March 23, 2012

FDA Enters Withdrawal: Agency Must Pursue Limits on Penicillins and Tetracyclines

Tyler Smith

Tyler Smith

Program Officer, Food Production and Public Health

Johns Hopkins Center for a Livable Future

Yesterday, a federal magistrate ordered the Food and Drug Administration (FDA) to move ahead with a decades-old effort to withdraw approvals for several uses of antibiotics considered “critically important” to human health by the World Health Organization.  This is a solid win for public health advocates and comes as FDA has proven unwilling to take seriously the threat of antibiotic resistance.

In 1977, FDA proposed withdrawing approvals for the use of penicillin antibiotics for growth promotion and the use of several tetracycline antibiotics in animal feed.  Research showed then—more than three decades ago—that these uses were likely to select for antibiotic-resistant bacteria that can infect humans.  Unfortunately, lobbyists for the pharmaceutical and animal agricultural industries persuaded Congress to delay the restrictions pending additional research.  FDA did more research but took no further action for the next 34 years.

Evidence supporting the withdrawals has only grown since then, but FDA has done almost nothing about it.  Frustrated by FDA lethargy, the Natural Resources Defense Council and other advocacy groups sued the agency last year to force action.  Despite this, FDA announced in December that it had no plans to take regulatory action on either penicillins or tetracyclines.

Then the court stepped in.  Because FDA found in 1977 that the misuse of these drugs posed serious risks to the health of the public, and because the agency has reaffirmed this finding many times since, it has to follow through on efforts to withdraw approvals, the magistrate ruled.  In other words, FDA cannot find a problem and do nothing about it.

FDA may appeal the decision, which could further delay action.  Still, if the ruling stands, the agency will need to re-issue “notices of opportunity for a hearing” (NOHs).  These notices are the first step in the withdrawal process: they indicate that FDA intends to withdraw one or more approvals for a drug and gives the manufacturer of that drug an opportunity to contest the withdrawals at a hearing.  If the administrative law judge who presides at the hearing finds for FDA, the approvals are withdrawn, pending any appeal by the manufacturer.

Notably, the court did not require FDA to withdraw approvals, only to complete the process by which withdrawals are made.  FDA could make lackluster arguments at the hearing, essentially throwing the game for the drug companies.  Still, yesterday’s decision could begin a process that leads to lasting change in the ways that antibiotics are used in food animal production.  That would be very good news for public health.

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  1. Pingback: Government Accountability Project Sues FDA for Antibiotic Sales Data | Center for a Livable Future

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