Endo International Places a Second Temporary Hold on Compounding Lawsuit
As Endo International faces a number of lawsuits related to its opioid-painkiller that could be financially devastating, the company has agreed, for now, to extend a temporary stay of its own lawsuit against the U.S. Food and Drug Administration.
In October 2017 Endo subsidiaries Par Sterile Products, LLC and Endo Par Innovation Company, LLC filed a lawsuit that accused the FDA of ignoring components of its laws regarding bulk compounding. The lawsuit is critical of an interim policy set up under Section 503B of the Drug Quality and Security Act of 2013 (DQSA). When it filed the litigation Endo said the interim ruling allowed for the bulk compounding of many drugs, including copies of its own.
Endo and its subsidiaries believe the ruling contradicts the law because “it authorizes bulk compounding of new drugs where the applicable DQSA requirements are not satisfied and because it is fundamentally inconsistent with the plain language and structure of the FDCA statutory regime for introducing new drugs.”
Additionally, through the lawsuit the company is seeking the immediate removal of vasopressin from FDA's Category 1 nominations list. The company said it wants it removed to assure that outsourcing facilities “do not engage in bulk compounding of vasopressin-containing drug products” under the 503B section of DQSA.
This morning the company said it has agreed to extend a temporary stay of litigation against the FDA. This is the second temporary stay of litigation in this lawsuit. Endo agreed to a temporary stay in January following the regulatory agency’s statements that it intends to alter the compounding policy and comply with DQSA. Endo said the stay also related to subsequent discussions between its legal team and the FDA. The stay of litigation was set to expire on March 30, but Endo agreed to a second stay following new draft guidance for compounding released in March.
Endo noted that on March 23 the FDA issued draft guidance describing the procedures that FDA intends to follow regarding DQSA, as well as the criteria that FDA intends to apply. This morning Endo pointed to the new draft guidance which said the FDA offers a new interpretation of the DQSA requirements. The new interpretation says there should be a "clinical need" for compounding from bulk substances. The FDA’s guidance, Endo said, states that because "compounded drug products are subject to a lower regulatory standard than FDA-approved drugs, they should only be used by patients whose medical needs cannot be met by an FDA-approved drug."
Additionally, the FDA said that in some situations the compounding of FDA-approved drug products instead of bulk drug substance would both meet the needs of patients and present less risk. Endo noted that the new guidance specifically describes the dilution of FDA-approved drugs by outsourcing facilities to produce intravenous bags for hospitals as such a situation.
With the new draft guidance in hand, Endo said it will extend the litigation stay for 180 more days. That will allow the FDA time to implement the new compounding policy.
While Endo and the FDA work toward an amicable end to the compounding litigation, a number of states have filed lawsuits against the company over its opioid medication Opana ER. The company, along with others, has been accused of aggressive marketing of its addictive medications that have created a crisis of addiction and death across the country. Last year the FDA asked Endo to cease marketing of Opana ER in the United States.