S-3557 : Still Just a Bill

Summary of S. 3557: This bill directs the Secretary of Health and Human Services to prepare and publish a report on the FDA's review of opioid analgesic drugs. The report must include:

• An opportunity for public input on the regulation of opioid analgesic drugs.
• An update on actions taken by the FDA to review the effectiveness, safety, benefit-risk profile (including public health effects), and use of approved opioid analgesic drugs.
• A timeline for assessing the potential need for labeling changes, revised postmarketing requirements, enforcement actions, or withdrawals of opioid analgesic drugs.
• An overview of steps taken by the FDA to support the development and approval of non-addictive medical products for pain or addiction treatment, and planned future actions.
• An overview of the FDA's consideration of clinical trial methodologies for analgesic drugs, including enriched enrollment randomized withdrawal methodology, discussing benefits and drawbacks.

The report must be published on the FDA's website within one year of the bill's enactment.