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

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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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SIX TRUTHS

Reclaiming power from those who abuse it often starts with telling the truth. And in "This Is How Authoritarians Get Defeated," MoJo's Monika Bauerlein unpacks six truths to remember during the homestretch of an election where democracy, truth, and decency are on the line.

Truth #1: The chaos is the point.

Truth #2: Team Reality is bigger than it seems.

Truth #3: Facebook owns this.

Truth #4: When we go to work, we're in the fight.

Truth #5: It's about minority rule.

Truth #6: The only thing that can save us is…us.

Please take a moment to see how all these truths add up, because what happens in the weeks and months ahead will reverberate for at least a generation and we better be prepared.

And if you think journalism like Mother Jones'—that calls it like it is, that will never acquiesce to power, that looks where others don't—can help guide us through this historic, high-stakes moment, and you're able to right now, please help us reach our $350,000 goal by October 31 with a donation today. It's all hands on deck for democracy.

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