FDA’s Missing More Than 9,000 Drugs From its Rolls


Now that the FDA has finally approved over-the-counter emergency contraception it needs to turn its attention to elsewhere in the beleagured agency. A report released last week by the Department of Health and Human Services found that FDA’s current list of 123,856 medications includes 34,257 that are no longer available and is missing another 9,187.

For 16 percent of missing [medications], drug firms confirmed that they did not submit the required FDA forms for listing the drug products. In nearly all of the remaining cases in which drug firms claimed to have submitted listing forms, evidence of submission was not provided or the documentation provided was inconclusive. However, in 9 percent of cases, firms’ claims to have submitted forms were corroborated by forms we found in FDA’s files. In these cases, FDA had failed to appropriately process the forms.

Currently all 120,000-plus drugs are tracked by a total of 15 staff who manually enter data from paper registrations each time companies file to sell or stop selling certain medications. (They’ve got to be in a windowless office in a basement somewhere too, right?)

The new system would require companies to provide updates electronically every six months on the drugs they have on the market. Wait, they aren’t required to do this already? This is the country’s regulatory arm of a multi-billion dollar pharmaceutical industry and in 2006 its proposing that companies check in twice a year.

The FDA might just miss the brouhaha over Plan B; it distracted us all from the rest of their mess.

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