Removing the essential use designation for albuterol

1
Removing the essential use designation for
albuterol

• PADAC Open Public Hearing
• 10 June 2004
• Comments of the
• US STAKEHOLDERS GROUP ON MDI TRANSITION

2
The U.S. STAKEHOLDERS GROUP

• Formed in 1996
• Comprised of nine leading patient and medical
  professional associations
• Contributes expertise to international and
  domestic deliberations on elimination of CFCs in
  MDIs

3
The STAKEHOLDERS Petition

• Filed January 2003
• pursuant to July 2002 FDA Final Rule establishing
  essentiality criteria
• initiated because the essentiality criteria
  met/could be met
• requested FDA issue a proposed rule by July 2003
• Why did STAKEHOLDERS Petition FDA?
• environment and health
• opportunity to improve disease management
• uninterrupted supply of medications

4
Since the Petition was filed

• Continued uncertainty about supply
• new questions about CFC plant in Baton Rouge
• heightened scrutiny of U.S. essential use
  nominations by Montreal Protocol Parties
• Increased understanding of albuterol market and
  costs of transitioning
• NERA report
• increased costs to most patients will be
  reasonable
• mitigating factors should reduce costs
• e.g., competition, buyer power, additional
  products

5
The COSTS of transition

• STAKEHOLDERS agree that it is appropriate to
  consider affordability and access when
  considering whether to remove an essential use
  designation
• STAKEHOLDERS believe potentially at-risk
  subgroups can be adequately served
• increased samples/enhanced Patient Assistance
  Programs
• education and outreach
• phased-in transition with monitoring/reporting

6
The TIMING of transition

• Key timing factors for patients
• need to act before CFC supply is interrupted
• need to consider production capacity
• need to develop and implement outreach to
  patients, physicians and payers
• Effective date of December 31, 2005
• sensible because it takes into account above
  factors
• achievable

7
THE US STAKEHOLDERS GROUP ON MDI
TRANSITIONwww.inhalertransition.org

• Pamela Wexler
• 202.332.2386 ? cell 202.744.6443 ?
  wexkk_at_patriot.net