A United States regulator's perspective on the ongoing chlorofluorocarbon transition

Area of Science:

• Environmental Science
• Public Health Policy
• Pharmaceutical Regulation

Background:

• The FDA banned chlorofluorocarbons (CFCs) in regulated products in 1978, with exemptions for essential public health uses.
• International agreements like the Montreal Protocol mandate a global phase-out of CFCs.
• The FDA has collaborated with industry to develop and test alternatives for metered dose inhalers (MDIs).

Purpose of the Study:

• To outline the FDA's strategy for transitioning away from CFCs in metered dose inhalers.
• To ensure patient safety and continued access to vital medical products during the transition.
• To meet the public health objective of protecting the ozone layer.

Main Methods:

• Developing a collaborative transition policy with governmental and nongovernmental stakeholders.
• Publishing an advance notice of proposed rulemaking (ANPRM) to gather public input on essentiality criteria for CFC use.
• Incorporating public comments into the ongoing rule-making process.

Main Results:

• An ANPRM was published in March 1997 to solicit public comment on determining when CFC use in drug products is no longer essential.
• Extensive public debate and valuable input were generated through the ANPRM process.
• The FDA is actively using this feedback to refine its regulatory approach.

Conclusions:

• The FDA is committed to a dual goal: safeguarding patients using metered dose inhalers and protecting the ozone layer.
• The transition policy aims to balance patient needs with environmental protection.
• Ongoing rule-making will incorporate public feedback to finalize the transition strategy for CFC-containing MDIs.