US court dismisses lawsuit against opioid drug manufacturers
US Federal Judge Mark Goldsmith has dismissed a lawsuit filed by the American Pain Society and other organizations to prevent the importation of new opioids into the US.
The groups argued that the DEA’s new opioid scheduling would not allow for safe and effective distribution of the new drugs, which include fentanyl, a powerful painkiller that has been linked to thousands of overdose deaths in recent years.
In his ruling, Goldsmith said he “does not believe that the plaintiffs’ arguments are sufficient to overcome the DEAs burden of proof to establish that the proposed schedule does not meet its stated objective of preventing the import of drugs that pose a threat to public health.”
The DEA is currently working on a schedule for opioids that would allow for more than 50 percent of the drugs to be sold in the US, according to the Associated Press.
Goldsmith did not address the lawsuit filed in June by the pharmaceutical giant Pfizer, which argued that allowing importation would prevent it from doing business in the United States.
However, the decision did allow the lawsuit to move forward on its original claim that the scheduling would “put Pfizer at a competitive disadvantage by undermining the company’s ability to market its drugs globally and by undermining Pfizer’s ability, and potential, to protect its product safety.”
In addition to the American Society for Pain and Trauma, the groups said the DEA has also delayed its final rule for opioids.
Last month, the agency released its final version of the opioid scheduling, which was based on a draft released by the Drug Enforcement Agency in December.
The agency said it would not release the final version until a year after it is finalized.