CFC-Free Medication for an Ailing Ozone Layer

by Food and Drug Administration (FDA)

More than 20 million Americans, including those who use metered-dose inhalers for their asthma or chronic obstructive pulmonary disease, could be affected if the Food and Drug Administration finalizes a policy to phase out medical products that contain chlorofluorocarbons (CFCs).

FDA is seeking comments from the public on a rule the agency first proposed in March that also covers CFC-containing products far less common than metered-dose inhalers, such as nitroglycerin sprayed into the mouth to relieve chest pain.

Metered-dose inhalers and some other medical products use CFCs as propellants to carry the drug to the lungs or elsewhere in the body. While these products don't present a direct threat to users' health, they contain CFCs that eat away at the Earth's protective ozone layer and lead to increased ultraviolet radiation reaching the Earth's surface. Because increased UV rays are linked to skin cancer, cataracts, suppressed immune systems, and other health problems, CFCs indirectly can contribute to these conditions.

FDA's move toward phasing out CFC-containing medical products is part of a worldwide reduction in CFC production under the international agreement "Montreal Protocol on Substances that Deplete the Ozone Layer" and the U.S. Clean Air Act. Signed by more than 160 countries, the protocol called for a general ban on CFC production in industrialized countries by January 1996.

The use of CFCs in essential medical devices, including metered-dose inhalers, has been exempt from the ban.

"While we have an international agreement which aims for zero CFC use, FDA will always keep in mind that millions of Americans depend on these products to breathe," says Tunde Otulana, M.D., a medical officer with FDA's division of pulmonary drug products and head of an agency CFC work group. "Our goal is to protect the environment without putting patients' health at risk."

Under the approach being considered, the sale of the remaining CFC-containing medical products would be phased out as safe and effective alternatives become available.

"Naturally, patients may have concerns because they will have to switch to new medications as the products they have trusted for many years are replaced," Otulana says. "But while the look of the non-CFC products may be different, and the taste may be different, FDA is working to ensure that the effectiveness and safety of the drugs will be comparable to patients' current medications."

Public Perspective

The agency published an "advance notice of proposed rulemaking" in the March 6, 1997, Federal Register with a 60-day public comment period ending May 5. The notice is available on the Government Printing Office's web site

Generally, the rule in its proposed form states that CFC-containing medical products would be considered for a phaseout once these conditions are met:

Acceptable treatment alternatives exist for the particular metered-dose inhaler or other drug product so each patient can find a product that meets his or her medical needs.

The alternatives are marketed for at least one year and are accepted by patients.

The supply of alternative products is sufficient to ensure that there will be no drug shortages.

After considering the public's comments on the March notice and incorporating changes, FDA will publish a proposed rule in the Federal Register. The public will then have another 60 days to comment. Comments should be sent to FDA's Dockets Management Branch, HFA-305, Room 1-23, 12420 Parklawn Drive, Rockville, MD 20857.

Products with Promise

Faced with the prospect of the eventual removal of CFC-containing medical products from the market, companies are developing alternative products, Otulana says.

FDA has already approved one: 3M Pharmaceuticals' Proventil HFA (albuterol sulfate), which is marketed by Key Pharmaceuticals Inc. FDA approved the drug in August 1996. Its active ingredient, albuterol, remains the same as the now-marketed CFC-containing Proventil metered-dose inhaler. But the propellant hydrofluoroalkane (HFA) carries the drug into the lungs with no known ozone-depleting chemicals.

"[I]n the very near future there will be a whole family of HFA-propelled products to replace the family of CFC inhalers," says Maria J. Westfall, global program manager at 3M.

Dry powder inhalers that can hold several doses of medication are another possible alternative to CFCs. The dry powder drug substance would be inhaled without using any propellant.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.