One Step Forward, Two Steps Back: FDA on Cephalosporin, Penicillin, and Tetracycline

Last Tuesday, the U.S. Food and Drug Administration (FDA) announced that it will ban the “extra-label” use of cephalosporin antibiotics in food animals—that is, veterinarians will not be permitted to use drugs in this class of antibiotics except in ways approved by FDA.  (A “drug class” refers to a group of drugs that work in similar ways.  Cephalosporins are members of the broad group of beta-lactam antibiotics, which includes penicillin drugs as well.  Beta-lactams kill bacteria in similar ways.) FDA’s announcement came almost two weeks after the agency said it would not restrict the use of the other group of beta-lactams, penicillins, as well as tetracyclines, two other drug classes on which it had contemplated taking action. In the span of just two weeks, then, FDA has moved to prevent misuse of one drug while shirking its responsibility for two others. One step forward, two steps back. Read More >

CLF opposes Rehberg amendment, antibiotic-resistant Salmonella infections in children

The FY 2012 Agriculture appropriations bill, voted out of the House Appropriations Committee last week, includes an amendment that would severely limit the authority of FDA to regulate the use of antimicrobials, including antibiotics, in food animal production-a key concern of public health researchers.  Sponsored by Rep. Denny Rehberg (R-MT), the amendment would prohibit the agency from spending any money appropriated by the bill on actions “intended to restrict the use of a substance or a compound” unless certain conditions are met.  Although the amendment is broad-affecting any “substance or compound,” notably including tobacco-Rep. Rehberg has told The Washington Post that his goal was to block FDA action on the use of antimicrobials by food animal producers.  Indeed, the amendment would, among other things, preempt upcoming FDA restrictions on the misuse use of cephalosporin-the antibiotic of choice for serious Salmonella infections in children.  (Researchers have reported increased incidence of cephalosporin-resistant Salmonella infections [Foley and Lynne, 2008].)   Joining many others in the public health community, researchers at the Center for a Livable Future recently sent a letter to Congress , urging members to strike the amendment from the legislation before final passage.

The Rehberg amendment reads as follows (we have broken it into numbered and lettered points to make the language easier to follow):

None of the funds made available by this Act may be used by the Food and Drug Administration to write, prepare, develop or publish a proposed, interim, or final rule, regulation or guidance that is intended to restrict the use of a substance or a compound unless the Secretary

  1. bases such rule, regulation or guidance on hard science (and not on such factors as cost and consumer behavior), and
  2. determines that the weight of toxicological evidence, epidemiological evidence, and risk assessments clearly justifies such action,
  3. including a demonstration that a product containing such substance or compound

a.  is more harmful to users than a product that does not contain such substance or compound, or

b.  in the case of pharmaceuticals, has been demonstrated by scientific study to have none of the purported benefits. Read More >