Among other provisions, the Food and Drug Modernization and Accountability
Act of 1997 offered companies pediatric exclusivity—a period of marketing protection
from competitor (generic) drugs—when they undertook pediatric studies of a drug based
on a written request from FDA. This exclusivity extends for 6 months beyond any
existing period of marketing protection because of patents or other types of exclusivity.
When granted, pediatric exclusivity applies to all forms of a company’s drug that
contain the same active moiety or ingredient. For a drug with a lucrative market among
adults, this added period of marketing protection is economically significant.
Exclusivity
is available when a company meets the terms of FDA’s request, whether or not the results
support pediatric use, because information about a drug’s lack of efficacy or safety is as
important as positive findings.
Pediatric exclusivity is generally not relevant to drugs that have no existing
exclusivity or remaining patent life. Thus, in 2002, Congress directed the National
Institutes of Health (NIH) to create a pediatric drug development program under BPCA
and to set priorities for pediatric studies of off-patent drugs (a task that has since been
expanded to cover pediatric therapeutics broadly). Under this program, NIH has
supported the study of several high-priority off-patent drugs.
Congress reauthorized the exclusivity incentive in 2002 (under the BPCA title)
and again in 2007. BPCA is due for reauthorization in October 2012.
Among other provisions, the Food and Drug Modernization and Accountability
Act of 1997 offered companies pediatric exclusivity—a period of marketing protection
from competitor (generic) drugs—when they undertook pediatric studies of a drug based
on a written request from FDA. This exclusivity extends for 6 months beyond any
existing period of marketing protection because of patents or other types of exclusivity.
When granted, pediatric exclusivity applies to all forms of a company’s drug that
contain the same active moiety or ingredient. For a drug with a lucrative market among
adults, this added period of marketing protection is economically significant.
Exclusivity
is available when a company meets the terms of FDA’s request, whether or not the results
support pediatric use, because information about a drug’s lack of efficacy or safety is as
important as positive findings.
Pediatric exclusivity is generally not relevant to drugs that have no existing
exclusivity or remaining patent life. Thus, in 2002, Congress directed the National
Institutes of Health (NIH) to create a pediatric drug development program under BPCA
and to set priorities for pediatric studies of off-patent drugs (a task that has since been
expanded to cover pediatric therapeutics broadly). Under this program, NIH has
supported the study of several high-priority off-patent drugs.
Congress reauthorized the exclusivity incentive in 2002 (under the BPCA title)
and again in 2007. BPCA is due for reauthorization in October 2012.