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Questions and Answers on Final
Rule of Albuterol MDI’s
| Updated information is now available on the phase-out of Chlorofluorocarbon-containing (CFC) Albuterol MDIs. (05/30/2008) |
What did HHS/FDA do today?
The FDA announced a final rule to amend our
regulation (21 CFR 2.125) on the use of ozone-depleting substances (ODSs)
in medical products. This rule establishes December 31, 2008, as the
date by which production and sale of single ingredient albuterol CFC
MDIs must stop, by removing the essential use designation for
albuterol metered-dose inhalers (MDIs) under 2.125.
What are ODSs?
ODSs are substances that deplete stratospheric
ozone. They include chlorofluorocarbons or CFCs. Once released, CFCs
rise to the stratosphere. Within the stratosphere, there is a zone
about 10 to 25 miles above the Earth's surfaces in which ozone is
relatively highly concentrated. Once in the stratosphere, CFCs are
gradually broken down by strong ultraviolet light and they release
chlorine atoms that then deplete stratospheric ozone. Depletion of
stratospheric ozone by CFCs and other ODSs leads to higher
ultraviolet B radiation levels, which in turn has increased skin
cancers and cataracts, as well as caused other significant
environmental damage. Albuterol MDIs have historically used the
chlorofluorocarbons trichlorofluoromethane (CFC-11) and
dichlorodifluoromethane (CFC-12) as propellants, both of which are
potent and previously common ODSs.
What is “essential-use”?
The use of chlorofluorocarbons or CFCs, an ODS, has
been generally banned in consumer aerosols in the United States
since 1978. However, the
Clean Air Act has permitted certain
essential uses of ODSs. Since 1996, newly produced CFCs are only
allowed for essential medical uses. Under 21 CFR 2.125, HHS/FDA
specifies a list of drug products that are considered essential uses
of ODS under the Clean Air Act, and therefore can be legally
produced and used in the United States. Albuterol MDIs are currently
listed as an essential use of ODSs.
What conditions had to be met for albuterol MDIs
to no longer be considered “essential use”?
Under 21 CFR 2.125, several criteria must be met for
a listed product to be considered no longer essential. These
criteria are the following:
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Sufficient non-ODS alternatives are available with
the same indications and approximate level of convenience;
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There is adequate post-marketing data for the
alternative products.
-
Supplies are adequate to meet the demand;
-
Patients who require the product are adequately
served; and
HHS/FDA initiated notice and comment rulemaking in June of 2004 to
allow public input into the determination. The agency received over
75 comments. After thoroughly reviewing and evaluating the comments
received, and in consultation with other federal agencies, HHS/FDA
has determined these conditions will be met by December 31, 2008,
which will render the use of CFCs in albuterol MDIs no longer
essential.
How will the rule affect my access to albuterol MDIs?
HHS/FDA is committed to ensuring an orderly transition to the HFA
albuterol MDIs, over the next three years. HHS/FDA is also committed
to ensuring these products will be available to populations that
need them. Currently, there are three non-ODS albuterol MDIs
marketed-Proventil HFA (marketed by Schering –Plough), Ventolin HFA
(marketed by GlaxoSmithKline) and a similar product from IVAX. Under
21 CFR 2.125, only Proventil HFA and Ventolin HFA can formally be
considered as alternatives, because IVAX has only recently marketed
its product. The final rule has an effective date of December 31,
2008. The effective date of the final rule is the date on which
albuterol MDIs that contain ODSs will no longer be able to be
produced, sold and marketed in the United States. HHS/FDA chose the
date to assure adequate supplies would be available in the market.
We are balancing our international obligations and concerns about
the environment on public health with the important needs of
patients who rely on these medicines and the associated public
health issues.
What programs will be in place to help patients get the albuterol
MDI they need, since the albuterol HFA MDI currently cost 20 dollars
more per MDI than the generic CFC MDIs?
HHS/FDA is encouraged that the manufacturers of the three HFA
products are implementing programs to help assure access to these
albuterol MDIs for patients for whom price could be a significant
barrier to access to this important medicine. These programs include
MDI giveaways, coupons for reducing the price paid and
patient-assistance programs based on financial need.
What is HHS/FDA’s advice to patients who use albuterol MDIs?
It is important that patients who use albuterol CFC MDIs talk with
their doctors about the phase-out of the CFC products to establish
the timing and manner of their move to HFA albuterol MDIs or other
product/medication. This final rule goes into effect in about 40
months, and even when in effect, will not mean that albuterol MDIs
will no longer be available, just that they will change. It is
advisable that patients begin their own planning, and move to the
HFA product in advance of the final date, since HFA supplies will be
increasing over this time, and CFC supplies diminishing. While HHS/FDA
have previously found the albuterol MDIs safe and effective, and
through this rule found them good alternatives, they are somewhat
different (in taste, delivery feel and other attributes) and
patients should anticipate this as they consider their switch to the
newer products. It is also important to note that while all CFC
albuterols contain the same inactive ingredients, this is not true
of the albuterol HFA products, so patients might wish to try the
various kinds to find one that is most agreeable to them.
What will be the long-term effect of this phase-out on the price
and availability of albuterol products for asthma and COPD patients?
HHS/FDA carefully thought through the rule and the effective date to
assure availability of albuterol HFA products would not be an issue
throughout this three-year transition. Currently, the HFA albuterol
products are more expensive than the generic albuterol CFC inhalers.
Three current HFA products will compete in the market place as CFC
products are withdrawn, and the long-term effect of this rule on
price is not certain. However, HHS/FDA carefully considered programs
the albuterol HFA MDI manufacturers are establishing to assure
access for patients for whom price is a significant issue, and
believes these programs will help ensure patients will have adequate
access by the effective date of the rule.
How does this rule affect other MDIs that contain CFCs?
This rule only affects albuterol CFC MDIs.
It does not affect other currently marketed asthma or COPD CFC
inhalers, which HHS/FDA separately consider as to whether and when
they are no longer essential under our regulation. Notably, this
action does not affect Combivent MDI, a combination product that
contains albuterol as well as ipratropium, since HHS/FDA has
designated it as an essential-use product distinct from the
single-ingredient albuterol MDIs.
How is this rule related to the Montreal Protocol?
The Montreal Protocol on Substances that Deplete the Ozone Layer is
an important international environmental treaty to which the United
States is a party. The United States has generally banned the use of
CFCs in consumer aerosols (like hairsprays) for decades, and
eliminated almost all manufacture and importation of CFCs as of
January 1, 1996. However, the Montreal Protocol permits developed
countries, such as the United States, to continue to produce or
import CFCs for use in medical products (principally for asthma and COPD), if the parties find such production or importation to be
medically essential. The United States has received permission to do
this for albuterol MDIs containing ODSs, as well as other inhalers
for asthma and COPD.
What are the U.S. Government’s obligations under the Montreal
Protocol?
The United States is a party to the treaty, and as such, has agreed
to phase out production and importation of ODSs, including CFCs,
according to the timetables agreed to by the participating
countries, including the United States. Congress amends the Clean
Air Act (CAA) in 1990 in response to the Montreal Protocol, and the
CAA and its implementing regulations call on HHS/FDA to determine
which uses of ODSs in medical products remains essential. HHS/FDA
does that in 21 CFR 2.125(e).
If there have been alternatives to albuterol MDIs containing ODSs
for several years, why did HHS/FDA not act sooner?
There are many reasons for this. One of the criteria for beginning
the process of finding a drug to no longer be an essential use of
CFCs is that there must be adequate post-marketing experience with
the alternative(s). Ventolin HFA, the second product necessary for
beginning this process for albuterol, only began marketing in 2002.
HHS/FDA believed it needed to allow at least a year prior to
initiating rulemaking on albuterol’s essentiality to ensure there
was adequate post-marketing experience with both CFC-free albuterol
alternatives. Another criterion is adequate supply capabilities. To
date, there have not been, and are not currently, adequate supplies
of the HFA albuterol MDIs to meet the needs of all asthma and COPD
patients in the U.S. Finally, under the criterion of making sure
that patients are adequately served by the alternatives, HHS/FDA is
expected to take into account the potential for price differences to
act as a potential impediment to patient access to the medications.
How was the Pulmonary Drugs Advisory Committee meeting of June 10
related to this rule?
HHS/FDA convened the June 10 meeting to discuss albuterol CFC
inhalers and whether the criteria under 21 CFR 2.125 had met the two
CFC-free albuterol MDIs. This meeting took place at the early stage
in the rulemaking process, the day after the proposed rule was made
public. HHS/FDA considered the public and advisory committee
discussion in preparing the final rule.
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Date created: March 31, 2005; updated May 30, 2008 |
