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U.S. Supreme Court Sides With Doctors, Drugs With High Abuse Potential More Likely to be Approved, and White House Supports Telehealth Addiction Treatment
Here is a recap of some of the top industry-related news stories of the week:
U.S. Supreme Court Sides with Doctors Challenging Opioid Convictions
The U.S. Supreme Court gave two doctors found guilty of misusing their licenses in the midst of the U.S. opioid epidemic to write thousands of prescriptions for addictive pain medications another chance to challenge their convictions.
The justices ruled 9-0 in favor of Xiulu Ruan and Shakeel Kahn, who had argued in appealing their convictions that their trials were unfair because jurors were not required to consider whether the two physicians had "good faith" reasons to believe their numerous opioid prescriptions were medically valid.
Liberal Justice Stephen Breyer said that once defendants produce evidence that they were authorized to dispense controlled substances like opioids, prosecutors must prove they knew they were acting in an unauthorized manner.
States have sued drug companies and pharmacies to hold them liable, but another key element in the public health crisis has been the role of doctors in prescribing massive volumes of highly addictive pain medication.
Ruan, who practiced in Alabama, and Kahn, who practiced in Arizona and then Wyoming, were sentenced to 21 and 25 years in prison, respectively, in separate criminal cases.
Prosecutors said Ruan with a business partner ran a clinic in Mobile that issued nearly 300,000 controlled-substance prescriptions from 2011 to 2015 and was one of the top U.S. prescribers of certain fentanyl-based pain medications.
Prosecutors said Kahn regularly sold prescriptions for cash and unlawfully prescribed large amounts of opioid pills, resulting in at least one patient dying of an overdose.
New Drugs With High Abuse Potential More Likely to Be Approved and Go to Market to Treat Pain
Despite the prevalence and societal costs of pain in the US, investment in pain medication development is low, due in part to poor understanding of the probability of successful development of such medications,” said the authors of a study published in Anesthesiology.
“The opioid crisis has highlighted the need for new therapeutics with low abuse potential to treat chronic pain,” they said.
“While pharmaceutical companies recognize this need, because of the subjective nature of pain… the conduct of clinical trials for new drug approval is a lengthy and costly proposition.”
The study found that 27.8% of drugs with high abuse potential made it all the way through the development process, compared to only 4.7% of new drugs with low abuse potential.
Although the number of drugs with high abuse potential being developed has decreased since the peak of the opioid epidemic in 2010, they are more likely to successfully complete the development process and receive regulatory approval than medications with lower abuse potential.
White House Backs Extension of Telehealth Addiction Treatment
The Biden administration is making a play to set in stone the pandemic era expansion of telehealth access for people struggling with addiction, offering a series of suggestions for federal agencies and lawmakers in a new report.
The expansion, made possible by the declaration of a public health emergency for the Covid-19 pandemic, has opened new doors for treating Americans suffering from substance use disorder. But the White House’s Office for National Drug Control Policy says whether the impact will be positive in the long term remains to be seen, noting that both state and federal requirements will pose barriers to access upon the end of the pandemic emergency.
“Across the United States, fewer than 1 out of 10 people with substance use disorder get the care they need. That is unequivocally unacceptable,” Rahul Gupta, director of the ONDCP, said in a statement. Telehealth provides “a cost-effective way to increase access to care for vulnerable people with substance use disorder by meeting them where they are.”
The plan calls for the federal government to weigh legislation or other steps to knock down barriers between state licensing systems for medical professionals that ONDCP says stand in the way of enacting nationwide telehealth efforts.
It also asks that the government make permanent and expand telehealth regulatory changes made available during the public health emergency, such as the US Drug Enforcement Administration permanently authorizing qualified professionals to prescribe controlled substances remotely without an in-person evaluation.
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