ABPI encourages children's medicines data sharing
Companies that have submitted data on medicines use in children to the US Food and Drug Administration are to be encouraged by the Association of the British Pharmaceutical Industry to send the data to UK regulators.
The announcement, made at a BNF conference on prescribing excellence
last week, follows attempts by the Medicines and Healthcare products
Regulatory Agency to extract data from US firms.
The MHRA wrote to companies that have had labelling changes in the US,
asking them to submit their American data so that UK labelling could
be reviewed. Not all companies responded.
Speaking at the BNF conference, Julia Dunne, specialist in paediatric
issues, MHRA, said she thought it a great shame that the MHRA had to
write to pharmaceutical companies. Some had indicated that they were
not going to submit data to other regulatory authorities because there
was no benefit for the individual company itself. “As somebody
from the UK pharmaceutical industry said to me, ‘why should we
do something for nothing?’,” she said. “I don’t
think you can say that the industry is not neglecting children,” she
added.
Legislation has been introduced in the US to tackle the problem of the
lack of research in and development of paediatric medicines. Companies
are offered financial incentives, such as patent extensions, to conduct
specific studies.
This has, so far, resulted in 70 changes and the involvement of some
41,000 children in drug trials. Legislation to encourage such activities
in Europe is being developed (PJ, 20 March, p341), but is not expected
to come into force for at least 18 months. This is
regrettable, Richard Tiner, ABPI medical
director, said. |
The
Pharmaceutical Journal
Acrobat
Reader