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

Gabriel Michael gabriel.j.michael at gmail.com
Tue Mar 22 10:34:48 PDT 2011

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 Michael

Doctoral Student
The George Washington University
Department of Political Science
gabriel.j.michael at gmail.com

More information about the Ip-health mailing list