FDA sets deadline for CFC phase-out

Related tags Asthma Chronic obstructive pulmonary disease Us

The Food and Drug Administration (FDA) has set the end of 2008 as
its deadline for the complete phase-out of albuterol inhalers using
ozone-depleting chlorofluorocarbons (CFCs) as propellants,
reports Phil Taylor.

But albuterol metered dose inhalers (MDIs) will be the only products affected by the ruling, and MDIs used to deliver other drugs will remain exempt from the prohibition, in stark contrast to Europe where more than 75 per cent of all MDIs have switched to the use of more environmentally friendly hydrofluoroalkanes (HFA) propellants.

CFCs have been used as propellants for various pressurised products including MDI treatments for asthma and chronic obstructive pulmonary disease (COPD), which includes emphysema and chronic bronchitis. Since 1978, the use of CFC-emitting aerosol products in the US has been largely banned because of increasing evidence that CFCs contribute to the depletion of the earth's protective ozone layer, with a specific prohibition on commercial uses agreed internationally in 1996. But their use in MDIs has been exempt from this ban on the grounds of medical necessity.

Resistance to the switch to HFAs comes from a combination of sources. For manufacturers of asthma drugs the cost of conversion can be enormous, requiring additional clinical trials as the propellant can markedly affect the behaviour of the active pharmaceutical ingredient (API). Supply has been a concern, with only a handful of companies - including Solvay and DuPont - licensed to supply HFAs for pharmaceutical use, and the greater cost of HFAs has raised fears that the cost of these drug products could rise and exclude some patients from receiving treatment.

Now, the US Department of Health and Human Services (HHS) published a notice in the Federal Register on 31 March saying that sufficient supplies of two approved HFA-based albuterol inhalers will exist by 31 December, 2008, and this will allow the phasing out of the less environmentally friendly versions.

Access issue resolved

In a statement, the HHS said it was satisfied that three manufacturers of albuterol inhalers would be able to assure access to HFA-based albuterol MDIs to patients 'for whom price could be a significant barrier to access to this important medicine', in recognition of the fact that HFAs are more expensive than the CFCs they replace, and this increase in cost is reflected in the final price of the MDI product.

Last year, the FDA had said it was concerned that up to a million canisters of albuterol may fail to reach patients after the ban because of price rises. But it now says the companies have committed to a range of access programmes, including MDI giveaways, coupons for reducing the price paid and patient-assistance programs based on financial need, that circumvent this problem.

The FDA's criteria​ for imposing the deadline in the case of albuterol are that two non-CFC products with the same active drug are marketed with the same route of administration, for the same indication, and with approximately the same level of convenience of use as the CFC product that contains that active ingredient.

In addition, sufficient supplies and production capacity for the non-CFC product will exist by the deadline, and adequate US post marketing use data are available to back up the safety and efficacy of the MDIs. It can be expected that similar prohibition will be put in place when similar conditions are met with other drugs delivered using MDIs.

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