Promise of patent extension in return for studies in children improves safety
Legislation in the United States that rewards drug companies for conducting clinical studies in children has led to improved safety, say researchers from the US Food and Drug Administration.
In 1997, the US government adopted a new law that allowed companies to
be granted an additional six months of market exclusivity for a product
if they conducted paediatric studies requested by the FDA.
The researchers report that such studies have resulted in important dose
changes and an improved understanding of the pharmacokinetics of certain
drugs prescribed for children.
They found that between July 1998 and April 2002, 53 drugs were granted
paediatric exclusivity and drug licences were amended for 33 products
to include paediatric information. Trial data for seven products led
to major adjustments in dosing instructions (JAMA 2003;290:905).
However, Dr Peter Budetti, University of Oklahoma, and the author of
an accompanying editorial, warns: “Although the exclusivity provisions
have led to important information on some drugs, this approach has left
large gaps.” He points out that extension of market exclusivity
could lead companies to focus on drugs with large adult markets but only
limited application in children. Furthermore, the approach does not provide
any incentive for paediatric studies of drugs with expired patents (ibid,
p950).
A spokesman for the Association of the British Pharmaceutical Industry
told The Journal there was scope for a similar incentive scheme in the
United Kingdom. However, he added that the issue of conducting trials
of medicines in children should be addressed at an international level.
“What we don’t want is one country asking for a different
set of clinical trials to another,” he said. |
