[Ip-health] Note on use of Orphan Drug Act to increase price of hydroxyprogesterone caproate from $10 to $1, 500 per dose

Krista Cox krista.l.cox at gmail.com
Wed Mar 23 11:06:26 PDT 2011


It wouldn't necessarily have to be.  The other option would be that if it
affects more than 200,000 people but there is no reasonable expectation that
the cost of development in the US would be recovered from sales in the US of
that drug.

Jeff Fritsch would not tell me what the basis of the estimate used was.

On Wed, Mar 23, 2011 at 1:49 PM, Ruth Lopert <ruth.lopert at gmail.com> wrote:

> Well it would have to have been wouldnt it - isnt that part of the
> definition? The question is what was the basis of the estimate used?
>
> On Wed, Mar 23, 2011 at 12:35 PM, Krista Cox <krista.l.cox at gmail.com>wrote:
>
>> According to Jeff Fritsch at the FDA in charge of designations at the
>> Office
>> of Orphan Product Development, the drug was designated under the provision
>> of the Orphan Drug Act that the condition affects less than 200,000
>> persons
>> in the United States.
>>
>> On Wed, Mar 23, 2011 at 10:46 AM, Jamie Love <james.love at keionline.org
>> >wrote:
>>
>> > As described http://keionline.org/node/1100. the FDA says "There are
>> > no unexpired patents for this product in the Orange Book Database."
>> *>
>> *> I also don't think the exclusive rights in the trials are very
>> > important, given the many trials that others have done on the drug.
>> > So it is basically about the Orphan Drug Act exclusivity, which was
>> > granted on Jan 25, 2007, and which is in effect until Feb 2018.
>> >
>> > On Wed, Mar 23, 2011 at 10:39 AM, Sarah Sorscher <sesorscher at gmail.com>
>> > wrote:
>> > > Does anyone have updated information on whether there are any patents
>> > listed
>> > > on Makena?
>> > >
>> > > Assuming there are no patents listed, is there any legal barrier to
>> > > compounding pharmacies making and selling Hydroxyprogesterone Caproate
>> at
>> > > the generic price as they were doing prior to FDA approval?
>> > >
>> > > Even if there are no legal barriers, is there a concern that insurance
>> > > companies will only reimburse for the FDA-approved version (thus
>> costing
>> > > consumers and taxpayers millions for a drug that was already paid for
>> > with
>> > > NIH funds in the first place)?
>> > >
>> > > Sarah
>> > >
>> > >
>> > > On Wed, Mar 23, 2011 at 8:38 AM, Jamie Love <james.love at keionline.org
>> >
>> > > wrote:
>> > >>
>> > >> Dear Gabriel, I checked with FDA page on the Orphan Designations.
>> > >> The approved Orphan Designation is:  "To reduce the risk of preterm
>> > >> birth in women with singleton pregnancy who have a history of
>> > >> singleton spontaneous preterm birth."  They may have used a narrower
>> > >> subset of patient to obtain the Orphan Status.  I am not sure what
>> > >> other details of the process are public information.  Jamie
>> > >>
>> > >>
>> > >> Generic Name: Hydroxyprogesterone Caproate
>> > >> Trade Name: Makena
>> > >> Date Designated: 01-25-2007
>> > >> Orphan Designation: Prevention of preterm birth in singleton
>> pregnancies
>> > >> Orphan Designation Status: Designated/Approved
>> > >> FDA Orphan Approval Status: Approved for Orphan Indication
>> > >> Approved Orphan Indication: To reduce the risk of preterm birth in
>> > >> women with singleton pregnancy who have a history of singleton
>> > >> spontaneous preterm birth
>> > >> Exclusivity Start Date: 02-03-2011
>> > >> Sponsor: KV Pharmaceutical Company
>> > >> One Corporate Woods Drive
>> > >> Bridgeton, MO 63044
>> > >>
>> > >>
>> > >> On Tue, Mar 22, 2011 at 1:34 PM, Gabriel Michael
>> > >> <gabriel.j.michael at gmail.com> wrote:
>> > >> >
>> > >> > According to the Time article, the CDC, and a variety of other
>> > sources,
>> > >> > there are around a half million preterm births annually in the
>> U.S...
>> > which
>> > >> > part of Sec. 526 [360bb] (a)(2) is being used to justify this move?
>> > The
>> > >> > "less than 200,000 persons" provision, or the no cost recovery
>> > provision?
>> > >> >
>> > >> > Also note that as reported by Time, Preckshot of the Professional
>> > >> > Compounding Centers of America gets the facts wrong: "Preckshot
>> adds
>> > that
>> > >> > compounding pharmacies may still be able to make a different
>> version
>> > of
>> > >> > hydroxyprogesterone that would not violate the patent on Makena.
>> > "There's
>> > >> > the possibility of using different vehicles, other oils, than the
>> one
>> > used
>> > >> > in Makena," says Preckshot, who is also a compounding pharmacist
>> > himself."
>> > >> > But the KEI note shows that there are no patents at issue.
>> > >> >
>> > >> > Gabriel
>> > >> >
>> > >> > --
>> > >> >
>> > >> > Gabriel Michael
>> > >> >
>> > >> > Doctoral Student
>> > >> > The George Washington University
>> > >> > Department of Political Science
>> > >> > gabriel.j.michael at gmail.com
>> > >> >
>> > >> >
>> > >> >
>> > >> >
>> > >> > _______________________________________________
>> > >> > Ip-health mailing list
>> > >> > Ip-health at lists.keionline.org
>> > >> >
>> > >> >
>> >
>> http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org
>> > >>
>> > >>
>> > >>
>> > >> --
>> > >> James Love.  Knowledge Ecology International
>> > >> http://www.keionline.org, +1.202.332.2670, US Mobile:
>> +1.202.361.3040,
>> > >> Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.
>> > >> twitter.com/jamie_love
>> > >>
>> > >> _______________________________________________
>> > >> Ip-health mailing list
>> > >> Ip-health at lists.keionline.org
>> > >>
>> >
>> http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org
>> > >
>> > >
>> >
>> >
>> >
>> > --
>> > James Love.  Knowledge Ecology International
>> > http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
>> > Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.
>> > twitter.com/jamie_love
>> >
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>> > Ip-health at lists.keionline.org
>> >
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>> >
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