On the recordJune 22, 2018
I want to enter into the Record my extended remarks regarding a provision included in H.R. 6 that does not enjoy bipartisan support. Section 301 was passed out of the Energy and Commerce Committee on a party-line vote. Had a committee report been filed, I would have filed the dissenting views that I am now seeking to have added to the Record. Mr. Chair, H.R. 5806, the 21st Century Tools for Pain and Addiction Treatment Act, would require the Food and Drug Administration (FDA) to hold a public meeting regarding the challenges and barriers of developing non-addictive pain and addiction treatments and to issue guidance regarding the eligibility of such treatments for either the Accelerated Approval Program or Breakthrough Therapy Designation. This legislation could undermine FDA's implementation of the Accelerated Approval and Breakthrough Therapy Designation programs and divert critical financial and personnel resources away from activities related to addressing the opioid crisis for purposes of incentivizing an industry that is already taking advantage of these programs. This legislation is a solution in search of a problem. Opioid overdose death rates are now the leading cause of unintentional, non-traumatic deaths in the United States. According to the Centers for Disease Control and Prevention (CDC), overdose deaths from opioids have quadrupled in the last 20 years.…
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