[Congressional Record Volume 153, Number 140 (Thursday, September 20, 2007)]
[Senate]
[Pages S11831-S11841]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




          FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007

  Mr. KENNEDY. Mr. President, I ask unanimous consent that the Senate 
proceed to the immediate consideration of H.R. 3580, received from the 
House and is at the desk.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The bill clerk read as follows:

       A bill (H.R. 3580) to amend the Federal Food, Drug, and 
     Cosmetic Act to revise and extend the user-fee programs for 
     prescription drugs and for medical devices, to enhance the 
     postmarket authorities of the Food and Drug Administration 
     with respect to the safety of drugs, and for other purposes.

  There being no objection, the Senate proceeded to consider the bill.
  Mr. KENNEDY. Mr. President, every day, families across America rely 
on the Food and Drug Administration in ways they barely realize. When 
they put dinner on the table, they are counting on FDA to see that it 
is free from contamination. When they care for a sick child, they are 
trusting FDA to make sure the drugs prescribed are safe and effective. 
From pacemakers to treatments for cancer to the foods we eat, FDA 
protects the health of millions of Americans, and oversees products 
that account for a quarter of the U.S. economy. The agency does all 
this on a budget that amounts to less than 2 cents a day for each 
citizen.
  Yesterday, the House of Representatives approved legislation on FDA 
reform by a broad bipartisan majority of 405 to 7. Our House colleagues 
from all parts of the political spectrum united to send that bill to 
the Senate with a resounding bipartisan endorsement. We cannot wait 
another month, another week--or even another day. We must take action 
here and take action now to send that bill to the President.
  The stakes could not be higher. Funding for the FDA's vital safety 
mission is reaching the breaking point. Unless we act, the FDA 
Commissioner will send a letter tomorrow to over 2,000 employees 
informing them that their jobs are slated for termination. This 
legislation provides nearly $500 million in new resources for FDA--
including over $50 million for drug safety and $6 million for review of 
direct to consumer ads.
  Americans are worried about the safety of the products they use--from 
food to toys to drugs--and they are right to be worried. Dangerous 
lapses in safety oversight have exposed American families to 
intolerable risks from lead paint in toys, to bacteria in foods, to 
drugs that cause unreported and lethal side effects. The right response 
is comprehensive, considered and bipartisan legislation--and that is 
what we have before us today.
  At the heart of our proposal is a new way to oversee drug safety that 
is flexible enough to be tailored the characteristics of particular 
drugs, yet strong enough to allow decisive action when problems are 
discovered.
  A second major element of our legislation is a public registry of 
clinical trials and their results. A complete central clearinghouse for 
this information will help patients, providers and researchers learn 
more and make better health care decisions. Now, the public will know 
about each trial underway, and will be able to review its results.
  Our bill recognizes that innovation is the key to medical progress by 
establishing a new center, the Reagan-Udall Foundation, to develop new 
research methods to accelerate the search for medical breakthroughs.
  The bill helps preserve the integrity of scientific review by 
improving FDA's safeguards against conflicts of interest on its 
scientific advisory committees, and it will end the abuse of citizens 
petitions that are too often used not for their intended purpose of 
brining important public health concerns to the attention of the FDA, 
but rather to delay the approval of generic drugs.
  The proposal before the Senate today strikes the right balance on 
this issue. It rightly states that the mere filing of a citizen 
petition should not be cause for delay, but allows FDA to delay the 
approval of a generic application if it determines that doing so is 
necessary to protect public health. This is the right approach. It 
prevents abuse, but protects health.
  The legislation also includes important reforms of direct-to-
consumer, or DTC, advertising. I thank Senator Roberts and Senator 
Harkin for working with Senator Enzi and me and with many members of 
the committee on this important provision.
  Instead of the moratorium included in our original bill, the current 
proposal puts in place strong safety disclosures for DTC ads, coupled 
with effective enforcement. Under current law, safety disclosures can 
be an afterthought--a rushed disclaimer read by an announcer at the 
conclusion of a TV ad while distracting images help gloss over the 
important information provided. Our proposal requires safety 
announcements to be presented in a manner that is clear and conspicuous 
without distracting imagery. We also give FDA the authority to require 
safety disclosures in DTC ads if the risk profile of the drug requires 
them.

[[Page S11832]]

  Our legislation also takes important first steps toward a safer food 
supply. These are only first steps--our committee will work on a 
comprehensive package of food safety legislation in the fall--but they 
are important steps. Consumers and FDA have too little information 
about contaminated food. Our bill creates a registry and a requirement 
to report food safety problems. Consumers will have information about 
recalls at their fingertips, and FDA's response will not be slowed by 
antiquated and inefficient reporting systems. Our bill also establishes 
strong, enforceable quality standards for the food we give our pets, to 
guard against the problems of tainted pet food that we have seen in 
recent months.
  In this new era of the life sciences, medical advances will continue 
to bring immense benefits for our citizens. To fulfill the potential of 
that bright future, we need not only brilliant researchers to develop 
the drugs of tomorrow, but also strong and vigilant watchdogs for 
public health to guarantee that new drugs and medical devices are safe 
and beneficial, and that they actually reach the patients who urgently 
need them. Congress has ample power to restore the luster the FDA has 
lost in recent years, and this bipartisan consensus bill can do the 
job. I ask my colleagues to approve this needed legislation without 
delay.
  H.R. 3580, the Food and Drug Administration Amendments of 2007, does 
a great deal to improve the regulatory process and to strengthen FDA's 
ability to enforce drug safety standards, particularly in the 
postmarket period. A recent study by the Institute of Medicine 
described FDA's post-market drug safety authority as ``aging and 
inadequate.'' Currently, FDA's ability to address potential health 
problems that become known after the drug has gone on the market is 
very limited. This is a serious weakness in the present system that 
must be corrected. This legislation will give FDA the authority, for 
the first time, to compel a drug company to add warnings of newly 
discovered risks on the drug label. As a result, in many cases the 
health risks involved in using potentially dangerous drugs will be 
disclosed to the public much sooner than they are today.
  At the same time, this legislation makes clear that drug companies 
will continue to have the same independent responsibility to update the 
warning labels on their drugs in the future that they have under 
current law today. If a drug company learns of new dangers that its 
product potentially poses to the patients taking it, the company has a 
legal responsibility to immediately warn those patients of the risk of 
injury.
  By enacting this legislation, we do not intend to alter existing 
state law duties imposed on a drug manufacturer to obtain and disclose 
information regarding drug safety hazards either before or after a drug 
receives FDA approval or labeling. We do not believe that the 
regulatory scheme embodied in this act is comprehensive enough to 
preempt the field or every aspect of state law. FDA's approved label 
has always been understood to be the minimum requirement necessary for 
approval. In providing the FDA with new tools and enhanced authority to 
determine drug safety, we do not intend to convert this minimum 
requirement into a maximum. The Institute of Medicine and others have 
found that FDA's past performance has been inadequate. While we fully 
expect substantial improvement as a result of the enactment of this 
bill, we cannot and do not expect the FDA or this new process to 
identify every drug specific safety concern before a drug manufacturer 
becomes aware or should have become aware of such concerns. Nor are the 
bill's requirements that companies disclose certain safety information 
to the government intended to substitute for the disclosure 
requirements that may be required under state law.
  No one should be under the mistaken impression that the new 
authorities and resources provided under H.R. 3580 lessen in any way 
the obligation of a drug company to scrutinize vigilantly the safety 
signals for their drugs and proactively study such signals or change 
their labels when the evidence supports such a change. This new 
postmarket authority for FDA is not intended to alter the drug 
companies' independent obligation to promptly warn consumers of a 
drug's risks. Under current FDA regulations, a drug company is required 
to add new warnings to its labels as soon as it learns about new risks 
potentially posed by its drugs. The company must add the new warning 
even if FDA has not required a labeling change.
  It is worth putting the situation in a little perspective. The 
legislation increases FDA's resources for post-market drug safety 
efforts significantly. FDA's current resources of about $25 million are 
increased by almost $55 million in the first year, to nearly $80 
million. There will be increases in the next four years of $10 each 
year, so that FDA's post approval drug safety budget will be at about 
$120 million in 2012. This is the entire budget at the FDA to collect 
and analyze post-market safety information and respond with appropriate 
regulatory action. FDA must use these resources to police every 
prescription drug on the market--thousands of drugs.
  By contrast, the drug industry had annual revenues in 2005 of over 
$200 billion. To be sure, significant portions of these revenues 
support research and development, profits, and marketing of drug 
products, but a mere 1 percent of these sales exceeds the entire budget 
of the FDA. It exceeds the agency's budget for postmarket drug safety 
by a factor of over one thousand. Many major brand drugs have annual 
revenues that exceed FDA's annual budget for postapproval drug safety. 
Consider the top 200 selling drugs in 2006: Merck's drug Fosamax Plus D 
came in 200th in 2006, with U.S. sales of $140 million. Sales from this 
one drug alone exceed the entire $120 million FDA budget for drug 
safety in the last year of this program. The 100th drug, Abbott's 
Kaletra, had 2006 sales of $350 million, nearly three times the FDA's 
annual drug safety budget for 2012. Thirtyeight drugs had U.S. sales 
exceeding $1 billion in 2006. The top selling drug, Pfizer's Lipitor 
had 2006 sales of nearly $6.6 billion, an amount more than 50 times 
FDA's annual drug safety budget in 2012 under this legislation.
  Clearly, the resources of the drug industry to collect and analyze 
postmarket safety data vastly exceed the resources of the FDA, and no 
matter what we do, they will always have vastly greater resources to 
monitor the safety of their products than the FDA does. It is absurd to 
argue that the FDA, even with the enhanced resources and authorities 
provided by this legislation, commands the field when it comes to 
postmarket drug safety. The drug companies have the capacity to do a 
far more comprehensive job. If we are serious about quickly alerting 
the public to the health risks posed by drugs, the companies must be 
required to take the initiative in monitoring the safety of their 
products and immediately warning the public of newly discovered risks. 
Drug manufacturers cannot be allowed to ignore their responsibility and 
wait for the FDA to act.
  To be sure, the legislation gives FDA the authority to command some 
of the resources of a drug company. FDA can order an epidemiological 
study or even a clinical trial, but this authority is not unlimited. 
Certain standards must be met before FDA can act to require a drug 
company to investigate a safety signal.
  Importantly, a drug company has the ability and the responsibility to 
conduct these studies or clinical trials on its own initiative. Nothing 
in H.R. 3580 requires a company to wait and react to an order from the 
FDA for such a study or clinical trial, or to wait for FDA to order the 
company to change its label. The legislation retains the current, 
ongoing requirement, found in section 502(a) of the Federal Food, Drug, 
and Cosmetic Act, for a drug company to ensure that its label is not 
false and misleading. This statutory imperative is recognized in 
current FDA regulations. Section 901 of H.R. 3580 cites these 
regulations in the new section 505(o) of the Federal Food, Drug, and 
Cosmetic Act. These regulations obligate a company to propose a 
labeling change to enhance a warning or improve safety information 
without waiting to hear from FDA, and allow the company to implement 
the labeling change before the FDA has reviewed and approved the 
change.
  In most cases, a drug company will learn about new risks from its 
product before the FDA does. Usually, it is the

[[Page S11833]]

manufacturer that possesses the information demonstrating a potential 
danger from the product. It is imperative that patients and health 
professionals learn about those new health risks as quickly as 
possible. For that reason, drug companies have, and must continue to 
have, an independent duty to warn drug users of the danger as soon as 
the company becomes aware of it. Otherwise, there will be long delays 
before consumers are alerted, and the number of injuries caused by the 
product will multiply.
  What should motivate a drug company to investigate drug safety 
signals and take appropriate action to mitigate a safety risk? You can 
find the answer in several places: from the simple moral duty to do the 
right thing; from the duty to one's customers, who use one's products 
with the understanding, often promoted by direct-to-consumer 
advertising, that the company's highest interest is to bring safe and 
effective cures to the sick and ill of the Nation; and from a duty 
under State law to offer products that are free of defects, with 
adequate warnings about their risks. This legislation changes none of 
these duties, in any way, whether they arise from simple ethics, 
principles of contract law, or of tort law. Rather, the legislation 
provides FDA with additional resources and authority to be better able 
to step in when a company fails to live up to these responsibilities.
  But some drug companies don't want to fully inform the public about 
these risks to patients' health, and they don't want to be held 
accountable when patients are injured or killed by their drugs. They 
would have liked this legislation to change the law to escape this 
responsibility. These drug companies wanted to convert FDA regulation 
from a safety floor into a ceiling, from a minimum safety standard 
designed to protect consumers into a liability shield designed to 
protect the drug companies. But Congress firmly rejected this approach.
  If companies were allowed to conceal safety information until the FDA 
ordered them to disclose it, consumers would continue taking these 
dangerous drugs without knowing their risks for months or even years 
after the risks were discovered. Then, when the public finally learned 
of the risk, the drug company would be immune from suit for failing to 
warn its customers. Those who were seriously injured by the drug would 
have no legal recourse, even though the company had concealed the risk. 
The company would completely escape accountability for its failure to 
warn consumers. That would be totally unacceptable, and is not what we 
intend by this legislation.
  Regulation by the Food and Drug Administration and product liability 
lawsuits against the manufacturers of harmful drugs work together to 
protect consumers. Both are needed to force drug companies to disclose 
health risks posed by their products as soon as those risks are 
discovered. Both are essential to identifying dangerous drugs and 
getting them off the market quickly. Effective regulation by the 
federal government and litigation by victims of dangerous drugs work 
hand-in-hand to keep patients safe and make drug companies more 
responsible. This legislation improves FDA oversight of postmarket drug 
safety, and does not undermine or preempt the efforts by injured 
patients to seek redress under State product liability law.
  Congress has stated very clearly in the legislation that we do not 
intend the new authority being given to FDA to preempt common law 
liability for a drug company's failure to warn its customers of health 
risks. The legal duty of drug companies to warn consumers of the health 
risks of their products as soon as those risks are discovered is 
essential to effectively protecting the public from dangerous drugs. 
Legislation designed to protect consumers from dangerous drugs must not 
be distorted into a shield protecting drug companies from 
accountability.
  Mr. ENZI. Mr. President, I rise today in support of HR 3580, the Food 
and Drug Administration Amendments of 2007. This comprehensive bill 
will enhance drug safety and provide key resources to the Food and Drug 
Administration. I am pleased that the House passed this bill yesterday, 
and that we have a chance to act on it today. It's been a long road for 
this bill, and I strongly urge my colleagues to vote yes and endorse 
the most comprehensive drug safety overt1aul in more than a decade.
  This key FDA package includes four reauthorizations that must be done 
this year, along with essential new authorities for FDA to be able to 
react in a timely way to any safety problems that arise after a drug 
has been brought to market. With this new toolbox, FDA has the ability 
to identify side effects after the drug is marketed through active 
surveillance. FDA also has the authority to request labeling changes in 
response to new safety information, as well as a separate study or 
clinical trial to learn more about a particular, potential safety 
problem.
  Not everyone got everything they wanted in this bill. That is as true 
of me as it is of anyone. I am deeply concerned about the provisions 
related to labeling changes and liability, given that we do not fully 
understand the implications of that language. This new rule of 
construction was part of the House-passed language and not something 
the Senate fully debated. If I would have drafted the bill, that 
language would not have been included. But this is a compromise bill, 
one that provides important new authorities, while preserving the 
quality we have come to expect of the agency. The changes made in the 
drug safety components of this legislation are critical to restoring 
peace of mind to Americans who want to be assured that the drugs they 
purchase to treat illnesses and chronic medical conditions can be 
relied upon and trusted. By acting today, we are ensuring that nearly 
2000 dedicated public servants at FDA can continue to evaluate drugs 
and devices in a timely and thorough way, speeding these discoveries to 
patients while protecting the public health.
  These new authorities will assist the agency in quickly and 
effectively responding to potential safety issues, including making 
labeling changes and requiring post-market studies to more fully 
examine potential risks. In addition, this bill expands access to 
clinical trials information for patients and providers and creates new 
methods to address potential conflicts of interest of advisory 
committee members to ensure greater accountability and preserve 
scientific integrity.
  FDA currently has no mechanism for active, routine surveillance of 
potential safety problems. It cannot easily detect safety problems 
after a drug has been put on the market. This legislation fixes that 
challenge and ensures that FDA has the right tools to address drug 
safety after the drug is on the market. The legislation creates the 
capacity for routine, active, safety monitoring using large linked 
databases, what I like to call ``health IT for drug safety.'' I want to 
thank Senator Gregg for being the champion of this provision and 
ensuring that we crafted this provision appropriately.

  This bill also includes renewal of two key provisions focused on 
children--the ``Best Pharmaceuticals for Children Act'' and the 
``Pediatric Research Equity Act,'' which together ensure that drugs 
used in children are tested on children; as well as a proposal that 
will increase our ability to develop medical devices for children.
  There has been a lot of attention paid to medical products in this 
debate. But we mustn't forget the ``F'' in FDA. This bill contains 
important food safety provisions to better protect our pet food supply, 
and track when food is adulterated.
  I want to thank my colleagues Senators Roberts and Harkin for their 
tireless efforts to provide an appropriate balance for direct-to-
consumer advertising. I would also like to thank one of my colleagues 
on the other side of the Capitol, Representative Schakowsky of 
Illinois, for her constructive involvement in these issues. It was not 
an easy task to reconcile some very different opinions, and I am so 
pleased that we were able to reach a resolution to this issue that we 
could all support.
  I would like to thank Senator Alexander, Senator Allard, Senator 
Bond, Senator Dodd, Senator Clinton and others for their leadership on 
behalf of kids. Finally, I would like to thank Senator Hatch for his 
work on the antibiotics and other Hatch-Waxman issues.
  On the other side of the Capitol, I would like to thank Chairman 
Dingell, Ranking Member Barton, and

[[Page S11834]]

Representatives Pallone and Deal for shepherding this legislation 
through the process.
  I want to take a few minutes to thank the staff, who have spent 
countless hours over the past months negotiating and drafting this 
legislation. This dedication to public service often overlooked. They 
spent many evenings and weekends away from their homes and their 
families.
  My health team worked overtime to get this bill to the floor and 
passed in the Senate. I would first like to thank my Health Policy 
Director, Shana Christrup. I also want to greatly thank Amy Muhlberg, 
for her work on drug safety, food safety and PDUFA. Her knowledge and 
drafting skills were central to this bill. I would also thank Keith 
Flanagan for his work on the children's statutes in this bill and Dave 
Schmickel, our resident drug patent expert for his work on citizens 
petitions and antibiotics issues. I would also like to thank Todd 
Spangler who provided the required backup that goes with moving a bill 
of this magnitude. Finally, I would like to thank my Staff Director, 
Katherine McGuire, whose steady hand and negotiating and communication 
skills provided the cement for the entire process.

  I would also thank Ilyse Schuman, my chief counsel for her precision 
and attention to the details. Finally, I thank Amy Angelier Shank for 
her great work on the budget aspects of the bill and my press team 
Craig Orfield and Mike Mahaffey. My Chief of Staff Flip McConnaughey 
was great at putting out brush fires throughout the process.
  Megan Hauck with Senator McConnell's office, David Boyer with the 
White House, Craig Burton and Vince Ventimiglia at HHS and Stephen 
Mason of FDA were key to helping with both policy and process issues 
throughout the negotiations.
  On Senator Kennedy's staff, I would like to thank: Michael Myers, 
David Bowen, and David Dorsey. Senator Kennedy's staffers were 
reasonable negotiators throughout the process and open and patient to 
hearing all sides of any issue.
  On the other side of the Capitol, I would like to thank Chairman 
Dingell, as well as John Ford, Virgil Miller and Pete Goodloe of his 
staff for their tireless work. Bobby Clark with Mr. Pallone and John 
Little with Mr. Deal were also instrumental in the negotiations. 
Ranking Member Barton and his staff Ryan Long and Nandan Kenkeremath 
were outstanding. Yesterday, when this bill passed the House, Mr. 
Barton reported that Ryan had been up all night working on the bill and 
was therefore wearing the same clothes as the day before. I would like 
to state for the record that all my staff showered today--I think.
  Warren Burke with House Legislative Counsel and Stacy Kern-Sheerer of 
Senate Legislative Counsel were tremendous in handling a long and 
complex bill with lots of moving parts. There would be no bill without 
their efforts.
  I would like to thank Senator Hatch and his staff Pattie DeLoatche, 
Trisha Knight, Remy Yucel and Matt Sandgren for their efforts on the 
bill overall, but particularly on the Citizen Petitions, antibiotics, 
and enantiomers provisions. Leigh-Anne Ross of Senator Cochran's staff 
and Landon Stropko of Representative Cubin's office were also key on 
these antibiotic provisions.
  With Senator Gregg's office, and for their assistance with ``health 
IT for drug safety,'' I thank Dave Fisher and Liz Wroe. Stephanie 
Carlton, from Senator Coburn's staff and Jenny Ware with Senator Burr 
were also integral to many parts of the bill.
  I would also like to thank my colleague from Kansas, Senator Roberts, 
and his staff Jennifer Swenson, for their incredible work on direct-to-
consumer advertising. I also thank my colleague Senator Harkin and his 
staffer Janelle Krishnamoorthy for their hard work on this issue. 
Lindsay McAllister of Representative Schakowsky's office was also 
integral to the success of these negotiations.
  I would like to thank Isaac Edwards and Amanda Makki of Senator 
Murkowski's staff, Tyler Thompson with Senator Isakson, and Jennifer 
Claypool with Senator Allard for their hard work and dedication.
  Ellie Dehoney of Senator Brown's office was critical to reaching 
agreement on the Citizen Petitions and tropical disease provisions. 
Melanie Benning of Senator Brownback's office was also instrumental on 
the tropical disease issue.
  I would like to thank Mary-Sumpter Johnson with Senator Alexander, 
Kelly Childress with Representative Rogers, Jennifer Nieto with 
Representative Eshoo, Ann Gavaghan with Senator Clinton, Tamar Magarik 
and Jeremy Sharp with Senator Dodd for their exceptional work on the 
pediatric provisions.
  And last, but not least, Cameron Bruett of Senator Chambliss's 
Agriculture Committee staff, Adela Ramos of Chairman Harkin's 
Agriculture Committee staff, and David Lazarus of Senator Durbin's 
staff were extraordinarily helpful on the food safety provisions in the 
bill.
  As you can see, this was a real team effort. I urge my colleagues to 
vote yes on this important bill. Patients are waiting. I yield the 
floor.
  Mr. LEAHY. Mr. President, I am pleased that today the Senate is 
poised to pass H.R. 3580, a bill regarding the Food and Drug 
Administration. This legislation addresses many important health care 
issues and I commend the Senate leaders and relevant committee chairmen 
for coming to agreement on this complex bill. I have been monitoring 
the ongoing negotiations between the House and Senate on this 
legislation because a slight variation in language between the two 
relevant bills could have affected the claims of thousands of injured 
American consumers.
  Last week, I chaired a Senate Judiciary Committee hearing on the 
emergence of regulatory agencies like the FDA asserting that its 
regulations preempt all State laws, even in the absence of 
congressional intent to do so. At this hearing we received extensive 
testimony that the Bush administration has been using this approach to 
shield corporations from civil liability. This regulatory preemption 
model has been especially troubling in the area of pharmaceutical 
drugs. Several times in the past several years we have learned from 
whistleblowers and smoking gun documents that certain corporations knew 
of dangers in their medical products yet failed to adequately warn 
consumers. Many consumers have been injured as a result of this 
corporate misconduct and it is certainly not congress' intent to shield 
such corporate decisionmaking.
  The legislation we are set to pass today contains a rule of 
construction making clear that Congress has again decided that we are 
not preempting State law regarding the responsibility of drug 
manufacturers to immediately notify consumers of dangers without 
waiting for the FDA to act. Drug companies maintain the authority to 
correct their warning labels if they learn of any information that 
their products could harm consumers. These corporations can and must 
immediately correct any existing warning that has been issued and 
cannot hide behind the Byzantine regulatory structure of the FDA to 
shield them from liability for causing serious injury. To do otherwise 
would endanger all Americans who may be injured by their products and 
would remove the important incentive the corporations currently have to 
make their products safer and to adequately warn consumers of potential 
dangers.
  Mr. HATCH. As the Senate completes its consideration of H.R. 3580, 
the Food and Drug Administration Amendments Act of 2007, I want to take 
this opportunity to commend publicly the Food and Drug Administration 
and especially to express support and appreciation to the dedicated FDA 
employees who work so hard to ensure the safety of our drug and food 
supply. They are led by a very capable and hard-working Commissioner, 
Dr. Andrew von Eschenbach.
  In our race to legislate and regulate, we often forget the impact of 
our actions on agency employees and their ability to safeguard American 
consumers. And so I want to take this opportunity to thank them for 
their work.
  While I will not belabor the point here, as the legislation makes 
clear, the agency is operating under severe funding constraints. That 
is a pressing public health issue of great priority and the Congress 
must work to address it in a meaningful way.

[[Page S11835]]

  With passage of this legislation today, we will end the protracted 
game of ``chicken'' that threatened the jobs of hundreds of FDA 
employees, the stability of the agency, and indeed the integrity of 
Congress, an institution which has been under public criticism for not 
doing its job.
  I am proud to support the passage of H.R. 3580. I want to applaud the 
efforts of HELP Chairman Kennedy and Ranking Republican Member Enzi. 
They have worked tirelessly to ensure this bill would be completed 
before the expiration of the user fee programs at the end of this 
month. They have worked in a bipartisan way and they have worked very 
hard to embrace the views of each and every member of our committee.
  Let me highlight some of the important components of the FDARA bill.
  First, it is imperative that we continue the drug and device user fee 
programs. This is true for one simple fact--the agency relies greatly 
on the funding from these programs, and without it there would be 
unconscionable delays in drug and device reviews.
  This is particularly important for Utah, a State with the hallmark of 
innovation, a State which is the home to countless drug and device 
manufacturers.
  And while there are some problems with how these programs have 
worked--problems I have been pursuing, and will continue to pursue, 
with the FDA--all in all it must be recognized that there is no 
alternative to the user fee programs being continued.
  The drug safety provisions that Chairman Kennedy and Ranking Minority 
Member Enzi developed will be seen as an important hallmark in our 
Nation efforts to improve the safety of pharmaceuticals that Americans 
rely on.
  The food safety legislation that our colleague Senator Durbin 
developed--again, that is a vital component. I am supportive of that 
language, and especially appreciative to my colleagues for including 
the three pieces of language Senator Harkin and I authored to make 
certain that the new food reporting system did not override the Dietary 
Supplement Health and Education Act's regulatory structure and that it 
did not supersede the serious adverse event reporting system for 
dietary supplements enacted last year--the Dietary Supplement and 
Nonprescription Drug Consumer Protection Act.
  This legislation also includes many other laudable provisions. One 
particular provision in this legislation establishes a new and enhanced 
mechanism for the prompt consideration of new safety-related 
information and sets forth strict timelines for the evaluation of such 
new data. That provision is designed to ensure that all potential 
safety-related labeling changes are promptly raised and duly considered 
by the agency in carrying out its statutory duty to oversee the 
appropriate and accurate content of a drug's labeling.
  This new procedure is designed to implement a more thorough and 
regularized methodology for the consideration and implementation of 
safety-related labeling changes and to ensure that FDA is the ultimate 
authority in making certain that drug labels convey safety information 
in a clear and consistent way.
  This provision, which adds a new section 505(o) to the Federal Food, 
Drug and Cosmetic Act, is designed to ensure that both the agency and 
pharmaceutical companies are able to modify quickly with the agency's 
approval drug labels so that physicians are alerted promptly to new or 
increased risks associated with a drug. The provision does not affect 
the agency's general policy on labeling or its current labeling rules 
and policy.
  Also, the legislation promotes pharmaceutical and medical device 
advancements in pediatric therapies. The bill reauthorizes the Best 
Pharmaceuticals for Children Act and the Pediatric Research and Equity 
Act which have been vital for important research used by doctors and 
parents. The final language on both these provisions is a good 
compromise between the House and Senate bills.
  Finally, it is my profound regret that the bill we consider now does 
not contain the Biologics Price Competition and Innovation Act, 
legislation that Senators Kennedy, Enzi, Clinton, Schumer, and I have 
authored. This bill is intended to offer consumers access to lower cost 
biosimilar products, copies of such important medications as insulin or 
human growth hormone, while preserving the incentives for researchers, 
universities and manufacturers to develop and market the innovator 
biologics.
  I am extremely disappointed that the bill could not be contained in 
H.R. 3580, but I recognize the importance of allowing the House to 
develop its version in regular order.
  It remains my high priority, and I believe the priority of my 
colleagues as well, that this legislation be enacted in 2007.
  Mr. DURBIN. Mr. President, today, the Senate will send a bipartisan 
bill to the President that will improve the FDA's ability to assure the 
safety of drugs in our medicine cabinets and the food in our kitchens.
  The FDA is an essential guardian of the public's health and safety. 
In recent years, FDA's reputation has been marred by drug safety 
incidents and questions about its scientific independence.
  In 2004, the public learned that taking Vioxx, a heavily marketed 
pain medication, increased your risk of a heart attack and stroke. The 
revelation raised serious questions about how the drug manufacturer 
responded to signs of a problem and how FDA handled disagreements among 
its staff.
  The Vioxx episode and problems with other FDA-approved drugs in 
recent years exposed significant weaknesses in our Nation's drug-safety 
system.
  This year, Congress decided to do something about it. In addition to 
reauthorizing user fee programs for prescription drugs and medical 
devices, we have engaged in a serious effort to improve drug safety.
  The bill gives the FDA more tools to detect the safety problems of 
drugs after they are available to consumers. It also creates an active 
surveillance system that will help detect problems that were not 
apparent during the clinical trials conducted prior to a drug's 
approval and it promotes greater openness by requiring disclosure of 
clinical trials performed by drug companies. Lastly, the FDA is given 
greater authority to require drug companies to add warning labels and 
to conduct safety studies.
  I note the provisions in the bill that give FDA the authority to 
compel a drug company to make changes to a drug's labeling. That 
authority should not be seen as an absolution of the companies' 
responsibility regarding drug labeling. Consumers should be made aware 
of a drug's risks at the earliest possible moment, and drug companies 
remain responsible for ensuring that consumers are provided with prompt 
and adequate warning of a drug's risks.
  We have noticed a creeping trend in recent years towards implied and 
agency preemption of state laws. Last week, a Senate Judiciary 
Committee hearing looked at techniques that Federal agencies, including 
FDA, have recently used to assert that agency rulemakings preempt state 
liability laws. The drug labeling provisions in today's legislation 
include a rule of construction that makes clear that Congress does not 
intend to preempt state requirements regarding drug companies' 
responsibilities. Rather, this legislation recognizes that State 
liability laws, including liability laws for improper drug labeling, 
play an essential role in ensuring that drug products remain safe and 
effective for all Americans.
  The bill addresses two other issues of particular interest to me, new 
restrictions on conflicts of interest for FDA advisory committees and 
important provisions related to food safety.
  I have been troubled by the large number of waivers of conflicts-of-
interest rules that FDA issues to members of its advisory committees. 
The public depends on these committees to make independent assessments 
about the safety and effectiveness of drugs. Including members with 
financial conflicts can erode the public's trust in the process.
  When the Senate debated this bill in May, I offered an amendment with 
Senator Bingaman that would have limited the number of waivers to one 
per advisory committee meeting. While the amendment was defeated on a 
47-47 vote, the House included the language in its FDA bill.

[[Page S11836]]

  The final bill includes a 25-percent reduction in waivers over the 
next 5 years. I would have preferred more of a reduction, but this 
compromise moves us in the right direction and I commend the conferees 
for addressing concerns raised in both chambers around conflicts of 
interest.
  On the issue of food safety, I am happy to report that the bill 
includes food safety language that I originally offered on the floor of 
the Senate. The language passed on the Senate floor by a 94-0 vote.
  The language creates a new reporting requirement for food companies 
that determine there is a significant adulterated food product in their 
supply chain. Previously, companies consulted trade associations and 
attorneys to determine when to report significant adulterations to the 
FDA. Uncertainty about reporting requirements and an incentive to keep 
products on store shelves resulted in uneven, delayed reporting of 
significant incidents to FDA.
  Under this new policy, companies will now be required to report these 
types of incidents to FDA within 24 hours of determining the presence 
of such an adulteration. These reports will trigger an FDA review and, 
depending on the findings of the review, FDA would then have the 
authority to require further action from the company, including an 
investigation, submission of additional information, and the sending of 
notifications to affected parties in the supply chain. Companies would 
be required to maintain records of reports and notifications for a 
period of 2 years. Failures to report incidents, falsify reports, or 
comply with follow-up FDA requirements would be subject to civil and 
criminal penalties.
  The effect of this language will be to involve Federal regulators in 
the review process earlier, resulting in faster recalls, alerts, and 
notifications through the supply chain. Contaminated products will be 
tracked and removed from the supply chain earlier and faster. Recalls 
will be more targeted to specific lots and batches of contaminated 
products. We will minimize some of the uncertainty around the extent of 
contaminations once they are discovered.
  This provision is an important step forward for food safety.
  In addition to this provision, the language directs FDA to establish 
pet food ingredient, processing, and nutrition labeling standards. 
Previously, these standards were completely voluntary and did not carry 
the weight of law. This section also directs FDA to establish an early 
warning and surveillance system to identify pet food adulterations and 
outbreaks of disease. In addition, the language directs FDA to improve 
its outreach and coordination with professional associations, 
universities, and state and local authorities during recalls. The 
agency is also asked to enhance the display of recalls on its website.
  The bill directs FDA to strengthen its coordination with states to 
ensure the safety of fresh and processed produce and requires the 
Department of Health and Human Services to submit more detailed reports 
to Congress on the number of inspections conducted each year and the 
number of violations and adulterants discovered through inspections.
  Lastly, it includes sense-of-Congress language that commits this 
Congress to working on comprehensive food safety reform.
  On that note, I want to emphasize one thing--the food safety 
provisions in this legislation are only the starting point for more 
comprehensive efforts to improve our Nation's food safety system.
  For too long we have gone without updating the resources and 
authorities for our food safety efforts, and a broad coalition of 
stakeholders understands that our system is broken. We need to close 
the gaps in our current system.
  Several months ago, Robert Brackett, Director of the FDA's food arm 
said this in response to the pet food recall, ``These outbreaks point 
to a need to completely overhaul the way the agency does business. We 
have 60,000 to 80,000 facilities that we're responsible for in any 
given year. We have to get out of the 1950s paradigm.''
  Also in response to this recall, Dr. Stephen Sundlof, Director of the 
Center for Veterinary Medicine of FDA, implied the same when he said, 
``We're going to have to look at this after the dust settles and 
determine if there is something from a regulatory standpoint that we 
could have done differently to prevent this incident from occurring.''
  I agree with their sentiments and look forward to making more 
progress on the issue of food safety.
  I would like to thank my colleagues, Chairman Kennedy and Senator 
Enzi, for their cooperation and willingness to work on this language. I 
would also like to highlight the efforts of the following members of 
their staffs: David Noll; Amy Muhlberg; David Dorsey; and David Bowen. 
I look forward to working with the Senate HELP Committee on future food 
safety efforts. I would also like to thank Senators Harkin, Brown, 
Hatch, and Casey for their assistance with this language.
  In particular, I also would like to thank Chairman Kennedy and 
Senator Enzi for their extraordinary leadership and hard work on this 
overall bill.
  Mr. ALLARD. Mr. President, today I wish to speak on an issue that is 
weighing on the minds of many Members of this body, employees of the 
Federal Government, and patients in the United States.
  Many people working for the FDA are faced with the possibility of 
receiving a reduction in force notice if new user fee legislation is 
not passed quickly. The FDA needs the necessary resources so that they 
may approve drug applications within a timely manner. Being able to 
access new drugs can allow patients to live fuller lives, and in some 
cases, save them from death.
  I am frustrated by what I have seen as a desire to have a partisan 
debate on an issue of liability. We have been working for some time now 
on a bipartisan level to ensure that we have a bill passed by Friday. 
We should not be throwing partisan politics into the debate during the 
11th hour. Because I am committed to working on a bipartisan level, I 
continue to hope that we will have legislation passed to ensure that 
patients can get the drugs that they desperately need.
  Some believe that the Senate position on liability may have favored 
the pharmaceutical companies. However, I am of the opinion that the 
House position favored the trial lawyers. Should we make any changes we 
should also ensure that any labeling change authority would not provide 
for an opportunity for partiality by the courts. I strongly believe 
that every individual should be allowed to argue equally for their 
particular case in court.
  Currently the FDA regulation allows for labeling changes by accepting 
submissions from companies, and the company may make a label change. 
This is referred to as ``changes being effected'' or CBEs. A company 
also has the opportunity to discuss the change with the FDA before 
making a label change, since the regulations have a particular bound on 
what sort of changes can and cannot be made under this regulation.
  The current authority may not be adequate to deal with all cases in 
which a labeling change may be necessary. An example that is referenced 
frequently deals with a Vioxx label change in which FDA had been 
talking to the company for 18 months. This situation has led to many 
pending suits related to Merck's ``failure to warn'' people that the 
drug had some potential side effects.
  In the user fee reauthorizations this year both the House and Senate 
decided to give FDA the authority to do an expedited labeling change 
provision. In addition to this new authority, the House and Senate 
language included provisions that made it clear that the ``changes 
being effected,'' CBE, regulations should still stand. However, the 
House and Senate took different stances as to how that additional 
information or regulatory option should play out in court.
  The Senate-passed language, which was done on a bipartisan level, 
would have established a new labeling change process. This language 
would have also implied that if a company was already in discussions 
with the FDA about the labeling issue, and attempting to determine if 
the labeling change was necessary, then a future lawsuit would have to 
argue how the company was acting in an improper way. In this situation, 
the FDA regulation would have ``occupied the field'' with respect to 
liability for failure to warn.
  The House-passed language would have the opposite effect. Essentially 
a

[[Page S11837]]

company would not be able to use the argument that they were in the 
midst of discussion with the FDA as a defense. In my mind, the House 
language is a huge boon to trial lawyers. It also makes it harder for 
companies that are working in the best interest of the patient to prove 
that they are doing so. I have long been a supporter of reducing the 
opportunity for frivolous lawsuits, and in my mind the House language 
increases this.
  I would even be happy dropping both the House and Senate language 
regarding liability. This would leave a situation in which either side 
would be on an equal playing field to argue a case on failure to warn. 
This situation would allow suits to be determined on a case-by-case 
basis. Congress would not be weighing in one way or the other.
  The legislation that is expected to pass uses the House language on 
liability. It provides a source for bias in the courts and opens the 
floodgates for frivolous lawsuits. This is a definite boon for trial 
lawyers.
  As with many other instances in which Congress has addressed the 
demands of trial lawyers, I am not willing to risk the livelihood of 
the employees at the FDA or the health of my constituents who rely on 
the drug applications approved by the FDA. I will not hold up the 
legislation, but I wanted to take this opportunity to express my dismay 
at the partisan way that the liability issue was addressed.
  Mr. DODD. Mr. President, I rise today to voice my support for H.R. 
3580, the FDA Amendments Act of 2007. H.R. 3580 contains two bills 
which I authored, the Best Pharmaceuticals for Children Amendments of 
2007 and the Pediatric Medical Device Safety and Improvement Act of 
2007. I believe these bills will go a long way toward improving the 
health and safety our Nation's children. The bill will also make 
important changes to our Nation's drug safety system so that the FDA 
has clear authority backed up by new enforcement tools to ensure the 
safety of prescription drugs once they are on the market.
  As the original author of BPCA in 1997 and its two subsequent 
reauthorizations, I am proud to say that no other program in history 
has done more to spur research and generate critical information about 
the use of prescription drugs in children than this one. In 10 years, 
nearly 800 studies involving more than 45,000 children in clinical 
trials have been completed due to BPCA. Useful new pediatric 
information is now part of product labeling for more than 119 drugs. In 
sum, there has been a twentyfold increase in the number of drugs 
studied in infants, children, and adolescents as a result of BPCA since 
its enactment.
  Ten years ago when Senator Mike DeWine and I undertook this effort, 
only 11 drugs on the market that were being used in children had 
actually been tested and studied for their use. Prior to the enactment 
of BPCA 10 years ago, pediatricians were essentially flying blind 
because they lacked information regarding the safety and effectiveness 
of drugs they were prescribing for children. But it was children who 
suffered the most from taking drugs where so little was known about 
their effects.
  With BPCA, we have changed the landscape both for drug companies and 
the FDA with respect to prescription drugs and children. However, we 
still have much further to go because even with the progress we have 
made so far, still less than half of all drugs being used in children 
have been studied for their use. H.R. 3580 makes several key 
improvements to BPCA that will better inform parents, pediatricians, 
and the public about the safety and effectiveness of drugs used in 
children. For instance, H.R. 3580 will improve transparency and 
accountability by making written requests for pediatric studies public 
and it will improve the accuracy and speed of labeling changes as a 
result of BPCA studies.
  However, H.R. 3580 represents a real missed opportunity to inject a 
measure of rationality into this program to ensure that it will 
continue to thrive well into the future. H.R. 3580 dropped a Democratic 
compromise provision reducing the length of pediatric exclusivity from 
the current 6 months to 4.5 months only for blockbuster drugs, drugs 
with annual sales exceeding $1 billion. Five years ago and again 
recently, my colleagues on both sides of the Capitol dome have 
criticized this program over the 6-month length of the exclusivity that 
may be granted if the FDA believes a drug company successfully 
completed the pediatric studies it requested of them.
  Most recently, data released by researchers at Duke University show 
that some companies receive as much as 73 times the amount they spent 
to conduct the pediatric trial under the 6 months of exclusivity. BPCA 
has always been about balancing the needs of children with the cost to 
consumers. That is why I strongly supported the provision I authored in 
the Senate bill, S. 1082, which reduced the length of exclusivity to 3 
months for blockbuster drugs.
  I was proud to have brokered a compromise between the House and 
Senate of 4.5 months for blockbuster drugs because this agreement was 
the right policy. But I am profoundly disappointed that the decision 
was made to drop this compromise. When my colleagues seek to make 
similar changes to the length of exclusivity in 5 years, I believe that 
the deal the House and Senate cut in H.R. 3580 will only make doing so 
more difficult.
  I must also express my strong disappointment that the final bill 
inserts a 5-year sunset on the Pediatric Research Equity Act. As an 
original cosponsor of the reauthorization of PREA and a long-standing 
supporter of ensuring FDA has the authority to require pediatric 
studies of drugs in certain circumstances, there should be no 
expiration date on FDA's authority to ensure the safety of drugs in 
children.
  The interplay between BPCA and PREA is changed slightly in H.R. 3580 
from the Senate-passed bill. It is my understanding that H.R. 3580 will 
not delay the FDA's ability to utilize PREA's authority to require a 
pediatric assessment of new drugs that have not yet been approved 
should a company decline a written request under BPCA for such drug.
  Similarly, an exhaustion provision was retained in BPCA that would 
allow the Secretary to take up to 30 days to certify in the affirmative 
that the Foundation for the National Institutes of Health has 
sufficient funding to initiate and fund all studies in a declined 
written request before determining whether an assessment under PREA can 
be required. Although the Secretary may take up to 30 days to make such 
a certification, the Secretary need not impose any delay before 
determining whether an assessment under PREA is warranted. As the 
Government Accountability Office found in its March 2007 report on 
BPCA, contributions to the Foundation for the National Institutes of 
Health by the drug industry totaled a mere $4 million since 2002. While 
I hope contributions to the foundation will improve significantly, 
there should be no unnecessary delays when it comes to important safety 
information about medications prescribed to our children.
  Mr. President, BPCA has shown us that it is unsafe to simply treat 
children as small adults. Children face a similar inequity with respect 
to medical devices. Far too few medical devices are specifically 
designed for children's small and growing bodies. Experts say that the 
development of children's medical devices lags 5 to 10 years behind 
that of adults. That is largely due to the limited size of the market 
for pediatric devices.
  When a medical device suitable for a child is needed to save that 
child's life but it does not exist, doctors are often forced to ``jury-
rig'' adult versions of the device or, in some cases, perform a riskier 
surgery on the child. Ventilator masks, for instance, are far too large 
to fit over a baby's mouth. Often, the only alternative is to run an 
invasive tube down the baby's throat.
  Because of what we witnessed over the past 10 years with the market 
incentives provided under BPCA, I introduced an initiative, the 
Pediatric Medical Device Safety and Improvement Act, to create similar 
incentives for device manufacturers. I am pleased that this legislation 
is contained within H.R. 3580 and I believe it will produce tremendous 
improvements in children's health.
  This legislation streamlines the approval process for cutting-edge 
technology and establishes grants for matchmaking between inventors and 
manufacturers and the Federal Government. It is my hope that the FDA 
will

[[Page S11838]]

utilize its Office of Orphan Products Development to administer these 
matchmaking demonstration grants.
  Balancing safety with reasonable incentives, this legislation closely 
mirrors recommendations made by the IOM in its 2005 report on pediatric 
medical device safety to improve the serious flaws in the current 
postmarket safety surveillance of these devices. Specifically, the IOM 
called for and the legislation allows the FDA to require postmarket 
studies as a condition of clearance or approval for certain categories 
of devices and it gives the FDA the ability to require studies longer 
than 3 years with respect to a device that is to have significant use 
in pediatric populations if such studies would be necessary to address 
longer-term pediatric questions, such as the impact on growth and 
development. This provision should not be seen to encourage or promote 
off-label pediatric use of devices that have been cleared or approved 
for adult use but for which there is no or limited safety and 
effectiveness data concerning uses in children.
  H.R. 3580 will also go a long way toward restoring the public's 
confidence in the FDA to protect them against harmful prescription 
drugs and foods. For too long, the FDA has lacked the clear authority 
to require labeling changes when new safety information about a drug 
arises. H.R. 3580 will change that.
  For too long, the pressure on FDA to approve drugs has outweighed the 
necessity to have a systemic, unbiased review of the post-market safety 
of drugs whereby the FDA can take swift action should new safety 
information arise. I am pleased that the drug safety provisions of H.R. 
3580 will require contain requirements that the FDA's office 
responsible for post-market safety of drugs have equal footing with the 
office responsible for reviewing drugs.
  As the author of S. 467, the Fair Access to Clinical Trials Act, I am 
pleased that H.R. 3580 contains many major improvements to the clinical 
trials provisions. Physicians, researchers, and the public will now 
have access to a clinical trials registry with information on results, 
making it tougher for companies to hide or skew undesirable clinical 
trial results data.
  I would like to thank Chairman Kennedy for his leadership on this 
bill and his willingness to work so closely with me to improve 
children's health. I would also like to recognize the many staff who 
put in long hours and weekends working on this legislation. In 
particular, I would like to commend Tamar Magarik and Jeremy Sharp, of 
my staff, who worked extensively on this bill.
  Mr. President, the past several years have been marked with major 
drug controversies--Vioxx, Ketek, Avandia--with millions of families 
affected. The public deserves better. The mission of the FDA, to 
protect the public health by assuring the safety, efficacy, and 
security of human and veterinary drugs, must be restored. H.R. 3580 
provides the necessary reforms to restore the FDA as the gold standard 
for assuring the safety of the public for many years to come.
  Mr. BURR. Mr. President, I stand here with a heavy heart. Congress 
had the chance to reauthorize many important programs at the Food and 
Drug Administration and pass a targeted drug safety bill. Instead, we 
are passing a massive bill that triples FDA regulation and 
responsibility, puts clinical data out in the general domain that may 
be misleading to patients, and contains conflict of interest language 
that could harm participation on the FDA's advisory committees--a key 
part of the drug approval process.
  I will start with a good part of the bill. This bill reauthorizes 
many important programs at the FDA, including the pediatric exclusivity 
program. The Best Pharmaceuticals for Children Act was originally 
enacted as part of the Food and Drug Administration Modernization Act 
in 1997, legislation I sponsored on the House side and was reauthorized 
in 2002. The goal of BPCA is to encourage the study of more drugs in 
the pediatric population. BPCA provides that incentive by giving drug 
companies an additional six months of market exclusivity to a product, 
or pediatric exclusivity, in exchange for conducting voluntary studies 
of prescription drugs on children.
  Since its enactment, BPCA has been viewed as a highly successful 
program and has produced at least 132 completed studies, leading to 
approximately 120 pediatric label changes. According to the most recent 
General Accountability Office study on BPCA, issued March 22, 2007, 
prior to enactment of the Food and Drug Administration Modernization 
Act few drugs were studied for pediatric use. As a result, there was a 
lack of information on optimal dosage, possible side effects, and the 
effectiveness of drugs for pediatric use. Almost all the drugs--about 
87 percent--that have been granted pediatric exclusivity under BPCA 
have had important labeling changes as a result of pediatric drug 
studies conducted under BPCA. Exclusivity is working.
  Senator Dodd tried to change the Best Pharmaceutical for Children Act 
by decreasing the exclusivity for some drugs. At a Health, Education, 
Labor, and Pension Committee hearing, witnesses expressed concern about 
Senator Dodd's idea and speculated whether it would decrease the number 
of drugs studied for pediatric indications. I am pleased that the final 
bill does not include that misguided change to the pediatric program.
  From the beginning of the HELP Committee's consideration of the drug 
safety issue I recognized the need to clarify existing authority or 
provide the FDA with a few new authorities in order to improve the 
interaction between the FDA and drug companies on safety issues. It was 
clear that labeling changes and clinical trials and studies were two 
key areas in which Congress should act.
  To that end, I offered an amendment during the committee markup that 
provided the Secretary with additional authority and control over a 
drug or biological product's approved labeling, including the authority 
to require the holder of an approved application to make safety-related 
changes following an accelerated labeling review process. Under the new 
procedures added by my language, if either the Secretary or the holder 
of an approved application became aware of ``new safety information'' 
that the party believed should be included in the labeling, the other 
party should be notified promptly, and discussions should be initiated 
regarding whether a labeling change is needed and, if so, the content 
of any such labeling change.

  That construct made sense to me and it made sense to Chairman Kennedy 
who passed the amendment by unanimous consent. Given that current 
practice today is for a company to call the FDA when they become aware 
of new safety information, I thought it was a good idea to put current 
practice into statutory law. I want companies and the FDA to talk to 
each other about drug safety issues.
  I support the safety labeling language in H.R. 3580, which reinforces 
the FDA's broad authority over prescription drug labels. These 
provisions allow the FDA to mandate changes to a drug's approved 
labeling whenever the FDA becomes aware of new safety information that 
it believes should be communicated in the labeling. Although the FDA 
already has broad authority over drug labeling and must approve all but 
the most minor labeling changes, this provision will enhance FDA's 
authority and help to ensure that labeling changes are made 
expeditiously using a process that facilitates dialogue between the 
drug company and the FDA. FDA has comprehensive authority over the 
regulation of drug products, particularly drug labeling, and this 
provision further accomplishes that goal.
  As I said earlier, I have three main concerns with H.R. 3580. First, 
the bill is a complex web of regulation. It is going to take months, if 
not years, for drug companies and the FDA to understand all of the new 
regulations. I supported improving the FDA's authority in two areas: 
safety labeling changes, and clinical studies and trials. This bill 
goes far beyond those two areas and sets up a structure called REMS--
Risk Evaluation and Mitigation Strategy. The REMS does not add any 
significant new authority. The FDA currently uses Risk Maps which do 
the same things as REMS. Now Risk Map regulations, which have never 
been studied for their effectiveness, are becoming law. It means more 
paperwork, deadlines, and checkpoints for drug companies, with

[[Page S11839]]

no guarantee that it will improve patient safety. I do not support 
regulation for the sake of regulation.
  Second, H.R. 3580 expands the scope of the Government's current 
clinical trials website, www.clinicaltrials.gov, and adds clinical 
trial results. I understand the desire of some members to make clinical 
trials transparent and the desire of scientists to have as much access 
as possible to clinical trial data. But I am very concerned that 
average citizens will not understand all of the complex scientific 
information being presented to them and instead of talking to their 
physicians to understand the data about adverse events, primary and 
secondary outcomes, and baselines, they will instead avoid taking drugs 
that could make them feel better or save their lives. I hope that the 
National Institutes of Health and the Food and Drug Administration are 
very careful while implementing this title of H.R. 3580. If expanded 
improperly, clinicaltrials.gov will frighten people, not educate and 
assist them.
  Third, this legislation changes the FDA process for granting waivers 
for participation on advisory committees. The FDA has 23 advisory 
committees that meet to discuss applications pending before the FDA and 
other issues. Currently, only four of those advisory committees have 
complete membership. Serving on an advisory committee is not a 
glamorous job, even though we rely on those committees to guide the 
FDA's approval and regulatory processes. Understandably, scientists 
that serve on the committees have more to gain from doing their 
research and making tenure, than working part-time for the Government. 
Given all of those issues, instead of creating incentives to work on 
the committees, this legislation makes it more burdensome and complex. 
People have expressed concern about biased committee members, but the 
facts demonstrate that the FDA is quite vigilant about screening 
individuals to serve on the committees. And the FDA has been working on 
new regulations to strengthen the screening process even more. I hope 
that we do not see a slowdown in the drug approval process due to an 
inability to fill the membership of advisory committees.
  Senator Brown and I also worked on language that would help bring new 
antibiotics and generic versions of old antibiotics to market. At the 
last minute, that language was stripped out of the House bill in order 
to pay for a half month of pediatric exclusivity. I hope that 
Representatives Dingell and Barton hold to their promise of moving that 
antibiotics legislation in the near future.
  Overall, I am disappointed that necessary FDA reauthorizations became 
vehicles for legislation that need more work, are overly broad, and 
will weigh down the FDA at a time when we need to be helping, not 
hurting, the FDA.
  Mr. COBURN. Mr. President, today the full Senate will probably agree 
to legislation--H.R. 3580, the Food and Drug Administration Amendments 
Act of 2007--that constitutes a massive overhaul and expansion of the 
Food and Drug Administration's authorities. Up until a couple days ago, 
determining the scope and details of the bill was an open and 
bipartisan process. Unfortunately, all of that changed at the eleventh 
hour and we were locked out of discussions to determine what a final 
product would look like. Now we are forced to either accept what we do 
not fully agree with or cause thousands of FDA employees to lose their 
jobs. This is not the way to ensure that we ``get it right'' with drug 
safety.
  While this bill achieves the important and necessary objectives of 
reauthorizing the Pediatric Research Equity Act, the Best 
Pharmaceuticals for Children Act, the Pediatric Medical Device Safety 
and Improvement Act, the Prescription Drug User Fee Amendments, the 
Medical Device User Fee Amendments, and establishing a scientifically-
based surveillance system for drug safety risks. There was still 
important work to be done to complete a bipartisan product. Because of 
unfair Democratic Majority tactics I and my colleagues have no 
opportunity to further amend and perfect this legislation.
  Furthermore, I am frustrated that certain important provisions were 
removed from the final language of the bill at the last minute. We lost 
a provision to provide incentives for developing new antibiotics--a 
disastrous decision at a time when we are seeing a huge rise of 
antibiotic resistance in this country. Last minute negotiators also 
refused to recognize that patients desiring marijuana for medical 
purposes deserve to know critical information about whether or not 
marijuana can be safely used. Finally, the final bill did not contain 
an important Senate-passed resolution to protect American 
pharmaceutical companies' intellectual property rights around the 
globe.
  This legislation is a very delicate balancing act. No drug is 
completely safe--otherwise a doctor's prescription wouldn't be needed--
but we do have to ensure that lifesaving medicines are able to get to 
patients. New authorities in the area of Risk Evaluation and Mitigation 
Strategies, REMS, labeling, and postmarket commitments should not be 
taken lightly. These new authorities we are giving the FDA need to be 
used based on a measured assessment of risk vs. benefit in the intended 
patient population. For instance, labeling changes should only be 
undertaken when reliable data clearly shows safety problems that are 
not already reflected in the drug's label. If that data happens to come 
from a third party unknown to the application holder they should have 
the opportunity to review it along with the Agency so that appropriate 
labeling changes can be made based on sound science.
  Another new authority granted to the FDA in a REMS is possible 
restrictions on distribution and use. If used, this restriction has the 
potential to impede patient access to important therapies and therefore 
should not be imposed where less burdensome approaches are available. 
This concept of a ``less burdensome approach'' is an important one and 
it is essential that product manufacturers have the opportunity to 
present alternative proposals to the Agency that would accomplish the 
goal of safety without imposing unduly restrictive actions to products 
and ultimately to patients. This legislation establishes that the FDA 
will not limit or restrict distribution or use unless a drug has been 
shown to actually cause an adverse event. We absolutely need FDA to 
have all the tools necessary to ensure the safety and efficacy of 
drugs, but doctors need tools as well, and one of those important tools 
is new drugs on the market. I appreciate the significant changes that 
were made in this language of the bill between Senate HELP Committee 
markup and full Senate consideration. These improvements remain in the 
final bill and are critical to ensure that physicians--not the FDA--can 
make risk/benefit decisions with their patients.
  This bill ensures that the FDA has broad and exhaustive authorities 
to make sure that drug companies are doing the right and 
scientifically-justified thing when it comes to drug safety and the 
labeling of their drugs. This authority is placed rightly in the hands 
of highly-trained scientists at the FDA. It is clear that Congress 
relies on the scientists at the FDA to assess safety risks and 
drug labeling and this should be squarely and solely the FDA's role--
that is why we have spent months and months trying to get this issue of 
drug safety right. The newly expanded role of the FDA does and should 
preempt State law when it comes to drug safety and labeling. In order 
to ensure scientific drug safety the last thing that we need is the 
regulatory nightmare of every State court being a mini-FDA.

  Let me be clear, the FDA is the expert Federal agency charged by 
Congress with ensuring that drugs are safe and effective and that 
product labeling is truthful and not misleading. Appropriate preemption 
of State jurisdiction includes not only claims against manufacturers, 
but also against health care practitioners for claims related to 
dissemination of risk information to patients beyond what is included 
in the labeling.
  Product liability lawsuits have directly threatened the FDA's ability 
to regulate manufacturer dissemination of risk information for 
prescription drugs. I note a recent case in California, Dowhal v. 
SmithKline Beecham, where trial lawyers tried to assert that a drug 
company had failed to warn consumers that nicotine-replacement products 
allegedly cause birth defects--even though there wasn't scientific 
evidence to back that up. In this case, the FDA had previously told

[[Page S11840]]

SmithKline Beecham that they should not include such an unscientific 
warning in its label because it would clutter up the label's warnings 
that actually were scientifically justified. A California court 
asserted that more warnings were always better. Subsequently, that 
assertion was overruled unanimously by the California Supreme Court as 
the FDA again asserted that its scientific judgment should prevail. The 
case was not properly before the court by operation of the doctrine of 
primary jurisdiction. Unless State law is preempted in this area, State 
law actions can conflict with the FDA's interpretations and frustrate 
the FDA's implementation of its statutory and scientific mandate.
  Should the FDA's scientific judgment on drug safety and labeling be 
set aside, we would risk eroding and disrupting the truthful 
representation of benefits and risks that medical professionals need to 
make decisions about drug use. As a physician, I know that exaggeration 
of risk can discourage the important and right use of a clinically 
therapeutic drug. Superfluous liability concerns can create pressure on 
manufacturers to expand labeling warnings to include merely speculative 
risks and limit physician appreciation of potentially far more 
significant contraindications and side effects.
  I note that the FDA has previously stated that ``labeling that 
includes theoretical hazards that are not well grounded in scientific 
evidence can cause meaningful risk information to `lose its 
significance.' Overwarning, just like underwarning, can similarly have 
a negative effect on patient safety and public health.'' In this bill, 
we have created a clear labeling pathway between the FDA and a drug 
sponsor in this bill to ensure that consumers get scientifically 
accurate and appropriate warning of drug safety risks.
  Furthermore, if not preempted in drug safety information and 
labeling, State law could conflict with achieving the full objectives 
of Federal law if it precludes a firm from including certain labeling 
information. If a manufacturer then complies with State law, the firm 
would be omitting a statement required under Sec. 201.100(c)(1) as a 
condition on the exemption from the requirement of adequate directions 
for use, and the omission would misbrand the drug under 21 U.S.C. 
352(f)(1). The drug might also be misbranded on the ground that the 
omission is material within the meaning of 21 U.S.C. 321(n) and makes 
the labeling or advertising misleading under 21 U.S.C. 352(a) or (n).
  While it is true that a manufacturer may, under FDA regulations, 
strengthen a labeling warning on its own, it is important to understand 
that in practice manufacturers typically consult with FDA before doing 
so. Otherwise they could risk enforcement action if the FDA ends up 
disagreeing.
  Some misunderstand the FDA's labeling requirements to be a minimum 
safety standard and have used State law to force manufacturers to 
supplement safety regulation beyond that required by FDA. I want to be 
clear that the FDA's labeling requirements establish both a ``floor'' 
and a ``ceiling.'' Therefore, risk information beyond what is required 
by the FDA could be considered unsubstantiated or otherwise false or 
misleading. Given the comprehensiveness of FDA regulation of drug 
safety, effectiveness, and labeling additional requirements for the 
disclosure of risk information are not necessarily more protective of 
patients.
  Finally, I want to specifically comment on language in H.R. 3580 that 
includes a new mechanism to further encourage the timely and accurate 
communication of new safety information on prescription drug labels. 
That mechanism reiterates the FDA's primacy in determining the content 
of prescription drug labeling, including through the new power to 
command a safety labeling change. New section 505(o)(4)(I) also makes 
clear that this enhanced safety labeling mechanism does not affect the 
obligation of a company to maintain a drug product's labeling in 
accordance with FDA's regulations, including 21 C.F.R. Sec. 314.70. 
This provision is meant to confirm the basic obligation of a drug's 
sponsor to propose--or, in some cases, make--changes to the approved 
labeling to reflect changes in the conditions established in the 
approved application and/or new information. Nothing in this rule of 
construction changes that obligation or FDA's ultimate authority over 
drug labeling; nor is it intended to change the legal landscape in this 
area. That is because there is an overriding Federal interest in 
ensuring that the FDA, as the public health body charged with making 
these complex and difficult scientific judgments, be the ultimate 
arbiter of how safety information is conveyed. In this manner, there 
can be confidence that uniform drug labeling conveys clear, consistent, 
and scientifically justified safety and medical information.
  In fact, the courts have repeatedly upheld FDA's supremacy over 
prescription drug labeling in cases brought under State law. Nearly 20 
years ago, the U.S. Court of Appeals for the Fifth Circuit emphasized 
that ``. . . manufacturers cannot change the language in the product 
insert without FDA approval,'' and accordingly ``[i]t would be patently 
inconsistent for a state then to hold the manufacturer liable for 
including that precise warning when the manufacturer would otherwise be 
liable for not including it.'' Hurley v. Lederle Labs. Div. of Am. 
Cyanamid Co., 863 F.2d 1173, 1179 (5th Cir. 1989). As a more recent 
Court expressed this bedrock principle, allowing a State to decide what 
warnings are appropriate, and thus potentially subject companies to 
liability for otherwise FDA-approved labeling, would upset the careful 
benefit-risk balance that FDA has struck in approving a product for 
market, and doing so would ``undermine FDA's authority to protect the 
public health through enforcement of the prohibition against false and 
misleading labeling of drug products in the Federal Food, Drug and 
Cosmetic Act.'' Sykes v. Glaxo-SmithKine, 484 F. Supp. 2d. 289, 312 
(E.D. Pa. 2007) (internal quotation omitted) .


                          citizens' petitions

  Mr. HATCH. Mr. President, I wish to take this opportunity to clarify 
one issue related to the language on citizens' petitions and petitions 
for stay of agency action which is included in FDARA. As my colleagues 
are aware, I was a cosponsor of the citizens' petition amendment 
included in the Senate-passed bill, and I was pleased to work closely 
with my colleagues in the Senate--Senators Kennedy, Enzi, Brown, 
Stabenow, Lott and Thune to develop an acceptable compromise with the 
House. I understand the importance of making certain that generic drug 
approvals are not delayed unnecessarily, which is the intent of this 
amendment.
  Mr. KENNEDY. Indeed, that was an important objective of the Food and 
Drug Administration Amendments Act, and I agree the citizens' petition 
language is an integral part of the final legislative effort.
  Mr. HATCH. As my colleagues are aware, we had a number of discussions 
about this provision, and one issue we worked hard to balance was the 
need for the Food and Drug Administration to have adequate time to 
review any meritorious issues raised by a petitioner against the 
importance of not holding up the Abbreviated New Drug Applications--or 
ANDAs--or applications submitted under section 505(b)(2) of the Federal 
Food, Drug and Cosmetic Act. Our colleagues, Senators Brown and 
Stabenow, were particularly forceful in their arguments that there 
should be a deadline for FDA action on a petition, but that the agency 
could have the ability to delay review of an application if it found 
that the petition raised a legitimate public health issue.
  My concern, which I want to discuss with the chairman, goes to the 
discussions we had about the operation of that language. In particular, 
I want to discuss the ability of the agency to conserve its resources 
and not waste time acting on petitions that do not merit review. 
Indeed, the concept we discussed over the course of many days was that 
the agency would have the ability to deny a petition or a supplement if 
the petition were based on meritless or frivolous issues. We all 
recognized, however, that defining ``meritless'' and ``frivolous'' is 
imprecise at best. So, the final language contained in the bill we 
consider today says that the agency may deny a petition at any point if 
the Secretary determines that it was submitted ``with the primary 
purpose of delaying the approval of an application and the petition 
does not on its face raise valid scientific or regulatory issues . . 
.''
  MR. KENNEDY. The Senator from Utah is correct.

[[Page S11841]]

  Mr. HATCH. One concern that I raised, which we all agreed would have 
been included in the conference report language had we filed such a 
report was a clarification about the meaning of ``scientific or 
regulatory issues.'' It was our agreement during negotiations on FDARA 
about what is perhaps an obvious point: if the law requires a delay in 
approval of an ANDA or 505(b)(2) application, for example because of a 
patent or an exclusivity, this new provision will not change that 
required legal result. The law is the law, and its effect should not 
depend on whether or not it was brought up in a petition to FDA. I 
would appreciate the chairman clarifying if that was the agreement we 
had.
  Mr. KENNEDY. I do agree. Let us be clear: The citizen petition 
provision is designed to address attempts to derail generic drug 
approvals. Those attempts, when successful, hurt consumers and the 
public health. The citizen petition provisions are not intended to 
alter laws not amended by the provision. I thank the Senator.


                          Medicare Claims Data

  Mr. BAUCUS. Mr. President, today we have before us an important piece 
of legislation, the FDA Amendments Act of 2007. It has come to my 
attention that this bill includes a section that makes an effort to 
authorize the FDA to use and release Medicare claims data for use in 
postmarket surveillance of drugs approved by the FDA. I fully support 
the goal of making drugs safer for all Americans.
  As chairman of the Finance Committee, however, I am obligated to 
point out that any use of Medicare data is exclusively governed by 
title XVIII of the Social Security Act, and that the Finance Committee 
has exclusive jurisdiction over title XVIII. I would ask the 
distinguished chairman of the Health, Education, Labor and Pensions 
Committee, Senator Kennedy, to acknowledge that the Senate Finance 
Committee has sole jurisdiction over Medicare data and title XVIII of 
the Social Security Act and ask that he endeavor to consult us on 
matters before the HELP Committee that touch on the Senate Finance 
Committee's jurisdiction. I make the same commitment to him that he 
makes to me: I will commit to consult on matters before the Finance 
Committee that touch on the Senate HELP Committee's jurisdiction.
  To avoid unnecessary confusion as to the jurisdiction of the Finance 
Committee or further delay in the consideration of this important 
conference agreement, I would agree to accommodate your request to 
withhold any objection to the Senate's consideration of it with the 
acknowledgement that the release and use of Medicare data are governed 
by title XVIII of the Social Security Act and are under the exclusive 
jurisdiction of the Finance Committee. This does not represent any 
waiver of jurisdiction on the part of the Finance Committee on this 
subject.
  I would ask the chairman of the HELP Committee, Senator Kennedy, 
whether he would agree to this request.
  Mr. KENNEDY. It is a great pleasure to work with my distinguished 
colleagues from the Finance Committee on this reauthorization of 
important programs at the FDA. I know they have a deep interest in 
seeing that the medicines that Americans take are safe and effective.
  Senator Baucus and Senator Grassley have rightly raised a question 
regarding the interpretation of section 905 of this bill. Section 905 
adds a new paragraph (3) to section 505(k) of the Federal Food, Drug 
and Cosmetic Act. This new paragraph establishes a system for FDA to 
query databases regarding information that may help detect adverse drug 
effects. It is essential to detect drug safety problems early, so that 
they may be corrected before people are hurt and an electronic drug 
safety system is one important tool for doing so.
  The Medicare claims database is listed as one of several possible 
sources of data in section 505(k)(3)(C)(i)(III)(aa). I want to assure 
my friends from Montana and Iowa that our intent is that Medicare's 
participation will be determined by provisions of the Social Security 
Act, over which the Finance Committee has exclusive jurisdiction. 
Nothing in this section is intended to infringe on that jurisdiction or 
to in any way preempt the ability of the Finance committee to act to 
specify the participation or nonparticipation of the Medicare claims 
data base in the system established under section 905.
  The matter before the Senate amends the Federal Food, Drug and 
Cosmetic Act. The section to which you have raised concerns authorizes 
use of Medicare data ``as available.'' I acknowledge that under current 
law, that is not possible.
  Mr. BAUCUS. I thank the chairman. I intend to continue working with 
my good friend Senator Grassley to address the release and use of 
Medicare data by Federal health agencies and private researchers soon 
through legislation written by the Finance Committee.
  Mr. GRASSLEY. I agree with my colleague, Senator Baucus. I have been 
working a long time on legislation to permit the use of Medicare data 
to improve drug safety. After all this is some of the best and most 
complete data available. In fact, Senator Baucus and I joined together 
to introduce legislation to accomplish just that during the 109th 
Congress, S. 3987, the Medicare Data Access and Research Act, and this 
Congress, S. 1507, the Access to Medicare Data Act of 2007. Improving 
drug safety is a top priority of mine and the appropriate use of 
Medicare data will likely enhance drug safety. That will benefit all 
Americans. I look forward to completing our goals for Medicare data 
later this year and including this on legislation within the purview of 
the Finance Committee. We intend to clarify how Federal health agencies 
may use and release Medicare data and make the appropriate amendments 
in the Social Security Act. At that point, it will be important that 
the use of Medicare data be appropriately tied into the drug safety 
provisions of the FDA bill under consideration today. We would hope 
that our colleague, Senator Kennedy, would agree to make conforming 
amendments to the Federal Food, Drug and Cosmetic Act as needed to make 
FDA law consistent with appropriate Medicare law.
  Mr. KENNEDY. I appreciate that conforming amendments in the Federal 
Food, Drug and Cosmetic Act may be necessary as you point out. I agree 
to work with the Senator in the future on this issue.
  Mr. KENNEDY. Mr. President, I ask unanimous consent that the bill be 
read a third time, passed, the motion to reconsider be laid upon the 
table, and that any statements relating to the bill be printed in the 
Record, without further intervening action or debate.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The bill (H.R. 3580) was ordered to a third reading, was read the 
third time, and passed.
  Mr. KENNEDY. Mr. President, the New England Journal of Medicine, 
which is probably the most distinguished medical journal in not only 
this country, probably in the world, has made the comment that this 
legislation is the greatest progress, in terms of drug safety, in a 
century. This ought to be reassuring for every family as to the safety 
of their prescription drugs and also in terms of their food.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KERRY. Mr. President, I congratulate my colleague from 
Massachusetts on another landmark piece of legislation that he has been 
able to shepherd through this institution. It adds to a remarkable 
string of legislative accomplishments.
  We are all pleased this important reform effort and advance is going 
to be made. It is a terrific step forward. I congratulate Senator 
Kennedy, Senator Enzi, and others on the committee who worked so hard 
to make it happen.

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