LITTLE ROCK, Ark.--(BUSINESS WIRE)--Dr. James L. McCarley, Jr., Founder and CEO of Cantrell Drug Company, https://cantrelldrug.com/, a 503B Registered Outsourcing Facility, announced that his Company has filed for a Temporary Restraining Order to prevent the FDA from shutting the Company down. The motion was filed in the United States Bankruptcy Court Eastern District of Arkansas Little Rock Division.
Cantrell Drug Company, founded in 1952, provides sterile injectable pharmaceuticals that are primarily used in hospitals. These are drugs that are either in short (sometimes critical) supply or ones that require compounding in order to prepare the medication in a final form for administering to patients. Cantrell’s products also offer significant cost savings to hospitals who are under tight budget constraints.
“My back is really against the wall,” commented Dr. McCarley. “The FDA has inspected us twice in the last year and voiced concerns about quality deficiencies that are strictly regulatory in nature and not in response to any product problem or patient illness. I couldn’t be a stronger advocate for the safety of patients receiving our product. Over the years, we’ve manufactured millions of drug doses delivered to hundreds of hospitals and helped save thousands of patients’ lives. My honest desire is to do things right and fully comply with all the FDA’s regulations. I’ve dedicated the last twelve months and most of my life’s savings trying to satisfy the Agency. I even outsourced oversight of our Quality Assurance and Quality Control (QA/QC) authority for batch release to an expert third-party consulting firm. I hired a senior and seasoned QA/QC Director with years of experience working specifically in the 503B field to work with our third-party consultants and take the lead in documenting and communicating fully and frequently with the FDA. I had the facility and quality systems inspected and re-inspected by several outside QA/QC consulting firms. Those independent experts concluded that we were operating under a state of sufficient quality control for release of safe product. We have also implemented their suggestions for improvements. As one expert summarized in his report to Cantrell, “it appears there is a communication problem – not a compliance problem!”
Despite all the company’s efforts, Dr. McCarley heard very little back from the FDA other than broad categorical statements. “They declined an invitation to re-inspect our facility. They also declined to have a conference call with us to discuss our progress and what else they might need, leaving us guessing and trying to cover all bases,” commented Dr. McCarley. “Then I get a letter, dated December 27, 2017, from the US Department of Justice stating we’re still out of compliance, and they intend to file suit. It’s like they’re playing a game of ‘got you.’” Dr. McCarley indicated that none of this lines up with the FDA Commissioner’s February 13th statement about creating a Center for Excellence that would “provide much-needed education and training to improve product quality, safety and purchaser confidence, and help the FDA adjust its regulatory oversight to better match the scope of production of an individual compounding pharmacy.” Dr. McCarley added, “In fact, I’ll be kindly extending an invitation to the FDA Commissioner today to visit us. I think it would be great for him to see first-hand the operations and capabilities of our company.”
The letter from the DOJ to Cantrell indicated it would seek an injunction in federal court to prohibit Cantrell from releasing product unless Cantrell signed a Consent Decree of Permanent Injunction. In that Agreement with the FDA, Cantrell would have to shut down production again.
“They want to shut us down for a third time in spite of everything we’ve done, and this time it will be the end of the Company. We are a family-owned business, and we simply don’t have the resources to continue to fight a bureaucracy that makes broad claims against us, gives little feedback, and ignores independent third-party experts. All this is at a snail’s pace that would choke any small business. After the second shutdown, we were forced into Chapter 11 Bankruptcy. At that time, I vowed it was my intent to pay all my creditors 100 cents on the dollar. In just a few short months we’ve made tremendous progress, and, thanks to our loyal hospitals, business is good – very good. We’ve actually had to hire more employees to expand production in order to meet hospital demand for critical drug shortages. A third shutdown will be the end. And if that happens, our hospital customers lose, their patients lose, and our creditors lose.”
Cantrell Drug previously filed for Chapter 11 Bankruptcy reorganization on November 7, 2017 and is asking the Bankruptcy Court to protect the interests of its creditors for a grace period of at least 45 days during which time Cantrell hopes to negotiate a resolution with the FDA while it continues its normal business operations. Among the drugs compounded by Cantrell is a Morphine Sulfate injection used to relieve severe pain; that drug is listed on the drug shortage list by the FDA and is considered to be in critically short supply. Currently, Cantrell produces over 80,000 Morphine Syringes every month and is planning to increase production. “If Cantrell Drug shuts down, thousands of patients may not receive the pain medication they need and hospital pharmacists will be scrambling. All of this is in direct conflict with Congress’ intent to provide a solution for drug shortages through 503B Outsourcing Facilities such as Cantrell,” said Dr. McCarley.
Cantrell Drug Company (CDC) is registered with the FDA as an Outsourcing Facility under Section 503B of the Federal Food, Drug, and Cosmetic Act passed by Congress in 2013. The Company specializes in sterile product compounding of intravenous (IV) medications and drug shortage injections for hospitals, and to a lesser extent, for surgery centers and physician groups. For more information go to https://cantrelldrug.com/.