birth (10+ / 0-)

    very pro-corporate, not even pro-life.  fuck the r's and the corp's.  


      I apologize for essentially jumping the tip jar but this is very important.  Progesterone is available cheaply from compounding pharmacies and is prescribed for hormone replacement therapy ("HRT") much more often than for preventing preterm birth, due to the relative numbers of women affected. KV has got Makena, aka progesterone, approved as treatment for preterm birth only.  They are now threatening the compounding pharmacies with FDA enforcement action, citing section 460.200 of the FDA compliance policy guide. Let's see what the relevant part of this section has to say:

      when the scope and nature of a pharmacy's activities raise the kinds of concerns normally associated with a drug manufacturer and result in significant violations of the new drug, adulteration, or misbranding provisions of the Act, FDA has determined that it should seriously consider enforcement action. In determining whether to initiate such an action, the Agency will consider whether the pharmacy engages in any of the following acts:...
         8. Compounding drug products that are commercially available in the marketplace or that are essentially copies of commercially available FDA-approved drug products.

      1. Progesterone has been FDA approved since 1957.  Section 8 above only applies when there is a violation to begin with. As long as compounding pharmacies do not label or advertise their progesterone as being for prevention of "preterm birth", I do not see an FDA violation, much less a "significant" one.

      2. In any case, Makena is not approved for HRT, so progesterone supplied for this is not a copy of a commercially available drug for the purposes of this section.  Nor is it the responsibility of a compounding pharmacy to be sure they only fill prescriptions for one purpose instead of another.

      It is up to the FDA to decide what they want to enforce. I could be wrong, but I just don't see any grounds for an enforcement action here, nor any reason why the FDA would feel moved to act.  

      Scientific Materialism debunked here

      by wilderness voice on Tue Mar 15, 2011 at 11:25:36 AM PDT

      [ Parent ]

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