FDA to impose limits on antibiotic use
Agency asks for public feedback on proposed ban
Dr. Joshua Sharfstein, principal deputy commissioner for food and drugs at the FDA, has scheduled public comment on a proposal to virtually ban the use of antibiotics as performance enhancers and growth promoters.
“We’re sort of setting the foundation where we can talk about regulation, talk about legislation,” said Sharfstein in a media Q-and-A transcript that accompanied the announcement.
There is growing concern that the indiscriminate use of antibiotics in livestock production may contribute to emerging drug resistance. There is little scientific evidence to support this widely held regulatory and consumer perception, but the fact that a number of broiler companies have attempted to apply this presumption for competitive marketing advantage suggests that there is some basis for evaluation.
Industry production groups representing pork and broilers are making common cause with the pharmaceutical industry to resist controls similar to those introduced into the EU at the beginning of the 1990s.
From the press release, it is apparent that the FDA is concerned over antibiotics that were in general use before 2003; are used principally to enhance production and are administered without veterinary control to mass populations of poultry and hogs.
It is apparently not the intention of the FDA to restrict therapeutic use of antibiotics. It is, however, inevitable that there will be greater control over antibiotic use and regulations will in all probability follow the prudent use principles as issued by the USDA over 15 years ago.
Any regulations adopted should be science-based and should not unjustifiably add to the cost of production or detract from efficiency. Although there are a number of prebiotics and probiotics and their combinations available there are circumstances where feed additive antibiotics represent the only prophylactic option against clostridial enteroxemias (necrotic enteritis, ulcerative enteritis, focal duodenal necrosis and botulism) in poultry.
Foreign examples of bans
In the UK, withdrawal of feed additive antibiotics with an activity against Clostridium spp. was associated with the emergence of cholangiohepatitis as a result of clostridial infection of the duodenum ascending to the gall bladder and liver.
Despite the ban on feed additive antibiotic in the Nordic countries for approximately 20 years, total antibiotic use has not declined materially and there has been a shift from sub-therapeutic to therapeutic administration.
As a result, regulatory authorities are now tracking antibiotic use by companies and veterinarians and they are threatening to sanction any use which is considered to be excessive or beyond “normal” patterns.
Restrictions should de applied fairly
The proposed restrictions on use of antibiotics in food animals should, however, be coupled with similar restraints on indiscriminate prescription of antibiotics by the medical profession. There are far too many physicians and their assistants prescribing antibiotics for uncomplicated viral infections to both adults and children.
Defective hygiene and excessive use of antibiotics in critical care and neonatal wards has resulted in nosocomial infections as hospitals become reservoirs of drug resistant organisms.
Limits need to be justified by science
The submissions from stakeholders to the FDA should be based on scientific principles and should explore ways to ensure the judicious use of antibiotics according to class, recipient species and indication. The role of alternatives including pre- and probiotics must be explored for both human and food animal applications. Modifying production systems, improving management, nutrition, immunization and environmental control should also be considered in relation to host-pathogen relationships.
Above all, the intensive animal industries should be careful not to project an image of stonewalling scientifically justifiable measures which the public perceive as being in their interests. By the same token, manufacturers and distributors of alternatives to antibiotics should be diplomatic in their public representation promoting their probiotics and prebiotics so as not to make unsubstantiated claims.
Decisions regarding the use of antibiotics for therapeutic purposes must be the subject of risk assessment and evaluation. The recent history of the banning of enrofloxacin is a case in point.
Withdrawal of the drug for administration to food animal species has done little to reduce the emergence of drug resistant organisms in the human population but has deprived the veterinary profession of a useful class of antibiotics which could be used judiciously under strict supervision for breeding stock.
We must be careful not to throw out the baby with the bathwater.