GSK to pay $40.75M to settle case involving P.R. plant

GlaxoSmithKline and its SB Pharmco Puerto Rico unit have agreed to pay $40.75 million to 37 states and the District of Columbia over allegations of violating drug manufacturing standards.

In a statement, Illinois Attorney General Lisa Madigan alleged that GSK and SB Pharmco engaged in unfair and deceptive practices when they manufactured and distributed certain lots of the drugs Kytril, Bactroban, Paxil CR and Avandamet. Madigan and other attorneys general involved in the case alleged that from 2001 to 2004, drug batches were manufactured improperly at a facility in Cidra, Puerto Rico. The investigation involved instances in which certain batches were not sterilized or medication contained different dosages than indicated on the bottle, among other alleged violations.

GSK says in a release it agreed to settle to avoid the expense and uncertainty of protracted litigation and trial. The company did not admit to any wrongdoing or liability. It closed the plant in 2009 because of declining demand for the medicines made there and sold the facility last year, according to the statement.  

Last year, the company reached an agreement with the Department of Justice that settled allegations that false claims for reimbursement were submitted to government healthcare programs related to the drugs made at the plant. SB Pharmaco Puerto Rico also pleaded guilty to releasing adulterated medicines, as Reuters notes.

- get the GSK release
- check out the Illinois attorney general release
- read the Reuters story