New US legislation aims to expedite development of non-opioid pain drugs
The US Senate looks set to pass a set of laws designed to tackle the country’s opioid crisis, encouraging research into non-addictive painkillers, as well as preventing opioids entering the country from China through the mail.
More than 70 bipartisan bills, reported out of five Senate committees, are to be voted on this week and are designed to tackle nearly every aspect of the epidemic.
Key provisions affecting the drug industry include a requirement for the FDA to clarify regulations for non-addictive and non-opioid products, including new guidance on clinical trial endpoints.
The FDA will have to issue guidance to help drug companies develop non-opioid pain products that qualify for faster development pathways, such as Breakthrough Designation and Accelerated Approval routes.
There will also be FDA guidance on new pain endpoints, labelling, and help to advance development of products that can reduce, replace, or avoid patients’ use of opioids to control pain.
A new generation of non-opioid painkillers called nerve growth factor inhibitors are edging closer to the market after years of delays because of the FDA’s concerns about safety – but there is a need for more alternatives to break the US health system’s reliance on opioids to stop pain.
The FDA will also have to provide guidance on how it will consider the risks and benefits of drugs that have the potential to be misused or abused.
Other legislation clarifies how the FDA will interact with other agencies such as border protection and clarifies the agency’s post-market authorities for drugs such as opioids, which may have reduced efficacy over time.
On the research front the National Institutes for Health will be allowed to fast-track research connected to opioids.
Medicare will also be allowed to pay for substance use disorder treatment via telehealth.
Mail order opioids
Other measures in the legislation include allowing customs inspectors to screen parcels for fentanyl and other drugs entering the country via the US Postal Service, which will eventually provide advanced details to officials about all packages from high-risk countries.
Under existing laws the US Postal Service must generally obtain a warrant to inspect the contents of suspect parcels.
Required information includes the name and address of the sender, who will also be required to describe the contents of the package.
The law would close a loophole in the system as commercial carriers like FedEx and DHL must already provide the information, allowing packages to be screened.
The bill is called the Synthetics Trafficking and Overdose Prevention (STOP) Act and contains a provision where the postal service – an independent arm of the federal government – could be subject to civil fines if it fails to provide the information.
The service will initially be expected to provide information on at least 70% of the mail shipments, but this will rise to all shipments from high-risk countries such as China by the end of 2020.
Shipments for which there are no information will be blocked or destroyed under the new legislation.
Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.