On September 7, 2017, Allergan USA filed lawsuits against three companies: Imprimis Pharma­ceuticals; Prescriber’s Choice; and Sincerus Florida. The suits allege that the companies—which claim to be compounding phar­­macies—aren’t producing their drugs in accordance with established compounding regulations, are un­lawfully manufacturing and selling unapproved new drugs, and are engaging in unfair competition. The FDA has recently sent several warning letters to these companies relating to the claims in Allergan’s legal filings. (The FDA warning letters are available online at FDA.gov.)

Imprimis is widely known for products such as Dropless Therapy, LessDrops and Simple Drops. (Imprimis has also announced that it has a “development pipeline” that includes a forthcoming compounded eye drop intended to treat dry eye that may compete with Allergan’s well-known product Restasis.) Sincerus and Prescriber’s Choice are under common ownership; the former creates new drug formulations while the latter markets and distributes them.

Allergan’s Imprimis complaint claims that the FDA has found serious deficiencies in Imprimis’s production practices, and that Imprimis’s use of certain ingredients poses risks to patient safety. (An FDA statement issued on August 4, 2017, linked one of Imprimis’s unapproved drugs, an injectable curcumin emulsion, to two severe adverse events; one resulted in death, while the other sent the patient to the emergency room. Other warning letters have described serious health and safety concerns at Imprimis’s facilities.) In addition, Allergan states that the three companies are engaging in false and misleading advertising, and that all of these activities are putting both patients and doctors at risk by exposing patients to drugs and drug combinations that have not been shown to be safe or effective.

“In order to be a lawful compounder, you must meet specific regulatory requirements,” notes Donald P. Bunnin, Esq., senior counsel-litigation and commercial eye care, at Allergan. “Under certain circumstances, the com­­­pounded product must be patient-specific and not mass-produced. As we allege in the complaint, Imprimis is mass-producing a variety of products, including in the ophthalmology space. By doing that in these circumstances, they’re not following FDA guidelines.”

The complaint alleges that such activities give the defendants an unfair marketplace advantage by allowing them to avoid spending the money required to comply with the appropriate laws and regulations. However, Mark Marmur, a spokesman for Allergan, says that these lawsuits are about more than competition. “The actions that are being taken by these companies are putting patients at risk,” he says.

Mr. Bunnin adds that Allergan is not opposed to drug compounding. “We support lawful compounding and believe it provides a valuable service that addresses patient needs and is a valuable tool for physicians,” he says. “However, it needs to be done lawfully and in compliance with FDA regulations. The regulations are put in place in part to ensure that  patient safety is adequately addressed.”

Mark Baum, founder and CEO of Imprimis, contests Allergan’s portrayal of his company as being careless about patient safety. “We’ve invested tremendous sums of money in equipment, facilities, personnel and training to become a GMP [good manufacturing practice] facility,” he notes. “Our products are made to the exact same federal standards as Allergan’s products. While it’s true that our products are not FDA-approved, it’s also true that our flagship products, Dropless Therapy formulations, have been used in more than one million eyes. So our products have a significant track record of success in the ophthalmology community.”

Regarding the incident cited by Allergan in which a patient died, Mr. Baum says that was a malpractice case that did not involve an ophthalmic product, in which a physician gave a drug prescribed for one patient to a different patient who was allergic to it. “We had nothing to do with that,” he says. “In fact, we never formulated a drug for the deceased patient. The FDA recently agreed with our recall statements regarding this case, and we have not been named in any litigation connected to this case.

“Let me be clear: We abide by federal and state laws,” he continues. “Imprimis Pharmaceuticals has never been sued or paid out a nickel in settlements relating to any drug we’ve dispensed—not the one Allergan cites in their complaint, not any ophthalmology product, not anything. I’m very proud of that. It says a lot about the quality of our products—and I don’t think Allergan can make the same statement.”

Regarding Allergan’s claim that Imprimis is not abiding by the laws governing compounding pharmacies, Mr. Baum notes that FDA inspectors recently spent three months at Imprimis’s New Jersey manufacturing facility. “The FDA knows everything about what we make, what we dispense, how we train our people and our equipment,” he says. “Do you think they would let us stay in business if they believed we were putting patients at risk or not abiding by the law?”
Mr. Baum says Allergan’s lawsuit is not about Imprimis’s business model or patient safety, but about the possibility of competition for Allergan’s drug Restasis. “Allergan derives 9 percent of its revenue and 16 percent of its profits from Restasis,” he points out. “It’s a billion-and-a-half-dollar franchise, and they know that competition is coming. This lawsuit is an attempt to prevent lower-cost providers from entering the market. Our more than 1,700 physician customers know that Imprimis products work really well for their patients. Our formulations are affordable and innovative, and we do a great job in terms of servicing our customers.”

Mr. Baum adds that the idea that his company has an unfair advantage over Allergan because it doesn’t have to run clinical trials is absurd. “Allergan is an $85 billion corporation with thousands of salespeople and significant financial resources,” he says. “I think they have more lobbyists and government-relations people than we have employees in our entire company. They have every single advantage that we don’t have. The idea that we’re taking unfair advantage of them is absurd. That would be the equivalent of the United States complaining to the United Nations that East Timor was trying to take advantage of it.”

Allergan also made headlines in September when, in a surprise, unprecedented (at least in ophthalmology) move, it sold the key patents related to Restasis to the Saint Regis Mohawk tribe of Akwasasne, N.Y. The tribe, in turn, granted Allergan exclusive use of the patents. Under the terms of the agreement, the tribe will receive $13.75 million upon the finalization of the agreement, and is eligible to receive $15 million in annual royalties.

According to a company statement, the tribe, a recognized sovereign tribal government, is filing a motion to dismiss the ongoing inter partes review of the patents based on their sovereign immunity. The agreement with the tribe has no impact on the pending abbreviated new drug application patent litigations regarding the patent family, which recently completed a five-day trial in Federal District Court in Marshall, Texas.  REVIEW