CRE Homepage About The CRE Advisory Board Newsletter Search Links Representation Comments/Ideas
Data Access
Data Quality
Regulation by Litigation
Regulation by Appropriation
Special Projects
CRE Watch List
OMB Papers
Abstracts and Reviews
Regulatory Review
Voluntary Standards Program
CRE Report Card
Public Docket Preparation
Consumer Response Service
Site Search

Enter keyword(s) to search

®: CRE Regulatory Action of the Week

An Open Letter to HHS on Drug Diversion
CRE has written Secretary Thompson providing regulatory recommendations for addressing the growing problem of drug diversion. The letter recognizes the Secretary's invaluable leadership on this issue and the important steps that FDA is taking to help curb diversion. CRE has been working on the drug diversion issue for some time and has written a working draft white paper, "Dirty Deals: The Drug Diversion Trade, How it Victimizes the Vulnerable and How to Stop It," that analyzes this multi-faceted issue and provides initial regulatory recommendations. In the letter to Secretary Thompson, CRE provided three specific key recommendations:

  1. FDA ensure that there are no further delays in fully implementing the pedigree provisions contained in their December 1999 Final Rule.

  2. The Office of Pharmacy Affairs require that 340B covered entities make public, in a manner consistent with patient privacy, records documenting that discounted drugs have been administered to only eligible patients.

  3. Manufacturers shall disclose the identities of their authorized distributors.
  • Click to read CRE letter to Secretary Thompson.
  • Click to read CRE white paper.