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Cantrell Drug Company Responds to FDA Injunction

Update:
LITTLE ROCK, Ark. (News release) - 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 Preliminary Injunction 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,” Dr. McCarley said.

Original story (U.S. Takes Little Rock Pharmacy to Court for Unsanitary Practices):

WASHINGTON D.C (News release) – The United States filed a civil complaint and a motion seeking a preliminary injunction against Cantrell Drug Company and its co-owner and Chief Executive Officer, James L. McCarley Jr., to stop the manufacturing and distribution of adulterated drugs, the Department of Justice announced on Thursday.

The complaint, filed in the U.S. District Court for the Eastern District of Arkansas at the request of the U.S. Food and Drug Administration (FDA), alleges, among other things, that defendants distribute adulterated drugs in interstate commerce.

According to the complaint, defendants’ drugs are adulterated because they are prepared, packed, or held under insanitary conditions whereby they may have been contaminated or may have been rendered injurious to health. The complaint also alleges that defendants’ drugs are adulterated because defendants fail to comply with current good manufacturing practice regulations.

“The Department of Justice is committed to ensuring that patients receiving compounded drugs are protected by the safeguards established in federal law,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice will continue to work actively with FDA to ensure that the law’s protections are fully enforced.”

Cantrell initiated voluntary recalls of drug products in 2016 and 2017. The 2016 recall, initiated due to lack of sterility assurance, involved 29 lots of unexpired sterile drug products. The 2017 recall, also due to a lack of sterility assurance, encompassed all lots of unexpired sterile drug products that Cantrell had compounded and distributed between Feb. 16, 2017, and July 19, 2017.

FDA inspected Cantrell’s facility in 2013, 2016, and 2017, and the agency issued a Warning Letter to Cantrell in 2015. As alleged in the complaint, during the 2017 inspection, FDA documented evidence of insanitary conditions and significant deviations from current good manufacturing practice regulations. 

For example, as alleged in the complaint, FDA observed that the pharmacy’s own documentation revealed that Cantrell repeatedly recovered several types of microorganisms in the air and on surfaces used for sterile processing, demonstrating that products manufactured in those areas were prepared, packed, or held under insanitary conditions.

 As alleged in the complaint, on at least 12 occasions between January and May 2017,
defendants’ environmental monitoring in one of its clean-room areas detected microbes in excess of their “action limit” (i.e., a level of contamination high enough to trigger a response such as an investigation and corrective action).

As noted in the complaint, the contamination consisted of bacteria, including Bacillus oleivorans, Staphylococcus epidermidis, Micrococcus luteus, and Bipolaris spicifera. The presence of any of those organisms in an injectable product administered to a patient could cause serious adverse effects to the patient.

In addition, as alleged in the complaint, FDA found deviations from current good manufacturing practice regulations in the pharmacy’s sterile drug manufacturing operations. For example, the complaint alleges that the pharmacy failed to conduct adequate investigations of microbial contamination found in aseptic processing areas (on surfaces, in the air, and on personnel), as well as spore-forming bacteria detected in areas of the pharmacy used for drug compounding and on operator gloves.

“The Food, Drug, and Cosmetic Act is designed to protect patients from potentially unsafe drugs,” said U.S. Attorney Cody Hiland for the Eastern District of Arkansas. “This action demonstrates our commitment to enforcing these laws. We remain steadfast in our dedication to keeping the citizens of our communities safe by whatever means available under federal law.”

If entered by the Court, the Proposed Order of Preliminary Injunction sought in conjunction with the filed complaint would require defendants temporarily to cease their current operations and to recall and destroy all non-expired drugs manufactured, held, and/or distributed by them. The Proposed Order also provides defendants with a pathway to resume manufacturing and distribution by establishing specific actions defendants must take to remedy their operations.

The government is represented by Trial Attorney Raquel Toledo of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Shannon Smith of the U.S. Attorney’s Office for the Eastern District of Arkansas, with the assistance of Associate Chief Counsel, Litigation, Jennifer Kang of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.
A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.

Additional information about the Consumer Protection Branch and its enforcement efforts may be found here. For more information about the U.S. Attorney’s Office for the Eastern District of Arkansas, click here.


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