IHA Daily Briefing: Aug. 6

FDA Issues Guidance for MAT Drugs
Andrade Joins IHA Team
CDC Study Shows Importance of Flu Vaccine

FDA Issues Guidance for MAT Drugs
Today, the U.S. Food and Drug Administration today issued new draft guidance for the development of novel medication-assisted treatment (MAT) drugs for the treatment of opioid use disorder (OUD). The draft guidance outlines new ways for drug developers to consider measuring and demonstrating the effectiveness and benefits of new or existing MAT products.

The FDA is encouraging drug sponsors to consider a variety of ways to evaluate the effect and clinical benefit of MAT, including the impact of a new drug on adverse outcomes like mortality (overall mortality or overdose mortality), emergency medical interventions and Hepatitis C seroconversion (the period during which antibodies develop and become detectable). Efficacy may also be measured by studying the proportion of patients that transition from meeting criteria for being diagnosed with moderate to severe OUD – based on both drug use and its impact on patient wellbeing – at baseline to being considered in remission at the end of the study. Improvements in the ability to resume work, school, or other productive activity may also demonstrate clinical benefit.

MAT for opioid dependence relies on prescription drugs, including buprenorphine, methadone and naltrexone, to stabilize brain chemistry; reduce or block the euphoric effects of opioids; relieve physiological cravings; and normalize body functions. Regular adherence to MAT helps patients gain control over their use of opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse. MAT, coupled with relevant social, medical and psychological services, is a highly effective treatment for OUD. Additionally, patients receiving MAT cut their risk of death from all causes in half, according to the Substance Abuse and Mental Health Services Administration.

See the FDA’s press release for more details.


Andrade Joins IHA Team
Luis Andrade, former lead human services and Medicaid analyst for the Office of the Illinois House Speaker, officially joins IHA today as its director of government relations. Andrade will take the lead on city of Chicago, Cook County and collar county government relations and also will provide assistance with state advocacy efforts. After orientation, Andrade will be based at IHA’s Chicago office.


CDC Study Shows Importance of Flu Vaccine
Findings from a new Centers for Disease Control and Prevention (CDC)-supported study, conducted over multiple flu seasons, showed that adults who got the flu shot had a reduced risk of getting severe influenza. In addition to lessening the severity of the illness, the flu shot also reduced the risk of hospitalization and admission to the intensive care unit (ICU). The study was published in this month’s edition of Vaccine.

The study was conducted over four flu seasons from 2012 to 2015 and found that flu vaccination prevented severe disease:

  • Flu vaccination among adults reduced the risk of being admitted to the hospital with flu and placed in a general ward bed by 32 percent; and
  • Flu vaccination was even more effective in preventing the most severe forms of flu and reduced the risk of being admitted to an ICU with flu by 82 percent.

Read more from the CDC.