[Senate Hearing 113-]
[From the U.S. Government Publishing Office]
S. Hrg 113-867
PROTECTING SENIORS FROM MEDICATION LABELING MISTAKES
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HEARING
BEFORE THE
SPECIAL COMMITTEE ON AGING
UNITED STATES SENATE
ONE HUNDRED THIRTEENTH CONGRESS
FIRST SESSION
__________
WASHINGTON, DC
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DECEMBER 11, 2013
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Serial No. 113-13
Printed for the use of the Special Committee on Aging
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SPECIAL COMMITTEE ON AGING
BILL NELSON, Florida, Chairman
RON WYDEN, Oregon SUSAN M. COLLINS, Maine
ROBERT P. CASEY JR, Pennsylvania BOB CORKER, Tennessee
CLAIRE McCASKILL, Missouri ORRIN HATCH, Utah
SHELDON WHITEHOUSE, Rhode Island MARK KIRK, Illinois
KIRSTEN E. GILLIBRAND, New York DEAN HELLER, Nevada
JOE MANCHIN III, West Virginia JEFF FLAKE, Arizona
RICHARD BLUMENTHAL, Connecticut KELLY AYOTTE, New Hampshire
TAMMY BALDWIN, Wisconsin TIM SCOTT, Scott Carolina
JOE DONNELLY, Indiana TED CRUZ, Texas
ELIZABETH WARREN, Massachusetts
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Kim Lipsky, Majority Staff Director
Priscilla Hanley, Minority Staff Director
CONTENTS
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Page
Opening Statement of Chairman Bill Nelson........................ 1
Statement of Ranking Member Susan M. Collins..................... 2
Statement of Senator Kirsten E. Gillibrand....................... 3
PANEL OF WITNESSES
Janet Woodcock, MD, Director, Center for Drug Evaluation and
Research, U.S. Food and Drug Administration.................... 4
Doris Peter, Ph.D., Associate Director, Consumer Reports Health
Ratings Center................................................. 5
Richard Scholz, Jacobs Scholz and Associates, LLC................ 7
Gerald McEvoy, Pharm.D., Editor in Chief, AHFS Drug Information
and Consumer Medication Information, American Society of
Health-System Pharmacists...................................... 9
APPENDIX
Prepared Witness Statements and Questions for the Record
Janet Woodcock, MD, Director, Center for Drug Evaluation and
Research, U.S. Food and Drug Administration.................... 30
Questions submitted for Dr. Woodcock......................... 45
Doris Peter, Ph.D., Associate Director, Consumer Reports Health
Ratings Center................................................. 54
Richard Scholz, Jacobs Scholz and Associates, LLC................ 59
Gerald McEvoy, Pharm.D., Editor in Chief, AHFS Drug Information
and Consumer Medication Information, American Society of
Health-System Pharmacists...................................... 67
Additional Statements for the Record
National Association of Chain Drug Stores........................ 78
Ruth S. Day, Director, Associate Professor, Psychology and
Neuroscience, Medical Cognition Laboratory, and Senior Fellow,
Duke Center for the Study of Aging, Duke University............ 82
Kate Miller, constituent of Senator Gillibrand................... 85
PROTECTING SENIORS FROM MEDICATION LABELING MISTAKES
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WEDNESDAY, DECEMBER 11, 2013
U.S. Senate,
Special Committee on Aging,
Washington, DC.
The Committee met, pursuant to notice, at 3:48 p.m., in
Room 562, Dirksen Senate Office Building, Hon. Bill Nelson
presiding.
Present: Senators Nelson, Gillibrand, Warren and Collins.
OPENING STATEMENT OF SENATOR BILL NELSON, CHAIRMAN
The Chairman. Good afternoon.
I want to thank the witnesses.
This is a topic that is a true consumer protection issue.
It ensures--the issue is to ensure that every senior receives
the right information at the right time for every prescription.
I want to especially thank our colleague, Senator Kirsten
Gillibrand for bringing this issue to the Committee's attention
and for her many years of tireless work to try to ensure that
people are given the correct information that they need as they
consume prescription drugs.
Naturally, when we find out about this, all of us are
shocked.
Adding to that shock is the fact that, knowing my own
habits: I receive the prescription in a bag. It has got a label
on the outside. It may or may not have all kinds of papers on
the inside. And, if I really want to get into the detail, which
some of the providers need, there is another piece of
information that is about that thick, and it is wrapped around
the bottle.
And so, if you are like me, I get it from the drugstore; I
just rip open the bag, take out the little box, open the box
and take the medicine and stick it in my toiletries kit.
And, of course, there are four different patient leaflets
to say different things with one prescription.
That the one piece of information written for the consumer
for every drug--it has not been approved by the FDA--a simple
description.
So we are here to bring light in this Committee on what is
not working and to come up with recommendations on what can
work.
Consumer Reports surveys five different pharmacies and
finds that the information provided to consumers on the same
drug, in four of the five cases, omitted a warning that
violated an FDA violation.
And the strategy is less than optimal when the FDA says
that only 75 percent of patient medication--the information,
when actually provided to the patients, even meets the minimum
criteria for use--75 percent.
So the situation that we have here is unacceptable; it is
dangerous; it is not transparent, especially for seniors who,
as we know, have to take an awful lot of drugs at once.
And so we need to do better, and we are looking forward to
the course of this hearing, of having you all advise us how we
can make the process better.
Now our panel is star-studded.
We have Dr. Janet Woodcock. She is the Director of the
Center for Drug Evaluation and Research at the U.S. Food and
Drug Administration.
We have Dr. Doris Peter, the Associate Director for
Consumer Reports Health Rating Center.
We have Richard Scholz, an experienced pharmacist and a
litigator.
And then we will hear from Dr. Gerald McEvoy, the Editor in
Chief of the AHFS Drug Information and Consumer Medication
Information with the American Society of Health-Systems
Pharmacists.
I am going to turn the meeting over to my co-leader,
Senator Collins, and she is going to run the meeting until I
get back because there is a big colloquy going on, on the floor
of the Senate, that I tried to get started, but Senators can be
awfully long-winded----
[Laughter.]
The Chairman. [continuing]. On the floor of the Senate, and
I could not get a word in edgewise.
So I will go over there and make my statement and
immediately return. In the meantime, you will be in the tender,
loving care of Senator Collins.
OPENING STATEMENT OF SENATOR SUSAN M. COLLINS
Senator Collins. [Presiding.] Thank you, Mr. Chairman. I
promise to take good care of the gavel while you are gone.
I do very much appreciate the Chairman calling this hearing
to examine ways to ensure that the written information given to
patients with their prescription medications is clear,
accurate, easy to read and up-to-date.
In an ideal world, all patients would receive extensive
counseling about the risks, benefits and safe administration of
their prescription drugs from their physicians and pharmacists.
In the real world, however, these conversations are often
limited and sometimes nonexistent.
It is all too easy for us in the rush of everyday life not
to engage our health care providers about the details of the
medications that they are prescribing or to take the time at
the pharmacy for consultation with the pharmacist. As a
consequence, we often rely on the written information we
receive with our medications, either on the drug labels or in
package inserts.
Even when we have been counseled by our physician or
pharmacist, the written information can reinforce our knowledge
of our prescription medications.
Ensuring that patients have access to accurate, up-to-date
and consumer-friendly information is, therefore, an important
component of drug safety. This is particularly true for older
patients who may be taking multiple medications and who may be
experiencing vision or cognitive problems.
Most pharmacies send patients home with complex
instructions and warnings about their medications.
Unfortunately, too often, this literature simply is not helpful
enough. Patients may receive several different types of
information developed by different sources that may be
inconsistent and are often difficult to read and understand.
A 2008 FDA study found that while 94 percent of consumers
receive information leaflets with their new prescriptions, as
the Chairman pointed out, only 75 percent of these leaflets
meet even the minimum criteria for usefulness. It is no wonder
that the Institute of Medicine has identified poor labeling as
a critical source of the medication errors that injure at least
1.5 million Americans every year.
Improving the written information that accompanies
prescription drugs is one way that we can help to improve
patient safety.
My friend and colleague, Senator Gillibrand, has had a
longstanding interest in this issue since her days in the
House, and I want to recognize the fact that she suggested this
hearing to our Committee.
Again, I am grateful to the Chairman for calling this
hearing, and I look forward to hearing the testimony from our
panel of witnesses.
Before we do turn to our witnesses, however, I do want to
give Senator Gillibrand the opportunity to make any opening
remarks that she wishes to deliver.
OPENING STATEMENT OF SENATOR KIRSTEN E. GILLIBRAND
Senator Gillibrand. Thank you, Madam Chairwoman. I am so
grateful to you and Chairman Nelson for holding this hearing,
for your leadership on the Aging Committee and for your
steadfast resolve to really help our seniors. I really
appreciate it.
The issue before us is of grave concern to our seniors, to
our families, to families with children, and it is something
that all Americans have a right to know:
What is the medication I am taking?
What are the effects?
What are the side effects?
Can this medication be combined with other medications?
What the risks to my health?
And, if that information is not provided in a simple way
that is standardized and approved, for many, many people, that
information may be lacking. It may actually not be there, or it
may be limited in some way or inaccurate in some way. And that
is what really matters.
So I am extremely grateful for this hearing. As we will
hear today, the guidelines at the Department of Health and
Human Services in 1996 regarding the information that should be
provided to patients is very outdated. The FDA has been
studying how best to streamline this information that patients
received for the past five years.
But I am concerned that if FDA continues to provide only
guidelines and is not given new oversight authority over the
content of leaflets, we will continue to see patients struggle
with inadequate information or lack of understanding of all
they need to know for their drug regimes. It can lead to deadly
mistakes.
So I am grateful that we are looking at this issue. This
bill that I have drafted, that is one of the issues of today's
hearing, has been endorsed by the AARP and the Consumers Union,
who are both represented here today.
And I encourage them and other witnesses to help us
thoroughly understand this topic and suggest steps that we can
do and take to ensure that patients receive all the
scientifically accurate, up-to-date information that is
consistent for all identical or similar products.
Thank you very much.
Senator Collins. Dr. Woodcock, we are going to begin with
you if you would proceed, please.
STATEMENT OF JANET WOODCOCK, M.D., DIRECTOR, CENTER FOR DRUG
EVALUATION AND RESEARCH, U.S. FOOD AND DRUG ADMINISTRATION
Dr. Woodcock. Thank you, and I thank the members of this
Committee for having the hearing.
I am Janet Woodcock. I am the Director of the Center for
Drug Evaluation and Research at the FDA.
This is a very important issue to patients, as you have
already said, particularly seniors, and I really appreciate the
opportunity to discuss patient medication information and what
we are doing.
It is common practice in many, if not most, developed
countries to provide a leaflet containing patient-centric
information when a prescription is dispensed. And the FDA has
long tried to establish a similar system in the United States,
but these efforts have been thwarted for several decades by
various challenges.
Most recently, in the late 1990s, the agency was instructed
to evaluate the private sector's ability to provide such
information. Several evaluations, which were contracted out to
independent groups, showed that the information provided did
not meet key minimum criteria for things like legibility,
readability and so forth.
FDA presented these findings at a public advisory committee
meeting, and the FDA advisors recommended that the agency
explore other mechanisms to get this information patients and
that we collapse other existing mechanisms called Med Guides
and patient package information and so forth, prescribing
information, into a single leaflet.
Since that time, FDA has been conducting research on the
content and format of such patient medication information, or
PMI, and has held extensive stakeholder consultations, public
meetings and workshops. And we have learned, among other
things:
Number one, the standard format and content is very
important, similar to what has been adopted for food labels and
for OTC drugs. This standardization helps people navigate the
information and find out more easily what they want to know and
locate that in the information.
And, second, user testing is very important. Experts, by
definition, know too much, and they cannot predict what a
nonexpert--how a nonexpert will interpret certain information.
For example, use of a circle with a slash through it, that
was used over a symbol of a pregnant woman, to say do not use,
was taken by some people to mean the drug was a contraceptive
and, therefore--the drug was a teratogen, causing birth
defects. It should never be used by pregnant women.
As you can see, the experts and what they think consumers
will walk away with may not be true. We have to have consumer
testing, we think.
As a result of the research and stakeholder input, we plan
to institute rule-making about a patient medication information
leaflet.
I understand that there are additional issues that members
have raised. And some, including people testifying today, have
asserted that PMI should be the responsibility of a single
private entity to ensure uniformity.
We suggest that information about a manufacturer's product
is best produced and tested by that manufacturer. Certainly,
many pharmaceutical manufacturers may choose to contract out
the design and testing of patient information about their drug
to a third party. But, particularly in the early years after
approval of a drug, when there is a rapid pace of change around
information of safety and efficacy, the drug manufacturer is
the entity most up-to-date on these changes.
Finally, concern has been raised about the currency of the
physician package insert. That is what Senator Nelson was
referring to--the very thick document in there, which is for
prescribers.
FDA completed a regulation years ago, requiring a new
format for this document, but we were constrained by economic
considerations from dealing with inserts earlier than, I
believe, 2003, unless there was new clinical information
submitted.
And, as a result, all new labels have this new format, all
the physician-prescribing, but that is only 15 percent of all
labels that have been updated.
I am happy to tell you today that we now have in place a
program to update and maintain all drug labels. It is a big
project. It is going to take a while, but we have a contract in
place. We are conducting a pilot phase, and we have secured the
cooperation of a number of major manufacturers.
Obviously, the physician insert information is what PMI
will be based on, and it must be up-to-date if the patient
information is going to be meaningful.
In closing, I thank you for your interest in this issue
that is important to patients, particularly our senior citizens
who rely on medication to sustain their health, and I look
forward to the discussion.
Senator Collins. Thank you.
Dr. Peter.
STATEMENT OF DORIS PETER, PH.D., ASSOCIATE DIRECTOR, CONSUMER
REPORTS HEALTH RATINGS CENTER
Ms. Peter. Good afternoon. Thank you very much.
So I work at Consumer Reports, and I really appreciate the
chance to be here today to bring you the consumer's perspective
on how to improve prescription drug information that is given
to consumers, often referred to, as was here, that stuff
stapled to your bag when you leave the pharmacy, with the aim
to address the more than 1 million people who experience
preventable adverse events each year and the 100,000 people
over the age of 65 who are hospitalized each year.
So I bring you this from the perspective of: I am a mother
of three, also a caregiver of my mother, who recently died and
a consumer myself of this information, but also the perspective
of my work in this area through the Consumer Reports Best Buy
Drug Project.
It is a grant-funded project that has been going on for
about 10 years, where we provide millions of consumers with
free, unbiased, evidence-based comparisons of drugs, in terms
of their effectiveness, safety and cost. So we have a lot of
experience in designing this information for consumers.
So I am here to advocate a somewhat different point,
relating more to the actual content of the patient information,
and I am here to advocate that consumers can be provided with--
that they need to be provided with--the type of information in
the right format so they can make informed decisions. And that
is not possible today, and it is also not possible given the
current plans for patient medication information.
Consumer information about drugs has to be evidence-based,
patient-centered and transparent, and this is a chance for FDA
to make a big impact in the ability of consumers to participate
in their health care and play an active role in decision-
making.
So, specifically, consumers need--and there is proof they
can understand--quantitative information about the benefits and
risks of a drug. And, without that quantitative information,
consumers are not able to weigh those benefits and risks, and
determine whether the drug is the right choice for them or not.
So there is an evidence-based approach to present this
information, called the Drug Facts Box, and there is an example
in the testimony I submitted that has been developed by Drs.
Lisa Schwartz and Steve Woloshin. And it is a one-page table
that summarizes the benefits and harms for each use of a drug.
This approach has been carefully studied, including through
national randomized trials, and has shown that most consumers
can understand this information and that it improves decision-
making.
FDA, in their own work in this area, identified that
consumers are afraid of side effects, and that is the single
greatest deterrent from filling and taking prescription drugs.
But one of the reasons they are afraid of it is because it
is presented in a long list that does not put the benefits and
the harms in balance with each other. And that is what this
quantitative presentation can do. It can let them weigh that
information.
In addition, the results from FDA focus groups underscore
the point that consumers feel they want to be involved in this
process of weighing the benefits and harms. They do not want it
to be the physician that does it for them. They want to be
involved. The only way they can do that is if they have the
same information.
So withholding this information from consumers is not
transparent, and it does not allow them to participate in their
own decision-making of their care.
So, in relation to that, another piece of information that
is not currently presented in PMI is the dosing information--
standard dosing information--of the drug. This is really
important. The consumers need to know what the standard use is
and the standard way these drugs are used.
In a database that we collected of consumer-reported harm
related to drugs, 40 percent of the reports were related to
dosing errors alone.
And, in other countries, these usual dosages can be found
as part of the patient leaflets, but not the consumer medical
information that is here in the United States.
So I think we need to have a level playing field where
consumers know what this information is. They can use this to
alert the possibility of a prescribing error or possibly an
off-label use of a drug that may not be in their best interest.
So it is really important to have this content available.
Our third recommendation for going forward and developing a
new PMI is that the package insert not be used as the source of
the information for consumer information for all the same
reasons that were brought up before about the package inserts
containing errors and not being up-to-date and inconsistent.
It is interesting to hear that there is a process for
keeping the package inserts up-to-date, but the track record
shows there can be even decades before new safety information
gets into labels.
And we have our own case of a patient--one example, a
patient who took a medication in 2007, and 2003 was when the
safety information was known but not in the package label, and
the package labels were only updated in 2013. So that is the
reality right now.
The final recommendation is that manufacturers not author
PMI. FDA's own work in this area has shown that consumers
mistrust the pharmaceutical industry because they feel the
industry is more concerned with profits than with safety. To
ensure the generation of objective, unbiased PMI and ensure
consumer confidence and trust in the content, the PMI should be
delegated to an independent, unbiased third party other than
that of the drug manufacturers.
Thank you for your attention. I am happy to answer any
questions.
Senator Collins. Thank you.
Mr. Scholz.
STATEMENT OF RICHARD SCHOLZ, JACOBS SCHOLZ
AND ASSOCIATES, LLC
Mr. Scholz. Thank you, Madam Chairman, Senator Gillibrand.
We appreciate the opportunity to be here today.
I am Richard Scholz. I am a registered pharmacist and also
a member of the Florida bar and a practicing attorney, and I am
a managing member of Jacob Scholz and Associates, LLC.
I am here today to share with you some of my experiences
over 36 years as a pharmacist and being in the pharmacy
industry and being in the PBM industry, which is the industry
that acts as an intermediary between insurers and employer
groups as well as patients.
But I really come to you from a perspective as a pharmacist
and to share with you some of the experiences I have had
dealing with individuals who have struggled with their
medication management, as well as in the most vulnerable
population, which is our seniors, and it is because of their
multitude of health issues as well as the volume of
prescriptions that they have to consume to manage their health
care.
The perspective that I use is that--and I like to keep it
kind of simple because I am a simple farm boy. I grew up in
Ohio on a farm, and my mother still lives on the farm where I
grew up. She is 83 years old, and she struggles with this on a
regular basis.
I mean, she has to manage medications. Fortunately, she
calls me or whatever, and we can go through them. But other
people do not have that opportunity.
I want to try to impress upon you the myriad of information
that is going on out there, and the influences.
My mother is a patient. She is in the center of this
paradigm.
She has got the physician who is getting information from
the FDA through the package insert, which should always be
there with the medication at all times, also getting drug
manufacturers doing advertising to the physician. So that is a
source of information that skews that particular input.
That information from the physician trickles down to my
mother, occasionally, not always. Most of the time there is no
counseling at the physician's office when there is a
prescription issued.
Pharmacists, quite frankly, do not have time to counsel
and, quite often, do not take time.
There is no standard document that is given to her with her
prescriptions.
She gets information from her insurance company, who is
trying to influence her to change her medication because it
does not fit the formulary or it is on a three-tier formulary--
so, another influencer for these senior citizens trying to
balance all this information coming to them.
What they really need is they need unified, concise, FDA-
approved, manufacturer-printed, manufacturer-distributed,
pharmacy-dispensed--mandatory pharmacy-dispensed, like it is in
the EU--concise patient information so that they have a
fighting chance.
This document could be a reference document for all
patients, all seniors. This is a generation that grew up with
communicating on paper and verbal communication. They like to
take notes on things. It allows a reference document.
If we can get a proper PMI, it would be a wonderful
reference document so that when the senior goes back to the
physician, they could ask questions off of the reference
document.
The goal is to get a PMI that is in the marketplace with
every prescription. And, in the United States, the GAO report
that just came out said that there were 3.8 billion
prescriptions in the retail market dispensed in 2011. That is
3.8 billion opportunities to educate a patient on their health
care.
We have been on this track since 1979, when the patient
package insert initiative was proposed and then shelved in
1982. That is my entire career that this population has been
without this information.
And, quite frankly, we have had too many stakeholder
meetings, too many studies, too many of these things.
The only real stakeholder when my mother opens that bottle
in the morning and takes that medication is her, and that is
what we have to focus on here--getting this information to
every patient, about their medication, so that they can have a
full understanding.
They can be empowered with enough information to enter the
dialogue with heath care providers so that they can actually
empower them to improve their health.
In a moment, on the professional insert--very important for
me as a pharmacist. Throughout my career, anytime I needed
information, it was always written information accompanying the
product no matter where it was in the distribution system. That
is under siege today.
There is a--and I have it in your packet. In the record is
an OIRA packet on their dashboard. There is a proposed rule to
eliminate this, detach this, and have nothing with the package
other than this label.
And then, to have to go find this somewhere else, this
information--from a pharmacist's perspective, that is
catastrophic. Of those 3.8 million, this information is
accessed 12 times for every 1,000 prescriptions by pharmacists,
that they fill--to check that information to see if the dosage
is right, see if there is a contraindication.
Information that I would never propose to memorize, or
commit to memory, changes too fast. It is important to have it
here. That information is critical--that it never gets
decoupled from this distribution of the product.
Thank you.
Senator Collins. Thank you.
Dr. McEvoy.
STATEMENT OF GERALD McEVOY, PHARM.D., EDITOR IN CHIEF, AHFS
DRUG INFORMATION AND CONSUMER MEDICATION INFORMATION, AMERICAN
SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Mr. McEvoy. Good afternoon, Ranking Member Collins.
And I also want to thank Senator Gillibrand for her
leadership on this issue.
My name is Gerald McEvoy, and I serve as Assistant Vice
President of Drug Information for the American Society of
Health-System Pharmacists.
ASHP is the national not-for-profit professional and
scientific society representing over 42,000 pharmacists and
technicians who practice in hospitals and health systems.
ASHP has a nearly 40-year history of providing patients
with meaningful information about medication. Our patient
medication information is provided electronically, free of
charge to consumers, through the National Library of Medicine
and our own SafeMedication.com web site.
I am here today to provide ASHP's perspective on the issue
of patient medication information, or PMI.
It is critical that patients receive the necessary
information along with their prescription that will ensure
optimally safe and effective medication use. FDA has proposed
achieving this goal by putting manufacturers in charge of
authoring the patient information for each of their products.
Although we agree with the goal of streamlining and enhancing
the usefulness of PMI, we strongly disagree with FDA's plan.
The FDA approach fails to ensure that patients will receive
timely, accurate, consistent and impartial information. Under
their proposal, FDA would replace the existing system that
relies on independent publishers with manufacturer-authored
information. More than 800 manufacturers would be charged with
authoring PMI without any central editorial oversight.
First, we are concerned the FDA's proposal to allow
manufacturers to develop their own PMI will result in
inconsistent information across tens of thousands of drug
products, creating confusion and possible harm for patients.
There is no mechanism to ensure that PMI for identical products
would be identical or that similar information would be
included in every relevant medication within a drug class.
For example, Zocor's professional label first included a
warning about the increased risk of myopathy in patients of
Chinese descent in early 2010. Yet, almost four years later,
the label for some generic products still does not include this
critical risk information.
If a patient were switched from an innovator product to a
generic, or from a generic to another, what safeguards would be
in place to ensure the patient information is consistent
regardless of whose product the patient is taking?
Second, we have concerns with the timeliness in which this
information would be updated for all related products. FDA's
proposal to tie PMI to professional labeling is troubling due
to the lag times we currently see with respect to changes in
this labeling. Information that is critical to safe, effective
medication use must be made available to the patient as soon as
it is known and must be available consistently and at the same
time for all affected PMI.
For example, when Viagra was approved in 1998, the
professional label included an appropriate alert that it should
not be taken with a nitrate product, a potentially fatal
interaction. And, yet, almost 15 years later, we found that 29
of 30 nitroglycerin products still do not include the same
complete class-wide contraindication about Viagra and other ED
products in their professional labels.
Third, FDA maintains they lack the resources to review and
approve manufacturer-authored PMI. FDA claims approval is not
necessary because manufacturers will base their patient
information off of the FDA-approved professional label. Yet, as
I have described, this claim clearly is not valid.
Given these concerns, ASHP continues to urge FDA to
consider alternative models. ASHP believes that PMI developed
by a single entity is the best pathway to ensure that timely,
accurate PMI gets into the hands of patients to ensure safe,
effective medication use. FDA would be responsible for
developing the standards against which this PMI would be
judged.
We strongly support Senator Gillibrand's Cody Miller
Initiative for Safer Prescriptions Act, which would permit the
Secretary of HHS to pursue this alternative pathway.
As detailed in my written statement, FDA has never shown
that the current system of PMI authorship by independent
publishers has failed. Instead, FDA only has been able to show
that what patients receive at the point of dispensing failed
because of substantial downstream alteration of both the
content and format of PMI.
Notable in the 2008 final report is the finding that
independent publisher-authored PMI that was least altered at
the point of dispensing actually exceeded FDA's content
usefulness standards by over 20 percentage points. Thus, FDA is
focusing on addressing concerns with authorship quality that
simply do not exist.
Again, thank you for inviting me to testify today, and I,
too, am happy to address your questions.
The Chairman. [Presiding.] Thanks to all of you.
Senator Collins.
Senator Collins. Thank you, Mr. Chairman.
Mr. Scholz, I want to follow up on an issue that you raised
when you held up the bottle that had the prescription drug
information insert for providers and pharmacists attached to
it.
As you mentioned, the FDA is considering issuing a proposed
rule that would require just electronic information for
prescription drug products in lieu of these paper inserts,
including the one that you just demonstrated.
As the Chairman is well aware, when I was the Chairman of
the Homeland Security Committee and we did an in-depth
investigation into Hurricane Katrina, we learned during the
course of that investigation that there are times when
electronic technologies are simply not available, whether it is
due to temporary power outages or a catastrophic natural
disaster or terrorist attack.
In addition, as a representative of a largely rural state,
I know of many patients and health care providers that still
reside in areas that have limited access to the internet.
As a practicing pharmacist, do you think that such a switch
from paper to only electronic information would be in the best
interest of health care providers and their patients?
Mr. Scholz. Thank you, Senator Collins. Thank you for that
question.
Certainly, this is an area that I am very passionate about
because of the need to have this information available and have
it readily available.
You brought up several important factors, and that is when
the internet is not available and there would be a question
about the information that is in this packet and how it affects
that practitioner's decision as to how they dispense or whether
they dispense or what directions they give the patient
regarding this information.
That is clearly problematic in natural disasters.
It is clearly problematic in rural areas where there is
difficult internet reception.
Also, it is difficult for Department of Defense pharmacists
and health care professionals when they are in a forward
operating base that does not have that type of internet or they
are not able to use the internet based upon some security
issues.
So there are a number of different practice settings that
this information would be totally unavailable to those
practitioners at that time.
So that is incredibly important.
Then you go the next step, which is the fact that if you
look--and, unfortunately there is a lot--oftentimes, when we
look at health care policy, it is inside-the-Beltway thought
processes. And sometimes we have to go out and think of what
happens on the front line and outside the Beltway.
If you are a practicing pharmacist and you are working
really diligently to fill 400 or 500 prescriptions, sometimes
800 prescriptions a day, your focus is right medication, right
patient, right directions.
If something comes up as to a conflict or a question or a
dosage that you need to make an interpretation based upon the
fact that your patient has impaired renal function and this is
metabolized through the kidneys--those kinds of issues. That
information is here. It has always been here. It has been a
lifeline for pharmacists.
And the GAO, in 2006, when the FDA actually passed a rule
as to justify the financial significance of the rule, they
cited the fact that to increase the information that is in this
insert and increase the formatting, that would have significant
effect on adverse drug events and hospitalizations. We do not
disagree with that.
I think they were exactly right and this information needs
to be very robust; it needs to be available.
When you look at a normal pharmacy with a high volume, they
may have internet connectivity in their region, but from a
workflow standpoint, they are not out surfing the internet for
this information.
And there has been no study to my knowledge that has ever
determined--and again, if I go back to GAO and I go back to the
2006 FDA economic significant analysis for expanding this
professional insert, what we have is 12 times for every 1,000
prescriptions, this is accessed for information by the
pharmacist. That is a significant amount of inquiries into this
information that would not be available.
You cannot stop your workflow and go out and search the
internet to go get this because that internet--and these are
closed systems. They are closed operating systems, and they do
not actually go out and surf the internet because of obvious
HIPAA reasons and all the kinds of hacking reasons that would
go on.
So having this information readily available so I can turn
around, pick this up off the shelf and have this information is
absolutely critical.
Senator Collins. Thank you.
Dr. Woodcock, I am going to ask you whether the FDA is
still pursuing this idea in light of what Mr. Scholz has said.
The GAO also came out with a study in July that talked
about a number of disadvantages that could offset any potential
public health benefit of making that switch.
Dr. McEvoy, I have read, has this wonderful line when he
talks about that if you have the guide in print that it always
has power, it is immune from computer viruses and tampering, it
does not freeze, and you know it is from a reliable source.
What is the status of the proposed rule-making?
Dr. Woodcock. We are still pursuing it. Keep in mind this
is a proposal, and we would seek public comment.
I think, although I recognize people are very aligned with
what has happened, you know, over time and the way we have
always done things, I think we have to consider that sometime
in the future electronic information is going to be how we get
information. Actually, it is how many, many people get
information now.
These inserts cannot be changed rapidly. And we have had
situations where we have had new safety information, and the
insert that is out there, okay, is in paper, and it cannot be
rapidly revised. To modify that, we have to call all the
product back and change the information, which takes it then
out of the hands of patients and availability.
So there are liabilities to doing this. In addition, having
one of these inserts per every unit means that there are
millions of them produced for every product at a cost of over a
million dollars per product line to fold these up and stick
them into every package.
So there are tradeoffs here.
I understand the concern. We have discussed this for a long
time, about the desire to have written information available
for pharmacists.
So I think that is what will be discussed in the proposed
rule, and we will get comments from everyone about the
viability of this proposal at this point in time.
Senator Collins. Well, count me as one who thinks that it
is not a good idea.
And I also am concerned, as the Chairman and I were
discussing, if it extends to the patient insert, that there are
a lot of seniors who just do not use the internet, and that
would be a real problem as well.
But I think the many examples that Mr. Scholz gave,
including those of our soldiers in a forward operating base,
who may not, for security reasons, be able to get on the
internet. I think that is an excellent point.
So I hope that the FDA will not proceed. I think it would
lead--I understand your concern about updated information, but
surely, there is a more effective way to deal with that.
Dr. Woodcock. Well, there are also work-arounds for some of
the specific situations you have mentioned.
And, as far as patient information, we recognize that
different people want their information in different formats.
Some of the younger generation, as you well know, will throw
away a piece of paper, but they want to be able to swipe their
phone over 2D bar code and have the information available to
them.
So we would contemplate doing it both ways.
Senator Collins. Before I have to go back to the Chairman,
I would just respectfully suggest to you that if you did a
demographic study of who is taking prescription drugs, it is
far more likely to be an older person than a younger person,
particularly multiple medications.
Thank you.
The Chairman. In the last couple of years, I have had
occasion to go to that detailed pharmaceutical information
once.
And I have asked myself, as Susan and I have discussed
this, would I have gone--and I am computer-literate. Would I
have gone to the computer and tried to look this up? And I
think the answer would be no.
Now there are a lot of senior citizens, which is the
subject matter of this Committee--that we are trying to protect
their interest. So we want to have you consider--heavy
consideration--our concern.
Senator Gillibrand.
Senator Gillibrand. Thank you, Mr. Chairman, and thank you
again for holding this really important hearing. I am very
grateful.
To Dr. Peter, given your understanding of the needs for
drug information by consumers, what do you propose the FDA
should do in terms of proceeding in the development and testing
of patient medication information?
What would you propose--because we have heard several
concerns about, for example, not using the information from the
drug manufacturer, not using even the information from the
pamphlet that the FDA has approved because it can out of date.
What is your best recommendation?
Ms. Peter. Thank you, yes.
I think one of the key things is that there be attention to
some of the issues surrounding the evidence behind the content
itself, not just the format. There has been a lot of discussion
and testing of where things go, but I think there has been not
enough attention paid to the consumer needs for elements that
have not been presented in the PMI drafts from FDA.
So the first thing I would ask is that we go back to the
evidence base for what content, in terms of the specific
elements, consumers need and to show them all the possible
options of what could be in there because surveys of patients
in other countries, outside the United States, have shown that
consumers rank that dosing information just second to the
information about the intended uses of the drug.
So consumers need that other information that is there, but
the FDA testing and process had not, at least to my knowledge,
uncovered that yet.
We would also like the whole process to be more transparent
with a defined timeline. I was originally brought in to discuss
this back in 2010, now again in 2013, and nothing really--there
has not been much that has happened, and it was hard for us to
figure out what had happened in the interim--so, a very
transparent process with a defined timeline.
When it comes to the issue of, I already mentioned,
manufacturer authorship, that we would--based on our own
studies and those of others, the consumers do not trust the
manufacturers, and we would urge FDA to reconsider manufacturer
authoring of it.
And, finally, I do not know if this is even a possibility,
but many groups, including some Federal agencies, are including
consumers, not as stakeholders as a larger group, but as
consumers actually on the group that is working on the actual
medication information itself.
Senator Gillibrand. Who do you recommend should author it?
Ms. Peter. I would say a third party. I do not have an
individual group in mind.
But the manufacturer, for us----
Senator Gillibrand. Is there any group that is qualified to
do it?
Ms. Peter. I would guess there are. I mean, there are
currently other authors of this information now.
If the FDA has evidence-based standards to follow and those
standards have been developed in a proper way, then those
standards can be followed, I guess, by a number of
organizations.
We would not propose to be one of those groups. I think we
are an independent organization, but there are others that
could follow that--follow the standards.
Senator Gillibrand. Dr. Woodcock, could you comment a
little bit on some of the concerns that you have heard here
today?
Even the FDA has admitted in a quote in 2008 by John
Jenkins, the Director of the FDA's Office of New Drugs, who
said it is ``a false assumption that the FDA-approved labeling
is fully accurate and up-to-date . . . we know that many
current approved drug labels are out of date and in many cases
contain incorrect information.''
And we have heard that today through testimony.
If the professional labels are not accurate and up-to-date,
why would the FDA propose using those labels as the foundation
for the patient medication information?
Dr. Woodcock. Well, we think it is an unacceptable
situation that the professional labels are not up-to-date, and
as I said, we are launching an initiative that we have already
started to bring those labels into currency and maintain them
current.
I think it would be difficult to do patient medication
information without having a current label, a professional
label, to base it on because much of that information is highly
technical. And we want to translate it for the patient, but
drug interaction information and so forth is fairly technical,
whether there is a meaningful interaction or not.
So we do believe that the professional labels must be
updated. We have a new format, and many of the labels have
been--current new labels have been done in that format.
However, the older labels and many of the generic labels, as
some of the other panelists have alluded to, are not up-to-
date.
And Congress passed a user fee program for generics last
year, and this has provided us the resources to oversee this
industry more broadly.
Senator Gillibrand. Thank you.
I would also like to echo the concerns of Senator Collins,
that I do hope you maintain a focus on actually having a paper
pamphlet because for rural areas----
Dr. Woodcock. Certainly.
Senator Gillibrand. [continuing]. For the most at-risk, at-
need, who do not have access to computers, for those
communities, we have to make sure it is easily and readily
accessible.
Dr. Woodcock. For the patients, we want to provide it in a
format that they are going to use and that they most prefer. So
we totally agree with you there.
Senator Gillibrand. Thank you so much.
Thank you, Madam Chairwoman. Thank you, Mr. Chairman.
The Chairman. I want to ask you all to comment.
To make this a lot more simple for the consumer, can we get
a one-page other than your detailed pharmaceutical information?
Can this be boiled down to a one-page for the consumer to
understand the purpose of the drug, the dosage--well, they can
read their specific dosage by the doctor on the label, but--an
understanding of what are the caveats, what are the side
effects; such as, Dr. McEvoy, the example that you gave, don't
dare take any of the following products if you are taking this
drug, you gave of the nitrates?
Can we boil it down to a single page, Dr. Woodcock?
And then as you discuss that, can you also discuss--we are
in a world of generics. And I finally understand what a drug
is, and then I see the bottle of pills that I got is some long
name that I have never heard of, and then I have to go and do
my search to find out what it is in place of. So talk about
that, too.
Dr. Woodcock. Certainly. In our testing, consumers
overwhelmingly prefer a standardized, formatted, single-page
leaflet, okay, at least as the starting point, with the key
information, the kind of information you are talking about.
That is what they really want.
And people are used to the food label. You know where to
find whatever you are interested in--how many carbs, how much
fat. Whatever you want to know, you know where to find it in
the food label, all right.
The same with the OTC label that we have for OTC drugs--
there is a box you can look at.
So the consumers would really like that. The patients would
like that. And I believe that we can do that, all right.
And I agree; the generic names are very confusing. They are
technical. They are kind of made-up names for chemists to look
at. And we really need to explain to people kind of what they
are getting so that they can make sure they did not get the
wrong drug.
My husband came home last week with the wrong drug. He had
a Schedule II narcotic for some unknown reason put in his
prescription bag instead of what he was supposed to get.
So this happens all the time, and we need to help patients
guard against this.
The Chairman. What about Spanish-speaking consumers?
Dr. Woodcock. We are very sensitive to the language issues.
And we, for example, put our drug safety alerts out; we
translate them all into Spanish so that patients can have the
latest safety information.
I think that is one of the things we would have to talk
about--is language issues.
The Chairman. Many moons ago, when I was a young
Congressman, President Carter published a proposed regulation
regarding this kind of information.
And then President Reagan--the pharmaceutical convinced the
FDA that they could accomplish the same thing on a voluntary
basis, without a mandate, and the FDA withdrew the final
regulations. But that was 30 years ago, or more.
So you want to comment on that?
Dr. Woodcock. Well, as I said in my oral statement, we have
been thwarted for a long time. We have been trying for decades
to get a leaflet which most other countries have for their
patients and that is given to every patient when a prescription
is dispensed.
We did a test recently, in the last decade. Relatively
recently, we had an independent party test the quality of the
voluntary what has been provided, and we found that it has not
met the minimum standards.
Now, as was said by Dr. McEvoy, some of that is that the
pharmacies altered that in many ways after the information was
assembled, and that is a problem that we have to mutually
address--how do we get a leaflet handed out, right? How do we
make sure that happens, and it is not altered in different
ways?
The Chairman. What interaction do you have with patients as
you consider what you want to be labeled?
Dr. Woodcock. We have been doing a lot of research that
involves patients and what their preferences are and how they
interpret.
And what we have concluded is that each of these inserts,
or whatever you want to call them--leaflets--should have
consumer testing. That is sort of the best way to do this, to
test whether the information is in there and that the people
actually walk away with the right idea, with what we are trying
to communicate.
And social science has taught us that the best way to
figure that out is to test it because experts are very bad at
communicating information to nonexperts.
The Chairman. And, yet, you are talking about taking all
consumer information off the professional label; isn't that
what you are discussing?
Dr. Woodcock. What we are discussing is the following: A
proposal to have a single type of leaflet that is given to
every patient every time they fill--every time a prescription
is dispensed to a patient.
And you would--that would--right now, they get several
kinds of information.
They get this voluntary information that is often printed
on the white bag, that you were talking about, that people sort
of tear off and throw away.
They may get a Med Guide if there is a serious issue, which
is a long document that has some liabilities; that actually has
to be approved by the FDA.
And they may get patient information that is part of a drug
label, which we do for certain drugs where the consumer has to
understand how to use it.
So they may get any one of these types, or several types,
of information. That is very confusing.
And what the advisory committee and many other people have
recommended is that that be put into one leaflet, a single
document that people can expect.
The Chairman. Dr. McEvoy, when you write patient
medication, do you consult patients?
Mr. McEvoy. Do we consult patients?
The Chairman. Yes.
Mr. McEvoy. We have engaged. In fact, there is a piece of
active research that is going on now, evaluating the content of
patient information from a concision basis. And so, yes, it is
something that is periodically done.
We get feedback through the National Library of Medicine
itself directly from consumers about that information as well.
What we are proposing is that FDA actually have the
oversight for a new process but that that process not be run by
the manufacturers themselves, but that instead--just as Dr.
Woodcock has just mentioned, that they have a huge backlog of
outdated information.
And for generic drugs, for example, 90 percent of those
labels are older than 2001. And, yet, 80 percent of the drugs
that get dispensed are generic medications. And that was a
failure because the manufacturers did not voluntarily update
their information and put it into the format.
And the path that FDA has chosen to correct that is not to
go back to the manufacturers but to, instead, find a qualified
outside contractor to actually develop it.
So what we are suggesting is a similar path to be pursued,
to really create this information centrally. And we think that
the only way that you can address the issues that I have
described--inconsistency across labels, timeliness issues that
currently exist with those labels--is to have a centralized
process.
And we feel confident that if the FDA were to issue an RFP
that there would be a number of highly qualified organizations,
scientifically based and independent, who would step up and
actually respond to such a proposal.
And it is ASHP's belief that that is the preferred path as
opposed to having manufacturers author it independently.
The Chairman. Do you agree with that, Dr. Woodcock?
Dr. Woodcock. Well, let's think this through, all right.
It is true that we are doing a contract to get a version of
the other labels, but for us to regulate the package insert,
which is what Dr. McEvoy is talking about--that modified
package insert--the manufacturer must submit it to us. So there
has to be a step where the manufacturer adopts that as, or
modifies it as, their updated label, right.
Now what we are--as a result of our research, we think
there should be consumer testing of these labels. The actual
leaflet should have consumer testing to make sure that people
walk away with the right idea, okay; they do not have wrong
ideas about that specific label.
Now for FDA to do an RFP, that means we would pay for all
that testing, for every single label that would exist.
And, as far as I understand, for us to do any kind of
surveys or testing, we need to get a lot of clearances and
different things, as you are probably aware. So I think there
is difficulty in making that workable.
We believe that we should regulate these leaflets to ensure
that they are consistent, that they are consistent across
classes, that their format--and so forth, that they are
correct, that they are not promotional in nature, and so forth.
But it is unclear that we should be responsible for having all
that patient medication information generated.
The Chairman. In regulating this, you would include having
the correct, up-to-date information.
Dr. Woodcock. Absolutely. We----
The Chairman. What is your power? What is the stick of the
FDA to require the pharmaceutical companies to do that?
Dr. Woodcock. Well, as you know, clarity on our authorities
is always appreciated. As I said, we propose--we are
contemplating rule-making to establish this currently.
The Chairman. Senator Collins.
Senator Collins. Thank you, Mr. Chairman.
Dr. Peter, I am very intrigued by this drug facts sheet
that was included with your testimony because as a consumer, to
me, this is the kind of information that truly would be useful.
It is so clear--what is the drug for, who might consider taking
it, recommended monitoring, other things to consider, how long
it has been in use, then the comparison between the drug and a
sugar pill.
But I do not know what this drug facts paper comes from. Is
this something you are recommending as a patient insert? Is it
something that Consumer Reports does as part of its Best Buys?
Explain to me what this is.
Ms. Peter. Sure, definitely.
Senator Collins. I love it, but I do not know what it is.
Ms. Peter. Yes, we love it, too, and we cannot take credit
for developing it. Drs. Schwartz and Woloshin at Dartmouth
University developed the facts box.
We have been promoting it, and we have been working with
them to create more of them because they do not have the
funding to create them for all drugs.
So they have been thoroughly tested that consumers can
understand them and make better decisions.
And, believe it or not, you know, even physicians would
benefit from this because even the professional package insert
does not lay out the information in a way that even a physician
can weigh benefits and harms.
So I would--I mean, I would recommend it for both.
But for consumers, I would say this would go along with
additional information, like the dosing, administration, things
that are the standard information that is already part of the
PMI.
This helps with the decision-making part--should I take
this drug? Should I not take it? Am I experiencing a side
effect because of the drug? Am I not? What are the risks and
benefits?
So we see that it would go along with additional
information. It could be on the back side of a two-page
document or a one-page document, two-sided, if you are holding
to the one-page limit.
But I really think this helps patients. Patients are more
and more asked to participate in the decision-making, and this
is a tool that can help them do this. And it makes the
information transparent and available to them.
We have all this information. Why should they not have it?
Senator Collins. Thank you.
Dr. Woodcock, just one final question for you.
You mentioned that one reason the FDA is pursuing
electronic drug labeling is that it would allow a faster
turnaround if there is a new adverse consequence from the drug.
I do not know whether you are familiar with GAO's recent
study from the summer on electronic drug labeling, but the GAO
specifically addresses that issue and says that at least one
manufacturer said that they could provide revised labeling for
distribution within 24 hours.
The GAO also notes--and, goodness knows, I have found this
to be true of my own pharmacy--that pharmacies are not carrying
large inventories of drugs these days. They have moved more to
a just-in-time-inventory. So it is not like they are going to
have to replace a large quantity of drugs with new labeling.
GAO points out that it is much more likely that fewer drugs
are kept in stock at any one point of time as businesses
operate in a more just-in-time economy. So, with fewer drugs in
stock, it is possible that there are fewer drugs with out-of-
date labeling in circulation.
This seems to be contrary to, or at least answers, your
concern to some extent about the timeliness if we moved away
from the paper insert.
Dr. Woodcock. Well, first of all, I would say we have had
issues where a drug label out in circulation did not match a
new safety problem and people were very unhappy about that.
Second, FDA has tremendous experience with recalls and
trying to get a drug pulled, a certain drug out of circulation,
right.
And I do not know what the pharmaceutical company told the
GAO, right, but I know even with tainted Heparin, if you recall
that, we were still finding old Heparin that was contaminated
on crash carts, and so forth, months and months after everyone
knew that there was a problem with that Heparin.
So it is, by no means, trivial to extract those units out
of the drug supply. There is a long supply chain now with
intermediate, you know, suppliers and so forth.
So I understand your issue about the paper insert, and that
is heard.
Senator Collins. Well, I would suggest a tainted drug is
very different from a drug labeling issue. A tainted drug needs
to be recalled regardless of what the labeling has on it.
Dr. Woodcock. Sure. What I meant was there was a tremendous
effort to find that Heparin and get it out of the drug supply,
and we were not entirely successful.
Senator Collins. And I understand that, but that is
different from a labeling issue is my point.
Mr. Chairman, I have a few more questions, but I am going
to submit them for the record. And I thank you very much for
holding this very interesting hearing.
The Chairman. Thank you, Senator Collins, and as usual,
thank you for your excellent cooperation as the co-leader of
this Committee.
Dr. McEvoy, how frequently would you say that you see the
inaccuracies between labels of the same drug on two different
manufacturers?
Mr. McEvoy. I cannot give you a precise number. I have been
looking at labels for over 30 years in my capacity, and I can
tell you it is not uncommon occurrence.
I think where it is most common is across drug classes,
where relevant information that appears, let's say to every
statin, should appear.
We provided in our written testimony a study that looked
black box warnings, which are the most serious warnings, and it
took somewhere between 2 months and 14 years for some of those
black box warnings to appear on all affected products.
So, you know, it is not an insignificant problem.
The other area where it is common is in drug-drug
interactions, where the initial drug interaction will appear in
a given label, but the other drug with which it interacts is
not consistently updated.
We, as a publisher of drug information, then take it very
serious to harmonize the information and to harmonize it at the
same time. And what we are proposing is that FDA look at
alternative models that can accomplish that.
Dr. Woodcock believes that regulation through their
proposal is the only way to do that. We believe that FDA
actually could have far greater control through a contract
basis, where they establish specific metrics against which the
contractor would be judged for their work.
The requirements for testing--in terms of the
pharmaceutical industry, the overall cost of this is probably
far less if that money were tied into additional PDUFA funding
the next time that that is revisited than it is going to be for
the entire industry to do this independently.
All we are asking is that the agency sit down and talk to
people that have alterative models, that they be thoroughly
though through to see if, in fact, there are ways to accomplish
this because, at the end of the day, we do not want seniors to
be confused when they pick up a prescription this month, and
three months from now they get a generic version of that, and
the information that they receive is different because the
professional label for that manufacturer's product is
different. And that is our big concern.
The Chairman. If there were a simplified description of the
drug, like Senator Collins had shown here in this one for
Lunesta and showing it compared to taking a sugar pill, would
this have averted the disaster that Senator Gillibrand brought
up about Cody Miller?
Mr. McEvoy. I doubt that it would have because in the case
of the Cody Miller disaster, which is a very unfortunate one,
the information really had not emerged to a level to alert
people. If you look at when FDA actually issued their first
alert on that, it was some months after that particular
tragedy. So I am not sure that would have specifically avoided
that unfortunate situation.
But I think that the basis of what Senator Gillibrand is
focusing on, beyond that, is making sure that the information
gets into the hands of patients and their family members that
they care for as quickly as it becomes available.
And had that information been available and not been
available in the professional label upon which PMI was
developed, then it would have been an avoidable tragedy.
So, you know, I think that would not have necessarily
avoided it.
But I think that what that piece really shows is we need to
test. We need to determine what essential information the
patient needs, and we need to do that as the first.
And that is not the path that FDA has gone down. They have
made an assumption that one page is adequate. We do not know
that is the case. We do not know that it will contain all of
the essential information that a patient needs to safely and
effectively use that drug.
Dr. Woodcock mentioned the experience in Europe, for
example. And at one of their meetings at Brookings, they had
invited someone who is very active in creating labeling in
Europe. And he commented specifically on the prototype that FDA
had developed, that was limited to a single page, and looked at
what they had established in Europe through good consumer
testing as the required level of information the patients
needed for safe and effective use of their drugs, and that was
four or five pages.
So all we are saying is we want a science-driven process to
establish that information. We do agree that what is out there
now is far too long, but it is far too long because the
standards that created that have not been revised since 1996.
The Chairman. Senator Warren.
Senator Warren. Thank you very much, Mr. Chairman and
Ranking Member. As always, you put together terrific and
important hearings.
I want to apologize for being late. We are doing flood
insurance on the floor and have a Banking hearing going on
simultaneously.
But, when I was doing my homework for this hearing and
reading all the materials that we got together and reading your
testimony, I was struck by something I really wanted to come
here today to ask about.
I understand from reading all this that the FDA does
regulate drug information, but the trick is it is only for
doctors, not for patients, and that patient information, like
how to take a medication or the risks associated with the
medication, are left largely unregulated.
And so this made me think of the Consumer Financial
Protection Bureau, and it seems to me this is like saying that
what the Consumer Financial Protection Bureau should do is make
sure that mortgage brokers and credit lawyers understand the
terms and conditions of mortgages and credit cards but not so
much for making sure that consumers understand, when they are
signing on the dotted line, what it really means.
So what I came today to try to understand is why consumers
are not guaranteed the basic information they need to keep
themselves safe and to keep their families safe.
So here is where I want to start this. In 2010 alone, the
CDC found that over 15,000 people died from unintentional
prescription pharmaceutical drug overdose. Unintentional--which
means that some of them were not clear about how they should be
taking their medications.
Now certainly some of these cases result from prescription
drug abuse, but the FDA's own web site says that the
readability of the labels is a major problem, particularly for
older Americans.
Ten years ago, the FDA required over-the-counter
medications to contain a consumer-friendly label for exactly
this reason, but still, there is nothing in place for
prescription drugs, which are significantly more dangerous.
So, Dr. Woodcock, we have, so far as I know, only the one
study from 2010. But, is there anything particularly unusual
about 2010, or is it fair to assume that thousands and
thousands of people die every year from unintentional drug
overdoses?
Dr. Woodcock. I think that is fair. I do not think we know
the exact numbers, but it is fair to assume.
Senator Warren. Fair to assume, okay.
Is it safe to assume that better information would have
saved some of those people?
Dr. Woodcock. That is very likely.
Senator Warren. All right. So when does the FDA plan to use
its regulatory authority to implement effective, standardized
patient information for prescription drugs?
Dr. Woodcock. Well, we have tried, as I said in my oral
testimony, multiple times and have been thwarted, but we plan
to engage in rule-making soon and try again to establish a
patient leaflet that would be dispensed with every prescription
given to a patient in the United States.
Senator Warren. I am glad to hear that you want to aim in
that direction, but I really am asking a when question. What is
your timeline for when we are going to get these
identifications, this information, into the hands of consumers?
Dr. Woodcock. Well, putting in place regulations in time-
consuming----
Senator Warren. Yes.
Dr. Woodcock. [continuing]. And is frustrating. So it
usually take a number of years for us to get a regulation in
place if we are successful.
And, as you probably read, we have tried multiple times to
do this and have been thwarted in our efforts. So we plan to
try again.
We have done quite a bit of research. We think it is
necessary. Other countries have this. And we think it would be
very desirable for the patients.
Senator Warren. So, Dr. Woodcock, I actually--remember, I
actually worked at one of these regulatory agencies and got
this process started.
So let me ask it in smaller pieces. When are you starting
the regulatory process? When are you going to put it in place?
Dr. Woodcock. We have had a Part 15 hearing. We have done a
lot of research. You know, we have to have a lot of supporting
information and documentation when we do put a rule forward.
So I cannot tell you when FDA will put that rule forward,
but that is what we plan to do.
Senator Warren. I do not want to hear the plan that you are
going to start this. Is the plan--have you already started?
Dr. Woodcock. We have started writing the rule-making, but
we----
Senator Warren. Has the rule-making process started?
Dr. Woodcock. It depends what you mean by the rule.
We have not proposed a rule. No, there is no proposed rule
out there.
Senator Warren. So when do you plan to do that?
Dr. Woodcock. As quickly as we can.
Senator Warren. So you are telling me that this is going to
be a real priority for the FDA and that you are going to get
this rule through.
Maybe I should ask this another way. What is the fastest
you have ever gotten a rule through?
Dr. Woodcock. A few interim final rules on safety issues,
where Congress told us to do it, we got it in place maybe in
six months.
Senator Warren. So it can be done in six months if it
involves safety.
Dr. Woodcock. And congressional direction. Most of those
had congressional direction that we do it.
Senator Warren. Did the congressional direction give you
new authorities you did not otherwise have.
Dr. Woodcock. Sometimes, in some cases.
Senator Warren. Okay, but not in all cases. So you have the
authority to get the rules done.
Dr. Woodcock. Well, with most regulations, our authority is
always in question, as you know. And so that is one of the
issues that happens in rule-making--is questioning whether the
agency has the authority.
We regulate manufacturers, all right. And so one of the
issues is, can the pharmacies be required to give out this
information?
Senator Warren. Are you saying you have some doubt about
whether or not giving patients information that is effective,
about how they should take their medications, is within the
scope of the authority of the FDA?
Dr. Woodcock. I would say that certain parties would
express doubt about that and how----
Senator Warren. Well, I understand that is what litigation
is about.
Dr. Woodcock. That is right.
Senator Warren. But I also understand that the rule-making
process can go forward.
Dr. Woodcock. We regulate manufacturers. We do not regulate
the practice of a pharmacy.
Senator Warren. I understand that. I understand that, but
this is a question about getting the information out--safety to
the patients. That was right.
And you did this for over-the-counter drugs.
Dr. Woodcock. Well, we regulate those directly. The
manufacturers put that on the label. So we did do that.
Senator Warren. Good.
I just want to say on this one, Mr. Chairman and to all of
you, and particularly to the FDA, that if the FDA cannot commit
to get this done in a reasonable time, then it is time for
Congress to act. We are talking about a fundamental safety
issue here. And it seems to me that is the judgment call we are
going to have to make here.
The FDA has had a long time to do this and a lot of people
who have died in the meantime. It is time for us to do
something.
The Chairman. Well, I would suggest something we can do now
that it looks like we are going to get a budget and a top line.
The next process is the appropriations process. So let's visit
with the appropriators with regard to the formulation of their
appropriation for the FDA on language that would start this
regulatory effort.
Let's talk about that.
Senator Warren. Good, let's do.
Thank you, Mr. Chairman.
The Chairman. Okay. We want to thank all of you. This has
been most enlightening, and you have been an excellent panel.
Thank you very much.
The meeting is adjourned.
[Whereupon, at 5:09 p.m., the Committee was adjourned.]
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APPENDIX
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Prepared Witness Statements and Questions
for the Record
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[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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Additional Statements for the Record
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[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Statement From Kate Miller, Constituent of Senator Gillibrand
Hello, my name is Kate Miller. I would like to make a victim impact
statement in regards to a very important legislation, ``The Cody Miller
Initiative for Safer Prescriptions''.
On August 4, 2007, our only child Cody took his life by hanging
himself in an upstairs closet. This terrible tragedy could have been
prevented had we been informed consumers of the prescription drug,
Singulair.
This drug was prescribed to our child for allergies. I asked the
doctor the right questions. He said it was perfectly safe and would be
a better choice for our son. So I read all the material and did not see
any terrible things listed. I filled the prescription and started
dispensing the drug to my child. I will never stop regretting that
decision.
The doctor, the pharmacist, myself and my husband, were all unaware
that depression had been added to the labeling four months before it
was prescribed to our son. The new updates were not communicated to the
prescribing physicians and were not in our Consumer Medicines
Information (CMI) or the Patient Package Insert (PPI).
The people who did know about the updates were the FDA and the drug
manufacturer, Merck.
I can tell you as the mother of my child, I would never have given
him a drug with side effects of that nature for a seasonal allergy. At
the very least, I should have had all the information about possible
risks in order to make an informed decision. I would have known that my
child was having an adverse reaction to the drug. I and many other
consumers were denied that right.
After the early communication announcement, the FDA allowed the
drug company and their employees to be in the driver's seat on the
information highway. They used our dead and injured children like they
were speed bumps in the road to remarketing this drug. They veered
around the truth and watered down the side effects language.
I refer to this as `damage control'. Patients were told there were
no real dangers of these side effects, doctors were being kept in the
dark. This important issue was being downplayed, always going back to
the clinical trials, where to my knowledge, depression was seen and
should have been considered more thoughtfully in the initial labeling
of this drug.
There has to be a way of speeding up the notification process and
getting important information into the hands of the prescribers and
consumers. Patients are being treated for side effects that are
diagnosed as primary illnesses. This is a pattern we as an advocacy
outreach group have reported about Singulair. Prescribing physicians
are not being informed that these are updated side effects that have
been linked to a pattern of reports. Families have been through hell
and children are dying because of critical side effect information not
reaching key people in their treatment.
Our pediatrician and every pediatrician in that practice, had zero
information in regards to any reported neuropsychiatric side effects
being reported. These side effects have been reported to the FDA for
many years and it took this long to make it to the label. We believe
the lag in communication time was a direct contributor to our tragic
situation.
I work in a business where I encounter many elderly people. As we
all know they are usually on a great deal of medications. That being
said, I believe it would greatly benefit the elderly to have this
legislation in place as a consumer safety net. Many prescriptions are
refilled over and over again without the newly added side effects being
brought to the consumers attention.
The elderly consumer may experience side effects and not know or
realize they are in fact having adverse reactions to their medications.
This often leads to more tests and more medications.
If medication sheets were regulated by the FDA, people would be
continually updated on emerging side effects of medications they are
consuming. This is a fundamental right as a consumer, to be updated in
a timely manner, with accurate information about their prescriptions.
In the year 2006 the consumer medication sheet should have reached
95 percent accuracy as Congress had proposed. I believe with FDA
regulation it has the potential to reach 100 percent accuracy. It is
time to take big pharma out of the driver's seat and put safety back at
the wheel.
I can attest to the fact, that had the safety information made it
onto our sheet, I would be enjoying my family and watching our son
enjoy his senior year of college. I would not be imploring this panel
to do something that will greatly improve our health care system.
Please take this moment to think about your own loved ones and ask
``At What Cost Must Change Come''?
Thank You.
[all]