Comment on The Food and Drug Administration (FDA) Request for Comments: Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format; Draft Guidance for Industry, FDA-2019-D-1917-0001 (Jul. 2, 2019)

Ultimately, while the authors recommend changes to the scope and strength of FDA-2019-D-1917, we also recognize that many of the most urgent changes to labeling must have the force of law behind them. We would recommend that the Senate HELP committee and the Ways and Means Subcommittee on Health draft new laws that would require labels to be uniform in structure and language, with standards developed by the agency. Clarity and uniformity will allow physicians and patients alike to make informed decisions. We would also recommend that this legislation require lay language to be included to describe dependence risks and symptoms, so that patients could better understand both risks and dependence itself. It is our duty to use our knowledge regarding the science to require language on prescription drug labeling to be more informative, direct, and administered to patients in a manner that makes them more aware of the dangers associated with opioid-based prescription medications.

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Work Title Comment on The Food and Drug Administration (FDA) Request for Comments: Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format; Draft Guidance for Industry, FDA-2019-D-1917-0001 (Jul. 2, 2019)
Subtitle Content and Format; Draft Guidance for Industry, FDA-2019-D-1917-0001 (Jul. 2, 2019)
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Open Access
Creators
  1. Tara L. Pickens
  2. Elizabeth Eisenhauer
  3. Brett Green
  4. Jeremy Sutherland
  5. Mariam Taleb
Keyword
  1. public comment, regulations, opiates, addiction, drug, drug abuse, prescription, labels, dependence
License All rights reserved
Work Type Research Paper
DOI doi:10.26207/yagr-7j34
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Deposited May 27, 2020

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Version 1
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  • Created
  • Added Comment_from_The_Penn_State_Science_Policy_Society__1_.pdf
  • Added Creator Tara L. Pickens
  • Added Creator Elizabeth Eisenhauer
  • Added Creator Brett Green
  • Added Creator Jeremy Sutherland
  • Added Creator Mariam Taleb
  • Published