i_opioidsubstance_2017a_2017-08-22t09:36:32z5 Hearing Summary

Date: 08/22/2017

Location: RM 271

02:17 PM -- Federal Perspectives and Initiatives



United States Senator Michael Bennet and Scott Gottlieb, Commissioner, US Food and Drug Administration (FDA), came to the table. Senator Bennet commented on the opioid epidemic in Colorado. He discussed the desire of members of Congress to address the opioid epidemic.





02:20 PM



Commissioner Gottlieb addressed the committee. He told the committee that the misuse of opioids is a major concern to many elected officials in Washington. He stated that the FDA plays a role in the crisis and discussed the FDA's withdrawal of an opioid from the market due to its highly addictive nature, efforts to reduce overuse of opioids, and regulatory oversight around dispensing and prescribing procedures.





02:27 PM



Commissioner Gottlieb responded to questions about access to and the cost of Naloxon. He explained that the price of drugs may be related to the lack of competition from generic equivalents. He addressed committee questions about co-packaging drugs.





02:31 PM



Commissioner Gottlieb said that the lack of generic equivalents for some name brand drugs directly correlates to the cost of the drug and clarified that generic drugs must have the same delivery directions as the name brand equivalent. He explained that this requirement can be problematic since many of the delivery systems are patented, and to make a delivery system with the exact same instructions can be difficult.