FDA Failing in Resources, Science, Technology
If you want a good scare this morning, go read yesterday’s FDA Science Board report, FDA Science and Mission at Risk in this pdf. In it, the board outlines how the agency that oversees the safety of this entire country’s food and drug supply doesn’t have the money and therefore the kind of adequately trained scientific staff or the technology it needs to ensure the safety of Americans.
Let’s take a look at some of the more frightening passages:
The subcommittee concluded that science at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities. (Section 1.1., emphasis mine)
That’s just plain alarming. It’s not like we’re going to see fewer health issues as the population continues to increase and the world gets more crowded, yet the agency doesn’t have the scientific base to regulate properly what’s going on now?
FDA’s failure to retain and motivate its workforce puts FDA’s mission at risk. Inadequately trained scientists are generally risk-averse, and tend to give no decision, a slow decision or, even worse, the wrong decision on regulatory approval or disapproval. (Section 1.2.2., emphasis mine)
The FDA regulates the safety of our drug supply.
Including asthma medications.
Including asthma medications for children.
There are inadequate emergency backup systems in place: recent system failures have resulted in loss of FDA data. Critical data reside in large warehouses sequestered in piles and piles of paper documents. There is no backup of these records, which include valuable clinical trial data. (Section 1.2.3)
Paper records only. In 2007.
There is much, much more to
terrify you read about in the rest of the report, including how funding shortages for the past 2 decades have led to the deficiencies. Underfunding of the FDA is not a new subject, but the admission of failure by the agency itself is, apparently.
The board is calling for public hearings and I don’t know about you, but I’ll be keeping an eye on those and the fallout from this report.
On the Other Hand
Still, you may want to try using the FDA website’s new email tool. According to my blog stats, a substantial number of you come here for information about the recent FDA review of children’s use of Serevent and Advair or for background on the drugs. I’d really rather you keep visiting Asthma Mom for information and maybe even subscribe to my feed, but there’s also a brand-new way to get the most up-to-date FDA information. You can use this link to sign up for email updates on your favorite FDA pages, everything from Consumer Health Information to MedWatch.