Public Meeting Transcript: April 21, 2006

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

In the Matter of:
PUBLIC HEARING ON THE 2006 ESSENTIAL USE EXEMPTION PROPOSED RULE METERED DOSE INHALERS.

Docket No. 20060158

Friday, April 21, 2006

Environmental Protection Agency
Room 152
1310 L Street, N.W.
Washington, D.C.

The hearing in the above-entitled matter convened, pursuant to notice, at 1:01 p.m.

BEFORE:

ROSS BRENNAN, Chief Stratospheric Program Implementation Branch
Stratospheric Protection Division
Environmental Protection Agency

CONTENTS

Speakers

STEPHEN CAMPBELL (Armstrong Pharmaceuticals) - < comments>
PAMELA WEXLER (U. S. Stakeholders' Group) - < comments>
KRISTEN MORRIS (Boehringer-Ingelheim) - < comments>
JAMES A. LOSE (GlaxoSmithKline) - < comments>

PROCEEDINGS

CHAIRMAN BRENNAN: Good afternoon.

I think just about everybody is here. We may have a few more people trickling in, but we might as well get started.

My name is Ross Brennan. I am the Chief of the Stratospheric Program Implementation Branch, in EPA's Office of Atmospheric Program. We are the folks who are responsible for the essential use program at EPA.

I'd like to thank everybody for attending today's hearing, particularly on so much short notice.

Specifically, the proposed rule that is the subject of today's hearing is the proposed rule that was published April 11, 2006, Docket No. 20060158. The proposed rule, as you no doubt know, would allocate 1002.40 metric tons of CFC-1112 and 1114 for use in meter dose inhalers specifically in the year 2006.

As you probably know, the purpose of today's hearing is to allow interested parties to provide verbal comments to EPA. You should feel free to provide handouts and I know that at least one speaker has provided handouts as well. Those handouts will be included as a part of the formal docket for the rulemaking and, therefore, are incorporated as part of the public record.

As we assemble the final rulemaking, we will basically consider the verbal comments we receive today in exactly the same manner that we will consider written comments. If you are attending the hearing and you wish to submit written comments, feel free to do so. If you are speaking today and you wish to supplement your comments with additional written materials, obviously, feel free to do so as well.

Please remember, the deadline for submitting comments is May 22nd. The reason for that date is because, in fact, there was a hearing requested for today and for that reason, the deadline for submitting comments on the proposal has been moved from May 11th to May 22nd.

As a reminder, the purpose of the hearing, again, is not to answer individual questions. I welcome you to talk to the members of my staff who were involved in the MDI program for essential uses offline. If you have further clarifying questions, I would point out Hodayah Finman and Kristen Cappel of our division as the two staff leads on this particular issue.

By now, I hope everybody is signed in. I hope, certainly, that if you are interested in speaking that you have checked the box on the sign-in sheet.

I have here two individuals who have requested to be able to submit comments today. The first is Stephen Campbell and the second is Gretchen Trout. Is there anybody else who is interested in providing comments at today's hearing?

MS. TROUT: I'm Gretchen Trout and I am not interested in providing comments.

CHAIRMAN BRENNAN: Pam Wexler, perhaps?

MS. WEXLER: Did I check that off? Yes, right now, all right.

CHAIRMAN BRENNAN: Very good.

As you may have noticed, we do not have a microphone in the room to amplify speakers' voices. We do have microphones to capture people's comments for the public record. I would ask, because we have a court reporter here, that you speak slowly and clearly as you provide your comments; that you begin by providing your name and that of the organization. Please spell out your name if it is a difficult name to spell. Again, recognize that, because we don't have the microphone, please speak slowly and clearly.

Because we do have a court reporter for today's hearing, we will have a transcript of today's hearing available on EPA's website and we expect that to be available within a couple of weeks. So, you can look at epa.gov/ozone for a posting of the transcript of today's hearing.

With that, I'd like to begin and I think I will start at the top of the list of today's speakers. Mr. Campbell, I understand that you have a Powerpoint presentation that you would like to provide and some handouts that go along with that.

MR. CAMPBELL: Actually, at this point, we have not loaded the Powerpoint. We are going to work just off the printed materials.

CHAIRMAN BRENNAN: Very good. We will capture your verbal comments then for the record as well as a copy of the paper presentation for the record.

Thank you.

MR. CAMPBELL: Thank you, Mr. Brennan.

On behalf of Armstrong Pharmaceuticals who I am actually here to represent, rather than Amphastar, my actual employer. I would like to thank the agency for this opportunity to present our comments publicly in this type of a forum.

My name is Stephen Campbell, C-a-m-p-b-e-l-l. I am with Amphastar Pharmaceuticals, the parent company of Armstrong Pharmaceuticals.

I'll start with a little bit of background, but I think most of the people in the room know that background. So, I'm going to move through it very rapidly. If I'm moving too rapidly for anyone but the court reporter, please raise a hand, because the reporter can get this off of the written materials.

The reason we are here, as you know, is metered dose inhalers. Albuterol metered dose inhalers are used as a rescue medication for patients suffering from asthma and from chronic obstructive pulmonary disease or COPD. In 2005, according to numbers available through IMS, approximately 59.84 million Albuterol MDIs were sold in the United States. As of January, 2006, 21 million, 21.24 million imported units were lost to the U.S. market.

A shortage of Albuterol MDIs has arisen as a result of the loss of these imported MDIs. Armstrong, at this point, appears to be the only CFC MDI manufacturer with sufficient excess capacity to meet the current demands for CFC MDI Albuterol inhalers.

It is important to note that, Albuterol MDI inhalers lose their essential use status at the end of 2008 and, therefore, as of that date, there will be no more Albuterol CFC MDIs. Armstrong supports that position and is working on its own to help continue to supply the market with non-ozone depleting MDIs after 2008.

We believe at this point that, inadequate amounts of CFC propellants have been allocated for 2006 to replace the loss of those imported MDIs. Issues for HFA MDIs that prevent them from capturing more of the market share at this point are items such as third party and Medicaid reimbursement. In fact, as we will see later when I show some numbers, the percentage of HFA MDIs in the marketplace has actually steadily decreased over the last four years.

The market for MDIs over the last four years is split up primarily among Warrick, which is the generic arm of Schering, IVAX; Schering has their own small amount and Armstrong, Armstrong formerly being part of Andrx. Total CFCs for--CFC units in 2002 were 40 million, 46.5 million roughly in 2003, virtually flat for 2004 and a sudden spike in 2005 that took the total number of CFC units alone to over 58 million.

In the first quarter of 2006, we have, of course, only our internal numbers. What we have seen in the first quarter for Armstrong is 1.6 million where last year, 2005, we did a total of 3.29 million for the entire year. The total market based on graphic projections for the first quarter is somewhere around 15 and a half million, which is moving toward better than 60 million units for this year.

HFA contributions have been relatively small. IVAX brought theirs on the market last year and did about .6 million. Schering has been out there the longest with the best presence, but their presence in that marketplace, again, per IMS numbers has decreased steadily from 2.49 million in 2002 to less than a million in 2005.

The total market share has also dwindled from eight percent in 2002 down to two percent of the total market in 2005. CFC allocations have also steadily declined during this period. In 2001, the allocation was 3,098 plus metric tons. This year we know it is down to 1002.4 metric tons. This is based on a couple of misassumptions [sic]. That is what I'm really here to talk about.

In the first slide, titled False Hope, we thought one manufacturer had informed the U.N. committees dealing with this issue, with MDIs, that they had 805 metric tons of CFC pre-1996 available for sale. Eventually, they sold this material to Honeywell, but there were restrictions placed on this. Only four firms were allowed to buy this material.

As of last night, we reconfirmed with that firm, which is GlaxoSmithKline, that they will not sell that material to anyone other than the four firms listed in the joint letter sent to the committee by both GSK and Honeywell.

Interestingly, as we get into who those firms are, you will notice they are firms that have no use for the material.

Another issue in that letter is that, resale of that material from a company that is authorized to buy it to any company not on the list is forbidden.

The companies eligible are Boehringer-Ingelheim Pharma. Their product, Atrovent, is not a CFC Albuterol. INYX, an arm of Teva, is already converted from CFC Albuterol to HFA Albuterol. 3M has converted from CFC Albuterol to HFA Albuterol.

Wyeth manufactures Primatene Mist, an over the counter epinephrine product, which does not compete directly with Albuterol either in the HFA or CFC formulation.

So, again, the firms authorized to buy this material have no use for it. Those firms who are still manufacturing CFC materials are not permitted to purchase any of this material. Those are notably Schering-Plough.

Schering-Plough, we understand and, I won't speak for them, but only to state our understanding is that, they are basically at capacity on their lines and don't intend to add additional capacity, which makes sense since in another year and a half to two years, this product is going to go away. It does not make sense to invest additional capital.

The other firm notably off that list is Armstrong pharmaceuticals. Armstrong has excess manufacturing capacity. We have a shortage of CFC propellant due to some shortsightedness from prior owners of the company. As late as last night, we were again refused access to the GSK formerly owned material.

In conclusion and, unfortunately, it is a long series of conclusions, we believe that FDA and EPA failed to take into account the impact of the loss of imported CFC inhalers from Ireland when IVAX closed off manufacturing at the end of last year. GSK has orchestrated a subterfuge, convincing the U.N. and the EPA that the pre-'96 propellants are available when they are, in fact, not.

Both FDA and EPA failed to recognize the significance of the loss of 180 tons of CFC propellant through the Irish manufacturing site although, in fact, the MTOC, which is the Medical Technical Options Committee within the U.N., specifically recommended that that 180 tons be added back into the U.S. allocation for 2006. The result is a significant shortage of Albuterol MDIs for the treatment of asthma and COPD.

Armstrong has the capacity to manufacture 10 to 12 million CFC Albuterol units a year. If--and this is the big if--if sufficient propellant is available. The 180 ton allocation recommended as replacement of the EC produced MDIs should be added to Armstrong's allocation for the year 2006 to avoid a significant shortfall in capacity nationally within the next few months.

Thank you.

CHAIRMAN BRENNAN: Thank you, Mr. Campbell.

[Discussion off the record.]

CHAIRMAN BRENNAN: I believe the next empaneled speaker is Ms. Pamela Wexler.

MS. WEXLER: Thanks very much.

Good afternoon, my name is Pamela Wexler and I am here today to speak on behalf of the U.S. Stakeholders' Group on MDI transition.

The Stakeholders' Group is a consortium of nine patient and medical professional organizations. Since 1997, we have collectively attempted to inform both the domestic and the international policy makers on how to achieve a transition to HFA inhalers that is smooth for patients.

First, let me say thanks to EPA and that I apologize for not having slides or written comments. Working with the consortium and the timing of this hearing, we were not able to collaborate in-depth. We do intend to submit written comments to the final rule. So, my remarks today are going to be very brief, which for those of you who know me in the room, will be a surprise, a shock for you.

Very brief, the main point that we want to communicate today is that, as outlined in the proposed rule that EPA has published, the timelines of events, as described, may not necessarily take into account the most current information. As most people know and as Mr. Campbell has described, there have been some very recent developments regarding Albuterol in the marketplace.

It is not clear that FDA's estimates, the companies' estimates, the FDA estimates or EPA's proposals reflect that most current information.

In fact, from what our reading is of the proposed rule, that the allocation could be based on information that is anywhere from six to 12 months old. We think that EPA should at least reconfirm with FDA and take that into consideration.

The second point, which is related to a rapidly changing marketplace, is simple to reiterate a position that the Stakeholders have always had and continue to maintain. That is that in an environment where CFC, raw CFC materials are finite, that there really needs to be a full consideration of how allocations will affect moietiese for which there are no alternatives.

Upon our reading of the numbers, if you see that the tonnage being authorized for 2006 is significantly reduced from what EPA or the U.S. Government requested from the international community and that number has been adjusted, yet the lion's share of that 1100 tons is still being sent to Albuterol.

We would just encourage EPA to, again, consider in a rapidly changing marketplace whether this has been taken into account when looking at the authorization and to ensure that the moietiese that really need that Albuterol will have it whenever they get to the reformulation stage.

With that, again, thanks very much and we will submit our comments.

CHAIRMAN BRENNAN: Thank you, Ms. Wexler.

Is there anybody else in the room who would like to speak at today's hearing?

Please come forward and state your name.

MS. MORRIS: Hi, Kristen Morris with Boehringer, B-o-e-h-r-i-n-g-e-r Ingelheim, I-n-g-e-l-h-e-i-m. I just wanted to offer a point of clarification to Mr. Campbell's testimony.

The product that actually we are using CFCs for currently is for Combivent. Atrovent is, indeed, phased out of the CFC. That's the end of the comments. If there are any questions, I'd be happy to take any.

MS. WEXLER: Could I ask a question about the appropriate--I wanted to ask her the expedience of the--Mr. Campbell said that only firms that have no use could buy them. Is it possible for you to clarify that BI has no use for the CFCs that they purchased?

MS. MORRIS: That's to the point. Yes, the purchase of the CFCs is for our Combivent product. So, we do have use for the CFCs that were out of the GSK stockpile.

MS. WEXLER: Okay, I understand.

MS. MORRIS: Thank you.

CHAIRMAN BRENNAN: Thank you, Ms. Morris.

Is there anybody else who would like to provide comments today?

MR. LOSEY: My name is Jim Losey. I represent GlaxoSmithKline.

I wasn't intending to make comments today. We will be submitting written comments after we have had a chance to more fully review the rule. I do wish to make a brief remark regarding Mr. Campbell's remarks.

On behalf of Glaxo, we take great umbrage and profoundly disagree with his characterization of our sale being a subterfuge. I was personally involved in that sale and the negotiations over several months. I kept the U.S. Government involved and apprised of the sale and its terms throughout that period. The terms were made publicly, were publicly disclosed in a letter to UNEP. That letter is available. Indeed, I can fax it to you at any time.

There is nothing hidden. There is no subterfuge in it. It was GSK's right as a company to sell its goods to whomever it wanted to. Beyond that, we have many reasons, which we will detail in our comments, why we chose those companies which you have just heard--need the CFCs.

I just wanted to note for the record that was a completely above board sale and was done on principle.

Thank you.

CHAIRMAN BRENNAN: Thank you, Mr. Losey.

Any other comments on the proposed rule that anyone would like to offer today?

[No verbal response.]

CHAIRMAN BRENNAN: If not, I thank you all very much for coming. I remind you that, within two weeks, we will have a written transcript of today's hearing available on EPA's website. Those materials, obviously, will be included in the docket for the rulemaking as well.

Thanks very much and have a good weekend.

MR. KAST: I'm sorry, did you say the transcript will be available on the web?

CHAIRMAN BRENNAN: Yes, sir.

MR. KAST: In two weeks?

CHAIRMAN BRENNAN: In two weeks.

[Whereupon, at 1:23 p.m., the hearing concluded.]

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