Company sues FDA over rejecting opioids intended to deter abuse
Pharmaceutical Manufacturing Research Services has filed a lawsuit against the FDA after it rejected its application for opioids with updated labelling and appearance, meant to discourage misuse.
The drug intended to deter abuse through a novel combination of physical properties and labelling changes. However, the FDA did not consider the new label as a means of preventing misuse.
The agency instead found the language on the label to be “false and misleading”. This was because the company did not supplement its laboratory tests of a dye, an unattractive colour added to the capsule to discourage abuse, with clinical studies to prove its efficacy.
However, the business says that these clinical studies are not required by the federal statue for new drug approval and do not replicate real-world abuse scenarios.
“We presented a product that updates the opioid Roxicodone with a use indication for limited dosing and acute pain,” said PMRS, in a statement. “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 labelling of opioids for the treatment of ‘chronic’ pain is one of the drivers of the opioid crisis.”
The business claims to have asked for an opportunity to address the problem with a new product and labelling, but the FDA declined a hearing. The pharmaceutical company’s filings say that the refusal to consider the new approach 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.
The US Court of Appeals for the District of Columbia Circuit saw the complaint filed.