Robert Troy
Question:689. Deputy Robert Troy asked the Minister for Health if he will grant approval for Ampligen, a drug which helps people with Myalgic Encephalomyelitis; and if he will make a statement on the matter. [7111/13]
View answerTuesday, 12 February 2013
Questions (689, 692)
Robert Troy
Question:692. Deputy Robert Troy asked the Minister for Health if he has made any representations to the US Food and Drug Administration with regard to approving the drug Ampligen for all M.E. patients here. [7134/13]
View answerWritten answers
I propose to take Questions Nos. 689 and 692 together.
Before a medicine can be placed on the Irish market the manufacturer has to seek an authorisation from the Irish Medicines Board (IMB) or in the case of certain medicinal products, the European Medicines agency (EMA). In the case of Ampligen, because of the biotechnology nature of the active substance involved, any application for Ampligen to be made available to European patients has to be made to the EMA. I have no information on whether or not such an application has been received by the EMA.
The current position therefore is that Ampligen has not been authorised to be placed on the market in Europe. The Food and Drug Administration (FDA) is the regulatory authority for medicines in the US. The FDA has refused an application to make this product available in the US citing safety and efficacy concerns.
The FDA operates outside of this jurisdiction and it would not be appropriate for me to make representations to the FDA on the manner in which it regulates medicinal products for American patients.