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  5. Panel VI - Presentations by Health Professional Groups, Prescription Drug User Fee Act Public Meeting November 14, 2005
  1. Prescription Drug User Fee Amendments

Panel VI - Presentations by Health Professional Groups, Prescription Drug User Fee Act Public Meeting November 14, 2005

Panel V - Presentations by Industry Groups

MS. HENDERSON: Back on the record.

MS. HENDERSON: I'm very pleased to welcome our next panel, which is the panel on health care professionals.

Our first speaker is Carol Redding Flamm, who is senior medical director in the Office of Clinical Affairs at the Blue Cross and Blue Shield Association. Dr. Flamm's responsibilities at the association include improving the safety and health outcomes of episodes of care experienced by Blue Cross and Blue Shield plan members through collaboration with the providers to whom their care is entrusted. She also manages the many quality-based Blue Cross and Blue Shield Association Network Initiatives.

Prior to work at the Association, Dr. Flamm was an instructor of radiology at Harvard Medical School, and also served as an associate in radiology in Beth Israel Hospital in Boston, Massachusetts. She received her medical degree from the University of Pennsylvania, and holds a master's degree in public health from Harvard.

So we are very pleased today to have Dr. Flamm.

DR. FLAMM: Thank you. I'm here on behalf of the Blue Cross/Blue Shield Association, representing the 39 independent plans ensuring more than 93 million people, nearly one in three Americans. And we thank you for this opportunity to comment on PDUFA reauthorization.

In our brief comments today we're going to be looking at PDUFA's impact on safety primarily, and offering some recommendations to further strengthen and improve PDUFA.

In 2001, Blue Cross/Blue Shield Association recommended expanding PDUFA user fees, and increasing activities to include post-marketing surveillance. And with the reauthorization in 2002, PDUFA was expanded to include drug safety functions, specifically looking at monitoring adverse events, and disclosing Phase IV studies.


In keeping with some of the comments that others have made today, we would also emphasize that safety should be integrated into delivering new drugs. There is the concern that faster drug approvals mean potential side effects and interactions are often not known at the time of market entry. This is important because adverse drug events cause 770,000 injuries and deaths each year, and we are firm in our belief that voluntary reporting of adverse event rates is not adequate.


Looking at where the money is spent in CDER's budget, 47 percent of CDER's budget comes from PDUFA fees. And the Office of Drug Safety gets 6 percent of CDER's budget.

The cross horizontal marks are PDUFA fees, and these are appropriation fees, and this down here is the Office of Drug Safety. So you can see that about 33 percent of the Office of Drug Safety fees come from PDUFA fees.


In terms of Blue Cross/Blue Shield's recommendations for safety, we would suggest keeping the emphasis on PDUFA's drug safety functions, and devoting additional PDUFA funds to the Office of Drug Safety. For example, shifting the relative proportion of PDUFA fees that CDER has in its budget from 47 percent, shifting the Drug Safety proportion from 33 percent up to 47 percent, and keeping that parallel would be one recommendation that would provide $7 million additional dollars.


We would also recommend to further strengthen and improve PDUFA in two ways by offering that PDUFA increase its role ensuring comparative information, as was mentioned by several other speakers earlier today. And we would suggest that it include monitoring of direct-to-consumer advertising activities and compliance.


There is a lack of comparative information in what consumers have available when drugs are available on the market. Consumers need information on relative costs, benefits and risks of new drugs that replace existing therapies, and the FDA should require manufacturers to provide this comparative information. Just as two examples, common conditions, asthma and diabetes, there are gaps in the knowledge that is necessary for patients to make decisions.

More information about the relative value of various asthma treatment, in terms of symptom-free days, decrease in work days loss, and any decrease in the use of in-patient services--things that matter to patients--would be very important.

And in diabetes, little is known about the effectiveness of new diabetes drugs compared to older therapies, in terms of their ability to reduce the long-term morbidity of that disease.


In terms of direct-to-consumer advertising oversight, lots of money is spent on this type of advertising: $2.7 billion in 2001; $3.2 billion in 2003. And today's DTCA spending is estimated to be $4.2 billion.


The FDA's Division of Drug Marketing, Advertising and Communications--DDMAC--is responsible for reviewing DTCA. This division employs 39 people, of which five are dedicated to reviewing DTCA; and the total budget is $5.5 million. We would suggest that you consider extending PDUFA funding to DTCA review, as well.


In summary, PDUFA has a very important role to play in improving safety, and our recommendations include increasing the percentage of PDUFA fees that should go to the Office of Drug Safety for post-marketing activities. PDUFA should ensure consumers get comparative information; and that PDUFA should be expanded to direct-to-consumer advertising monitoring as well.

Thank you.

MS. HENDERSON: Thank you very much, Dr. Flamm.

Our next speaker is Judith A. Cahill. As executive director of the Academy of Managed Care Pharmacy, Judy Cahill has responsibility for policy creation and implementation, administrative operations, and overall staff leadership of the Academy of Managed Care Pharmacy. The Academy is a professional society wit over 4,800 members nationwide which is dedicated to the continuing professional development of pharmacists and other health care practitioners engaged in the practice of pharmacy in managed care settings.

Ms. Cahill holds a bachelor of arts degree from LeMoyne College, a master of arts degree from the University of Cincinnati, and certification as an employee benefits specialist from the Wharton School of Business.

Take it away, Judy Cahill.

MS. CAHILL: Thank you very much. On behalf of the Academy of Managed Care Pharmacy I'm please to be here today, and to have the opportunity to present our views on at least one aspect of PDUFA renewal.

Let me explain to you the basis from which I speak: and that is from the organization that I represent, the Academy of Managed Care Pharmacy.


We are a professional society for pharmacists who have chosen to practice their profession by the application of managed care principles. We have individual pharmacists and health care practitioners in our membership who are dedicated to getting the appropriate drug to the appropriate person in a way that is affordable and accessible.

We apply those managed care principles in that endeavor in order to ensure that the quality of care that patients need from managed care organizations are extended to them.

And it is in that light that we are very concerned about the post-market surveillance activities that the agency can engage in. We have approximately 4,800 members nationwide. They in turn, because of the system they work for, service 200 million Americans.


I won't waste time on this because we've heard it several times today, about the aspects of PDUFA 2002 that did provide real benefits to the whole area of getting appropriate medicines to patients. But I do want to bring to your attention the last point on this slide, and that is that the 2002 renewal did little to address post-market surveillance. There were hours that were set aside for peri-surveillance, but those were only for the early years of usage of a drug in the marketplace. And we believe, within the Academy, that there needs to be more thorough, more comprehensive post-market surveillance.

Because we are firmly dedicated to the idea that when you look at populations you're able to draw conclusions that are not obvious from smaller studies, and that are now obvious by anecdotal, one-on-one patient encounters with drugs, there needs to be a thorough ongoing collection and review of data related to problems associated with a drug's use to determine if the drug can continue to be marketed with its original restrictions; if those marketing requirements need to be changed; or if the drug indeed needs to be removed from the marketplace for the safety of the population.


We support epidemiological studies that demonstrate the safety and effectiveness of medications when prescribed in the real world of the general population. Although randomized clinical trials can be used, and can be effective in rather narrow parameters, it is because of those narrow parameters that we favor the epidemiological studies. There you can look at patients who are using the drug, who have co-morbidities, who are taking multiple medications, and who are being prescribed drugs that are for not-indicated uses.

Because of the variety that epidemiological studies offer in the general population, we believe they are a better indicator of what happens when a drug moves to post-approval status.


We believe there's a shared responsibility for post-market surveillance. And I would put before you that there are three major players when it comes to post-market surveillance. There is the manufacturing community. There is the practitioner community. And there is the FDA.


Manufacturers of medications have the same obligation as manufacturers of any product that is put before the consumer, and that is: responsibility over the life-cycle of the drug. And we would suggest that post-market surveillance is an area of manufacturer responsibility that--as we have heard before, earlier today--is not often completed. We would encourage that that change. Practitioners have an obligation to report adverse drug events. And we've heard again today that that happens rarely. When it does happen, the Agency is not properly staffed or funded to be able to follow through on many of those ADRs that are reported.


The Agency itself, in its fundamental goal of promoting and protecting the public health by determining a drug or biologic's safety and effectiveness based on clinical research is at the heart of what we are talking about in both pre-, peri-, and post- surveillance. We, of course, know that FDA approval does not mean that a product is risk-free. There is no opportunity to be able to fully, effectively compare risks and benefits of a given product. But it is in the wisdom of the approval process that we are able to say, with at least some degree of certainty, that the benefits do outweigh the risks. Problems associated with drug use often only appear after several years of use in the general population.


FDA is in a unique position to aggregate data on what happens to the use of a drug in the general population. Post-market surveillance provides expanded data on what actually are the results of using a medication that can go to educate practitioners on minimizing risks for patients that they are prescribing medications for, and they can go to educating prescribers on the most appropriate use of drugs.


There are changes that are definitely needed. FDA's authority to monitor a drug after approval is limited. We heard statistics earlier today that only 12 percent of the Phase IV studies that are requested by the Agency are actually completed. Not a good track record.

FDA needs the authority to enforce the requests that they make for Phase IV studies. The suggestion that was made by a presenter earlier today that those Phase IV studies be the result of collaboration amongst stakeholders of many sorts I think is an excellent idea, and one that, should we be successful in getting funding for post-market surveillance in a meaningful way, will produce the guidelines that we need in order to be effective for the patient populations we serve.


We want to congratulate CDER on its recent award to managed care organizations with large data bases contracts that will allow those data bases to be mined, to see the interaction of health care encounters, and the medications the patients are on. We believe this will provide a rich trove of information that has not been available before this, and applaud CDER for the action in this area.


We do see the need for legislative change with regard to post-market surveillance, and would hope that this would happen prior to PDUFA renewal but, if not, certainly as a part of PDUFA renewal.

The Academy has been on Capitol Hill championing these two specific points, and that is: giving the Agency the authority to require post-market studies, and then funding the Agency to the extent that they will be able to enforce those studies.

I thank you for your time and attention today.

MS. HENDERSON: Thank you very much, Ms. Cahill.

Next on the panel is Susan Winckler. Susan Winckler is the vice president for Policy and Communications, and staff counsel for the American Pharmacists Association, the first established and largest national processional society of pharmacists, headquartered in Washington, D.C.. In that capacity she is responsible for coordinating the association's legislative, regulatory and private-sector advocacy agenda and communication programs.

Ms. Winckler serves as the primary spokespersons for the association for media interviews, and is the senior lobbyist for the association on Capitol Hill. In 12 years with APHA, she has served the profession in various capacities, including group Director of Policy and Advocacy, and Director of Practice Affairs.

Ms. Winckler is a graduate of the University of Iowa College of Pharmacy, and the Georgetown University Law Center.

Please join me in welcoming Susan Winckler.

MS. WINCKLER: Good afternoon. And on behalf of APHA, thank you for the opportunity to be here this afternoon.


To provide a baseline of where our comments are coming from, APHA, the American Pharmacists Association, represents pharmacists and all practice settings, whether in the community environment, the hospital, managed care, or any environment where folks with our education choose to practice.

We have more than 53,000 members, and are particularly interested in today's topic as we consider the FDA processes and the information that's available from those processes as funded by PDUFA, and how it affects the health care system, and how pharmacists help patients make those medications work.

We have two primary comments today: to assess the PDUFA performance; and then to comment about expanding the scope.


When we look at PDUFA performance and whether we have met the original goals--I think, as you've heard throughout the day, probably have no surprises from this panel--the fee-for-service model kind of set out by PDUFA has yielded more timely and predictable reviews. And for those drugs that meet the approval standards, they are getting to patients faster.

A question I think we must always raise when we talk about renewal of PDUFA, however, is that PDUFA does not replace the need for appropriations, and the understanding that we must continue to have Federal investment in this essential infrastructure in order for our health care system to continue to function.

We should also continue to have allocation for drug safety post-approval--and that's a piece that I'll talk about as we talk about expanding the scope--and understand, generally--and this hasn't happened with the Agency--but we should always keep an eye on the need for a focus on speed not distracting from our focus on quality. That hasn't yet happened. But likely the best way to keep that from happening is to keep in our minds that we want to make sure that it doesn't.


When we consider expanding the score of PDUFA there's two specific places that APHA recommends consideration. In collaboration, let's talk about expanding the post-marketing surveillance and the focus on safety, to consider the reality that safety of prescription drugs, there are three issues that come about.

We have challenges with the safety of prescription drugs when those drugs have risks that we don't know about. And so post-market surveillance and all of that work that helps us identify those risks is essential.

We also have problems with medications when we have the risks identified, but we don't do a good job of managing those risks. And so we need to do a better job of a systems-based approach to that risk management.

But there's a third area where we have problems with medications that often gets overlooked in this discussion, and it is a safety problem. And that's where we have benefits of medications, benefits where a certain patient population should be taking these products but they aren't because we don't have good dissemination of the information that we've learned in this post-market surveillance. And that's a piece that I'm not sure I've heard mentioned enough today. It's something that we need to consider. When we talk about "safety," it's not just risks, but it's making sure that people who could benefit from the medications, that those benefits also get into the literature and, more importantly, into health care practice.

When we talk specifically about risk management, there's a constant call from pharmacists in practice to see a more systems-based approach to the very formal risk management systems that address products like thalidomide, lotrinex, and other products where we have had a specific risk identified, and are instituting a very rigorous risk-management program.

And recommendations that would help health care practitioners deal with those are having a means test to determine when a rigorous risk-management system is necessary.

Part of the challenge here is you may have a new drug coming to market where a specific risk is identified, and so a formal risk-management system is instituted, but there's a drug that's already on the market that has the same risks and is not subject to the risk management system. So we do a very good job with the new drug, not such a good job with the existing drug, and may end up having clinical problems resulting from that.

To use standard tools to address similar risks: if we know that the risk with a protect is fetal exposure, do we have similar tools to address the risk of fetal exposure with thalidomide as we do with isotretinoin. And the Agency has made great progress in this area with the new isotretinoin program. We hope we'll see, as it goes live soon, where we now have some consistency among those tools to try and address that risk. But we must continue to make that Agency-wide and incorporate it better into the health care system.

We also need to do a better job in post-marketing surveillance of those risk-management programs. And so when we put those programs into place, what is the effect of those programs, and of those interventions, and are we truly managing the risks that we know about.

And, finally, that those systems work best when we have voluntary participation of health care professionals, rather than designating certain health care professionals who should work with certain products. If you limit the number of health care professionals who work with certain products, you likely limit the patient access to those products. So you may minimize the risk, because you have fewer people using them, but you're not necessarily minimizing the risk in the right way, if people who should have access to those medications don't.

To summarize: what we call for is just a better collaboration, which we have seen in previous PDUFA renewals but need to continue to see in this cycle; collaboration between the Agency, health care professionals, consumer and the industry to make sure that we get the right medications on the market, but then that we also have the tools and the information to make sure that those drugs are used correctly.

Thank you.

MS. HENDERSON: Thank you very much, Ms. Winckler.

Next, I'm pleased to introduce Dr. Allen Veda, who is the executive director of the Institute for Safe Medication Practices--the ISMP--in Huntingdon Valley, Pennsylvania. He previously served as Vice President of Clinical Operations at Mercy Suburban Hospital in Norristown, Pennsylvania.

Prior to his appointment as Vice President in 1995, Dr. Vaida held the positions of Director of Pharmacy, and then Assistant Vice President and Director of Pharmacy at Suburban General Hospital in Norristown, Pennsylvania.

Dr. Vaida has served as a trustee for ISMP from its incorporation in 1994, through his employment as executive director in the year 2000.

He received a bachelor of science in biology from the University of Scranton; a bachelor of science in pharmacy from the Philadelphia College of Pharmacy and Science; and a doctor of pharmacy degree from the University of Minnesota.

Dr. Vaida?

DR. VAIDA: Thank you. It is a pleasure to be here. What I'm going to do is just start, real briefly, for those of you that may not be familiar with our organization.


The Institute for Safe Medication Practices is an organization whose mission is to educate about system causes of errors; translate these errors into education; and to work closely although, as I mentioned before, independently with accrediting, regulatory, licensing, professional, manufacturers and government agencies, such as the FDA.


The crux of where we get our information is through the Medication Errors Reporting Program, which is operated by the United States Pharmacopeia in conjunction with ISMP. As you notice, USP and ISMP are FDA MedWatch partners, and that is the information we get in through this program we share with the FDA. And, in turn, through the Freedom of Information Act, we actually look at the medicationerrors that come through the FDA MedWatch program.

Now, you have my handout, and you're going to see an awful lot of pictures. And I'm going to go through some of these rapidly. And I'm not showing these to get down on manufacturers so much, or the FDA. But I just want to give you a view, through the eyes of ISMP where we still see some issues with names, labeling, packaging. And then just to sum up where we feel PDUFA funds should be reinstated, but that we do need some more emphasis on guidance documents for the manufacturers by the FDA.


There are still issues out there right now with name problems. We get in a lot of errors through our reporting program. And as you can see here there's Depo-Subq Provera 104 Depo. This is given sub-cu, this is given IM. You can see the names, the numbers in these.

The insulin products: Novologs.

Here is a brand new product we've already received five or six errors in, on this product: Omacor that has been mistaken for Amicar--especially verbally and written. This is something that's fairly new on the market.


Now, there have been some changes, actually voluntarily, by some pharmaceutical companies. We did have mixups between products Serazone and Seroquel. It was actually packaging changes.

Lamictal and Lamisil. It was packaging changes in this.


Zyprexa and Zyrtec: we still get a lot of mixups with that, although the company did do some packaging changes with this, and labeling changes.

And as I go through just with a couple of these, what I'm trying to build toward is: we do know a lot of these issues that are out there and should be changed. The FDA does have a list of close to 30 medications that they recommend tall-man lettering.


As you can see here: "hydrALAzine" compared to "hydrOXYzine."

This holds true, too, with some companies have come too, Cis platinol. There's also Carbo platinol, to try to differentiate these two oncology drugs that are serious mixups.

So we've heard a lot all day about safety, but basically what I'm talking about here is preventable adverse drug events: those cause by errors. The drug may be what we consider safe and efficacious, but if it's used wrong, if it's packaged inappropriately there could be problems with the drugs.


Here's a medication that's ben on the market, Cerebyx. If you notice here, the 50 mg per mL is prominent. This was involved in several medication errors and, in fact, several deaths. The packaging was changed, 100 mg. Because this was missed. So it shows here now: 100 mg in 2 mL. This is years ago.


Here was another product: oncology drug, 20 mg/mL, that had several errors because no one noticed it was a 5 mL bottle, and they thought it was only 20 mg. So it was changed. The company changed the labeling.


But then we wonder why this product is on the market: 100 mg/mL. This is after the labeling was changed on the other one. If you notice, it's a 2.5 mL vial. Ascorbic acid, 500 mg/mL, 50 mL vial.


Depo-Medrol, 80 mg, 80 mg. This is a 1 mL, this is a 5 mL. What have we really learned from those other issues?


And here, finally: 0.5, it's really 100 mL. These are package, marketing, why we need guidance documents with some of this funding.


The USP Advisory Panel recommendations for neuromuscular blockers, going back to '97. There are products that have "Warning: paralyzing agent" on this, but it's not across the board. And this is something that has been mixed up and is a fatal error.


Same NDCs for active drug and diluent issues out there.


We talk about dangerous abbreviations; not using trailing zeros. Here's packaging that has both: mics, that we've told them not to use the mu, and basically a 4.0--the trailing zero. In fact, there's a document now on the Library of Medicine that is actually on there for labeling etacrynic acid that actually has a trailing zero, and it doesn't have spacing between the strength and the units. That's actually up there.

Talking about never using abbreviations of drug names.


This is a combination product: HCT. It stands for hydrochlorothiazide. Years ago we reported on mixups between HCT being mistaken as "hydrocortisone," and hydrochlorothiazide.


Same thing here, what we see with advertising. We always recommend with the "QD" it always gets mixed up with QID.


And here's a product here--and, again, this is another recent product that's out. You're wondering, here's a product that's actually "mg/mL" is on the label, but it's dosed in micrograms, and it's administered in insulin units. This is actually for the patient--this piece here. You wonder: health professionals have a problem figuring this out; this is actually for the patient.


Cafcit--here's basically caffeine citrate injection. We've reported on this several times with the mixup with the oral solutions.


Packaging the same--and actually looking at Diprivan--propofol, which is basically an anesthetic, has been mixed up with fat solutions. It was actually almost mixed up with rodoglide. This is actually something to help insert catheters in the cath lab, these products.


Extended release suffixes, something the FDA was just involved in with the National Coordinating Council on Medication Error Reporting Programs, that actually took a look at suffixes, and the issues and problems that this causes.

I just have one up here: Cardizem, the diltiazem extended release. There's Cardizem CD, Caria XT, XR, and here's one with no suffix. These all stand for the same thing. This is just one. There's numerous products out there that you're trying to figure out why none of these are standardized.


Here's a product: Welbutrin SR. Sustained release? Here's generic: "extended release." This is the generic for this product. Not to get mixed up with Welbutrin XL, which is extended release, and is once a day.

So these are the type of things out there that we get reports in, and reports do come through the MedWatch program, too. But on packaging, labeling, things that we know.

I know that the FDA isn't really an authority over over-the-counter, but this is something else that I really think they have to take a real good look at to say: what could we do about some of the over-the-counter packaging and branding. I don't know if anything in the PDUFA could be used for something like that.


This is a recent change that we had promoted. These were Tylenol children's. You notice here it says, "Medication per dos 80 mg." But there actually was two tablets, so it was 160 mg. This has since been changed, this came out.


Maalox Regular, Maalox Total Stomach Relief. We got an error report in on this, actually from a pharmacist who recommended this to their grandfather. Told him to take Maalox. Grandfather called and had bloody stools.

If you notice--you can't read this up here--but this is our same great Maalox, how it's advertised. But if you turn it over, this product doesn't contain any Maalox. There isn't any Maalox. This is bismuth subsalicylate in this product. But this is what we're seeing more and more of with brand-name extensions in over-the-counter products.


Bisacodyl--Dulcolax stool softener.


Kaopectate, that we all know. Here's Kaopectate, 180 degrees: stool softener.

So these are the type of things that I think need to be addressed. And although we've had several series of this PDUFA funding, these things need guidance documents.


Finally, with preventable adverse drug reactions, this is something else that we should take a look at. We heard about the post-marketing surveillance which is so important.

This is something else: respiratory depression, use of fentanyl patches, PCA, patient-controlled analgesias; local reactions.

What we are seeing through our reporting program is we're starting to get some adverse drug reactions. And when we go in the hospitals, we see a lot of adverse drug reaction reports that actually really aren't adverse drug reactions. They're preventable adverse drug events. They're preventable ones. These are errors. These are basically not using the right doses of these fentanyl patches. It's picking the wrong patients. Using heating pads over the patch. This is using them inappropriately.

These aren't really what we would consider adverse drug reactions.


There is a need for guidance documents: proprietary name safety testing. Canada, just two weeks ago, came out with a guidance document for look-alike, sound-alike names.

Labeling requirements--concentration strengths, as I said; font size, use of colors.

Drug suffixes, to define and standardize.


We also need to have the FDA look at the information that it already has on the look-alike, sound-alike; a lot of the packaging that I've already shown you. We already know that is out there and it should be changed. Some of these things should be changed.

Mandate risk management programs for known safety issues. There are some drugs, there are some dosage forms that we know may be an issue. It doesn't mean that you have to keep those drugs off the market, but there should be some risk management programs in place.

They should also look to conduct some research. We don't have all the answers on the fonts and the colors and the use of tall-man lettering, and actually which ones should you use. We have come out with recommendations, and we've actually seen a decrease in some errors. But we don't have all the answers on that.


Communicate and work with independent organizations on post-marketing surveillance with the use of practical data sets; proactive monitoring.

Being to look at the preventable adverse drug reactions, as I mentioned about. This is something else that I think we really have to take a close look at.


And review some advertising by manufacturers to eliminate the dangerous abbreviations and other known safety concerns.

And to look at the brand-name extensions for OTCs, if there's any way that that could actually be addressed. Although right now it's basically under the FTC.

Thank you very much, Dr. Vaida.

And last on this panel is William Zellmer. Mr. Zellmer is deputy executive vice president of the American Society of Health System Pharmacists, a professional association that represents pharmacists that perform the full array of pharmacy functions in hospitals and health systems, including practice managers, front-line practitioners, and specialized clinical pharmacists who serve both in-patients and ambulatory patients.

He received his pharmacy education at the University of Wisconsin, and earned a master's of public health degree from Johns Hopkins University.

His responsibilities at ASHP include strategic planning, professional policy development, government affairs, public relations, and international affairs.

Please join me in welcoming Mr. Bill Zellmer.

MR. ZELLMER: Let me start by saying, with the name "Zellmer" I've had a lot of years of experience in sort of getting used to being last on the program. So I feel very comfortable in this spot this afternoon.

I think I'll start by telling you a little bit more about the perspective that I'm representing. The society I work for represents pharmacists who practice in hospitals and health systems. And their goal is to help prescribers, the institution and the patient make the best use of medicines.

And, given this mission, ASHP members are involved in the following types of activities: establishing drug use policies through the formulary system, by serving on pharmacy and therapeutics committees; providing drug information to physicians and nurses; managing drug product acquisition and drug product inventory; preparing drug products for administration to the patient, such as by being involved in an IV admixture service; and managing drug product distribution; providing front-line clinical pharmacy services, including reviewing medication orders before the first dose is administered; monitoring patients for response to therapy and adjusting therapy as authorized by the prescriber; and, finally, providing specialized clinical pharmacy services in areas such as intensive care, pediatrics, oncology and emergency care.

In short, ASHP members play a major role in fostering the safe and effective use of medicines in hospitals and health systems. And that's the perspective that I'm reflecting in my comments today.

Fundamentally, it seems to us that the FDA, as a major public health agency should be appropriated ample funds by Congress to achieve the full scope of its mission. In this way, the American public as a whole, through general tax dollars, will be supporting the vital work of the FDA, which benefits the entire population. I think in this regard we're aligned with the consumer groups who spoke earlier this afternoon.

However, we recognize that public policy has moved in another direction through PDUFA, and this is unlikely to change in the foreseeable future. So, given that political reality, we strongly encourage Congress to use the tool of users fees to expand FDA's focus on drug safetyissues.

PDUFA III addressed drug safety to some extent, but we would like to see the next reauthorization go much farther in this regard. Now our written comments from ASHP will expand on this point, but I'm going to limit my oral comments this afternoon to just one facet of what we have in mind here.

Specifically, I want to discuss ASHP's belief that user fees should be increased to support a research program that would have the following three goals; first of all, improved post-marketing safety regulation; secondly, answer important questions about the effect of marketing practices on medication use safety; and third, develop models of patient care that bring actual medication use into better alignment with medication safety information.

We were impressed by some of the ideas of Daniel Carpenter of Harvard University, who published an article last month in Health Affairs regarding allocating user fees to supporting a research program through the FDA. We like his suggestion that an FDA advisory panel should be charged with identifying the most important drug safety topics that merit research supported by user fees.

As stated by Carpenter, there are several ways that such research funds could be allocated. These include randomized controlled trials of widely used medications for chronic conditions; epidemiologic studies of post-marketing safety--Judy Cahill commented on that a few moments ago; and improvements in the FDA surveillance infrastructure. The results of these studies would be of immense value to pharmacists such as ASHP members in their efforts to foster the best use of medicines.

This past June, ASHP members in our house of delegates approved a policy position calling for an expansion of comparative clinical studies on the effectiveness and safety of marketed medications. There may be occasions when these studies should compare the effects of a particular medication with other medications or with medical devices, or with procedures to treat a particular disease. A research fund derived from user fees and administered by the FDA could be drawn upon to support these studies, perhaps as a supplement to similar studies that are being supported by the Agency for health care research and quality.

Some of the resources of the user fee research fund should be devoted to evaluation of the medication use safety implications of certain FDA policies and industry marketing practices. For example, consider the case of direct-to-consumer advertising of prescription medicines. Although such advertising has more than doubled over the past five years, there is very little objective information on the effect of such advertising on the appropriateness of medication use.

It would be consistent with FDA's public health mission for the Agency to commission research on this topic, and the funding could come from user fees that are allocated to research.

Finally, let me advocate that a portion of these research funds also be devoted to studying innovations in health care practice that may improve the safety of medication use. One of the big problems in health care is that insufficient attention is given to the evidence about how to use a medication safely. Susan Winckler talked about this just a little while ago in connection with her comments about a systems-based risk-management program.

The health policy community has largely ignored the prospect that my profession--the profession of pharmacy--could play a larger role in addressing this problem.

Consider the situation where it's well-established that a certain laboratory test must be performed periodically to ensure that the patient is not experiencing an adverse effect from the medication. It is easy to contemplate a system, using today's information technology, in which the pharmacy is a final check on whether that lab test has been performed. If the test has not been done, a computer assisted decision tree could guide the pharmacist through a number of options, ranging from a dialogue with the prescriber to a decision by the pharmacist to dispense only a few days' supply of medication until the necessary laboratory work has been completed and analyzed.

It will be consistent with FDA's public health mission to stimulate demonstration projects of this nature on practice innovations, and the funding could come from user fees that are allocated to research.

In conclusion, the reauthorization of PDUFA is an important opportunity for the United States to marshal resources to expand our knowledge about medication safety. Hospital and health system pharmacists urge Congress to expand the program in the direction I've discussed. Doing so will give pharmacists firmer ground on which to pursue their efforts to help patients, prescribers and health care institutions make the best use of medicines.

Thanks very much for having us here today.

MS. HENDERSON: Thank you very much, Dr. Zellmer. And than you to our panel.

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