The Outlook For Medical Gases

A W&GT Exclusive Interview with the FDA's Duane Sylvia

In January, Duane Sylvia, consumer safety officer at the FDA's Center for Drug Evaluation and Research, sat down with Welding & Gases Today's senior editor, Carole Jesiolowski, to talk about the outlook for medical gases, compliance, distributor concerns and regulations. Not one to mince words, Mr. Sylvia admitted that he is eager to have the guidance document completed, and move on to other pressing industry issues.

W&GT: What are the most critical challenges facing the independent distributor regarding the new draft guidance?
DS: The biggest challenge is in the area of expiration dating and stability studies. The industry provided us with old stability studies which were not valid. Unfortunately, that data showed that some cylinders were actually leaking their entire contents within a year to 18 months. If we had communicated better, the industry and FDA, we would have had them redo the study.

W&GT: Has there been any subsequent activity?
DS: Yes, we met with the Compressed Gas Association (CGA) in July 2003 to discuss their major concerns to the guidance. At that time, we agreed that the industry would organize a committee, and we would meet to discuss the technical issues that pertain to expiration dating at a later date. We're now waiting for CGA to come forward with that information and their request. We've also met with GAWDA's consultants and discussed GAWDA's SOP Program, and the actions the association is taking to bring about a coordinated compliance. So as you can see, the agency is very willing to work with the industry, and we are confident that we have been doing so.

“The FDA is focused on the public health of the consumer, and Medicare is currently focused in on reduction of costs. The two issues are mutually exclusive.”

W&GT: I know you are working towards a coordinated compliance. Will that happen?
DS: I believe it will happen. Once the guidance document is released, we probably will do a lot of training. One of the things I would like the industry to concentrate on, or maybe change their mindset on, is to remember that they are producing a prescription drug, and they also produce industrial gases. We typically hear the reverse, “We are industrial manufacturers, and we produce medical gases as an additional product line.”

W&GT: How are you going to change this mindset?
DS: Ideally through training, education and continuing to work with the industry. If we could get everyone to understand that they are providing a prescription drug, they would understand how the GMP's impact their program. I understand that a lot of people in the industry use the GMP's to get a better handle on their industrial product.

W&GT: So instituting the GMP's is good business practice?
DS: Exactly. Here's why, by way of an example. A quality control manager who attended the Air Products & Chemicals' GMP training session in Atlantic City approached me last year at a GMP training seminar in Chicago. Her company had just been inspected, and did not receive a 483, which, as you know, for a welding supply company experiencing its first inspection is impressive. It proved that this is do-able.

W&GT: Good advice...institute the GMP's.
DS: Absolutely. It felt good to hear this distributor's success.

W&GT: Previously published reports indicate that the review will be released in March or April of this year. Do you have a targeted date?
DS: No official target date. There are so many factors to consider, and we have to follow all the Good Guidance Practice regulations that are in place. I review it; then I give my comments to our office of chief counsel; they make sure that nothing has changed and everything is on board legally. That's why it's really tough for me to give you an official answer, but I can say, personally, that I'd like to see it out before the middle of the year.

W&GT: Late spring, early summer?
DS: No official answer.

W&GT: This is like building a house!
DS: That's a very good analogy. There are just so many factors to consider that can change the move-in date.

W&GT: Will there be additional meetings to discuss the comments that have been submitted?
DS: Yes. We continue to meet with the industry, hosting discussions regarding air separation units, because that will involve a separate guidance. GAWDA is intricately involved in the process, and we are grateful for the association's representation.

W&GT: The FDA is in the process of finalizing its GMP guidance document, at the same time that Medicare is reducing payments. In fact, GAWDA distributors are dealing with a 20% reduction in Medicare reimbursement for oxygen. The manufacturer is being squeezed in the middle. Is the FDA paying attention to this issue, and have you given any thought as to how the GAWDA distributor should handle this?
DS: Wow. I was not aware of this, because the two agencies don't have discussions on this topic.

W&GT: I understand the need for compliance. And I understand the need to focus on cost. This is the dilemma.
DS: With regard to medical gases, I have had no communication with Medicare. The FDA is focused on the public health of the consumer, and Medicare is currently focused on reduction of costs. The two issues are mutually exclusive. The FDA doesn't get involved in any Medicare cost issues. We make sure that we are not over-exceeding our boundaries, and we don't want to institute excessive guidelines. That's not our goal. Our goal is to assure the consumer of getting a safe and good quality drug, and to not increase the cost to industry for fully complying with the GMPs.

W&GT: Do you think the two agencies will ever work together with regard to these issues?
DS: I don't like to say never. There is always the possibility.

W&GT: What do you think the phase-in period is for the guidance document, given a mid-2004 release?
DS: Once the document has cleared all of the hurdles and is published in the Federal Register as a final rule, it then becomes the agency's official guidance document.

W&GT: How quickly will FDA inspections utilize the document?
DS: I would say almost immediately. Everyone knows it's coming. The final rule means that the guidance is in place. Let me qualify that. Under the expiration dating and stability testing, there is going to be a communication and a dialogue between the agency and the industry on implementation time, because it can't be accomplished immediately. We will work with the industry in that area.

W&GT: Based on what inspectors are seeing, what should distributors focus on in the next couple of months?
DS: Their quality control unit.

W&GT: What's wrong with it?
DS: Usually, it's not defined. There are often no written procedures defining what the quality control unit is about and who is a part of that quality control unit. That's probably the most common violation.

W&GT: What's the second most common violation?
DS: The next most common violation after the quality control unit is inadequate training, specifically covering GMP regulations. Based on the actions we have taken and the warning letters, 99% cover these two violations.

W&GT: What makes a good quality control unit from your perspective?
DS: One that is well defined, has well written procedures, and has separate autonomy from the production side. A lot of people panic when I say that. We're not saying that they've got to actually have a complete separate unit that can't also function on the production side. We're just saying that they need to clearly understand that when they're wearing their QC hat, they are responsible for QC only.

W&GT: As we go forward in 2004, is there anything else the GAWDA distributor needs to focus on?
DS: We're finding that if the quality control unit is not acceptable, it permeates the entire operation. Look at your quality control, evaluate it, and upgrade it.

W&GT: In this edition of Welding & Gases Today, we are discussing the most troublesome challenges facing the distribution channel. What is your greatest challenge?
DS: Providing assurance that the industry is first aware of the guidance, once it becomes final, and second, to make sure that there is adequate training available to the industry.

W&GT: What's next on the FDA's horizon?
DS: Next on the agenda is to solidify the labeling requirements. We will have meetings again with CGA and eventually provide labeling in the form of a guidance.

W&GT: More regulations?
DS: No. But interestingly, the FDA often receives pleas for more regulations. I personally think that more regulations would hurt the gases and welding industry. Your industry is not stationery nor static. It's moving and still developing. We are not doing regulations for regulations' sake.

W&GT: Any final comments?
DS: After home-care companies, GAWDA members represent the next largest group in the supply chain. We recognize and are appreciative that GAWDA members are on board with the FDA through the work of the association and your consultants, particularly Bob Yeoman and Ron Ball. I'd like to reiterate how important that kind of access is, as a member benefit. The association is working hard to help members be in compliance, and it shows.