Written answers

Tuesday, 22 September 2015

Department of Health

Medicinal Products Licensing

Photo of Michael Healy-RaeMichael Healy-Rae (Kerry South, Independent)
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757. To ask the Minister for Health the contact and involvement the Health Products Regulatory Authority has with each medicinal governing body in the 11 European Union countries from which the drug Roaccutane has been withdrawn; and if he will make a statement on the matter. [30562/15]

Photo of Michael Healy-RaeMichael Healy-Rae (Kerry South, Independent)
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758. To ask the Minister for Health if the Health Products Regulatory Authority had any correspondence with the Food and Drug Administration over the safety, or otherwise, of Roaccutane, since 1983; and if he will make a statement on the matter. [30563/15]

Photo of Michael Healy-RaeMichael Healy-Rae (Kerry South, Independent)
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765. To ask the Minister for Health the type of drugs that a pharmaceutical company (details supplied) is the world's largest manufacturer of; and if he will make a statement on the matter. [30593/15]

Photo of Michael Healy-RaeMichael Healy-Rae (Kerry South, Independent)
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768. To ask the Minister for Health if he and the Health Products Regulatory Authority are aware of the international lawsuits involving Roaccutane; the number there are; the reason these are happening; and if he will make a statement on the matter. [30607/15]

Photo of Kathleen LynchKathleen Lynch (Cork North Central, Labour)
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I propose to take Questions Nos. 757, 758, 765 and 768 together.

The Health Products Regulatory Authority’s (HPRA) regulatory role (and that of other medicines agencies) involves the technical assessment of safety data from various sources of post-marketing experience, including further studies, literature reviews, and evaluation of adverse reaction data.

The HPRA liaises on a continuous basis with all EU medicines regulatory authorities including regular, monthly meetings of a number of scientific committees co-ordinated by the European Medicines Agency (EMA).

One of these committees, the Pharmacovigilance Risk Assessment Committee (PRAC) is primarily responsible for risk management of the use of medicinal products including the assessment of the risk of adverse reactions. The PRAC also issues recommendations for co-ordinated regulatory action across the EU and liaises with the other scientific committees to support implementation. The HPRA has a representative on PRAC as have all other EU member states.

Roaccutane® is the brand name for the medicinal substance isotretinoin which is authorised for use in the treatment of severe forms of acne. Licences to market Roaccutane® in some Member States have been withdrawn by the marketing authorisation holder for commercial reasons. However, authorisations for other isotretinoin-containing medicines remain in place, with products continuing to be marketed in EU Member States. There have been no withdrawals of marketing authorisations for safety reasons.

The HPRA is not aware of any correspondence with the Food and Drug Administration in the USA regarding Roaccutane.

While the HPRA is aware of media coverage regarding international lawsuits, it is not privy to the details of these, with the exception of information which is publically available.

Requests for information on types and volumes of medicines manufactured by the pharmaceutical company referred to by the Deputy should be addressed directly to the pharmaceutical company concerned.

If the Deputy requires any additional information relating to Roaccutane® I would be happy to facilitate a meeting between the Deputy and the HPRA to discuss these issues further.

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