U.S. Food & Drug Administration (FDA)

 

While there is a dispute amongst attorneys about FDA’s authority to govern compounding in veterinary medicine in the absence of amendments to the Federal Food Drug and Cosmetic Act, there is no doubt that states may legislate or regulate this area of practice.

Compounding, defined by AVMA as “any manipulation of a drug beyond that stipulated on the drug label – is needed in veterinary medicine to provide individually mixed drugs for specific patients with special needs not met by FDA-approved drugs” remains an important tool for veterinarians, who must be vigilant in remaining in compliance with all relevant state and federal laws.

At least five states have recently introduced bills or regulations that limit or permit compounding by veterinarians for their patients in specified situations. “According to the American Veterinary Medical Association (AVMA), as of August 2015, nine states (including Virginia) have laws or regulations that permit licensed veterinarians to administer and dispense compounded products, in some cases under specified conditions.”

Maryland bill SB 614 “would provide an exception to state pharmacy law, specifying that it does not prohibit a licensed veterinarian from dispensing compounded preparations, provided by a pharmacy, for use in a companion animal, under specified circumstances. A pharmacy would be authorized to provide certain compounded preparations without a patient-specific prescription to a licensed veterinarian.”

Maryland defines “companion animal” as “a rabbit, bird, rodent, fish, reptile, amphibian, nonhuman primate, or any species of animal kept for pleasure rather than utility and accustomed to living in or about human habitation, or a cat or dog regardless of any utilitarian purpose. Companion animal does not include cattle, sheep, goats, swine, poultry, or any other animals kept for bona fide research or agricultural issues.”

Massachusetts HB 3989 would authorize a veterinarian to dispense a compounded drug, that is not prepared from bulk supplies, to the veterinarian’s patient under the following limited circumstances:

the animal is an animal companion; the quantity dispensed is no more than a 120 hour supply; the compounded drug is for the treatment of an emergency condition; and timely access to a compounding pharmacy is not available, as determined by the prescribing veterinarian.

The bill would also prohibit a veterinarian from selling or administering a compounded drug if it duplicated proprietary products or was a federally controlled substance.

In Colorado, HB 1324 would:

authorize a compounding pharmacy to compound and distribute a drug to a veterinarian without a specific patient indicated to receive the compounded drug; and a veterinarian to dispense a compounded drug, maintained as part of the veterinarian’s office stock, in an amount not to exceed 5 days’ worth of doses, if a patient has an emergency condition that the compounded drug is necessary to treat and the veterinarian cannot access, in a timely manner, the compounded drug through a compounding pharmacy.

Similar to the proposed Colorado bill, New York legislators are considering a bill that would permit veterinarians to inventory certain compounded drugs for use during emergencies and times that drugs would be available. Despite concerns about the safety of compounded drugs, the official justification for the bill stated:

Unlike human medicine, veterinary medicine has a unique service model. In many cases there is no ready alternative to a veterinarian having compounded medicines on hand at all times. This is especially true in emergency situations and at night and on weekends and holidays where there is no practical alternative but the animal hospital and its staff veterinarians for the purposes of filling a prescription for an animal with which a veterinary client patient relationship exists. The alternative to the safe and proper use of these safe substances would in many cases be suffering and possible death for the animal in need of them.

In Delaware, a proposed amendment to the Board of Pharmacy regulations would prohibit a pharmacist from selling “non-patient specific compounded products to a practitioner for office use unless covered under federal authority.” Unfortunately, this language does not provide much guidance to the regulated community.

“AVMA reports that compounding is critical for veterinary medicine because of the limited number of U.S. Food and Drug Administration-approved drug products for the many species and conditions that veterinarians treat.

Hopefully more states will permit the use of compounded drugs in veterinary practices so that practitioners can provide for the health of their patients.

A number of presenters at this recent conference described the landscape of federal and state oversight of veterinary drugs and therapeutics.

Here is a quick primer on the topic:

USDA’s Center for Veterinary Biologics (CVB) is authorized, under the Virus-Serum-Toxin Act (VSTA) of 1913, amended by the Food Security Act of 1985, to license and regulate veterinary biologics, which are defined as “vaccines, bacterins, allergens, antibodies, antitoxins, toxoids, immunostimulants, certain cytokines, antigenic or immunizing components of live organisms, and diagnostic components.”

As David A. Brake, BioQuest Associates, LLC, explained, the key to understanding what USDA-CVB regulates, compared to products regulated by FDA, is whether the veterinary biologic in question   “function[s] through an immunological process for treatment of an animal disease; including: Antibody products, immunomodulators and immunostimulants.”

FDA is authorized to regulate animal drugs.  “The term ‘drug’ means. . .(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man; or other animals. . .”    21 U.S.C. 321(g)(1).

Whether a biologic is regulated by USDA or FDA is based on consideration of its primary mechanism of action.

Biologics that do not function through an immunological process but are used to diagnose, cure, mitigate, treat or prevent disease in animals would be regulated by FDA.

USDA and FDA have signed a memorandum of understanding to confer with each other if there is a question about which agency should regulate a certain animal product.

Similarly, pesticides may be regulated by EPA under  the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), FDA under the Federal Food Drug Cosmetic Act (FFDCA), based on its systemic or local effect. (States also regulate pesticides under relevant state laws).

Each animal product, regardless of the agency in control, must be safe, efficacious, labeled as authorized by the governing agency, and approved based on rigorous agency-review of the relevant application and required facts and documents.

As antibiotic use in animals, particularly food animals, is increasingly scrutinized, other animal products are under development to combat infectious diseases.  New products, recently developed to replace antibiotics,  including monoclonal antibodies, will be carefully reviewed to determine if their mechanism of action is immunological or not.  The tension between USDA, FDA, and EPA will likely increase, as pharmaceutical companies continue to expand their use of newer technologies to treat diseases.

And we should not leave out FTC, whose mission is “to prevent business practices that are anticompetitive or deceptive or unfair to consumers . . . without unduly burdening legitimate business activity.”   As recently described, FTC has begun to closely scrutinize the accessibility of prescription medications to pet owners.

FTC’s Strategic Goals include:

  1. Protect Consumers: Prevent fraud, deception, and unfair business practices in the marketplace.

  2. Maintain Competition: Prevent anticompetitive mergers and other anticompetitive business practices in the marketplace.

  3. Advance Performance: Advance the FTC’s performance through organizational, individual, and management excellence.

FTC’s influence over the historically state-authorized practice of veterinary medicine remains to be seen.

It is clear that animal health, animal health products, and veterinary medicine has captured the attention of local, state and federal lawmakers, large and small businesses, pet and animal owners, as well as the general public.

As reported by VCA ANTECH INC, in its annual report filed 03/01/13 for the period ending 12/31/12:

According to American Pet Products Association, Inc.’s (“APPA”) 2011-2012 APPA National Pet Owners Survey, the United States population of companion animals is approximately 189 million, including about 165 million dogs and cats. APPA estimates that over $30 billion was spent in the United States on pets in 2012 for veterinary care, supplies, medicine and boarding and grooming. The survey indicated that the ownership of pets is widespread with approximately 73 million, or 62%, of U.S. households owning at least one pet, including companion and other animals. Specifically, 46 million households owned at least one dog and 39 million households owned at least one cat.

It is clear that animal health products and the animals they are developed to protect, will be increasingly under scrutiny by all relevant federal and state agencies.

 

I attended the first ever Legal, Regulatory and Compliance Forum on Animal Health and Veterinary Drugs and Therapeutics, “a comprehensive guide to the latest developments affecting drugs for companion animals and livestock,” held in New York City by the American Conference Institute, on September 10-11.

Attendees and speakers were the who’s-who of this area of law, affecting animals, their owners, veterinarians, pharmaceutical companies, the biomedical research community and more.

Topics discussed, as listed on the agenda (©ACI Agenda) included:

The Policy and Politics of Animal Health: Understanding How Certain Legislative‚ Political and Grassroots Initiatives May Impact the Animal Health Industry’s Future;

Consolidation in the Animal Health Industry: Understanding How Mergers‚ Acquisitions and Spinouts Are Reshaping the Legal‚ Regulatory and Economic Landscape of Veterinary Medicines;

Animal Medicines -The Approval Process;

Drug Compounding in the Animal Drug Industry: Assessing Fair and Foul Practices;

Patents and Veterinary Medicines: Exploring the Delicate Balance Between Brand Name and Generic Animal Drug Products and New Controversies;

Making A Name and Setting a Mark: Appreciating the Importance of Trademarks and Trade Names for Animal Medicines;

Exploring the Relationship Between Veterinary Medicines and Animal Feed and Pet Food;

Exploring Legal‚ Regulatory and Economic Concerns Associated With the Development of Advanced Biological Drugs for Use in Animals;

Navigating the Regulatory Maze of Advertising and Promotion in the Animal Medicines Industry;

Understanding the Importance of Current Good Manufacturing Practices in The World of Animal Drugs;

Establishing Best Practices for Adverse Event Reporting and Recalls in the Animal Health Space; and

Survey of Class Action Lawsuits in the Animal Drug Industry.

The panel on compounding was most entertaining.

Brian Malkin, Senior Counsel, McGuireWoods LLP, served as umpire (literally) for Rachel G. Pontikes, Partner, Duane Morris, who represents compounding pharmacies and veterinarians, and Theodore M. Sullivan, Counsel, Buchanan Ingersoll & Rooney PC who served up a full-fledged rally, with no clear winner, except for the audience, appreciative of the passionate presentation.

Amongst other points, the panel debated:

  • whether FDA has the authority (as it asserts) to prohibit veterinary compounding from bulk drug substances, under the umbrella of “new animal drugs” which FDA is clearly authorized to regulate; or
  • whether animal compounding remains governed by state laws; and
  • if FDA does not currently have that authority, will it have to obtain authorization from Congress, by way of statutory amendment, as it did to obtain authority over compounding in the human area.

The panelists also debated the meaning of the district court’s holding in U.S. v. Franck’s Lab, Inc., 816 F. Supp. 2d 1209 (M.D.Fla. 2011), namely, that FDA was not authorized to enjoin the “long-standing, widespread, state-regulated practice of pharmacists filling a veterinarian’s prescription for a non-food producing animal by compounding from bulk substances,” since the appeal that followed that decision was dismissed as moot.

In May, 2015, FDA issued Draft Guidance #230 titled, Compounding Animal Drugs from Bulk Drug Substances, which “Contains Nonbinding Recommendations”  (the panelists also debated whether FDA’s guidance documents are binding or not).

It remains to be seen whether and to what extent those recommendations are binding, or will be challenged as another unauthorized overreach by FDA into the governance of the practice of compounding medicines for animals, historically a state-governed fundamental aspect of veterinary medicine.

More to come about the other topics discussed during this historic conference.

As discussed in USDA, FDA, and EPA-confusing authority over livestock production and food labeling, several federal agencies have varying control over livestock production and the food resulting therefrom.

For example, the Food Safety and Inspection Service (FSIS) in USDA is “responsible for ensuring that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.”

But FDA has authority over almost everything else.

In general, FDA regulates:

Foods, including:

  • dietary supplements

  • bottled water

  • food additives

  • infant formulas

  • other food products (although the U.S. Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products)

Authority over eggs remains confusingly split between the two agencies.

USDA inspects and grades eggs, and has authority over egg products (liquid, frozen and dehydrated eggs) and poultry farming from an animal health perspective, but FDA is responsible for the food safety of shelled eggs, poultry feed and medicines.

USDA controls poultry vaccines.

FDA and USDA authorize or restrict the labeling of egg (and other) products under their authority, which can result in some confusion.

For example, FDA does not define the term “natural” because

From a food science perspective, it is difficult to define a food product that is ‘natural’ because the food has probably been processed and is no longer the product of the earth. That said, FDA has not developed a definition for use of the term natural or its derivatives. However, the agency has not objected to the use of the term if the food does not contain added color, artificial flavors, or synthetic substances.

FSIS, on the other hand, defines “natural” as:

A product containing no artificial ingredient or added color and is only minimally processed. Minimal processing means that the product was processed in a manner that does not fundamentally alter the product. The label must include a statement explaining the meaning of the term.

As consumer preference for “natural” and “organic” foods continues to escalate, maybe the two agencies can at least adopt similar definitions for shared terms.

Both agencies also have authority over ractopamine, a growth promotant sometimes used in U.S. hog and cattle production. USDA controls the labeling of meat produced by these animals, but FDA authorizes (or limits) its use as an animal drug and in animal feed and has established the following tolerance levels of residues of the drug found in tissues tested (by FSIS) after slaughter:

FDA’s tolerances for ractopamine, available at 21CFR556.570, include:

(a) Acceptable Daily Intake (ADI). The ADI for total residues of ractopamine hydrochloride is 1.25 micrograms per kilogram of body weight per day.

(b) Tolerances –(1) Cattle –(i) Liver (the target tissue). The tolerance for ractopamine hydrochloride (the marker residue) is 0.09 parts per million (ppm).

(ii) Muscle. The tolerance for ractopamine hydrochloride (the marker residue) is 0.03 ppm.

(2) Swine –(i) Liver (the target tissue). The tolerance for ractopamine hydrochloride (the marker residue) is 0.15 ppm.

(ii) Muscle. The tolerance for ractopamine hydrochloride (the marker residue) is 0.05 ppm.

(3) Turkeys –(i) Liver (the target tissue). The tolerance for ractopamine (the marker residue) is 0.45 ppm.

(ii) Muscle. The tolerance for ractopamine (the marker residue) is 0.1 ppm.

[68 FR 54659, Sept. 18, 2003, as amended at 73 FR 72715, Dec. 1, 2008]

 

 

The New York Times published an article[1] on the use of a growth promotant (ractopamine) used by some cattle and hog producers to increase the efficiency of the final stages of growth before animals are slaughtered. I recently described the shift away from the use of antibiotics in the livestock industry.

USDA recently approved food manufacturers in the U.S. to indicate that no ractopamine was fed to the livestock producing the meat so labeled. Not that many consumers will know what ractopamine is, but as previously discussed, consumers are increasingly choosing food from animal raised with more “natural” and untreated feed. “Ractopamine” is not a term or ingredient one thinks of as “natural.”

Two things came to mind when reading this article (that prompted this blog).

First, as the NYT article pointed out, food manufacturers and livestock producers have been eliminating the use of certain feed ingredients, including ractopamine, to avoid embargoes from other countries that ban the importation of such products. The influence of international markets on of livestock production in this country is expanding exponentially and will have an even greater impact in the future. Stay tuned for more on this topic.

Second, it occurred to me that many reading the article may not know that USDA, not FDA is responsible for food labeling of certain meat products, but there are at least three federal agencies with some authority over how livestock are raised (USDA, FDA, and EPA)[2].

The Food Safety and Inspection Service (FSIS) is the public health agency in the U.S. Department of Agriculture responsible for ensuring that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.

FSIS has a “glossary of meat and poultry labeling terms” on its website. Here are some defined terms:

According to FSIS “Natural” means:[1]

[1] FDA, another federal agency with authority over livestock feed and drugs, does not have a definition for “natural.”

A product containing no artificial ingredient or added color and is only minimally processed. Minimal processing means that the product was processed in a manner that does not fundamentally alter the product. The label must include a statement explaining the meaning of the term.

FSIS does not permit a label to state “No Hormones (pork or poultry)” because “hormones are not allowed in raising hogs or poultry.”

Therefore, the claim ‘no hormones added’ cannot be used on the labels of pork or poultry unless it is followed by a statement that says ‘Federal regulations prohibit the use of hormones.’

In addition to labeling requirements, FSIS also establishes and approves the laboratory methods used to test for the presence of ractopamine in bovine and swine muscle and liver.

But FSIS does not have the authority to establish which tolerance levels are permitted in these products or in the environment. FDA establishes the tolerance levels permitted in meats sold in interstate commerce, and EPA establishes permissible environmental tolerance values. For more on FDA’s authority go to “FDA’s authority over livestock production and food labeling.”

For decades pundits have discussed moving all food production and related commerce under the authority of one agency.

Maybe the next administration will consider this consolidated approach . . . Or maybe not.

[1] Stephanie Storm, New Label Identifies Pork Without a Growth Drug,” New York Times (September 5, 2015)

[2] U.S. Department of Health & Human Services lists FSIS, FDA, and CDC as three main federal agencies with authority over food safety at Selected Federal Agencies with a Role in Food Safety.

As discussed in prior postings, there are animal and public health concerns associated with the growing practice of feeding raw food to pets.

The Centers for Disease Control (“CDC”) recently reported they will step up their efforts to study potential risks from such feeding practices.

CDC described an investigation they have begun to determine the prevalence of certain pathogens in samples of raw food products sold for dogs and cats, specifically Salmonella, Listeria monocytogenes, Escherichia coli O157:H7 and Non O157:H7 Shiga Toxin-Producing Escherichia coli (STEC).

Scientific reports have described bacterial pathogens identified in raw pet foods:

Joffe (2002)1 reported that Salmonella was found in 80% of the samples of raw chicken dog food diets and in 30% of the stool samples from dogs fed the diets.

The FDA/Center for Veterinary Medicine/ Veterinary Laboratory Investigation and Response Network in collaboration with the Food Emergency Response Network (FERN) conducted a research study and found that among the 196 samples of raw dog and cat food purchased from online stores, 15 were positive for Salmonella (7.7%), 32 were positive for L. monocytogenes (16.3%), none were positive for E. coli O157:H7 and 10 were positive for non O157:H7 STEC (CVM, 2014).

Finley (2007) reported that, 50% of dogs fed Salmonella-contaminated raw food diets shed Salmonella in their feces, while none of the control dogs fed Salmonella-negative diets shed Salmonella. In addition, dogs fed Salmonella-contaminated raw food diets shed the same Salmonella serotypes as found in their food.

There are published reports of transmission of Salmonella from household dogs or cats with salmonellosis to people that became ill.  STEC and L. monocytogenes were found among clinical isolates from dogs.

Surveillance and testing of raw pet foods from retail stores will take place between June 1, 2015 through August 31, 2015.

CDC has warned that “[p]ositive findings of Salmonella, Listeria monocytogenes, E. coli O157:H7 in a sample of raw foods for dogs or cats product collected from a retail store may result in a Class I recall, press release, and Reportable Food Registry (RFR) submission” since such products would be considered “adulterated under section 402(a)(1) of the Act (21 U.S.C. 342(a)(1) in that it bears or contains a poisonous or deleterious substance, namely Salmonella, Listeria monocytogenes, or E. coli O157:H7.”

Concerns about raw pet food, previously discussed, have resurfaced with the laboratory isolation of listeria in pet food subsequently recalled by J.J. Fuds, Inc., out of an abundance of caution, as reported on FDA’s website.

Notably, J.J. Fuds, Inc. received no complaints about the health of animals or people resulting from exposure to the pet food, and announced that “the recall was a result of a routine sampling program by the Michigan Department of Agriculture and Rural Development resulting in a positive test for Listeria monocytogenes.”

According to the Center for Food Security & Public Health, “listeriosis is most common in ruminants (sheep, goats and cattle) but occasional cases have occurred in rabbits, guinea pigs, dogs, cats, pigs, poultry, canaries, parrots and other species.”  As a large animal veterinarian, I diagnosed and treated many sheep, goats, and llama infected with this bacteria, which, in these species, causes rapid-onset encephalitis which is often fatal.

The FDA has concerns about feeding raw pet food: “compared to other types of pet food, raw pet food is more likely to be contaminated with disease-causing bacteria, such as Salmonella and Listeria monocytogenes.”

Published guidelines on FDA’s website to prevent infection if handling raw pet food include:

  • Thoroughly wash your hands with soap and water (for at least 20 seconds) after handling raw pet food, and after touching surfaces or objects that have come in contact with the raw food.
  • Thoroughly clean and disinfect all surfaces and objects that come in contact with raw pet food. First wash with hot soapy water and then follow with a disinfectant. You can also run items through the dishwasher after each use to clean and disinfect them.
  • Freeze raw meat and poultry products until you are ready to use them, and thaw them in your refrigerator or microwave, not on your countertop or in your sink.
  • Carefully handle raw and frozen meat and poultry products. Don’t rinse raw meat, poultry, fish, and seafood. Bacteria in the raw juices can splash and spread to other food and surfaces.
  • Keep raw food separate from other food.
  • Immediately cover and refrigerate what your pet doesn’t eat, or throw the leftovers out safely.
  • If you’re using raw ingredients to make your own cooked pet food, be sure to cook all food to a proper internal temperature as measured by a food thermometer. Thorough cooking kills Salmonella, L. monocytogenes, and other harmful foodborne bacteria.
  • Don’t kiss your pet around its mouth, and don’t let your pet lick your face. This is especially important after your pet has just finished eating raw food.
  • Thoroughly wash your hands after touching or being licked by your pet. If your pet gives you a “kiss,” be sure to also wash your face.

CDC tracks food borne outbreaks and has identified seven investigations involving listeria from 2006-2014:

•Commercially Produced, Prepackaged Caramel Apples (2014) – Listeria monocytogenes

•Wholesome Soy Products Sprouts (2014) – Listeria monocytogenes

•Oasis Brands Cheese (2014)– Listeria monocytogenes

•Roos Foods Dairy Products (2014)– Listeria monocytogenes

•Crave Brothers Farmstead Cheeses (2013)– Listeria monocytogenes

•Frescolina Marte Brand Ricotta Salata Cheese (2012)–Listeria monocytogenes

•Jensen Farms Cantaloupes (2011)- Listeria monocytogenes

Justin Goodman, PETA’s director of laboratory investigations as David Grimm recently described in the article titled “The Insurgent” published in Science, Vol. 347, Issue 6220, January 23, 2015 “attempt[s] to show researchers that animal experimentation is flawed, cruel, and just plain worthless.”

Goodman owns a dog and two cats, according to Grimm.  Hopefully, those pets are vaccinated against common and preventable diseases, are tested for parasites, treated if appropriate, and are also provided medications when needed.

Those vaccines or medications are only approved by USDA or FDA, respectively, after they are sufficiently proven to be safe and efficacious.  Animal testing is an integral part of the approval process.

www.nature.com/…/v2/n1/images/nrd990-f1.gif

The history of the adoption of and amendments to the Federal Food and Drug law provides an explanation for the increasing testing and safety measures the law requires for drug approvals.

The initial passage of the Pure Food & Drugs Act of 1906 followed widespread public reaction to the publication of Upton Sinclair’s “The Jungle,” describing the unsanitary practices of the meatpacking industry in the U.S.

The 1937 Elixir Sulfanilamide Incident” preceded the  “enactment in 1938 of the Federal Food, Drug, and Cosmetic Act, the statute that today remains the basis for FDA regulation of these products.”  The Elixir resulted in “the deaths of more than 100 people after using a drug that was clearly unsafe.”

In 1962, following the birth of thousands of babies with congenital defects resulting from fetal exposure to thalidomide in utero, the law was amended to require the premarket establishment of safety and efficacy.

The expansion of premarket approvals for medical devices in 1976 followed pacemaker failures which were reported during 1972 and 1973, and thousands of injuries reportedly caused by the Dalkon Shield intrauterine device in 1975.

In 2007, the FDA obtained additional authority to perform post market surveillance and request additional data from drug companies.

In addition to protecting human health, the law has continued to evolve to benefit animals and their health, as described on FDA’s website:

While breeders and genetic engineers are focusing on animals as sources of food, other veterinary researchers continue to develop products to improve the health of pets. In 2004, the CVM approved Vetsulin, the first FDA-approved veterinary insulin for the treatment of dogs with diabetes mellitis. “We expect progress in disease and drug research to generate new drugs for our companion animals,” says Sundlof. “We’re seeing the same type of research to develop drugs for pets as for humans, such as treatments to improve the quality of life for older dogs and cats.”

While researchers are exploring and implementing alternatives to animal testing, this remains a critical phase to prove a drug’s safety and efficacy.

So while Goodman may not think animal testing is necessary, it remains a requirement for animal and human drug and vaccine approval.

As to Goodman’s tattoos which, according to Grimm cover “most of his skin,” they too have been tested on animals.

While FDA admittedly “has not traditionally regulated tattoo inks or the pigments used in them,” laboratories, including FDA’s Arkansas-based National Center for Toxicological Research (NCTR), are researching how the body metabolizes tattoo ink, as well as their short and long term effects, using animals when needed to investigate the potential toxic effects of tattoo ink in humans.

There are a lot of myths circulated by animal rights activists about the use of animals in biomedical research, which they are opposed to, even when such research benefits the animals themselves.

Most scientists and researchers understand that biomedical progress usually requires studies in animals to prove that vaccines, medications, and medical devices are safe and efficacious before they will be approved by FDA or USDA (USDA approves vaccines used to protect animal health).

FDA’s Guidance for Industry and Reviewers for Exploratory Investigational New Drug (IND) Studies explains why animal testing is required:

“Before the human studies can begin, an IND must be submitted to the Agency containing, among other things, information on any risks anticipated based on the results of pharmacologic and toxicological data collected during studies of the drug in animals (21 CFR 312.23(a)(8)). These basic safety tests are most often performed in rats and dogs. The studies are designed to permit the selection of a safe starting dose for humans, to gain an understanding of which organs may be the targets of toxicity, to estimate the margin of safety between a clinical and a toxic dose, and to predict pharmacokinetic and pharmacodynamic parameters.”

The Center for Veterinary Medicine at FDA provides guidance for new animal drug approval:

“New animal drugs are approved for specific intended uses (indications). To get a drug approved for a new indication, a sponsor submits a new animal drug application (NADA).”

The following information that must be submitted to support an NADA, usually requires animal testing.

  • Effectiveness
  • Chemistry, manufacturing, and controls
  • Safety to the target species
  • Environmental Assessment
  • Human food safety
  • Freedom of Information (FOI) Summary (food-producing animal species), and
  • Labeling

“The target animal safety section may include studies which identify the toxic syndrome(s) associated with the drug and the margin of safety of use of the product in the treated animal. The human food safety section may include short and long term toxicology studies, total residue and metabolism studies, analytical method validation studies, and tissue residue depletion studies.”

The American Association for Laboratory Animal Science (AALAS), an association of professionals that advances responsible laboratory animal care and use to benefit people and animals, describes the regulatory oversight of laboratory facilities:

“Laboratory facilities containing animals must meet strict federal, state and local requirements. Federal regulators routinely inspect laboratories to ensure that animals are adequately housed and cared for. Additionally, many laboratories submit to additional voluntary inspection for accreditation through the Association for the Assessment and Accreditation of Laboratory Animal Care, International (AAALAC).”

“Further, each institution must establish an animal care and use committee [an Institutional Animal Care and Use Committee (IACUC)] that includes an outside member of the public and a veterinarian. This committee oversees, inspects and monitors every potential study to ensure optimal animal care.”

The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), a private, nonprofit organization, promotes the humane treatment of animals in science through voluntary accreditation and assessment programs.

“More than 900 companies, universities, hospitals, government agencies and other research institutions in 39 countries have earned AAALAC accreditation, demonstrating their commitment to responsible animal care and use. These institutions volunteer to participate in AAALAC’s program, in addition to complying with the local, state and federal laws that regulate animal research.”

The IACUC, veterinarians, laboratory technicians, and researchers insure that the highest quality of animal care and treatment is provided to the animals they work with to provide the vital information required for the development and approval of life-saving drugs, vaccines, and medical devices.

As AALAS explains, the scientific community advocates highest quality of animal care the for two key reasons.

“First, working with animals in research is a privilege, and those animals helping us unlock the mysteries of disease deserve our respect and compassion. Second, only healthy animals are reliable models for the study of disease.”

Biomedical research remains vitally important to continue the amazing advancements in human and veterinary medicine that have saved hundreds of thousands of lives. The scientists and researchers on the front lines, and the animals they work with, should be respected and honored for their work.

 

Budding physicians at the University of Toledo are learning valuable surgical and emergency skills from pigs, a practice that has come under scrutiny by The Physicians Committee for Responsible Medicine, a DC-based animal activist group.  Claiming that simulation provides better training than the use of animals for practical training in these techniques, the group has reportedly asked the United States Department of Agriculture, the government agency responsible for enforcing the Animal Welfare Act, to investigate.

Copyright: marcogovel / 123RF Stock Photo

 

The medical school responded “that the USDA audited its research-animal programs in August and found they were in compliance with federal law. The university cited research that showed using its methods was better for training than simulation.”

USDA is reviewing the request and will investigate further if warranted.

The use of animals for research and teaching, while legal, and in many cases required, has come under increased scrutiny by activists.  In addition to filing complaints with the USDA, some groups, like Stop Animal Experimentation Now (SAEN), routinely post personal contact information about researchers online, encouraging its audience to contact the scientists directly.

The use of primates in biomedical research is most vehemently opposed.  Dr. Ruth Decker attacked research at the University of Wisconsin, circulating a petition urging the university to discontinue a study on the impact of early life stress on young rhesus monkeys.  The University’s response questioned the truthfulness of the information Decker distributed.

Copyright: skouatroulio / 123RF Stock Photo

“The truth is of little concern to activists who wish to end animal research, no matter the benefit to humans and animals. We don’t share that sentiment. We prefer people make their judgments on animal research with a fuller understanding of the research — of both its costs and potential benefits.”

“[W]e don’t appreciate the way petition’s author, Dr. Ruth Decker, misrepresents the research. By piling up mistakes, myths and exaggerations, and omitting important information, she asks well-meaning people to speak out with little understanding of the real science and the long, deliberative process through which it was approved.”

“This isn’t fair to the people who signed the petition, or to UW–Madison psychiatry professor . . . and the scientists involved in the work, or to the millions of people who suffer from mental illness for whom available treatment methods offer little relief.”

The University corrected several misrepresentations of the research in question, including:

•“This is not a repeat of experiments.”

• “There is no ‘solitary confinement.’”

• “The animals in the study are not ‘terrorized,’ and do not experience ‘relentless torture.’”

Instead of being “needless” and “unnecessary” this type of research will benefit hundreds of thousands of people suffering from mental illness.

Research involving animals for the benefit of humans or animals is highly regulated, and approval from each institution’s animal care oversight committee is required before research can begin.

Stay tuned for an explanation of how these committees work, and when animal research is required by FDA for drug approval.