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MPS-2.2 Data Details

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MPS-2.2 Reduce the number of non-FDA-approved pain medications

About the Data

Description of the data source, numerator, denominator, survey questions, and other relevant details about the national estimate.

Changed Since the Healthy People 2020 Launch: 
Yes
Measure: 
number
Baseline (Year): 
575 (2007)
Target: 
518
Target-Setting Method: 
10 percent improvement
Numerator: 

Number of non-FDA-approved pain medications (opioids, NSAIDs, and acetaminophen used to treat pain) that are on the market in one year

Comparable Healthy People 2010 Objective: 
Not applicable
Methodology Notes: 

    Pain medications are defined as opioids, non-steroidal anti-inflammatory drugs (NSAIDS), and acetaminophen.

    Each new drug application that goes through the FDA Approval Process is given a unique identifier and, once approved by the FDA, is required to list the product with the FDA in the database. The data for this objective will select Drug Listings for a given year that are determined to be “Unapproved” in the Drug Registration and Listing Database. The goal of this objective is to decrease the overall number of “Unapproved” drugs that are marketed and, subsequently listed with the FDA. This is not to imply that “Unapproved” drugs should not be listed with the FDA, but that the number of “Unapproved” marketed drugs should be minimized.

    The estimates are reflective of the drugs that have multiple ingredients, potency levels in a drug, and different routes of administration.

Caveats and Limitations: 
For the purposes of this measure, pain medications are defined as opioids, NSAIDS, and acetaminophen.

Revision History

Any change to the objective text, baseline, target, target-setting method or data source since the Healthy People 2020 launch.

Description of Changes Since the Healthy People 2020 Launch: 
In 2014, this objective was archived due to lack of a viable data source.

References

Additional resources about the objective

  1. Approvals of FDA-Regulated Products. US Food and Drug Administration.
  2. FDA Enforcement Report Index

  3. Is It Really FDA Approved? US Food and Drug Administration, September 30, 2008.
  4. Marketed Unapproved Drugs: Compliance Policy Guide Center for Drug Evaluation and Research. US Food and Drug Administration, June 2006.
  5. National Drug Code Directory

  6. US Sales and Prescription Information