Johnson & Johnson Under Fire for Test Protocol

Posted on August 24, 2009 in Consumer Goods, Health & Medicine

The Food & Drug Administration issued a warning to Johnson & Johnson for failing to properly monitor tests of the antibiotic ceftobiprole. If approved, ceftobiprole would be used to treat bacterial infections like MRSA.

According to the FDA, Johnson & Johnson did not make sure participants in a clinical test stored the drug properly while using it at home. The FDA also said that some of the participants may not have been eligible for the study based on the requirements, that investigators may have been unqualified and that the company failed to document some doses given to the patients. “We conclude that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations,” the letter stated.

The warning letter, dated August 10, gives Johnson & Johnson 15 days to respond with a set of precautions they will take in the future to avoid similar scenarios. The FDA said they would take regulatory action against the company if they fail to explain a strategy. Consequences could include fines and product seizures.

The FDA has delayed approval of ceftobirpole twice, citing similar problems with Johson & Johnson’s protocols. Johnson & Johnson said they were working with the FDA to address their concerns.