Drug Makers, Compounders at Odds Over FDA Oversight

The Animal Health Institute says “drugs crafted by pharmacies acting as manufacturers” are dangerous and illegal.

The Animal Health Institute, a trade group representing pharmaceutical manufacturers, is demanding that the Food and Drug Administration crack down on the illegal compounding of veterinary drugs, saying the practice puts animals at risk and jeopardizes the development of new medications.

The appeal was made during a media conference call Wednesday and at a recent meeting in Washington, D.C., involving stakeholders and organizations such as the American Veterinary Medical Association, the American Association of Equine Practitioners and the American Animal Hospital Association.

The Animal Health Institute is not asking for the elimination of all drug compounding. The group supports a pharmacist’s manipulation of FDA-approved drugs to meet individual patients’ needs and the occasional compounding of bulk, active ingredients under FDA’s discretionary powers.

“The third type of compounded drugs … is dangerous and illegal,” said Richard Carnevale, VMD, the Animal Health Institute’s vice president for regulatory, scientific and international affairs. “These are dangerous drugs crafted by pharmacies acting as manufacturers and often promoted to veterinarians as a way to increase profits.

“They are not looking to help Mrs. Jones’ cat,” Dr. Carnevale said of such companies. “They even offer disclaimers that they are not responsible for the safety or effectiveness of the preparations they compound.”

FDA acknowledged the Animal Health Institute’s plea but did not pledge stepped-up enforcement.

“FDA is greatly concerned about veterinarians and pharmacies that are engaged in manufacturing and distributing unapproved new animal drugs in a manner that is clearly outside the bounds of traditional pharmacy practice and that violates the Federal Food, Drug and Cosmetic Act,” the agency noted in a prepared statement.

“Enforcement action against unapproved drugs, including unapproved compounded drugs, may include warning letters, seizure of violative products and/or injunction against the manufacturers and distributors of violative products,” FDA added.

The International Academy of Compounding Pharmacists, which represented its members during the Washington roundtable discussion, noted that member pharmacies are heavily regulated and frequently inspected.

“If an organization is manufacturing drugs illegally, then of course they should be shut down at once,” the group stated.

Issues with drug manufacturers have led to a surge in demand for customized medications, the compounding organization added.

“One reason that compounding has increased in recent years is because many more drugs are commercially unavailable, both for humans and animals,” the group reported. “It is easy to point to an instance of a compounding error or a recall and provide that as evidence that compounded medications are unsafe.

“The truth, however, is that manufactured drugs are often the subject of recalls, and in fact the incidence of recalls seems to be increasing along with the growth in generic manufactured medications.”

The Animal Health Institute pointed to a 2014 case involving horses and Wickliffe Veterinary Pharmacy as an example of “dangerous and illegal” compounding. An overdose of pyrimethamine in a Wickliffe preparation prescribed for the treatment of equine protozoal myeloencephalitis left four horses dead and six debilitated.

What was supposed to be 17 mg/mL of pyrimethamine in the pyrimethamine-toltrazuril mixture was actually 229 mg/mL, according to a University of Florida analysis of one sample. Toltrazuril is not approved for use in horses, FDA reported.

Wickliffe expressed regret over the episode and stated that its compounding of toltrazuril and pyrimethamine was “completely legal.”

“In making its patently false allegations, the Animal Health Institute comes across as a collection of manufacturers desperate to increase market share,” Wickliffe reported. “Making medications is a high-risk business for compounders and manufacturers alike. That is why we have a rigorous quality program in place.

“We are heartbroken by the loss of horses resulting from medications provided by our pharmacy,” the company added. “We continue to enhance the safety controls needed to ensure that Wickliffe is producing only the highest-quality preparations.” 

While not specifying Wickliffe, Peter Pitts, a former FDA commissioner and co-founder of the Center for Medicine in the Public Interest, took aim at compounders during the conference call.

“Pharmacies masquerading as manufacturers cannot be allowed to ignore the law and put animal health at risk by selling cheap, substandard and illegal knockoff medicines,” he said. “These drugs are no bargains.”

The Animal Health Institute warned that illegal compounding hurts sales of approved veterinary medications and threatens to curtail multimillion-dollar investments in the search for new drugs.

“For the regulated industry, having to compete with illegal manufacturers clearly reduces the incentives to develop new safe and effective drugs,” Carnevale said. “If the majority of new drug sales are likely to be eaten up by illegal products, a company will be unlikely to invest the costs needed to get approval.”

He cited as an example the drug pergolide, which Boehringer Ingelheim Vetmedica Inc. sells under the brand name Prascend for the treatment of equine Cushing’s disease.

“The sales of this drug have been severely undercut by unfair competition from compounders who have ignored FDA warning letters against compounding this drug,” Carnevale said.

The International Academy of Compounding Pharmacists questioned the motivation behind some Animal Health Institute assertions.

“Given AHI’s mission, one must conclude that competition has something to do with their false statements,” the compounding group stated. “In health care today, disparate organizations should look to collaborate, not seek to win at any cost, including distorting the truth.”

FDA has stepped up scrutiny of compounders of illegal human drugs but stricter enforcement is needed on the veterinary side, Pitts said.

“It is time for FDA to get in the game when dealing with animals,” he said.

AVMA followed up its appearance at the Washington meeting with a letter to Bernadette Dunham, director of the FDA Center for Veterinary Medicine.

“We want to underscore the critical role compounding plays in allowing veterinarians to provide the best care for their animal patients,” wrote Mark T. Lutschaunig, VMD, MBA, the director of AVMA’s Governmental Relations Division.

But he also said, “We are opposed to pharmacies manufacturing under the guise of compounding because such products can be deleterious to animal health.”

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