May 18th, 2012 // 12:29 pm @ jmpickett
Three strikes and you’re out? In 2006, the FDA noticed that Acorda Therapeutics was having difficulty submitting serious and unexpected adverse event reports within 15 days of receiving such information as required by law. The same problem was observed during yet another inspection three years later. And when the FDA returned last summer, the agency found Acorda was still failing to report adverse events when required, according to a May 10 warning letter.
Acorda, however, was not just a few days late. The FDA noted there were five reports that were submitted more than 100 days past the deadline. One report described a patient who died and was due to be filed with the agency on August 28, 2010, but not received until January 10, 2011, approximately 136 days late. Other side effects that should have been reported included irregular heartbeats, arrhythmia, acute fulminant hepatitis, hypersensitivity, and memory impairment.
Just the same, Acorda is consistent, if nothing else. After the FDA issued a 483 inspection report last September, the drugmaker did send a written response. But the reply was received more than 15 days from the close of inspection. As a result, the FDA reviewed the response, but did not include its contents in its newly issued warning letters, citing an August 2009 Enforcement Initiative that was declared by the FDA commmish.
There was more, though. The FDA cited Acorda for failing to maintain adequate written procedures to ensure adverse events are detected, correctly identified, assessed, and reported to the agency. In fact, Acorda failed to maintain records of all adverse drug experiences, including raw data and any correspondence relating to adverse events, for a period of 10 years. That is a long stretch, yes?
Making matters worse, Acorda had previously promised to take corrective actions, such as hiring a new contractor to handle adverse event reporting, but the problem continue to occur. And the FDA could not find documentation to substantiate claims that Acorda, which sells the Ampyra multiple sclerosis treatment, had trained and audited it specialty pharmacy distributors.
And contractor paperwork was problematic, since Acorda did not have documents that were to have been sent from one pharmacovigilance contractor to another. “This became an issue,” the FDA wrote, when its inspector requested documents to back up claims for downgrading adverse events reports to “non-cases.” Acorda management repeatedly stated source documents were not available and the drug safety director could not find documents for some cases, the FDA writes. One example: a report that contained instructions to change “hospitalized for UTI” to just “UTI” without a rationale or justification for downgrading this report from serious to non-serious, the FDA letter states.
Meanwhile, Acorda failed to investigate an unspecified number of reports in which Ampyra was allgedly ineffective, even though the FDA notes that the Ampyra Annual Product Review for 2010 states the drug will not be effective in all patients and, therefore, a lack of efficacy is expected (here is the warning letter).
An Acorda spokesman tells us the drugmaker is “apprising FDA with regular updates, directed toward issues they raise in the letter. The inspection resulted in 483 that happened last summer… and we do believe we have addressed all the issues that have been raised.” He also says that a new pharmacovigilance contractor has been hired. The problems, he added, dated to when Acorda was “a young company growing up.” By now, though, the training wheels should have come off.