Roche Meds In Short Supply Over Plant Problems
January 23rd, 2012 // 1:43 pm @ jmpickett
Yet another drugmaker is suffering manufacturing problems that are causing supply disruptions for several widely used meds. The latest is Roche, which has issues at its Florence, South Carolina, plant and reports varying shortages of the Xenical diet pill; Tamiflu; the Valcyte eye med; the Pegasys component for a hepatitis C treatment and the Xeloda breast cancer drug.
The plant makes active pharmaceutical ingredients and intermediary products for those drugs. As a result, Roche is investigating other manufacturing sites to maintain supplies to patients in the US and elsewhere, according to a statement sent to us by a spokesman. For instance, this advisory was issued to doctors in the UK who prescribe Xenical, which is known there as Orlistat. Supplies of the diet pill have been halted altogether in the US.
“Roche is taking this issue and the supply of its medicines very seriously. We regret any inconvenience this may cause our patients and customers and are working closely with the FDA, CHMP and other Health Authorities outside the US to provide requested information. As of today, the FDA has not requested withdrawal or recall of products from the U.S market,†a spokesman writes us. The European Medicines Agency has also been notified.
In recent weeks, Novartis has closed a plant in Lincoln, Nebraska, that makes various over-the-counter and animal health meds, as well as contract manufacturing for prescription meds. This happened after the FDA inspected the plant last summer and issued a scathing 483 report that found numerous violations, such as failure to respond to consumer complaints and file reports with the FDA.
