On October 24, the President signed a sweeping, bipartisan legislative package aimed at combatting the opioid epidemic. Among the many provisions in the package are strategies to stop the flow of opioids into the nation, promote safer treatment and prescribing policies, and bolster research into non-addictive pain treatment and neonatal abstinence syndrome. One research component of the bill, specifically the focus on non-addictive pain treatments, is also a key tenet of NIH’s Helping to End Addiction Long-term (HEAL) initiative.
As noted last month, the FY19 Labor-HHS/Defense minibus package included a continuing resolution (CR) to fund, among several agencies, FDA and NSF through December 7. Although it is not clear exactly how long these agencies can expect flat funding, Congress reportedly remains committed to finalizing all appropriations bills before the end of the year. For a summary on the status of FY19 appropriations for NIH, CDC, FDA, NSF and AHRQ, see the chart on page 4.
There is still a chance that Congress will pass legislation to repeal the medical device excise tax this year, potentially as part of a package to complete the FY19 appropriations process. The medical device tax is under its second consecutive suspension, which is set to expire in 2019.
Public health officials have been working to contain an Ebola outbreak, officially declared on August 1, which has been impacting the Democratic Republic of the Congo (DRC). Though officials were able to contain a previous outbreak in the DRC, the current outbreak has proven more challenging. To date, more than 200 individuals have been infected and 120 lives have been lost. Concerns are rising that this outbreak may spread into the neighboring nations of Uganda and Rwanda. Meanwhile, the U.S. is dealing with an outbreak of acute flaccid myelitis (AFM), a polio-like syndrome that causes muscle weakness and paralysis. To date, public health officials are assessing 155 possible reports of the disease, which affects children, and have confirmed cases in 22 states.
The Trump Administration is continuing to focus on policy changes focused on prescription drug pricing. Department of Health and Human Services Secretary Alex Azar announced new regulations on this topic, which would require the posting of list prices in direct-to-consumer advertising of drugs and biologics. The public comment period for the proposal will run until December 17, and can be accessed here: http://bit.ly/2CT9uIy. The president announced other initiatives, including a “reference pricing” model that would base Medicare reimbursement for certain physician-administered medications on prices paid in other developed nations. It is unclear whether these proposals will advance.