CDER’s Controlled Substances Program Finds New Leader

Regulatory NewsRegulatory News | 12 February 2020 |  By 

Marta Sokolowska

The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) on Wednesday said that its newly established Controlled Substances Program (CSP) will be led by Marta Sokolowska, associate director for controlled substances in the Office of the Center Director.
CSP, which encompasses the Controlled Substances Staff (CSS) and Controlled Substances Initiatives (CSI), will help to coordinate CDER activities and emerging issues around controlled substances, including prescription opioids, benzodiazepines and stimulants. The program will also work within the agency and with outside groups on strategies and policies related to controlled substances, in addition to providing expertise on certain drug applications and drug scheduling, according to an email from Douglas Throckmorton, deputy center director for regulatory programs, to CDER staff.
The CSP in March is expected to launch an opioid data warehouse to better integrate diverse internal and external data sources, better assess vulnerabilities in certain populations, inform CDER of trends and support regulatory changes.
CSS, which will continue to be led by its director, Dominic Chiapperino, will continue to provide consultation services to CDER’s review divisions and act as the CDER and FDA liaison to other government organizations.
“Addressing the opioid crisis remains one of CDER’s top public health priorities. While it is encouraging to see that total drug overdose deaths in the US dropped 4.1 percent from 2017 to 2018 – the first decrease in almost three decades – there is still much work to do as deaths from drug overdoses remain at historically high levels,” Throckmorton wrote.
A recent study published in JAMA also found that the availability and use of medications for opioid use disorder was “relatively low” in residential addiction treatment facilities.
Meanwhile, according to the to the National Center for Health Statistics, from 2012 through 2018, the rate of drug overdose deaths involving cocaine more than tripled and the rate for deaths involving psychostimulants with abuse potential (e.g., methamphetamine) increased nearly five-fold.
Throckmorton said FDA is considering writing a Cocaine/Methamphetamine Use Disorder Medication-Assisted Treatment draft guidance. And FDA is still working through more than 1,000 comments on a public docket related to the development and evaluation of abuse-deterrent formulations of central nervous system stimulants.
On 10 March, FDA also will hold a Patient-Focused Drug Development (PFDD) meeting to obtain patient perspectives on the impact of stimulant use disorder, including cocaine, crystal meth and misuse of prescription stimulants such as Adderall or Ritalin, as well as views on treatment approaches.


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