Document ID: EPA-HQ-OAR-2006-0158-0049
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-09-28T04:00Z

Summary notes from meeting between Amphastar Pharmaceuticals,
Inc./Armstrong Pharmaceuticals Inc. and USEPA on July 17, 2006 

The following summary notes are from a meeting with representatives from
Amphastar Pharmaceuticals, Inc./Armstrong Pharmaceuticals (Armstrong)
and EPA’s Stratospheric Protection Division regarding EPA’s Proposed
Rule on the Allocation of Essential Use Allowances for Calendar Year
2006 (2006 EUA Proposal) on July 17th, 2006.

I. Armstrong representatives (Robert Sussman, Stephen Campbell, James
Luo, Jack Silhavy, and other); EPA representatives (Drusilla Hufford,
Ross Brennan, Hodayah Finman, and Kirsten Cappel)

II. Armstrong reiterated comments submitted to EPA in response to
EPA’s 2006 EUA Proposal and argued that their essential use allowances
of chlorofluorocarbon (CFCs) be increased.  

III. Armstrong also made the following key points (in summary):

Armstrong is committed to the phaseout of CFCs;

There is a severe shortage of CFC propelled metered dose inhalers (CFC
MDIs); 

The removal of IVAX from the market largely contributed to the shortage.
 

HFA Albuterol is significantly more expensive than the CFC MDI product;

Low-income patients will be particularly affected by the cost increase.

There is no insurance reimbursement for the purchase of HFAs.

Armstrong is in the position to produce more CFC MDIs; 

They have excess manufacturing capacity.

However, Armstrong needs additional quantities of CFCs to produce CFC
MDIs as their stockpiles of CFCs have decreased.

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