Printech Archives, August 1997: FDA approvals

FDA approvals

Dave Salman (
Mon, 04 Aug 1997 08:42:56 -0400

An interesting item from the EPA Enviro-Newsbrief on the subject of
FDA approval.

Enviro-Newsbrief July 31, 1997

The following is a daily update summarizing news of interest
to EPA staff. It includes information from current news sources:
newspapers, newsletters, and other publications. For more
information, contact the EPA Headquarters Information Resources
Center at (202) 260-5922, or e-mail LIBRARY-HQ.

**Viewpoints expressed in the following summaries do not
necessarily reflect EPA policy**

House Subcommittee Probes Federal Plans To Phase Out CFCs in
Metered-Dose Inhalers. Daily Environment Report, July 31, 1997,

EPA and other administration officials spoke at a hearing of
the House Commerce Subcommittee on Health and Environment
yesterday about plans to phase out chlorofluorocarbons in
metered-dose inhalers. The inhalers are used by asthma
sufferers, and the CFCs act as propellants to introduce a mist of
medicine into the lungs.
Phasing out CFCs in inhalers would eliminate 4000 tons of
CFCs annually, said Paul Stolpman, director of EPA's Office of
Atmospheric Programs. The 4000 tons released from
metered-dose inhalers in the US is a larger amount of CFCs than
are released from all sources in more than 100 other countries.
Stolpman called on the US to act as a world leader on the phase out
of CFCs.
The Food and Drug Administration has begun planning the
phase out. Although the American Lung Association and the
Asthma and Allergy Foundation of America support the FDA's plan,
some legislators want to stop the phase out because of concerns
for asthmatics that rely on the devices.
Murray Lumpkin, Deputy Director of the FDA's Center for
Drug Evaluation and Research, tried to ease the committee's fears
by saying that the number one concern of the FDA is the health of
people who use the inhalers. He said that FDA will not ban the
inhalers until "patient-acceptable products" for substitution are
readily available on the market.
Rafe Pomerance, deputy assistant secretary of state for
environment and development, told the panel that CFCs for the
inhalers can still be produced in the US because they are covered
as an "essential use" under the Montreal Protocol on Substances
that Deplete the Ozone Layer. However, the Open-Ended
Working Group of the Montreal Protocol recently produced a draft
decision encouraging a phase out of the use of such CFCs.
FDA announced its plan in an advance notice of
rule-making in March (62 FR 10242). It is evaluating the comments
that it received about the plan and hopes to issue a proposed rule
later this year or in early 1998.
Later in the hearing, EPA was attacked by Subcommittee
member Richard Burr because it had sent a letter to health care
providers about a CFC-free inhaler that was available on the
market. Burr accused EPA of endorsing the product, since it is
the only one that has been approved by the FDA. Burr noted that
it is illegal to promote a product by citing its FDA approval.
Stolpman countered Burr's claims, saying that the letter did
not endorse the product. Burr warned that Stolpman could expect
an inquiry about the letter from the House Commerce
Subcommittee on Oversight and Investigations.



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