Perhaps drug manufacturers, packers, distributors, and applicants have a lot of free time on their hands. Or, perhaps they wisely support the collection of adverse event reports tied to their products. Either way, pharma didn’t seem to have any problems with FDA’s annual information collection provisions, announced Dec. 16, 2008, and reissued Mar. 13, 2009, in the Federal Register.

The agency received no public comments, that’s right, zero comments, during the two-month comment period regarding its Dec. 16 Federal Register publication that reiterated the 21 CFR 210.305 and 314.80 regulations. These codes “impose reporting and recordkeeping requirements on the drug industry” in order to protect the public health from adverse drug experiences, according to the postings.

Specifically, these two regulations will require industry to spend 400 hours per year complying with 21 CFR 210.305(f), which covers keeping records for 10 years of all adverse drug experiences, according to FDA’s estimates. More burdensome, FDA predicts that industry will spend 688,680 hours per year complying with 21 CFR 314.80(c)(2), which requires quarterly reporting of adverse drug experiences for 3 years from the date of approval of the drug product application, and then at annual intervals, and a whopping 6.4 million hours complying with 21 CFR 314.80(i), which requires applicants to maintain records of all adverse drug experiences known to the applicant, including raw data and any correspondence relating to adverse drug experiences, for 10 years. Industry still has until Apr. 13 to comment on the Mar. 13 posting.

I’m actually happy to hear that there have been no complaints to date regarding this collection of information. Without adverse event reports and postmarket research, the drug industry could potentially miss a huge amount of product-related problems and never have the chance to correct them before someone is injured or even killed.