Wellcome On Wrong Side Of FDA

Burroughs Wellcome, the US affiliate of UK pharmaceutical company Wellcome, has been strongly criticized by the US Food And Drug Administration. News of this set off a wave of selling of Wellcome shares, and sent the company's share price on the London Stock Exchange down 25 pence to 643 pence at one point.

Burroughs Wellcome received a letter from the FDA on August 29 following a regular inspection of the company's production facilities. The warning letter from the FDA focussed on specific aspects of Burroughs Wellcome's manufacturing processes and product release procedures.

Wellcome issued a statement regarding the letter following a meeting with the FDA on September 8. Wellcome says that concerns raised by the FDA were fully addressed at the meeting with the FDA in early September. Its US unit is said to be taking "remedial measures" to comply with the FDA concerns. The company says that this should be done without disruption to product supply, and stresses there are no public health or safety concerns involved.