Washington-As the Food and Drug Administration (FDA) works to rewrite guidelines for compounding pharmacies, two lawsuits have emerged accusing the government agency of overstepping its regulatory bounds and unfairly targeting the industry.
Washington—As the Food and Drug Administration (FDA) works to rewrite guidelines for compounding pharmacies, two lawsuits have emerged accusing the government agency of overstepping its regulatory bounds and unfairly targeting the industry.
The lawsuits, one filed on behalf of 10 compounding pharmacies and the other by Kentucky-based Bet Pharm LLC, challenge FDA's jurisdiction over compounders and call a recent rash of federal inspections unwarranted, unauthorized and illegal.
Defining the FDA's role regarding pharmacies is at the heart of a regulatory battle to draw the line between manufacturing and compounding, each a unique system of drug distribution. Manufacturing means making an FDA-approved product in mass quantities for distribution to a large market. Compounding, whether it involves blending bulk raw ingredients or creating variations of existing manufactured drugs, is geared for specific patient prescriptions.
State pharmacy boards traditionally regulate compounding pharmacies, but in an effort to eliminate suspected copycat or banned products, FDA officials have executed a series of search warrants to inspect a handful of players in the veterinary market, including BET Pharm, where agents seized products from the equine fertility drug maker in August, court documents show. FDA officials describe BET's production as "large scale."
"There are a group of pharmacists who are desperately trying to protect their current practice, which as we have said all along constitutes illegal manufacturing," says Dr. Kent McClure, general counsel for the Animal Health Institute (AHI), which represents pharmaceutical manufacturers. "The only reason to run to court right now is to protect the prerogative of illegal manufacturing and to tie FDA's ability to enforce."
At presstime, FDA had not filed responses to the lawsuits and refused to comment on pending litigation. Awaiting the agency's reaction is Howard Hoffman, the Chicago attorney responsible for filing both cases.
"Clearly and unequivocally, FDA does not have a leg to stand on because Congress has not given them authority to regulate compounding pharmacies," Hoffman says. "I suspect the problem is big pharma has the ear of FDA, and they're complaining about losing business to compounding pharmacies. We contend that compounders don't make cloned drugs; they make products for individual patients based on prescriptions.
"I'm not at war with the FDA; I find them to be a worthwhile agency with an important mission. But they have to understand that there are limits to their authority. Veterinarians and physicians would be lost without compounding pharmacy to prepare what their patients need when manufacturers don't."
Watching the conflict between FDA and compounding pharmacies unfold are veterinarians who await the agency's revision of its Compliance Policy Guide (CPG), an internal reference for FDA agents that currently bans compounding from bulk ingredients for non-food animals.
Although the CPG is not law, critics claim FDA threatens to enforce it as such. Veterinarians, concerned they will lose access to non-veterinary drug equivalents, seek guidance from the American Veterinary Medical Association, which has spurred FDA to revise the CPG for clarification.
That revision is expected before next year. In the meantime, AVMA is creating a pocket guide on the do's and dont's of compounding. At presstime, brochures were at the approval stage.
"I'm advising all our members to just keep on waiting for the CPG," says Dr. Bruce Little, AVMA executive vice president. "I think until interpretations are made, it would not be a wise move for veterinarians to use compounded drugs."
While CPG uncertainties muddle rules directing compounding, the lawsuits don't help. The multi-pharmacy lawsuit names U.S. Attorney General John Ashcroft, Health and Human Services Secretary Tommy Thompson and acting FDA Commissioner Lester Crawford, DVM, as defendants. It contends that along with unlawful enforcement of the "purely internal" CPG, FDA has violated the plaintiffs' First Amendment rights to advertise by forcing tradeshows to require that compounding pharmacies sign a statement of compliance with the CPG.
While the tradeshow aspect adds a new twist, the American Association of Equine Practitioners' event and the Western Veterinary Conference (WVC) are the only meetings known to require them.
WVC Executive Director Dr. Steve Crane says the decision to require an affidavit was voluntary, not FDA derived.
"Caught in the middle like we are, we want to make sure everyone is aware of the laws even if they aren't that clear," says Crane, who reports roughly a dozen compounding pharmacies in line to exhibit at WVC next year. "Compounding pharmacies do an extraordinarily valuable service for all of us when they fill custom prescriptions, but in the case of illegal manufacturers, I don't want that liability on the tradeshow floor."
Risks especially emanate from the lawsuits themselves, a major association representing compounding pharmacies says. While International Academy of Compounding Pharmacists (IACP) did not return repeated phones calls by
seeking comment, the group warns that litigation might damage the relationship IACP has worked hard to develop with FDA in an e-mailed letter.
"While IACP agrees that pharmacy practice should be regulated by state boards of pharmacy and not FDA, we have several concerns with this litigation," the letter states. "First, we are concerned with the timing of the lawsuit. IACP members have invested substantial time, energy and finances to generate political pressure to motivate FDA to withdraw the CPG. We believe that the pressure resulting from our actions have caused FDA to rethink this flawed CPG and in turn, they have now publicly stated that a new CPG is being drafted and will be released for public comment.
"Second, we are mindful that there is risk in taking legal action if pharmacy should lose at the appellate level."
As for the BET Pharmacy seizure case, IACP is reviewing the facts to see if action is warranted, the letter adds.
Action against FDA is long overdue, compounders say. Carol Peterson, a pharmacist with plaintiff Women's International Pharmacy Inc., parent of Pet Health Pharmacy Inc., understands FDA's position but says the CPG is "opinion only, not law." To gain access to pharmacies, FDA operates on intimidation, Peterson says.
"The FDA has been very aggressive when going into pharmacies," she says. "They come in with U.S. Marshals, they're heavy handed; they threaten to put people in prison, and they disrupt your business. You have to get a lawyer, and that's very expensive. All the while, it's questionable whether FDA should even be there.
"You would think that AVMA would say, hey, wait a minute; this crackdown on pharmacy doesn't make sense. Veterinarians certainly have the right to compound themselves as well as use compound pharmacies. We have to fight."
At presstime, court dates for both lawsuits had not been set. While the BET Pharmacy suit is filed in U.S. District Court in Kentucky, the multi-plaintiff lawsuit is filed in Texas, far away from the New Jersey district court where a similar case by Wedgwood Pharmacy was fought and lost last year, backing FDA inspections of compounding pharmacies in that area.
AHI officials accuse the pharmaceutical plaintiffs of "forum shopping" to obtain a more favorable result. Steve Holtz, head of Premier Pharmacy in Texas agrees.
"A court case is like football, you've got to have a game plan," says Holtz, MD. "Sure we're going to file in a district where we think we might have the best chance. They best way to stop people from tyrannical action is to step up and fight them. Regulatory agencies will not work with you. They're more likely to run over you."