A small bill could have huge implications for preventing the evolution of antibiotic resistance. Every couple of years, the Preservation of Antibiotics for Medical Treatment Act (PAMTA) is offered for consideration. Two weeks ago, Democratic Rep. Louise Slaughter proposed PAMTA again for consideration. Here are the key provisions ofthe proposed bill:
- The findings are very comprehensive. Given the number of times, the legislation has been proposed, you would expect this (you just keep adding more justification), but citing NARMS (the National Antimicrobial Resistance Monitoring System) and the recent finding by USDA that agricultural antibiotic use contributes to the MRSA problem are good things. All the work people have done to characterize the problem is starting to influence legislation.
- There's no wiggle room to speak of: all classes of antibiotics and their derivatives are covered.
- Non-therapeutic use is defined the right way. Historically, the ag lobby has been able to define therapeutic use as prophylactic use (i.e., preventative use). It's pretty easy to cheat under the guise of prophylaxis. But the legislation is very strict about the definition (italics mine):
Nontherapeutic Use- The term 'nontherapeutic use', with respect to a critical antimicrobial animal drug, means any use of the drug as a feed or water additive for an animal in the absence of any clinical sign of disease in the animal for growth promotion, feed efficiency, weight gain, routine disease prevention, or other routine purpose.'.
- Drugs will be withdrawn for non-therapeutic use (as defined above) after no more than two years, unless a 'reasonable certainty' is shown by the applicant. First, this represents a fundamental shift in the burden of proof: rather than having to show that non-therapeutic antibiotic use is harmful, manufacturers have to show that it is not harmful. I can't emphasize what a fundamental shift this is (and which, no doubt, will make ag and pharmaceutical lobbyists break out in cold sweats).
Second, because many antibiotics are not under patent (i.e., they're generics), the economic incentives are reduced to preserve the use of unprotected drugs. Generic drug profits are made on the margins, unlike patent-protected drugs, whose owners typically have the resources to wage these fights (e.g., there just isn't enough profit to defend tetracycline production).
- Finally, because the coverage is broad, the 'default setting' is that a drug will be banned for non-therapeutic use after two years. Again, it means that non-therapeutic use has to be actively supported, or else it is lost.
*To the best of my knowledge, there isn't a companion resolution in the Senate, but it never hurts to put this on their radar screens.
The Senate bill is S. 619 (House bill is H.R. 1549).
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Thanks for covering this important issue.