Endo Gives FDA Breathing Room in Bulk Compounding Suit

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By Dana A. Elfin

Endo International agreed to press pause on its lawsuit against the FDA until March 30 to give the agency time to revise its bulk drug compounding policy.

In response to a joint request by Endo subsidiaries Par Sterile Products LLC, Endo Par Innovation Co., and the agency, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia Jan. 25 stayed Endo’s suit against the Food and Drug Administration. Endo, which owns intellectual property in the septic shock treatment Vasostrict (vasopressin), wants the court to order the FDA to put the kibosh on bulk compounding of vasopressin.

Based on statements the FDA made in its recently issued 2018 Compounding Policy Priorities Plan, it’s likely the agency will announce changes by March 30 that would remove vasopressin from the list of drugs that are allowed to be compounded in bulk. That’s the outcome Endo is seeking.

“We look forward to continuing our dialog with FDA and we are hopeful that the policy changes FDA has described, once effective, will address the multiple concerns that led Endo to file this case,” Endo Chief Legal Officer Matthew J. Maletta said in a Jan. 24 statement.

Endo’s suit alleges the agency’s failure to strictly oversee compounding facilities is allowing unlawful and unsafe bulk compounding.

Compounding is the practice of combining, mixing, or altering an existing drug’s ingredients to create medication specifically tailored to an individual patient’s needs. Compounders wanting to make larger amounts of drugs without individual prescriptions (bulk compounding) can voluntarily register with the FDA as 503B outsourcing facilities and become subject to federal manufacturing oversight.

Endo sued the FDA in October 2017, claiming the agency chose to implement its own interim policy on bulk compounding in contravention of the statute, essentially allowing compounders to engage in mass production of drugs while sidestepping the FDA’s drug approval process.

Endo agreed to the FDA’s request to stay the suit until March 30 but retained the option to end the stay if it becomes aware an entity has started or is likely to start bulk compounding of any vasopressin-containing drug product under Section 503B.

FDA Compounding Priorities

In its 2018 Compounding Policy Priorities Plan, the agency said it would place bulk drug substances on the 503B bulks list only when there is a clinical need to compound drugs using these substances.

“This protects patient health and the drug approval process, for example, by helping to ensure that outsourcing facilities do not compound using a bulk drug substance when an FDA-approved drug can be used to meet patient medical needs,” the agency said.

If the FDA alters its policy on vasopressin-containing products in response to Endo’s lawsuit, it could lead to litigation on a substance-by-substance basis rather than an agency review based on statutory criteria dictating what’s on the bulk compounding list, Karla L. Palmer of Hyman, Phelps & McNamara, P.C. in Washington told Bloomberg Law Jan. 26.

“A more restrictive bulk compounding list that may contemplate factors other than clinical need (i.e., competitive threat), could potentially deny patients access to needed compounded medications,” said Palmer, a life sciences lawyer who represents clients on both sides of the compounding.

2012 Meningitis Outbreak

Compounding received national attention in 2012 after contaminated compounded drugs sold by the now-shuttered New England Compounding Center (NECC) caused a deadly fungal-meningitis outbreak.

After that outbreak, new regulatory controls were imposed on compounders under the Drug Quality and Security Act of 2013 (DQSA).

Par Sterile Products LLC and Endo Par Innovation Co. are based in Chestnut Ridge, N.Y. Endo International’s global headquarters are in Ireland, with U.S. headquarters in Malvern, Pa.

The case is Par Sterile Products LLC v. Hargan , D.D.C., No. 1:17-cv-02221, order granting joint motion to stay 1/25/18 .

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bloomberglaw.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bloomberglaw.com

For More Information

The order staying the litigation is at http://src.bna.com/vYG. FDA's 2018 Compounding Policy Priorities Plan is at http://src.bna.com/vYy . Endo's lawsuit is at http://src.bna.com/ukN. FDA's interim bulk compounding policy is at http://src.bna.com/vYA.

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