Watchdog Sues FDA Over Animal Drug Data

In another battle over the extent to which purportedly confidential industry information can see the light of day, a watchdog group has filed a lawsuit against the FDA for refusing to disclose data about the sale of antibiotics that are sold for use in animals that are used to produce food.

The move comes almost two years after the Government Accountability Project filed a Freedom of Information request with the agency in search of the data, a step that was taken on behalf of The Johns Hopkins Center for a Livable Future. The FDA subsequently denied the request, which the watchdog appealed, but to no avail.

"The FDA frequently claims that documents sought through the FOIA process contain confidential commercial information," GAP Food & Public Health attorney Jeff Gulley says in a statement. "When tested in court, however, these claims frequently don't hold up. This response by FDA is a violation of FOIA and a wrongful withholding of agency records."

Drugmakers are required to report information about antibiotic sales to the FDA under the Animal Drug User Fee Act. The data includes how much of each drug is sold; whether the drugs are formulated for use in feed, water, or by injection; and the animals for which each drug is approved, the Government Accountability notes in its lawsuit.

However, the group maintains the disclosure is currently insufficient, alleging that the FDA publicly releases only "a limited summary of ADUFA data each year, but withholds almost all of what companies report" (here is the lawsuit).

The issue of antibiotic use in animals resonates because misuse drives the development of antibiotic-resistant bacteria that make human illnesses more dangerous and difficult to treat, GAP states, adding that the FDA should enforce stricter regulations and ensure data is publicly reported, instead of allowing voluntarily reduction in usage.

We have asked the FDA for comment and will update you accordingly. [UPDATE: An FDA spokeswoman wrote us to say the agency does not comment on pending litigation.]

cow pic thx to dave hogg on flickr