Hate to burst your anti-capitalist bubble, but:
Whichever way you look at it, the company was abiding by the law here. It was sending the reports as the FDA had instructed, and had not been told of the format changes. Once it was informed, it resent the reports. This is just another example of a government organization failing to do what it was set up to do, because once you get bureaucracy into the mix, efficiency goes down the plughole.
Oh, and I thought this was quite important as well, although you didn't seem to think so when you tried to make this about blaming an innocent company:
So, a company makes an experimental new drug that tries to help stop people smoking. They file reports to the FDA about the risks, and the FDA puts a caution on the drug. The company continues to report the incidents to the FDA, although for some reason they are not informed by the FDA about the change in format, which the FDA also doesn't pick up on for some reason. When the FDA finally get off their lunch break and realise they've fucked up big time, they ask the company to resend the reports in the new format. The company complies, and the FDA stick to the same caution they put on the drug 2 years ago...
...and you say the problem is with the corporation and not the FDA?
Quote:Federal Food and Drug Administration officials acknowledged that they asked Pfizer to resubmit thousands of records after realizing that the company was sending required reports in an inappropriate format that could not be added to the agency’s Adverse Events Reporting System, or AERS.So the company were sending reports of these incidents, just in the old format, which the FDA took ages to notice (i.e. a failure on their part). When they did finally notice, they requested that the reports were resent in the correct format, and only then did they find out the extent of their failure.
“Last year, FDA became aware that a few manufacturers were submitting adverse events reports to FDA through improper channels,” the agency said in a statement.
Pfizer officials said they were submitting reports as required and that when the FDA asked them to change, they did so immediately.
Whichever way you look at it, the company was abiding by the law here. It was sending the reports as the FDA had instructed, and had not been told of the format changes. Once it was informed, it resent the reports. This is just another example of a government organization failing to do what it was set up to do, because once you get bureaucracy into the mix, efficiency goes down the plughole.
Oh, and I thought this was quite important as well, although you didn't seem to think so when you tried to make this about blaming an innocent company:
Quote:FDA officials said the new reports did not change the agency’s position on the risks and benefits of the controversial drug, which received a black box warning that included suicide — the strongest caution possible — in 2009, according to agency officials who would not speak on the record.(bolding mine)
So, a company makes an experimental new drug that tries to help stop people smoking. They file reports to the FDA about the risks, and the FDA puts a caution on the drug. The company continues to report the incidents to the FDA, although for some reason they are not informed by the FDA about the change in format, which the FDA also doesn't pick up on for some reason. When the FDA finally get off their lunch break and realise they've fucked up big time, they ask the company to resend the reports in the new format. The company complies, and the FDA stick to the same caution they put on the drug 2 years ago...
...and you say the problem is with the corporation and not the FDA?
