§ Lord Onslow of Wokingasked Her Majesty's Government:
What arrangements there are for co-operation between the Medicines Control Agency and the United States Food and Drugs Administration for the exchange of urgent information on health hazard evaluation, with particular reference to the recall of faulty EpiPen equipment, which was initiated in the United States on 8 May, and only promulgated in the United Kingdom as a "caution in use" warning on 27 May. [HL2300]
§ The Minister of State, Department of Health (Baroness Jay of Paddington)It is the duty of the United Kingdom product licence holder to report to the Medicines Control Agency (MCA) any product defect which may warrant a recall or restriction of supply. Informal arrangements exist between the MCA and the United States Food and Drugs Administration (FDA) for the effective exchange of information on such products. In the case of US manufactured EpiPen auto injectors, the UK licence holder informed the MCA on 13 May that product from affected batches had been distributed in the UK. In this case, the FDA did not communicate with the MCA because the US manufacturer, and therefore the FDA, was not immediately aware that any of the defective product was on the market in the UK. This was because Denmark is the importing EC member state for this product before onward distribution to, among others, the UK. The MCA initiated discussions with the FDA and the US manufacturer and subsequently issued a Drug Alert/"Caution in Use" message on 21 May. This was upgraded to a Drug Alert/"Recall within 48 hours" message on 29 May, when replacement stocks of EpiPen became available.