June 15, 2011
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
- bases such rule, regulation or guidance on hard science (and not on such factors as cost and consumer behavior), and
- determines that the weight of toxicological evidence, epidemiological evidence, and risk assessments clearly justifies such action,
- 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.
If the amendment survives a procedural obstacle, it would impose three requirements-all worrisome-that FDA would need to meet before taking action to reduce the misuse of antimicrobials. First, the agency would need to base its action on “hard science,” a term without standard meaning in law or science. This requirement could create confusion for regulators, regulated industries, and the public health community-not to mention members of the general public with questions about government policies that affect their health. Second, FDA would need to show that the “weight of…evidence…clearly justifies” its actions. This creates a much higher standard for action than that currently found in the Federal Food, Drug, and Cosmetic Act, and would, we believe, limit the authority of FDA to take necessary actions to protect the public health.
Finally, and most problematically, FDA could not restrict the use of an antimicrobial unless a product containing that antimicrobial is shown to have “none of [its] purported benefits.” Even when “hard science,” toxicological evidence, epidemiological evidence, and risk assessments clearly demonstrate the public health hazards connected with the use of a pharmaceutical, FDA would not be permitted to take action if the products containing that substance or compound do, in fact, provide their “purported benefits.” In other words, even if the use of cephalosporins as antimicrobial growth promoters-drugs that increase the rate of food animals’ growth-is associated with cephalosporin-resistant Salmonella infections in children, FDA could not restrict cephalosporins’ use, provided that they do make animals grow faster. (The fourth requirement, “a demonstration that a product containing such substance or compound is more harmful to users than a product that does not contain such substance or compound,” applies to non-pharmaceuticals, and does not appear to affect antimicrobials.)
Unsurprisingly, the Rehberg amendment has encountered strong opposition from across the public health community. Rep. Rehberg may have intended only to block FDA action on antimicrobials. Despite this, he has picked a fight with countless other groups too: the amendment-applicable to any “substance or compound”-is so broad that it would affect not just FDA’s regulation of antimicrobials, but also the agency’s work on tobacco and other products. Especially concerned by the amendment’s implications for tobacco control, the American Public Health Association, the American Medical Association, the American Lung Association (see the ALA’s press release here) and 19 other marquee public health and medical organizations recently signed a letter asking Congress to remove the language from the appropriations bill.
Several researchers at CLF recently wrote a letter to Rep. David Dreier (R-CA) and Rep. Louise Slaughter (D-NY), the Chairman and Ranking Member, respectively, of the House Rules Committee, that urged their colleagues and them to remove the amendment before final passage of the bill. (Bills go to the Rules Committee before being debated and voted on by the full House.) Rep. Slaughter and her colleague, Rep. Henry Waxman (D-CA), have championed efforts to reduce the misuse of antimicrobials by food animal producers. We were happy to see that they’re on the case. Furthermore, Rep. Fred Upton (R-MI) has opposed the amendment on procedural grounds. Hopefully, Reps. Slaughter, Waxman, Upton, and others can remove the Rehberg amendment and allow FDA to take necessary steps to limit the use of antimicrobials in food animal production.
– Tyler Smith