QDIS Blog

Decline in FDA Enforcement

by Ed Vawter @ 1:47 pm. Filed under FDA

Recently, Rep. Henry Waxman (D-Ca) posted some interesting information on his website.

Committee on Government Reform Minority Office

Here is a link to the original pdf report:

“Prescription for Harm: The Decline in FDA Enforcement Activity”

While I find it interesting I am always cautious when looking at other peoples results of data. For one thing I want to make sure and see what kind of agenda (either hidden or open) they may have. Waxman is well known for the Hatch-Waxman act passed in 1984 which allowed basically created the generic drug industry.

Let’s take a look at the first of their figures shown below:

I’m always skeptical of a graphs with only two points. One could easily pick two years to prove a point but not necessarily a trend. So I went back and counted all the warning letters from the FDA (both CDER and CBER) listed on the FDA website and came up with my own chart shown below. Note I’ve excluded the Cyber warning letter that deal with web sites offering drugs.

I came up with different numbers since I did not include food safety, devices and radiological health, or vet medicines. Also, even for the years listed my numbers are slightly different. For 2000 I counted 124 for drugs and biologics and the report lists 130; for 2005 they list 79 whereas I counted 65.

While there are some differences, I think the trend stands. If anything it is even clearer since I went back to 1997 (as far back as possible with data on the FDA website). There definitely seems to be a drop off starting in 2002. I personally think this is a disturbing trend and will definitely be keeping an eye open to see if this continues or changes.

Here are the three key findings quoted from the report.

1. FDA enforcement actions have declined under the Bush Administration. The number of warning letters issued by the agency for violations of federal requirements has fallen by over 50%, from 1,154 in 2000 to 535 in 2005, a 15-year low. During the same period, the number of seizures of mislabeled, defective, and dangerous products has declined by 44%.

2. FDA headquarters officials have routinely rejected the enforcement recommendations of career field staff. Internal agency documents show that in at least 138 cases over the last five years involving drugs and biological products, FDA failed to take enforcement actions despite receiving recommendations from agency field inspectors describing violations of FDA requirements.

3. FDA’s recordkeeping and case tracking practices are inadequate. Although the Federal Records Act and internal agency procedures require FDA to keep records that document agency enforcement decisions, FDA does not appear to comply with these requirements. FDA’s response to Committee requests for relevant enforcement documents was haphazard, incomplete, and untimely. FDA officials explained that FDA could not provide prompt and complete responses because the agency lacks a system that enables it to track enforcement recommendations from field offices.

I especially find item 3 disturbing; while the FDA insists that pharmaceutical companies keep accurate records of all their data, it seems they themselves don’t keep track of enforcement recommendation from their field offices! It is really disturbing that they have no system of any kind for this according to my reading of this.

Other resources:

Press Release
Rep. Waxman’s Statement on the Anniversary of the FDA (pdf)
Letter from Professor Jerry Avorn, M.D. (pdf)
Letter from Professor Michael Wilkes, M.D., Ph.D. (pdf)
Letter from Sammie Young, former senior FDA enforcement official (pdf)

Technorati Tags: drug safety, FDA enforcement