Life Science Compliance Update

July

2018

The Sleeping Giant Awakens – Cantrell’s Consent Decree as a Study on How Not to Respond to FDA Enforcement Actions

Written by , Posted in Uncategorized

Carolyn Greene, Esq.

Cantrell Drug Company, a 503B outsourcing facility in Little Rock, Arkansas, has been subject to multiple FDA inspections over a five-year period. Each inspection found numerous deficiencies, many in critical areas relating to the prevention of microbiological contamination and aseptic processing. Cantrell defied FDA instructions and shipped products in interstate commerce. As a result, FDA referred the matter to the DOJ, which filed a civil enforcement proceeding seeking to enjoin Cantrell from further distribution. Ultimately, Cantrell entered into a consent decree with the FDA. This case played out much more publicly than similar situations, as Cantrell executives were posting comments on Twitter about the process. Unfortunately, the tone of the comments suggested that Cantrell did not take the FDA’s supervision seriously.


   or   

  • Return to July 2018 LSC Update Table of Contents
  • Copy abstract URL
  • Order Reprints
  • Topic tags:

    June

    2018

    Solving The Problems With Drug Compounding – Sparse Data And An Inconsistent Regulatory Framework Muddy The Waters

    Written by , Posted in Uncategorized

    Carolyn Greene

    At least partly in response to the 2012 fungal meningitis outbreak, Congress passed the DQSA to increase federal regulatory authority over compound pharmacies. Many states also joined in the increased FDA regulatory oversight, strengthening their quality requirements. Data on compound drug quality is limited, but the data that does exist depicts an industry with a substantial number of quality and safety problems, potentially endangering the health of millions of Americans. The compound pharmacy industry isn’t helping matters – instead, they insist that compound drugs are safe. Since the passage of the DQSA, significant improvements have been made in the quality and safety of compound drugs, but much work remains.


       or   

    Topic tags:

    Menu Title