[Pharm-policy] Pediatric patent extensions

[James Love]

The FDA has told us we will have submit formal FOIA requests to find out
how many patients are in these pediatric trials that extend patents for
six months.  The FDA web page says what is typically required is a Phase
I trial with around 15 to 20 patients, followed by (if the drug isn't
toxic), a single Phase II trial.  Apparently there have been 28 requests
for patent extentions so far, of which I believe 25 were granted 6 month
extentions, and one is still under review.  Jamie


Claritin Patent Is Extended for 6 Months 
Thursday, August 17, 2000 
 Byline: Associated Press 
                                                                           
The wait for a cheaper, generic form of the world's best-selling allergy
drug, Claritin, just got a little longer. Drug maker Schering-Plough
Corp. said the Food and Drug Administration has approved a six-month
extension on its Claritin patent because the company performed tests of
the drug on children. Congress a few years ago agreed to give
pharmaceutical makers extended patents if they would test their
medicines on children.

  [snip]

-- 
James Love, Consumer Project on Technology
v. 1.202.387.8030, fax 1.202.234.5176
love@cptech.org, http://www.cptech.org