The FDA may ease rules for over-the-counter opioid overdose antidote
As President Donald Trump continues his trade negotiations with China, U.S. security experts are skeptical about a key part of the new deal: whether Beijing is willing or able to keep its promises related to stemming the flow of opioids into the United States.
Ten current and former U.S. officials, congressional sources and China and trade experts told Reuters in interviews that China cooperates only when it believes it will get something in return.
In this case, several said, Beijing appears to have offered its help so that it could get the best deal possible from Washington in trade negotiations.
“Will they enforce this, or is this just another gesture to be used to secure something they want?” said Robin Cleveland, vice chair of the congressional U.S.-China Economic and Security Review Commission, which monitors the national security impact of bilateral trade and economic ties.
“I think they would hope to leverage it in some meaningful way in the context of trade talks,” she said.
Therefore, it makes sense that the administration is looking for other ways to reduce the staggering number of deaths from opioid overdoses in this country.
One approach being considered is for the Food and Drug Administration (FDA) allowing drug companies to make nonprescription versions of opioid overdose antidote naloxone.
The agency has created sample consumer-friendly labels drugmakers can use when they apply for permission to sell over-the-counter naloxone as a nasal spray or auto-injector, FDA Commissioner Scott Gottlieb said in a statement on Thursday. This is the first time the agency has created and tested a label for a drug consumers can purchase directly, he said.
Emergent BioSolutions Inc. sells a prescription naloxone nasal spray known as Narcan. Opiant Pharmaceuticals Inc. developed the spray and collects royalties on it. Kaleo Inc. markets prescription Evzio, a naloxone auto-injector. Most states allow naloxone to be dispensed without a prescription but pharmacist participation has been spotty.
Gottlieb said a requirement for testing showing that consumers can read a label and use a nonprescription drug properly has been a barrier for companies that want to sell over-the-counter naloxone. Companies will still have to ensure consumers understand parts of the label that are product-specific.
The approach has merit. A new study shows that in states where pharmacists were allowed to sell naloxone without a prescription fewer people died from opioid overdoses.
The passage of laws that let pharmacists sell naloxone directly to patients was associated with a nearly 30 percent drop in the number of opioid overdose deaths compared to states without pharmacist dispensing, researchers report in JAMA Internal Medicine.
“This is additional evidence that naloxone laws that focus on broad access in distribution are effective in reducing opioid related harm,” said study coauthor Rosalie Liccardo Pacula, senior economist and co-director of the Drug Policy Research Center at the RAND Corporation in Santa Monica, California. “Pharmacies are everywhere so they are easy access points.”
One of the big advantages of allowing pharmacists to sell naloxone without prescriptions is that they are the ones talking to patients when fulfilling prescriptions for opioids, she noted.
“The pharmacists are interacting regularly with patients when they are picking up opioids,” Pacula said. “If it’s a parent who is picking up opioids for a child who is getting them because of a surgery, the doctor may not have talked to the parent about the risks of the drugs. This provides a window for the pharmacist to raise the parents’ awareness of the risks associated with opioids.”
Further good news is that the use of prescription opioids such as OxyContin or Vicodin fell at a record rate last year.
Prescription opioid use in the U.S. was down 17% in 2018, marking the largest annual decline ever recorded, research firm IQVIA Institute for Human Data Science said. In 1992, prescription opioid use was at roughly 22 pain pills per U.S. adult per year and rose to a peak level of 72 pills per U.S. adult in 2011, IQVIA said. Since 2011, use has declined by 43% to 34 pills per adult.
The new data, unveiled in IQVIA’s 2019 report on health-care trends, provides some hope for combating the nationwide opioid epidemic, which kills roughly 130 Americans every day.
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