[Pharm-policy] Time between IND filing and NDA: Standard and HIV NCEs

[James Love]

According to this recent paper by Kenneth Kaitin and Elaine Healy from
the Tufts Center for the Study of Drug Development, the average time
between filing for an investigational new drug (IND)  application and US
FDA NDA marketing approval, was 7 years (83.7 months) for a standard New
Chemical Entity (NCE), but only 4.2 years (50.3 months) for HIV/AIDS
drugs.  In comparison, in 1991, DiMasi et all reported an 8.2 year (98.9
month) period from start of Phase I to NDA (this is what was assumed in
the best know study of drug development costs).  This is just one of
several items that suggests HIV/AIDS drug development is much cheaper
than is commonly assumed.  (Other factors are the relatively smaller
number of patients in trials, and the third is the substantial role of
the government in funding research).

To put this into perspective, note that when using a 15 percent cost of
capital (the high end of the 1991 DiMasi analysis), a four year period
increases costs by 75 percent (1.15^4 =3D 1.75).  Here are the data from
the recent Kaitin Healy paper:


                       TABLE 2=20
Median Clinical and Approval Phases (and Ranges)=20
for New Chemical Entity (NCE) Approvals in=20
               1996, 1997, and 1998=20

                    CLINICAL     APPROVAL      TOTAL=20
                    PHASE*       PHASE**       ***         =20

STANDARD NCEs       62.5         15.0          83.7=20
(n =3D 72)        (18.0 166.5)  (7.1 67.3)   (32.2 180.6)=20


AIDS ANTIVIRALS     41.6          3.9          50.3=20
(n =3D 9)         (18.8 61.9)    (1.4 8.7)    (21.4 65.8)=20


*Computed from date of IND filing to NDA submission. =20
**Computed from date of NDA submission to approval.=20
***Computed from date of IND filing to NDA approval.=20
=A7All values are given in months.=20


http://www.diahome.org/htmlabstr/English/dij341-1-1482.htm

Kenneth I. Kaitin, Elaine M. Healy, "The New Drug Approvals of 1996,
1997, and 1998: Drug Development Trends in the User Fee Era" Drug
Information Journal, Volume 34, Issue 1 (January-March) 2000


--=20
James Love, Consumer Project on Technology
v. 1.202.387.8030, fax 1.202.234.5176
love@cptech.org, http://www.cptech.org