Rahul Gupta, director of the White House Office of National Drug Control Policy, said in an interview on Tuesday that he made it clear to industry representatives that he was not dictating how companies should approach price negotiations.
“The availability of these products to people today is a reminder that price is a key factor, especially with co-pays starting at $10 to $100 for those going to pharmacies without insurance.” Especially when it spans more than the dollar,” Gupta said.
He said he emphasized making recovery medicines widely available in communities devastated by the opioid crisis, especially in rural areas where medicines are hard to find. “We don’t want [the medication] It’s just sitting on the shelf,” Gupta said.
In a statement on Tuesday, Emergent said it was committed to working with governments and local distribution groups to expand access for “millions of Americans” and “maintain affordability.”
While experts applaud the White House’s efforts, the summit could significantly increase drug makers’ prices, especially when many other factors, such as nasal spray manufacturing costs and health insurance coverage, affect prices. warned that it would not be lowered to
“I doubt that voluntary action by the commercial sector will address mitigating the overdose crisis,” said Michael L. Burnett, associate professor of health policy and management at the TH Chan School of Public Health at Harvard University.
With the domestic drug crisis killing more than 100,000 people each year, the Biden administration has made expanding access to naloxone part of a national strategy to reverse the rising death toll. Naloxone, which is safe to use in non-overdose cases, usually restores breathing within minutes, but multiple doses by rescuers are not uncommon.
The naloxone market changed in March when the Food and Drug Administration approved Narcan for sale without a prescription. The long-awaited approval will allow the nasal spray to be sold alongside pain relievers, condoms and antacids on the shelves of pharmacies, supermarkets and even gas stations. Narcan was already widely available in states through blanket prescription systems, purchased in bulk at “public good” prices through state and local health departments, and distributed to police officers, parents of school children, and even librarians.
Ultimately, the FDA may approve a generic over-the-counter nasal spray, but even then it will be months before the product is scaled up and hits stores.
“The market is not creating the competition needed to bring prices down like this crisis seems to require,” Barnett said.
Representatives of Emergent, Pfizer, Hikma, Padagis, Amphastar Pharmaceuticals, Teva Pharmaceuticals, Adamis Pharmaceuticals, and US WorldMeds, which manufacture or market naloxone, attended Tuesday’s meeting and Aptor Pharma, which makes devices that deliver nasal sprays, was also present. Executives from Indivior were also present. The company recently received FDA approval for a prescription OpVie nasal spray of nalmefene, another restorative drug touted as a powerful antidote to synthetic drugs such as fentanyl.
The summit unfolded as pharmaceutical companies faced criticism that they were trying to make money with stronger and more expensive opioid-restoring drugs, despite the availability of cheap, proven injectable naloxone.
“The danger is that public health agencies are beginning to believe that this expensive nasal naloxone and its more potent formulations are the only viable options,” says the drug policy of the funding group Open Society Foundations. Department Director Sarah Evans said.
The White House invited only companies with FDA-approved products. Not invited to the summit: Harm Reduction Therapeutics is a non-profit company awaiting FDA over-the-counter approval for its naloxone spray, RiVive. The company says it plans to sell RiVive at cost ($36 per two-dose kit) or give it away to harm reduction organizations.
“We would have been delighted to have that table,” said Michael R. Hufford, co-founder of Harm Reduction Therapeutics. “After all, they don’t have to persuade us. We’re already on board.”
Harm reduction groups were not invited to the summit, despite the important role played by harm reduction groups in the distribution of life-saving drugs in recent years. That includes the nonprofit Remedy Alliance, which has shipped 1.25 million doses of the vaccine to harm reduction groups since August, 164,000 of which were free. The organization has previously signed deals with Pfizer and Hikma for low-cost liquid naloxone. Remedy Alliance typically charges him $3.75 per dose, but many cash-hungry groups get the vial for free.
Maya Du Simkins, co-director of the Remedy Alliance, said Tuesday’s meeting was “good” and hoped harm reduction groups would have a bigger voice in future talks. rice field. “My hope is that this meeting is the beginning of the process, not the culmination of it,” she said.
