[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 11357-11358]
[From the U.S. Government Publishing Office, www.gpo.gov]




   AMENDMENTS TO THE FOOD AND DRUG ADMINISTRATION REVITALIZATION ACT

  Mr. GRASSLEY. Mr. President, there are two amendments I am going to 
bring up on the bill that will be before the Senate. Amendment No. 
1039, which Senators Mikulski and Brown will also be cosponsoring, 
provides for joint postmarketing decisionmaking between two offices 
within the FDA--the Office of Surveillance and Epidemiology and the 
Office of New Drugs. These offices would address jointly postmarketing 
drug safety issues.
  This postmarketing decisionmaking is intended to include labeling 
changes requiring additional postmarketing studies and restrictions on 
distribution and use of drugs. The joint decisionmaking would give the 
Office of Surveillance and Epidemiology signoff authority. This is 
different than its present role of being a mere consultant to the 
Office of New Drugs.
  It is very important to understand that the core of this amendment 
was recommended by the Institute of Medicine last fall.
  The other amendment is amendment No. 998, which Senator Dodd will 
also be cosponsoring. It provides for the application of stronger civil 
penalties for noncompliance with approved risk evaluation.
  Currently, S. 1082 contains penalties that are insignificant for 
large companies and amount to nothing more than the cost of doing 
business. This amendment is intended to give the FDA, the watchdog, 
some bite along with its bark.
  Big PhRMA doesn't like my amendments because they shake up the status 
quo. The status quo includes FDA's debacle, such as Vioxx and the 
failure of FDA to notify doctors and parents of potentially tragic 
effects of antidepressants on children.
  These amendments would make postmarketing safety concerns a 
forethought rather than an afterthought at the FDA. These amendments 
are intended to establish greater accountability, break the stronghold 
big PhRMA has on the FDA, and make postmarketing safety a meaningful 
effort at the agency.
  Today, through my amendments, I hope to help Senator Kennedy and 
Senator Enzi finish a very good job they started through the HELP 
Committee. S. 1082 is a first step in setting a new direction for the 
safety of prescription drugs. As I said the week before last, I am 
heartened by the fact that this bill attempts to address some of the 
many failures I have exposed over the last 3 years at the FDA, failures 
that negatively affect the core mission of the FDA. For the first time 
in almost a decade, we have an opportunity to reform, improve, and 
reestablish the FDA as what it should be: the gold standard of drug 
safety.
  The bills Senator Dodd and I have introduced in the past were 
intended to enhance drug and device safety and to bring transparency. 
Over the past two Congresses, I have worked with Senator Dodd on these 
bills. One of these bills asks for the creation of a new center devoted 
solely to postmarketing drug safety, a center that would bow to no one 
but the American consumer, a center that would be an independent voice 
for consumers, a center that would reside in the FDA and decide what to 
do and when to do it when an unexpected safety risk arises from a drug.
  There is strong opposition to such a center, I found. This is the 
case even though scientists and epidemiologists working in the FDA, as 
well as independent thought leaders, believe the Food and Drug 
Administration Safety Act of 2007 would prevent another Vioxx debacle.
  The HELP Committee incorporated certain aspects of Grassley-Dodd and 
Dodd-Grassley bills in the bill before us, and I thank Senator Kennedy 
and Senator Enzi for doing that.
  During floor debates, I have seen agreements and long-term 
commitments fall through. It is clear to me S. 1082 will never include 
a separate center for postmarketing safety. The way the process works 
will not allow a new center to be created in the FDA. That is very 
unfortunate. It is particularly unfortunate for our consumers. Senator 
Dodd and I concluded a new independent center was the best way to 
ensure postmarketing drug safety. But, again, there is strong 
opposition to such a center, despite the fact that it is the right 
thing to do.
  The wheeling and dealing and lobbying on this bill have made it 
impossible for a new postmarketing center to become a reality. So 
instead, I am here to offer a lesser amendment. It is lesser because it 
is not the best we can do. I know we can do better. Amendment No. 1039 
has its roots in the Institute of Medicine recommendations and should 
be embraced by every Member. Specifically, the Institute of Medicine 
stated in its report:

       The committee recommends that CDER appoint an OSE staff 
     member to each new drug application review team and assign 
     joint authority to OND and OSE for the postapproval 
     regulatory actions related to safety.

  Two members of the Institute of Medicine committee which issued the 
report reiterated recommendations in an article published last week in 
the Journal of the American Medical Association. In particular, they 
stated:

       The Institute of Medicine identified the imbalance in 
     authority between the Office of New Drugs and the Office of 
     Surveillance and Epidemiology as a major weakness in the drug 
     safety system. In an effort to facilitate a collaborative and 
     constructive team approach, the Institute of Medicine 
     recommended joint authority for the Office of New Drugs and 
     Office of Surveillance and Epidemiology in the postapproval 
     setting.

  These experts noted that the FDA's response to the Institute of 
Medicine's recommendations ``represent incremental progress'' but 
suggest that the

[[Page 11358]]

FDA failed to embrace, among other things, ``the equality between the 
preapproval and postapproval activity of the agency.''
  Having equality between the preapproval and postapproval activities 
at the FDA is fundamental to real reform. It is common sense. This is 
especially true when we think about what we have learned from the 
operation of the FDA over the past few years and those shortcomings.
  As we debate this bill, we are going to hear a lot about the 
impressive Institute of Medicine study and its recommendations to 
improve the FDA. We have and will continue to hear Members talk about 
how S. 1082 addresses many of the Institute of Medicine's 
recommendations. However, this is one important and sweeping 
recommendation that is not addressed in the bill before us.
  Amendment No. 1039 is intended to address that shortcoming. I have 
seen time and again in my investigations that serious adverse effects 
that emerge after a drug is on the market do not necessarily get the 
prompt attention they deserve. They are certainly not getting the 
attention from the Office of New Drugs.
  Even the Government Accountability Office report entitled, 
``Improvement Needed in FDA's Postmarket Decision-making and Oversight 
Process,'' stated:

       FDA lacks clear and effective processes for making 
     decisions about, and providing management oversight of, 
     postmarket safety issues.

  I, for one, have seen too many people suffer from the results of the 
Vioxx mess. I also have heard from parents whose children committed 
suicide on antidepressants.
  This amendment is about making postmarketing safety in S. 1082 a 
reality, not just another byline. Identifying a safety issue after a 
drug is on the market is the beginning of the process of protecting the 
American consumer.
  Once the safety questions are identified, FDA needs to be empowered 
and willing to take action to address those questions and to ensure 
timely notice to doctors and consumers of new safety risks for drugs 
that they are already taking.
  Senator Enzi stated last Monday that with Vioxx, the Food and Drug 
Administration did not have enough tools to deal with the new risks 
that became evident only after Vioxx had been on the market for some 
time.
  But the problem with the Vioxx mess and the antidepressant mess 
wasn't only about having enough tools, it was about FDA managers 
disregarding the concerns raised by its own scientists in the Office of 
Surveillance and Epidemiology and not taking action in a timely manner.
  Amendment No. 1039, which is in the Institute of Medicine 
recommendations, is intended to curb delays when it comes to safety.
  I have also been told by scientists and epidemiologists working in 
the FDA, as well as independent thought leaders, that S. 1082 as it 
stands will not prevent another Vioxx debacle.
  They have told me that the Office of Surveillance and Epidemiology 
needs, at the minimum, joint postmarketing decisionmaking authority 
with the Office of New Drugs to ensure prompt postmarketing action.
  I also am afraid to say, that right now, I am at the beginning of 
another review that will likely lead to concerns similar to those we 
have seen in the past--a situation where the postmarketing adverse 
events are severe and the public knows nothing.
  The other amendment I want to talk about, amendment No. 998, is just 
plain common sense.
  For FDA's new authorities to be meaningful, there has to be strong 
civil monetary penalties.
  I hear that there is a lot of opposition to having stronger civil 
monetary penalties than those currently in S. 1082. But that just does 
not make sense to me.
  Over the last week I have heard members talk about giving FDA some 
bite. Well, let's add some teeth.
  Civil monetary penalties need to be more than the cost of doing 
business.
  If civil monetary penalties are nothing more that the cost of doing 
business, you can't change behavior and, more importantly, you can't 
deter intentional bad behavior.
  Amendment No. 998 would increase the penalties that can be imposed if 
companies fail to comply with the requirements of the ``risk evaluation 
and management strategies,'' such as labeling changes and requirements 
for postapproval studies or risk communication plans.
  These requirements are at the core of S. 1082. But, FDA cannot be an 
effective regulator if it's all bark and no bite.
  The last thing we need to do with this bill is to provide the FDA 
with new authorities but little enforcement capacity. That's not 
accountability and that won't help FDA do its job better for the 
American people, and it won't punish bad players.
  That is why amendment Nos. 1039 and 998 make sense.
  They fit into S. 1082 and its stated goal of promoting postmarketing 
safety.
  I again thank Senators Kennedy and Enzi for the tremendous efforts 
that went into bringing this bill to the floor, and I again thank them 
for incorporating a number of the provisions set forth in the two bills 
filed by Senator Dodd and me.
  Mr. President, I yield the floor.

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