BILL ANALYSIS �
SENATE COMMITTEE on AGRICULTURE
Senator Cathleen Galgiani, Chair
BILL NO: SB 835 HEARING: 04/01/14
AUTHOR: Hill FISCAL: Yes
VERSION: 03/26/14 CONSULTANT: Anne Megaro
Food animals: medically important antimicrobial drugs.
SUMMARY :
This bill would codify the Food and Drug Administration's
Guidance for Industry #213 dated December 2013 by requiring the
secretary of the California Department of Food and Agriculture
to refuse to register a livestock drug administered in the feed
or drinking water of food animals if such drug is a medically
important antimicrobial drug.
BACKGROUND AND EXISTING LAW :
Antimicrobial drugs were first developed in 1928 and became
widely used in human medicine in the 1940s. These new drugs
quickly proved to have significant health benefits in both human
and animal medicine and to this day are extremely important and
valuable tools used to treat and prevent illness and infection.
However, incidences of antimicrobial resistance have been
recorded over time and, if not addressed, pose a serious threat
to public health.
Antimicrobial resistance may develop for several reasons, and
one of the most widely accepted contributors to antimicrobial
resistance is the misuse of antimicrobial drugs. When bacteria
are exposed to an antimicrobial drug, it provides the
opportunity for 'survival of the fittest' where only the
strongest, most immune bacteria survive. These surviving
antimicrobial-resistant bacteria then multiply to form new
colonies of resistant bacteria that may spread and infect other
individuals. For this reason, it is important to use
antimicrobial drugs judiciously in both human and animal
medicine as one method to mitigate resistance.
The Centers for Disease Control and Prevention (CDC) recently
issued a report titled Antibiotic Resistance Threats in the
United States, 2013. The CDC estimates that in the United
States more than two million people are sickened every year with
antibiotic-resistant infections with at least 23,000 infections
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resulting in death. In its report, the CDC lists four core
actions that fight the spread of antibiotic resistance: 1)
preventing infections from occurring and preventing resistant
bacteria from spreading, 2) tracking resistant bacteria, 3)
improving the use of antibiotics, and 4) promoting the
development of new antibiotics and new diagnostic tests for
resistant bacteria.
The CDC notes that the use of antibiotics is the single most
important factor leading to antibiotic resistance around the
world. Up to 50% of all antibiotics prescribed for people are
either not needed or not optimally effective as prescribed.
Antibiotics are also used in food-producing animals for the
purpose of promoting growth, which the CDC recommends phasing
out. The US Food and Drug Administration (FDA) is currently
developing guidance to promote judicious use of antimicrobials,
as described below.
Over the last few years, the FDA has worked on creating
guidelines for industry (GFI) regarding the judicious use of
medically important antimicrobial drugs. In a series of three
guidances, the FDA has compiled a list of medically important
antimicrobial drugs categorized by their importance to human
health (GFI #152), developed principals that determine the
appropriate or judicious use of such drugs by limiting use to
only when necessary to maintain animal health and with
veterinary oversight or consultation (GFI #219), and provided
recommendations as to the implementation of these guidelines
(GFI #213). The FDA concludes that using medically important
antimicrobial drugs for animal growth promotion or feed
efficiency is not a judicious use and that veterinary oversight
or consultation is necessary when using these drugs.
In December 2013, the FDA released the final draft of the
Guidance for Industry #213 (GFI #213). This document contains
nonbinding recommendations to industry regarding the use of
medically important antimicrobial drugs in the feed and drinking
water of food-producing animals. The FDA intends to work with
drug companies to help them voluntarily implement the
recommendations, which include: 1) phasing out the use of
medically important antimicrobial drugs in food-producing
animals for production purposes (growth promotion and feed
efficiency), and 2) include veterinary oversight of these drugs
when used in the feed or water of food-producing animals.
Existing law: Requires the secretary of CDFA to register
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over-the-counter livestock drugs and regulate their use for
safety and efficacy. Retail sales of restricted livestock drugs
require a license. Each licensee shall keep a record of each
sale of a restricted drug, including the kind and quantity of
the drug; sale date; purchaser's name, address and signature;
and any other information deemed necessary by the secretary.
(Food and Agricultural Code �14200 et seq.).
Existing federal law: The FDA is responsible for protecting
public health by assuring the safety, effectiveness, quality,
and security of human and veterinary drugs. Within FDA, the
Center for Veterinary Medicine regulates the manufacture and
distribution of drugs that will be administered to animals.
Case study - Denmark: The Danish Antimicrobial Resistance
Monitoring and Research Program (DANMAP) has monitored
antimicrobial resistance and use of antimicrobials in food
animals and humans in Denmark since 1995. Denmark banned the
use of antimicrobial drugs for growth promotion in livestock and
has continually recorded antimicrobial drug use and impacts on
animal health. DANMAP reports overall use of antimicrobials in
livestock has decreased by 46% since 1994 and has not
compromised animal health. However, this is challenged by the
American Veterinary Medical Association, indicating that pig
mortality has increased for several years after the ban and
prescription antimicrobial drugs have increased, although it is
noted that in recent years pig mortality has significantly
decreased.
PROPOSED LAW :
This bill:
Codifies the FDA Guidance for Industry #213 dated December 2013.
1. Defines "medically important antimicrobial drug" to mean
a drug listed in the FDA Guidance for Industry #152 which
categorizes these drugs as critically important, highly
important, or important antimicrobial drugs.
2. Requires the secretary of CDFA to refuse to register a
medically important antimicrobial drug administered to food
animals through feed or drinking water unless the drug
complies with the specified requirements below:
a. Requires drug manufacturers to remove from the
label of said drugs the approved use for growth
promotion or feed efficiency.
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b. Requires drug manufacturers to change the
over-the-counter availability of said drugs to 1)
requiring a veterinary feed directive if the drug is
administered in animal feed or 2) requiring a
veterinary prescription if the drug is administered in
drinking water.
c. Requires that medically important
antimicrobial drugs administered through feed or water
may only be used under the supervision of a
veterinarian to treat, prevent, or control disease.
3. Requires a veterinarian-client-patient relationship to
ensure that medically important antimicrobial drugs are
used according to professionally accepted best practices.
4. Requires drug manufacturers to comply with these
provisions by January 1, 2017, and reregister medically
important antimicrobial drugs with the secretary of CDFA.
5. Authorizes the secretary to continue registering a drug
during FDA's GFI #213 review period should the review be
delayed beyond January 1, 2017.
6. Authorizes the secretary to extend the implementation
date if revisions to the VFD cause FDA to delay
implementation of GFI #213.
7. Authorizes the secretary to promulgate regulations to
ensure that California regulations are consistent with GFI
#213 should revisions to the VFD cause the FDA to revise
GFI #213.
COMMENTS :
Need for this bill: According to the author, this bill is
necessary to preserve the efficacy of medically important
antibiotics by putting into California law the voluntary
guidelines issued by the FDA to phase out the nontherapeutic use
of medically important antibiotics in food-producing animals and
to require veterinary oversight of these drugs. "Nontherapeutic
use" is considered as using antibiotics for purposes of growth
promotion or feed efficiency.
Disease prevention: There is argument as to whether
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antimicrobial drugs are being used judiciously when administered
to animals for the purpose of disease prevention. The concern
relates to the use of antimicrobial drugs when a disease is not
clinically present and which could provide the opportunity for
the continual, prolonged, or routine use of antimicrobial drugs
in food animals. According to the American Veterinary Medical
Association, the use of antimicrobial drugs for disease
prevention is an important tool for veterinarians to ensure the
health of animals when there is a known disease risk present.
Drug accessibility: Currently, antimicrobial drugs may be
obtained one of three ways: over-the-counter (OTC), through a
veterinarian's prescription (Rx), or through a veterinary feed
directive (VFD) which does not require a prescription but does
require veterinary oversight of a food animal drug that is
administered through feed or drinking water. GFI #213 and the
current bill would change the status of antimicrobial drugs
administered in feed from OTC to VFD, and the status of
antimicrobial drugs administered in drinking water from VFD to
Rx.
VFD Revision : Due to the change of OTC to VFD marketing status,
the FDA recognizes that current VFD regulations must be revised
and streamlined to minimize impacts on veterinarians, the animal
feed industry, and producers. These revisions are believed to
be critically important and are scheduled to be completed before
the three-year implementation timeline for GFI #213.
Voluntary vs. Mandatory: The FDA guidelines are strictly
voluntary and are not currently enforceable. According to the
FDA, "a voluntary approach, conducted in a cooperative and
timely manner, is the most effective approach to achieve the
common goal of more judicious use of medically important
antimicrobials in animal agriculture." However, the FDA has
indicated that if there is not a strong response and adoption of
these guidelines by industry within three years other action may
be taken under existing provisions of the Food, Drug, and
Cosmetic Act. As of March 26, 2014, the FDA reports that 25 of
the 26 drug companies, representing 99.6% of the applications
affected by GFI #213, have agreed in writing that they intend to
implement FDA's recommendations.
Board of Pharmacy: CDFA is responsible for registering food
animal drugs; however, the Board of Pharmacy is responsible for
registering prescription drugs. This bill would require that
specified animal drugs be changed to Rx status, and thus may be
under the jurisdiction of the Board of Pharmacy. This issue is
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outstanding and may be addressed by further amendments.
Codifying Guidelines: The committee may wish to consider
whether or not it is appropriate public policy to codify federal
guidelines in California state law.
RELATED LEGISLATION :
SB 1311 (Hill) of 2014. Requires the Department of Public
Health to include antibiotic resistant infections on the list of
reportable diseases and conditions. Referred to the Senate
Committee on Health.
SB 416 (Florez) of 2009. Would have authorized a school
district to make every effort to purchase poultry and meat
products that have not been treated with nontherapeutic
antibiotics. Failed passage in the Senate.
SB 1058 (Alquist), Chapter 296, Statutes of 2008. Establishes
the Medical Facility Infection Control and Prevention Act, which
would require specified hospitals to implement procedures for
screening, prevention, and reporting of hospital-related
infections, including MRSA, an antimicrobial-resistant
bacterium.
SB 739 (Speier), Chapter 526, Statutes of 2006. Establishes the
Hospital Infectious Disease Control Program, which would require
the Department of Public Health and specified hospitals to
implement a disease surveillance and hospital associated
infection prevention program.
SUPPORT :
California Cattlemen's Association
California State Grange
California Veterinary Medical Association
The Pew Charitable Trusts
OPPOSITION :
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Consumers Union - Oppose unless amended