[Senate Hearing 113-]
[From the U.S. Government Publishing Office]


                                                        S. Hrg 113-867

          PROTECTING SENIORS FROM MEDICATION LABELING MISTAKES

=======================================================================

                                 HEARING

                               BEFORE THE

                       SPECIAL COMMITTEE ON AGING

                          UNITED STATES SENATE

                    ONE HUNDRED THIRTEENTH CONGRESS


                             FIRST SESSION

                               __________

                             WASHINGTON, DC

                               __________

                           DECEMBER 11, 2013

                               __________

                           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

                              ---------- 
                              
                              
                  Kim Lipsky, Majority Staff Director
               Priscilla Hanley, Minority Staff Director
                                
                                CONTENTS

                              ----------                              


                                                                   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

                              ----------                              


                      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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                  Additional Statements for the Record

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     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.
  

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