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Pharmaceutical Maker Sues FDA for Rejecting New Approach to Deterring Opioid Abuse

"Why Does FDA Resist a Move Away from 'Chronic Pain' Labeling?"

WASHINGTON, Sept. 18, 2019 /PRNewswire/ -- Pharmaceutical Manufacturing Research Services, Inc. (PMRS), a leading maker of pharmaceuticals for industry, has filed a petition asking the U.S. Court of Appeals for the District of Columbia Circuit to overturn the U.S. Food and Drug Administration's refusal to approve a new opioid capsule intended to deter abuse through a novel combination of physical properties and labeling changes.  

"We presented a product that updates the opioid Roxicodone with a use indication for limited dosing and acute pain," said PMRS. "We are working hard to manage the risks associated with effective pain management. Our updated product and label respond to findings from the Centers for Disease Control that FDA-approved labeling of opioids for the treatment of 'chronic' pain is one of the drivers of the opioid crisis."

"We asked for an opportunity to address this problem with a new product and more appropriate labeling, but the FDA wouldn't even give us a hearing."

Many experts agree the opioid crisis can be traced to 2001, when the FDA labelled opioids for long-term treatment of "chronic" pain despite an absence of scientific research validating the safety and efficacy of such treatment, particularly against known addiction risks.

Despite the ongoing crisis, the FDA refused even to consider PMRS's new label as a means of deterring abuse. Instead, the agency pinned review of PMRS's new capsule to the agency's 2015 guidance framework for determining whether a pharmaceutical's physical properties alone would deter abuse by snorting or injection. 

Applying this narrow approach, the FDA found the abuse deterrence language in PMRS's label "false and misleading" because the company did not supplement its laboratory tests of a dye – an unattractive color added to the capsule to discourage occasional misuse of the product by injection – with clinical studies proving that the color would actually discourage drug abusers.

"The FDA fixated on the dye we added to our formula as defining the product's ability to deter abuse," PMRS said. "But that makes no sense for two reasons.  First, intranasal and intravenous abuse are peripheral concerns for our product, which is limited in dosing and duration.  Second, the clinical studies the FDA demanded are not required by the federal statute for new drug approval and have never reliably predicted real-world abuse scenarios." 

So why would the FDA focus on such studies over new labeling designed to deter addiction and abuse?  PMRS suggests the answer lies in the agency's reluctance to acknowledge the link between the crisis and its longstanding approval of opioids for "chronic pain," which indication is present in the labeling of most opioids on the market today. 

According to PMRS, the dye "is the tail not the dog" on the issue of abuse deterrence, which PMRS addressed through both its product's formulation and new labeling that eliminates the chronic pain indication. The labeling is critical, the company explained, because limiting a prescription opioid's indication and dosing can help prevent the addiction that precipitates abuse. 

"Once people become addicted, they will take great risks to defeat abuse-deterrent properties of prescription drugs or turn to even more dangerous sources, which is why we need to approach abuse-deterrence from the standpoint of prevention, starting with the labeling." 

PMRS's court filings say the FDA's refusal even to consider this approach ignores current science and the public interest, and is fundamentally unlawful. 

"If FDA has a problem with specific language in our proposed label, it should modify the label, not disapprove the drug altogether," PMRS stated. "That is the approach the FDA has taken to other opioids with the 'chronic pain' indication. This country desperately needs a product that has the therapeutic properties of Roxicodone, but without the chronic pain indication that is still driving an ongoing national health emergency. This is no time to ignore novel solutions allowed by law and supported by science in order to protect a flawed regulatory regime built around the chronic use indication."

PMRS is represented by Gibson, Dunn & Crutcher LLP in Washington D.C.  The case is No. 18-1335, PMRS, Inc. v. U.S. Food & Drug Administration.  PMRS's petition is available at:

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SOURCE Pharmaceutical Manufacturing Research Services, Inc. (PMRS)



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