FDA and EMEA could collaborate on paediatric medicines

The European regulation on paediatric medicines, which will come into effect at the end of 2006, could lead to collaboration between the European Medicines Agency (EMEA) and its US counterpart, according to Murray Lumpkin, deputy commissioner of international and special programmes at the US FDA.

The draft European regulation, which is e-pected to be adopted by European Union member states and the European Parliament next month and to come into effect in December, takes its inspiration from a programme that has existed in the US since 1997. Both programmes provide incentives - in particular a six-month extension of intellectual property protection - for companies that undertake paediatric studies.

To take advantage of the US incentives, companies must present data in the form of a 'Written Request to the Office of Pediatric Therapeutics'. The European regulation says that companies must submit a paediatric investigation plan (PIP) to a new ad hoc EMEA committee. The exact content of this plan will be laid down in forthcoming guidelines.

Lumpkin suggested that cooperation between Europeans and Americans would be welcome, given that the number of children who can be included in clinical trials is limited. 'As you put together your PIP, you will probably submit the same data to us in your Written Request,' he said. 'The elements of a Written Request and of PIP might not be the same, but the core elements will be.'

In 2005, the FDA and the EMEA signed a confidentiality agreement under which the two age-cies exchange information. Arguments in favour of closer collaboration between the two agencies' paediatric programmes seem to have been welcomed by the pharmaceutical industry.

There are, however, still questions regarding ethical aspects of the programmes: for example, US and European ethical committee viewpoints could cause problems. It also remains to be seen whether the American programme - which was reformed in 2002 and will now last until 2007 - will be continued and if so in what form.

Since its creation, the FDA's programme to encourage paediatric medicines has produced 323 Written Requests by the industry, and 126 products have been granted paediatric exclusivity. A total of 43,427 patients have so far been enrolled in paediatric trials requested by the US agency under the programme.