[Congressional Record (Bound Edition), Volume 153 (2007), Part 7]
[Senate]
[Pages 9142-9145]
[From the U.S. Government Publishing Office, www.gpo.gov]




                              DRUG SAFETY

  Mr. GRASSLEY. Madam President, today I wanted to speak on an issue I 
speak on many times, drug safety. Today is a little different approach 
to it, though, because earlier today the Committee on Health, 
Education, Labor, and Pensions began marking up S. 1082, the Food and 
Drug Administration Revitalization Act. For the first time in almost a 
decade we have an opportunity to reform, to improve, and to reestablish 
the FDA as an institution committed to making patient safety as 
important as bringing new drugs to the market.
  S. 1082 presents a framework for the future of drug and device 
safety. I am gratified by some of its current contents and I express 
some disappointment about others. That is the purpose of my speaking to 
my colleagues.
  First, I am gratified the bill attempts to address some of the 
overarching issues plaguing the FDA that have been repeatedly revealed 
by the investigations I conducted of the FDA over the last 3 years. In 
particular, S. 1082 takes a number of steps to address the issue of 
transparency, the issue of accountability, and the issue of respect for 
the scientific process that has been lacking for some time at the FDA. 
S. 1082, for example, requires that within 30 days of approval, the 
action package for approval of a new drug must be posted on the FDA's 
Web site. This requirement, however, only applies to a drug with an 
active ingredient that has not been previously approved by the FDA. The 
action package would contain all documents generated by the FDA related 
to the review of a drug application, including a summary review of all 
conclusions and, among other things, any disagreements and how these 
disagreements were resolved. If a supervisor disagreed with the review, 
then the supervisor's opposing review would be available to the public. 
And to address the many allegations that the Food and Drug 
Administration safety reviewers are sometimes coerced into changing 
their findings, I greatly welcome the provision that states a 
scientific review of an application is considered the work of the 
reviewer and must not be changed by FDA managers or the reviewer once 
that review is final.
  The bill also takes steps to bring more resources to the FDA for drug 
safety, another matter I have been discussing for years. In addition, 
the bill requires the Food and Drug Administration's Drug Safety and 
Risk Management Advisory Committee to meet at least two times a year to 
address safety questions and to make recommendations regarding post-
market studies.
  I am also heartened to see that the bill incorporated several 
elements from the Dodd-Grassley bill entitled the Fair Access to 
Clinical Trials Act of 2007. S. 1082 ensures that the clinical trial 
registry includes trials of devices approved by the FDA. The bill 
requires a drug sponsor to certify at the time of the submission of a 
drug, biologics, or device application to the agency, that the sponsor 
has met all of the clinical trial registry requirements.
  Last but not least, S. 1082 attempts to give the Food and Drug 
Administration some teeth by requiring specific civil penalties, 
monetary penalties for submission of false certification, and false or 
misleading clinical trial information.
  These are, in my mind, some of the good things that are proposed in 
S. 1082. I wish to thank Chairman Kennedy and Ranking Member Enzi in 
this regard.
  I hope additions such as these, which strengthen S. 1082, will make 
it through the HELP Committee's vote as the committee considers further 
changes. As I said earlier, I am both gratified and disappointed by the 
contents of S. 1082.
  I turn now to some of what I consider to be lacking in the bill, that 
in my mind fails to address some of the issues that are critical to 
reestablishing the FDA's mission and putting John Q. Public and not 
PhRMA at the helm of the FDA.
  I commend the HELP Committee's attempt to ensure that the office 
responsible for post-market drug safety is involved in, among other 
things, decisions made regarding labeling and post-market studies by 
making specific references to that office throughout S. 1082. However, 
the bill does not address the outstanding critical problem that the 
office responsible for post-market drug safety lacks the independence, 
lacks the authority to promptly identify serious health risks and take 
necessary steps that will protect the public.
  As I think we all agree, the Federal Drug Administration is in 
desperate need of major overhaul. Over the past 3 years, my 
investigations have demonstrated that the depth and the breadth of the 
problems plaguing the FDA on both the drug and device side ought to 
stand out in everybody's mind as something Congress ought to be dealing 
with. Senator Dodd and I have written two bills that we believe will 
greatly enhance drug and device safety and improve transparency at the 
FDA and, most importantly, prevent another Vioxx debacle.
  The Federal Drug Administration's Safety Act of 2007 and the Fair 
Access to Clinical Trials Act of 2007 are intended to address some of 
the problems plaguing the FDA at its very core. Those are the bills 
that are the Grassley-Dodd bill and the other is a Dodd-Grassley bill.
  Let me be clear: Big PhRMA does not like these bills. FDA management 
does not like these bills. Lobbyists are spending hours upon hours 
lobbying against these bills. The Food and Drug Administration 
Revitalization Act does not embrace all the critical elements

[[Page 9143]]

of the Dodd-Grassley and the Grassley-Dodd bill.
  Let me ask each and every Member of the Senate the following: What is 
wrong with establishing a separate center within the FDA--not outside 
the FDA, within the FDA--with its only job being that of a watchdog for 
those drugs already in the market? What is wrong with supporting a 
group of committed FDA scientists who only watch for serious adverse 
effects that may pop up only occasionally, perhaps only 1 in 10,000 or 
1 in 20,000? What is wrong with ensuring that all clinical trial 
results, regardless of their outcome, are available to the scientific 
community, health care practitioners, and the public? What is wrong 
with supporting a clinical trial registry and results database that 
also requires sponsors to reveal their negative trials? And what is 
wrong with giving the FDA strong enforcement tools to combat bad 
players?
  I propose there is nothing wrong with any of these proposals, 
particularly the proposals that a new, separate, and independent center 
be created to address post-market surveillance, a proposal supported by 
Senator Dodd and me, not once but twice.
  I have heard the naysayers and the naysayers' many bogus arguments 
about why a new post-market drug safety center will not work. The 
arguments range from the absurd to the ridiculous.
  I will also address a few of those for you today. One argument is the 
creation of a separate center will slow down the drug approval process 
and delay much needed drugs from those who need them.
  This argument is, in plain English, a nonstarter. Why? Because this 
new center will be devoted to keeping an eye on drugs once they are 
already on the market, postmarketing surveillance.
  Another argument is that a new postmarket drug safety center will 
create an unmanageable bureaucracy at the FDA. That is a bogus 
argument. Why would taking an already existing office at the Food and 
Drug Administration, moving it on an organizational chart and providing 
it with new authority to watch for unknown and unexpected adverse 
events be bad? It does not make sense.
  These arguments at first blush made an impression on Dr. Steven 
Nissen, chair of the Department of Cardiovascular Medicine at Cleveland 
Clinic and immediate past president of the American College of 
Cardiology, who was not an original supporter of establishing a 
separate center within the FDA to address postmarketing surveillance.
  But, over time, his views have changed. Dr. Nissen probed more, 
evaluated the facts more, and as he talked more to on-the-ground FDA 
staff members, Dr. Nissen changed his mind and told the American public 
so.
  Dr. Nissen recently sent me a letter stating that not only does he 
support the Fair Access to Clinical Trials Act but also the Food and 
Drug Administration Safety Act. In other words, Dr. Nissen said:

       In particular, I support the creation of a new independent 
     center within the FDA called the Center for Post-Market 
     Evaluation and Research for drugs and biologics. Although I 
     had previously expressed some concern about creating this 
     center, I have become convinced that the separation of post-
     market surveillance from the Office of New Drugs represents 
     the best opportunity to improve the performance of the FDA in 
     handling drug safety issues.

  I ask unanimous consent to have that letter printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                             Cleveland Clinic,

                                    Cleveland, OH, March 29, 2007.
     Hon. Charles E. Grassley,
     U.S. Senate,
     Washington, DC.
       Dear Senator Grassley: I share your concern about the need 
     for a significant overhaul of the Food and Drug 
     Administration to improve drug safety. Over the last several 
     years, we have endured a series of disturbing revelations 
     about the lack of vigilance by the FDA in monitoring drugs 
     following approval. I have reviewed the two Bills that you 
     and Senator Dodd introduced, the Food & Drug Administration 
     Safety Act of 2007 and the Fair Access to Clinical Act of 
     2007. I strongly support the passage of both of these Acts 
     and believe that they will help protect the public health.
       In particular, I support the creation of a new and 
     independent center within the FDA called the Center for Post-
     Market Evaluation and Research for drugs and biologics 
     (CPER). Although I had previously expressed some concern 
     about creating this center, I have become convinced that the 
     separation of postmarket surveillance from the Office of New 
     Drugs represents the best opportunity to improve the 
     performance of the FDA in handling drug safety issues.
       Finally, I want to thank you and Senator Dodd for your 
     tireless efforts to promote public health through aggressive 
     oversight of the Food and Drug Administration. Your 
     leadership in this vital area has been invaluable and all of 
     the 300 million Americans who rely upon drugs to protect 
     their health are grateful for your steadfast efforts.
       The views expressed in this letter are my own personal 
     opinion and do not necessarily reflect the official views of 
     my employer or the American College of Cardiology.
           Sincerely,
     Steven E. Nissen, M.D.,
       Chairman, Department of Cardiovascular Medicine, Cleveland 
     Clinic, Immediate Past President, American College of 
     Cardiology.

  Mr. GRASSLEY. Coupled with Dr. Nissen's letter of support, I also 
received a letter from Dr. Curt Furberg, professor of public health 
science at Wake Forest University School of Medicine. Dr. Furberg is 
not only a professor of medicine, but he is also a member of the Food 
and Drug Administration Drug Safety and Risk Management Advisory 
Committee.
  Dr. Furberg knows the FDA from the inside, and you might say he knows 
it inside-outside, in and out. In fact, even Dr. Furberg has written me 
to say he is supportive of creating a new center, and he is 
particularly supportive of creating a new enforcement tool to be used 
against bad players in the drug industry.
  I also have that letter and would ask unanimous consent to have it 
printed in the Record as well.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:
                                                      Wake Forest,


                                           School of Medicine,

                                                   March 15, 2007.
     Hon. Chuck Grassley,
     U.S. Senate, Washington, DC.
       Dear Senator Grassley: I am pleased that members of the 
     U.S. Congress are taking constructive actions to address the 
     major problems with drug safety. Your Bills--FDASA and the 
     FACT Act--are excellent and, if passed, would greatly benefit 
     the U.S. public.
       My major concern relates to the FDA's lack of enforcement 
     tools. Regulations and commitments of any kind have limited 
     value if major and repeated violations involve no 
     consequences. Drugmakers who suppress or delay submission of 
     safety information to the FDA, stall label changes 
     (especially new Black Box warnings) or fail to honor their 
     commitments to complete post-market safety studies are rarely 
     (if ever) penalized for their unacceptable behaviors. Thus, I 
     particularly applaud the way your FDASA Bill would give the 
     Director of the Center for Postmarket Evaluation and Research 
     for Drugs and Biologics wide-ranging authority to take 
     corrective action.
       If I can be of any assistance in facilitating passage of 
     this legislation, do not hesitate to call me.
           Respectfully,
     Curt D. Furberg, MD, PhD,
       Professor of Public Health Sciences, Member of the FDA Drug 
     Safety and Risk Management Advisory Committee.

  Mr. GRASSLEY. Madam President, if these two thoughtful leaders can 
come forward and support a new center that is devoted to watching drugs 
once they are on the market so that American consumers and their 
doctors know about a problem promptly, what is wrong with that? That is 
why I hope the HELP Committee will take a second look at the Dodd-
Grassley bill. We have seen time and again that the FDA is not as good 
at this function as it should be. However, the reality is that the FDA 
needs to perform this function well because lives of American citizens 
and maybe around the world depend on it.
  I wish to see a bill passed that prevents another Vioxx debacle. This 
Congress has an opportunity to make meaningful and positive changes. 
Let's not allow that opportunity to slip through our fingers.

[[Page 9144]]




                                Medicare

  Madam President, I have another set of remarks that I wish to make 
dealing with the issue that we had before the Senate today, and that we 
had a cloture vote on, S. 3. Members on the other side of the aisle, 
including the assistant majority leader, said that Republicans do not 
want this debate. What are they talking about, do not want a debate 
about anything dealing with Medicare prescription drugs and all those 
sorts of things?
  This body has debated the so-called prohibition on Government 
negotiation. The Senate had four votes on this issue. What is rather 
amusing to me about the statement that we do not want the debate is 
that they did not seem to want the debate when the Senate considered S. 
1.
  S. 1 was the Senate version of the Medicare drug law. That bill had a 
noninterference clause in it just like the current law does. It is that 
clause that the other side has distorted to come up with the absurd 
claim that no negotiations occur under the Medicare drug benefit. Not 
once, I repeat, not once during the entire time that S. 1 was on the 
Senate floor in the year 2003 did anyone on the other side of the aisle 
bring up this issue.
  That is because this is not an issue of merit, it is simply one born 
out of political pandering. The assistant majority leader also talked 
about how Medicare should look like the VA because the VA seems to get 
lower prices.
  The VA gets lower prices because the Government passed a law to 
guarantee itself an automatic discount that no one else can get. By 
law, that price is automatically 24 percent less than the average price 
paid by basically all non-Federal purchasers. That is not negotiation, 
that is a federally mandated price dictation, or you might call it a 
24-percent discount, but it is federally mandated.
  I agree that the logical question then is: Why not have Medicare get 
that price? Experts who testified at the Senate Finance Committee, even 
the VA itself at a 2001 hearing before the Committee on Veterans' 
Affairs gave us the answer: They said that giving the Medicare VA 
prices will increase prices for veterans. Now, why would anybody in 
this body want to increase prices for veterans?
  Now I wish to turn to how the VA uses its own pharmacy benefit 
manager or PBM as we refer to them. The pharmacy benefit manager for 
the VA--the VA has one. In 1995, as part of an effort to better manage 
and monitor drug usage and purchasing and utilization oversight across 
the entire Veterans' Administration, the VA established its own benefit 
manager.
  The VA did it because it wanted to have its pharmacy operation work 
similar to the private sector. They did it because, as stated in the VA 
news release, they wanted to maximize a developing business strategy in 
the private sector. That business strategy was getting lower prices on 
drugs in the private sector.
  So here we have people holding out the VA as a model, which uses its 
own PBM to negotiate, and at the same time they are saying: Using PBMs 
in Medicare is wrong.
  Remember, that process has brought 35-percent lower costs on the 25 
most used drugs by seniors under the Medicare Program. I cannot help 
but see how that is a bit of irony when people say they want Medicare 
to negotiate like the VA negotiates.
  Well, the VA negotiates through its PBM. So the funny thing is, the 
VA actually negotiates similar to Medicare drug plans. You heard that 
right, but let me state it again. The VA system for negotiating is just 
like the one already used by Medicare through prescription drug plans 
that seniors join.
  If the VA's PBM looked at itself in the mirror, it would see a 
Medicare drug plan's PBM staring right back at it. There is another 
important difference between the VA and Medicare. The VA prescription 
drug benefit is just one part of the VA's health care delivery system. 
It is a very different system than Medicare.
  The VA system requires veterans to use VA hospitals, to use VA 
physicians, to use the VA national formulary, to use their pharmacies, 
and to use their mail order pharmacy. Now, don't get me wrong. The VA 
has a good system that works for veterans. But what it comes down to is 
choice. So I have a chart I want you to look at. Under the Medicare 
prescription drug benefit, beneficiaries have choices. They can choose 
the plan they want, a plan that covers all their medicines. They can 
choose the doctor and the hospital they want. They can go to their 
local pharmacy.
  Even the VA recognizes this fact. On its own Web site in a 
``frequently asked questions'' page, the VA does not recommend that 
veterans cancel or decline coverage in Medicare because a veteran may 
want to consider the flexibility afforded by enrolling in both the VA 
plan and the Medicare plan.
  For example, veterans enrolled in both programs may obtain 
prescription drugs that are not on the VA formulary if prescribed by a 
non-VA physician and filled at a local pharmacy.
  Making all Part D programs look like the VA and its formulary then 
will severely restrict access and will severely restrict choice to the 
44 million Medicare beneficiaries. Now, the other side says: No. No. We 
are not going to limit access to drugs. Yes, as I pointed out this 
morning, every Democrat on the Finance Committee cast a vote against my 
amendment that would have prohibited the Secretary from creating a 
national preferred drug list.
  I had thought, for all the talk about not allowing a Government 
formulary, the proponents of S. 3 would embrace a provision banning 
preferred drug lists. If they do not want to limit beneficiaries' 
access to drugs, my amendment should have been easy for them to 
support.
  But by voting against my amendment, they were voting in favor of the 
Government setting a preferred drug list. Now, the preferred drug list 
might sound like a good thing, but in reality it is not. It is a 
Government-controlled list of drugs that you can or cannot have because 
the Government is not going to pay for what they say you cannot have.
  The preferred drug list then operates similar to a formulary. In my 
opinion, if it walks like a duck, if it quacks like a duck, then it is 
a duck. But that is not what the courts have found. So what does that 
mean for Medicare beneficiaries? It means that even though S. 3 
prohibits the Secretary from using a formulary, it does not prohibit 
the Secretary from using a preferred drug list. It is clear now then 
from all this analysis and their votes on this amendment that 
supporters of this Senate bill want the Government to set a preferred 
drug list. They want the Government to determine for what seniors can 
get coverage.
  A number of States have implemented preferred drug lists. Michigan, 
for example, has a preferred drug list. Here is what the Kaiser Family 
Foundation found in a 2003 case study on that preferred drug list:

       Fearing opposition from the pharmaceutical industry, the 
     State sought virtually no input from providers, pharmacists, 
     beneficiaries and manufacturers.

  Continuing the quote:

       Ultimately the department [meaning Michigan] made only a 
     few changes to the list of drugs on the Michigan preferred 
     drug list in response to beneficiaries and provider concerns.

  Both the Illinois House and the Illinois Senate resolutions were 
introduced in 2002 to establish a committee to oversee that State's 
preferred drug list.
  The resolution noted that the creation of Illinois' preferred drug 
list ``could lead to unintended consequences such as inferior health 
care, increased hospitalizations and emergency care, increased 
admissions into long-term care, and unnecessary patient suffering and 
potentially death.''
  In a statement about this bill, S. 345, the assistant majority leader 
said that: The Medicare-administered plan envisioned under this bill 
would have a preferred drug list.
  So this morning I talked about fitting all of the pieces of a 
legislative puzzle together.
  Here are some of those pieces: The bill approved by the House allows 
price controls. The bill that was before the

[[Page 9145]]

Senate does not prohibit the Secretary from dictating the drugs 
beneficiaries can get. We have Senator Durbin's statement about his own 
bill and how he envisioned a preferred drug list.
  So despite claims by those on the other side of the aisle, this bill 
is not harmless to senior citizens. If this Trojan horse attack 
succeeds in a Government takeover of the drug benefit, here is what 
seniors can look forward to: They can look forward to fewer choices. 
They can look forward to fewer opportunities to choose a plan that best 
meets their needs--the needs of 44 million senior citizens in America.
  If the Senate bill were to pass, seniors will get only the drugs some 
Government bureaucrat determines they can have. All other Americans 
will see the prices of their prescription drugs going up. That is not 
me saying it. Professor Scott Morton of Yale University testified 
before the Senate Finance Committee to that mathematical fact, that if 
you have 44 million senior citizens, and you have the Government 
dictating the price, when you deal with that number of people, the 
price is going to go up for everybody. If that is what the other side 
calls harmless, I shudder to think what their definition of ``harmful'' 
might be.
  We should have and did stop this bill in its tracks. Voting no was a 
vote against Government-controlled drug lists, Government setting 
prices, and Government restrictions on seniors' access to drugs. That 
was the right thing to do today, and I am glad the vote came out the 
way it did. I hope it stays that way because if it ain't broke, don't 
fix it.
  (Mr. Casey assumed the Chair.)

                          ____________________