U.S. Food & Drug Administration (FDA)

The “PUPPERS” Act, H.R. 3197, a bill that would prohibit the use of canines in biomedical research at the Veterans Administration by eliminating required funding, is misguided and, if enacted, would be harmful to both humans and animals.

Esteemed scientific associations (listed below) wrote to Congressional representatives, in opposition to H.R. 3197, explaining that while scientists embrace efforts to reduce the number of animals needed in research and to replace animals when possible, animal models are still required before drugs or devices are sufficiently proven to be both safe and efficacious for their intended use.  While the number of dogs involved in biomedical research has been reduced, their contribution remains critical in finding cures for certain diseases and disorders, like the previously incurable and fatal genetic disorder affecting skeletal muscles in both humans and dogs, called Myotubular Myopathy (MTM), recently described here.

Canines are currently playing a vital role in the moonshot to end cancer, aging and Alzheimer’s, heart disease, diabetes, and most recently the first FDA-approved artificial pancreas was brought to fruition because of work at the VA. Additionally, 22 of the 25 most prescribed medications were brought to patients’ bedsides thanks to research with canines.

Quote from letter to Congressional representatives from:

  • American Academy of Neurology (AAN);
  • American Association for Laboratory Animal Science (AALAS);
  • American College of Neuropsychopharmacology (ACNP) ;
  • American Neurological Association (ANA);
  • American Society of Laboratory Animal Practitioners (ASLAP);
  • American Society for Pharmacology & Experimental Therapeutics (ASPET);
  • American Thoracic Society (ATS);
  • Americans for Medical Progress (AMP);
  • Associated Medical Schools of New York (AMSNY);
  • Association for Research in Vision and Ophthalmology (ARVO);
  • Association of American Medical Colleges (AAMC);
  • Association of American Universities (AAU);
  • Association of American Veterinary Medical Colleges (AAVMC);
  • Association of Public and Land-grant Universities (APLU);
  • Baylor College of Medicine California Biomedical Research Association (CBRA);
  • Coalition for the Life Sciences The College on Problems of Drug Dependence, Inc. Comparative Biosciences, Inc. Council On Governmental Relations (COGR);
  • Federation of American Societies for Experimental Biology (FASEB);
  • IACUC 101 Series Massachusetts Society for Medical Research (MSMR);
  • Michigan Society for Medical Research (MISMR);
  • National Animal Interest Alliance (NAIA) National Association for Biomedical Research (NABR);
  • National Association of Veterans’ Research & Education Foundations (NAVREF);
  • New Jersey Association for Biomedical Research (NJABR);
  • North Carolina Association for Biomedical Research (NCABR)
  • Northwest Association for Biomedical Research (NWABR);
  • Oregon Health & Science University (OHSU);
  • Pennsylvania Society for Biomedical Research (PSBR);
  • RxGen SNBL USA, Ltd. Society for Neuroscience (SfN);
  • Society for the Study of Reproduction (SSR);
  • States United for Biomedical Research (SUBR);
  • Texas Society for Biomedical Research (TSBR); and
  • University of California, Los Angeles University of Illinois Urbana-Champaign Washington University in St. Louis.

Our ability to study and find cures for many human and animal diseases and disorders would not have been obtainable without studies involving animals, including the following medical achievements:

  • the cardiac pacemaker;
  • the first liver transplant;
  • nicotine patch;
  • the discovery of insulin;
  • vaccinations against canine distemper, parvovirus, rabies, coronavirus, leptospirosis, Lyme disease, measles, and hepatitis;
  • prevention of canine intestinal parasitic diseases, fleas, ticks, mites and mange.

Like the entities listed above I look forward to a time when biomedical research does not involve animal testing, but we currently are not knowledgeable or scientifically advanced enough to entirely replace animals with other models.

Therefore, federally proposed bills, including H.R. 3197 and a similar amendment offered by Rep. Dave Brat (R-VA) to the Defense, Military Construction, Veterans Affairs, Legislative Branch, and Energy and Water Development National Security Appropriations Act, 2018, if adopted, would only serve to harm both human and animal health, and should therefore be opposed.

 

FDA’s recent announcement that it is “withdrawing draft Guidance for Industry (GFI) #230, ‘Compounding Animal Drugs from Bulk Drug Substances’” reminded me that pet owners can become confused about what type of medications are available for treating their pets.  For example, while serving on the New Jersey State Board of Veterinary Medicine, I recall a fair number of consumer complaints that alleged that a veterinarian provided substandard medical care because the medication prescribed to a pet was labeled “for human use only.”  Consumers therefore concluded that the medication harmed their pet.

However, the fact that medication is not specifically approved for use in animals does not mean that it would necessarily be harmful to those animals.

In fact, the use of an approved drug in a manner that is different than stated on the label, has been a fundamental tool used in veterinary medicine since drugs were first labeled.  This “extralabel” drug use was memorialized by Congress in the Animal Medicinal Drug Clarification Act of 1994 (AMDUCA).  See AVMA’s description of AMDUCA.

As AVMA describes on it’s website, “Compounding: FAQ for Veterinarians,” “compounding for animal patients . . . [is] a subpart of  [the] Extralabel Drug Use (ELDU) Rules.”

The ability to use approved drugs in species, for treatments, or at dosages, frequencies, or routes of administration that are not included on the label, is a tool that veterinarians use on a daily basis.  Since obtaining drug approvals for all uses in all types of animal species is cost-prohibitive, the only way some animals can be treated is through the use of drugs in an extra-labeled fashion.

When used properly and pursuant to the standard of care in veterinary medicine, such use should be considered legal.

While FDA has stated that “[c]urrent law does not permit compounding of animal drugs from bulk drug substances,” whether, and to what extent FDA governs compounding in the veterinary space has been the subject of legal debate.

However, FDA’s withdrawal of its guidance document related to compounding animal drugs from bulk substances creates even more confusion and uncertainty for the regulated community.  The now withdrawn guidance document,  Guidance #230, had set forth the situations in which FDA had indicated that it would not take regulatory action against a pharmacy or veterinarian when “an animal drug compounded from bulk substances may be an appropriate treatment option.”

Now, instead of finalizing the draft guidance based on comments received, “FDA intends to publish the new draft in early 2018 for public comment.”

So, the regulated community will be without guidance for a short period of time.

Hopefully FDA’s new guidance will continue to permit compounding from bulk substances when needed to provide adequate medical care for animals in need thereof.

 

After a whirlwind of comments and criticisms, USDA has updated its statement regarding the abrupt deactivation of its Animal Care Search Tool, available here https://content.govdelivery.com/accounts/USDAAPHIS/bulletins/185b051.

Similar to statements published on interested parties’ websites, USDA confirmed that this decision was based on internal discussions and review that predated the new administration.

In 2016, well before the change of Administration, APHIS decided to make adjustments to the posting of regulatory records.

USDA noted that the deactivation resulted not only based on guidance from the Department of Justice (see Department of Justice Guide to the Freedom of Information Act and Overview of the Privacy Act), that provides a comprehensive review of litigation related to FOIA and the Privacy Act, but that their action was also related to litigation “APHIS is currently involved in . . . concerning, among other issues, information posted on the agency’s website.”

USDA/APHIS did not identify which litigation it referenced in its updated statement.

Like USDA, many federal agencies struggle to balance transparency with personal and business protections required by federal law.

 Recently, PETA (largely) lost it’s lawsuit against HHS, alleging that the Centers for Disease Control and Prevention had impermissibly withheld information pursuant to PETA’s FOIA request “seeking records submitted by importers of nonhuman primates . . . to CDC pursuant to certain agency regulations.”   People for the Ethical Treatment of Animals v. United States Department of Health and Human Services, No. 15-cv-309, slip op. (D.D.C. January 5, 2017).

In the final Order, the Court granted Defendant’s Corrected Motion for Relief under Fed. R. Civ. P. 60(b) holding:

“The four categories of information the Court previously held qualified for protection pursuant to FOIA Exemption 4 with respect to the records of seven objecting importers—quantity of animals imported, the descriptions of crates used in shipments, the names of the companies that export the animals, and the names of the airline carriers that transport the animals—also qualify for such protection with respect to the records of Central State Primate (‘CSP’), Dallas Zoo Management (‘DZM’), and SBNL USA (‘SNBL’). It is further ORDERED that Plaintiff’s [52] Cross-Motion for Relief under Fed. R. Civ. P. 60(b) is GRANTED-IN-PART and DENIED-IN-PART. Plaintiff’s motion is GRANTED in that information regarding the quantity of animals imported and the descriptions of crates used in shipments on the records of Worldwide Primates, Inc. (‘WWP’) and Primate Products Inc. (‘PPI’) does not qualify for protection pursuant to FOIA Exemption 4. Plaintiff’s motion is DENIED in all other respects.  Id., slip op. (D.D.C. Feb. 6, 2017).”

PETA has appealed this decision.

In preparation for the VFD final rule, which outlines the revised process for authorizing use of VFD drugs (animal drugs intended for use in or on animal feed and that require the supervision of a licensed veterinarian), FDA released it’s final version of its industry guidance #233 titled “Veterinary Feed Directive-Common Format Questions and Answers.”

While rejecting a suggestion that FDA require a uniform veterinary feed directive form, FDA has provided a “common VFD format [that] would help veterinarians, their clients (i.e., animal producers), and distributors (including feed mills) quickly identify relevant information on the VFD.”

In addition to providing a list of information that is required, FDA has provided a blank VFD form and several examples of completed forms, several of which are reproduced below.

Blank VFD form
Blank VFD form
Example 1 VFD form
Example 1 VFD form
Example 2 VFD form
Example 2 VFD form

Example 2 VFD form

The information that must be included pursuant to § 558.6(b)(3) on any form utilized includes:

the veterinarian’s name, address, and telephone number;

the client’s name, business or home address, and telephone number;

the premises at which the animals specified in the VFD are located;

the date of VFD issuance;

the expiration date of the VFD;

the name of the VFD drug(s);

the species and production class of animals to be fed the VFD feed;

the approximate number of animals to be fed the VFD feed by the expiration date of the

VFD;

the indication for which the VFD is issued;

the level of VFD drug in the feed and duration of use;

the withdrawal time, special instructions, and cautionary statements necessary for use of

the drug in conformance with the approval;

the number of reorders (refills) authorized, if permitted by the drug approval, conditional

approval, or index listing;

the statement: “Use of feed containing this veterinary feed directive (VFD) drug in a

manner other than as directed on the labeling (extralabel use), is not permitted.”;

an affirmation of intent for combination VFD drugs as described in § 558.6(b)(6); and

the veterinarian’s electronic or written signature.

It would be surprising if veterinarians did not use the forms suggested by FDA to insure they were providing all the information required.

Not everyone is satisfied by the increased restrictions set forth by FDA regarding antibiotics for food animals provided in feed and/or water.

A number of nonprofits filed a citizen petition under section 512(e) of the Food, Drug, and Cosmetic Act, 21 U.S.C. Section 360b(e), “to request that the Commissioner of Food and Drugs withdraw approval of the use of medically important antibiotics in livestock and poultry for disease-prevention or growth-promotion purposes.”

These nonprofits want to prohibit the use of critically important antibiotics that prevent disease in food animals.  Such use is imperative to continue to protect food animals from preventable illness.

FDA, gearing up for the implementation of the Veterinary Feed Directive (VFD), recently “issued a letter reminding retail establishments that sell medically important antimicrobials for use in feed or water for food animals that the marketing status of those products will change from over-the-counter (OTC) to prescription (Rx) or to veterinary feed directive (VFD) at the end of calendar year 2016.”

As reported in the Daily Herald, those servicing livestock producers in Utah have also been trying to spread the word:

“Local veterinarians, feed suppliers and livestock producers gathered in Lehi on Thursday to learn how the federal feed directive, which goes into effect on Jan. 1, will affect their operations.

The meeting is just one of a series of meetings being held across the state to make sure livestock producers aren’t taken by surprise when the new directive takes effect. It is expected to affect almost everyone who raises animals for human consumption — from 4-Hers to turkey farmers to bee keepers.”

The VFD sets forth “the process for authorizing use of VFD drugs and provides a framework for veterinarians to authorize the use of medically important antimicrobials in feed when needed for specific animal health purposes” as reported by Lydia Zuraw on JUNE 3, 2015 at Food Safety News.

FDA announced that the final rule is:

“an important piece of the agency’s overall strategy to promote the judicious use of antimicrobials in food-producing animals. This strategy will bring the use of these drugs under veterinary supervision so that they are used only when necessary for assuring animal health.”

Notably, as previously discussed here, the rule memorializes the concept that veterinarian may only prescribe antibiotics to animals “within the context of a veterinarian-client-patient relationship (VCPR), which includes sufficient knowledge of the animal, visits to the farm, and follow-up evaluation or care.”

While many states include that requirement in state veterinary medical practice acts, not all states include a definition of or specifications for the “veterinarian-client-patient relationship.”  (See table of state laws compiled by AVMA).

The VFD will require veterinarians to follow state-defined VCPR requirements as long as the state requirements include the key elements in the final VFD.

FDA requires:

“the veterinarian engage with the client (i.e., animal producer or caretaker) to assume responsibility for making clinical judgments about patient (i.e., animal) health, have sufficient knowledge of the animal by conducting examinations and/or visits to the facility where the animal is managed, and provide for any necessary follow-up evaluation or care.”

However, “where the FDA determines that no applicable or appropriate state VCPR requirements exist, veterinarians will need to issue VFDs in compliance with federally defined VCPR requirements.”

FDA issued a draft revised guidance for industry, “General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals” in July 2016 that “described the type of information that the Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) recommends sponsors provide [the agency] to address the human food safety of new animal drugs used in food-producing animals.”

In addition to proving that drugs are safe and efficacious in the targeted livestock species, drug companies (sponsors) face increasing hurdles to prove that “food derived from treated animals is safe for human consumption.”

FDA has already begun implementing other changes to “the way medically important antibiotics have been used in animal agriculture for decades.” See FDA’s Guidance #213.

As reported on its website, FDA explains:

“[o]nce the changes are fully implemented, it will be illegal to use these medically important antibiotics for production purposes, and animal producers will need to obtain authorization from a licensed veterinarian to use them for prevention, control or treatment of a specifically identified disease.”

Food animal veterinarians and livestock farmers are concerned about their ability to treat animals with antibiotics appropriately when needed. In response,

“[t]he FDA acknowledges the important role medically important antimicrobials play in treating, controlling, and preventing disease in food-producing animals. However, the agency has been actively engaging veterinary organizations, animal producer organizations and other stakeholders to express our position that medically important antibiotics labeled for continuous or undefined durations of use is not consistent with judicious use principles, as outlined in previously-released guidance documents.”

In “General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals” FDA “provides, in one document, an overview of the overall process for the human food safety evaluation of new animal drugs used in food-producing animals, including:

  • Determining an acceptable daily intake (ADI);
  • Calculating safe concentrations;
  • Assignment of a tolerance;
  • Calculation of a withdrawal period and a milk discard time; and
  • Evaluation of carcinogenic compounds.”

In addition to analyzing the appropriate withdrawal times for meat, milk, and eggs, the agency evaluates the proposed drugs for their potential to create additional pressures on antibiotic resistance in humans.

However, FDA has identified drugs that may not have to undergo this analysis if it (and its metabolites and excipients) are not:

  • “regularly considered to have properties that would exert pressure towards the emergence or selection of bacteria of public health concern;
  • used to treat zoonotic gastroenteritis or other bacterial diseases in humans;
  • under development to treat bacterial diseases in humans; or
  • indicated for a bacterial disease in food-producing animals (i.e., indication is instead antifungal, antiprotozoal, anthelminthic, etc.).”

With the emergence of new methods of disease treatment and  prevention (using, for example, genetically immune livestock) hopefully veterinarians and farmers will not have to rely on antibiotics to treat animals and keep them healthy, since it will be increasingly difficult to obtain and retain the ability to use these drugs in livestock.

 

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]