FDA alleges drugs were illegally compounded; pharmacy disputes charges
On Aug. 12, U.S. marshals seized compounded equine drugs from a Kentucky pharmacy that the Food and Drug Administration alleges is violating the federal Food, Drug, and Cosmetic Act by illegally compounding drugs.
The FDA issued a warning letter to BET Pharm, LLC, in November 2003 stating that the pharmacy was illegally manufacturing drug products from bulk ingredients without FDA approval, compounding drug products that mimic approved drugs, and selling compounded drugs outside a valid veterinarian-client-patient relationship. The agency gave the pharmacy 15 days to correct the problems. Follow-up inspections in the months following found that the corrections had not been made and the agency decided a seizure was warranted, according to Jon Scheid, a spokesman for the FDA.
At that point, the FDA recommended that the Department of Justice initiate a seizure action. The department filed a complaint with the U.S. District Court for the Eastern District of Kentucky, and the court issued the seizure warrant on Aug. 11.
At press time in August, the pharmacy was challenging the FDA's charges. Howard Hoffman, a Chicago-based attorney for BET Pharm, contends that the FDA has no jurisdiction to regulate state-licensed pharmacies such as BET Pharm and that the standards the FDA is trying to impose on the pharmacy apply only to manufacturers.
Jeffrey L. Osman, the interim executive director of the Kentucky Board of Pharmacy, verified that the pharmacy was licensed by Kentucky. The board is currently conducting a joint investigation of the pharmacy with the FDA. Osman said that at the conclusion of the investigation, the board would review the FDA's findings and would make a ruling about the pharmacy's status.
While the FDA has stated that it will defer to state authorities on the day-to-day regulation of compounding by veterinarians and pharmacies, the agency will pursue enforcement action when pharmacies or veterinarians cross the line into drug manufacturing.
This stance is outlined in a Compliance Policy Guide published by the FDA in July 2003. The CPG states that the agency is concerned about veterinarians and pharmacies that were compounding veterinary drugs to circumvent the FDA approval process, and that "pharmacies and veterinarians who engage in activities analogous to manufacturing and distributing drugs for use in animals may be held to the same provisions of the (Federal Food, Drug, and Cosmetic Act) as manufacturers."
According to Scheid, the Federal Food, Drug, and Cosmetic Act gives the FDA the authority to regulate new animal drugs—including compounded drugs—and the companies that produce them. A new animal drug is any drug intended for use in animals, and which, among other things, is not generally recognized by qualified experts to be safe and effective for use under the condition prescribed, recommended, or suggested in the labeling.
"FDA approval applies to new animal drugs, including those that are compounded," according to Scheid. "The Federal Food, Drug, and Cosmetic Act allows some extralabel use of approved animal and human drugs in animals, including compounding from such approved animal and human drugs. This applies only to approved drugs and (that law) does not permit compounding from bulk substances."
In the CPG, the FDA cites two federal appeals court decisions as affirming its position on bulk compounding. Also, section 530.13(a) of Title 21 of the Code of Federal Regulations states that "nothing in this part shall be construed as permitting compounding from bulk drugs."
Hoffman disagrees with the FDA's position on bulk compounding.
"(In the warning letter,) they do not cite a single section of the Food, Drug, and Cosmetic Act that prohibits compounding for animal health from bulk ingredients," Hoffman said.
Furthermore, he said, the pharmacy uses only bulk ingredients from FDA-approved sources. He also challenged the FDA's allegations that the pharmacy is compounding drugs that mimic approved drugs, and that the pharmacy is operating outside a valid veterinarian-client-patient relationship.
"BET does not compound any drugs—pursuant to its (veterinarians') prescriptions—if there is, for that drug, a suitable alternative that is manufactured by big pharma entities," Hoffman said.
The drugs in question are for reproductive use in horses.
"Veterinarians will testify that there is no suitable alternative for these horses ... that is available on the marketplace from a manufactured source," Hoffman said. "There may be others out there, but they're not suitable for a variety of reasons for the uses to which the veterinarians want to put them."
Pharmacists challenging FDA
The dispute between BET Pharmacy and the FDA about whether the agency has jurisdiction over compounding pharmacies is part of an ongoing conflict between the agency and organizations representing compounding pharmacists.
In fact, BET Pharm's attorney Hoffman was a member of a team of lawyers who, in 2002, successfully fought to overturn FDA restrictions on advertising by compounding pharmacies. The case was decided by the U.S. Supreme Court, which ruled that the restrictions violated the pharmacies' right to freedom of speech.
The International Academy of Compounding Pharmacists has launched a campaign to encourage the FDA to withdraw the CPG and is lobbying Congress to help change the FDA's policy on compounding from bulk drugs. The IACP is also encouraging affected compounders to file a complaint with the U.S. Small Business Administration under the Small Business Regulatory Enforcement Fairness Act.
"IACP strongly supports the rights of pharmacists to compound for nonfood animals from bulk ingredients," according to an issue brief posted on the IACP Web site. "Such compounding is part of the fundamental, historical practice of pharmacy and necessary to preserve the health and well-being of many companion, exotic, and performance animals. If pharmacists are limited to using FDA-approved, commercially available drugs, many animals will die, go untreated, or suffer needlessly."
The CPG outlines the agency's reasoning behind limiting animal drug compounding:
"There is a potential for causing harm to public health and to animals when drug products are compounded, distributed, and used in the absence of adequate and well-controlled safety and effectiveness data or adherence to the principles of contemporary pharmaceutical chemistry and current good manufacturing practices. Use of compounded drugs in animals can result in adverse reactions and animal deaths."
The AVMA Council on Biologic and Therapeutic Agents has expressed concern that compounding intended to circumvent the FDA approval process will discourage drug companies from developing drugs for animals because they must undergo FDA-approval. This would result in fewer approved animal drugs that have demonstrated safety, efficacy, and quality being available for treatment.
The AVMA considers the CPG to be in need of improvement because veterinarians and pharmacists aren't afforded the regulatory discretion to compound unavailable but medically necessary drugs from bulk ingredients for specific nonfood animal patients. The AVMA is working directly with the FDA to promote amendment of the CPG.
At press time, the FDA announced that it would issue a revised CPG for comment this fall.
BET case likely headed for court
According to the Scheid, BET Pharm has the right to go to court to attempt to claim the seized products. If a claim is made, the FDA and the Department of Justice will enter litigation with BET, Scheid said.
Hoffman said the pharmacy would contest the seizure in court.
According to Scheid, the FDA and BET also could come to an agreement and sign a consent decree that would describe how the seized products would be disposed of, or how the seized products could be brought into compliance.
Hoffman said the pharmacy would consider negotiating an agreement with the FDA, if appropriate accommodations were made for the pharmacy.