[Congressional Record (Bound Edition), Volume 153 (2007), Part 18]
[Senate]
[Pages 25160-25164]
[From the U.S. Government Publishing Office, www.gpo.gov]




            FOOD AND DRUG ADMINISTRATION REFORM LEGISLATION

  Mr. KENNEDY. Madam 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 two cents a day for each 
citizen.
  An agency that does so much so well deserves to be supported and 
strengthened. Yet too often, the opposite has been true. FDA's vital 
mission has been jeopardized by inadequate resources, occasionally 
insufficient legal authority, and absent leadership.
  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 the Senate has approved.

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  The prestigious New England Journal of Medicine editorialized earlier 
this year that the bill was ``the most important drug-safety 
legislation in a century.''
  Earlier this week, the House of Representatives approved this 
bipartisan measure by a broad bipartisan margin 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. I am 
pleased that the Senate did the same, sending that bill to the 
President with a unanimous voice of approval.
  The stakes could not be higher. Funding for the FDA's vital safety 
mission has reached the breaking point. If we had not acted, the FDA 
Commissioner would have sent a letter today to over 2,000 employees 
informing them that their jobs were slated for termination.
  Each of those individuals is a trained and experienced professional 
with many career options in academia or industry--yet each of them has 
made the decision to devote themselves to public service. If those 
talented public servants had left the agency, the consequences would 
have been with us for years--in terms of slower access to medicines for 
patients, weaker safety oversight and loss of America's competitive 
edge in the life sciences.
  FDA has an urgent need for these funds. Its workload has increased 
massively in recent years but its resources have not kept pace. Since 
1990, the number of adverse events submitted to the FDA has increased 
by over 1,300 percent, but the agency's resources have increased only 
130 percent. The legislation provides over $400 million this year for 
the review of drugs and medical devices at FDA, and over $50 million 
for needed safety reforms to give these talented professionals the 
tools they need to do the job we are counting on them to do.
  The bill before us is not just about resources--far from it. It is a 
strong and comprehensive measure to improve the safety of the medicines 
we rely on, and it takes important steps toward a safer food supply and 
less expensive prescription drugs.
  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. For drugs that pose little risk, these actions might be as 
simple as a program to report side effects and a label with safety 
information--items that are currently required for all drugs. Drugs 
that raise major potential safety concerns might require additional 
clinical trials, a program to train physicians in using the drug 
safely, or a requirement that the prescribing physician have special 
skills.
  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. 
During the discussions that led to consideration of this bill, we heard 
time and again that there was a major need for better research tools to 
aid FDA in evaluating the safety of drugs and devices and help 
researchers move through the long process of developing these products 
more effectively.
  If new research tools and better ways to evaluate the safety and 
effectiveness of drugs could be developed, patients will benefit from 
quicker drug development. If current procedures can be made more 
effective, then the cost of developing new drugs will drop.
  The Reagan-Udall Foundation sets up a way to develop these new 
tools--not so they can help just one researcher or one company, but so 
they can help the entire research enterprise.
  The bill helps preserve the integrity of scientific review by 
improving FDA's safeguards against conflicts of interest on its 
scientific advisory committees--not through a rigid policy that could 
deny FDA needed expertise, but though a flexible approach that will 
reduce the number of waivers given for conflicts of interest at FDA 
overall.
  The bill also takes action on the abuse of citizens petitions. FDA 
has a commonsense policy to allow ordinary citizens or medical experts 
to submit petitions to the agency about drugs that it is considering 
approving. This procedure should be used to protect public health--but 
too often, it is subverted by those who seek only to delay the entry 
onto the market of generic drugs.
  Even if the petitions are found to be meritless, they will have 
accomplished their mission--delaying access for consumers to safe and 
lower cost medicines. Some petitions do present legitimate public 
health concerns, and FDA should not ignore them. The critical test of 
any proposal on citizen petitions is that it strike a balance so that 
the abuse of citizens petitions is prohibited, but those petitions that 
have genuine safety information are reviewed.
  The proposal the Senate approved strikes that balance. 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 protects 
health.
  The legislation also includes important reforms of direct to 
consumer, or DTC, advertising. I want to 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, conspicuous 
and neutral, 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.
  Our legislation also takes important first steps toward a safer food 
supply. These are only first steps, and our committee will work on a 
comprehensive package of food safety legislation later 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 congratulate my colleagues on approving this legislation, and 
look forward to working with them on its effective implementation.
  The comprehensive legislation approved by the Senate is over 400 
pages long, and it reflects important contributions from many, many of 
our colleagues.
  My partner in this effort from Day One has been my friend and 
colleague

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from Wyoming, Senator Mike Enzi. Our work on drug safety began when he 
chaired our committee and I was Ranking Member--and our work didn't 
miss a beat when our roles were reversed after last year's election.
  I also commend Senator Dodd, Senator Clinton, and Senator Alexander 
for the important contributions they made to bring new drugs to 
children. I regret that several of these important provisions were not 
included in the bill, but I will work with them to see if those 
worthwhile proposals can be included in other legislation.
  Senator Gregg contributed important proposals on using health 
information technology to improve FDA's ability to detect drug safety 
problems. No drug is free from risk, and FDA needs the best possible 
methods to detect unexpected risks as quickly as possible.
  No Senator is more justly proud of the good work that FDA does than 
Senator Mikulski. Her state of Maryland has two of the great jewels of 
the federal government--the National Institutes of Health and the Food 
and Drug Administration, and her proposals to increase the transparency 
of FDA operations were included in the bill.
  Senator Hatch and I have worked together on the life sciences for 
many years. Whether the issue is stem cells or biologics or the FDA 
itself, Senator Hatch is always at the forefront of the debate--and the 
bill includes important provisions he offered to accelerate the 
development of new cutting-edge drugs.
  The proposal on citizens petitions in this legislation is a true 
bipartisan effort--uniting Senators Stabenow, Brown, Lott, Hatch and 
Thune. These Senators were deeply committed to this proposal, and they 
participated actively in the final negotiations on the bill.
  Senator Roberts and Senator Harkin collaborated productively to 
develop an effective and workable proposal on direct-to-consumer 
advertising that both protects consumers and respects the Constitution.
  A number of other colleagues also made major contributions to this 
bipartisan achievement. Senator Obama offered provisions on genetic 
testing. Senator Reed contributed a proposal on the safety of tanning 
beds. Senator Brown and Senator Brownback came up with new and 
thoughtful incentives for new treatments for neglected tropical 
diseases. Senator Dorgan contributed provisions on counterfeit drugs. 
Senator Rockefeller added provisions to increase reporting on 
authorized generics, and Senator Coburn contributed provisions to allow 
FDA to restrict the use of approved medicines only when the drug cannot 
otherwise be prescribed safely.
  I especially commend Senator Richard Burr. No Senator is more 
committed to the search for innovations in the life sciences than he 
is. Senator Burr and his staff were skillful and tireless in their 
support for strong measures in the bill to see that FDA has the 
resources it needs to review new drugs quickly and effectively. No 
Senator worked harder to see that our deliberations on this bill were 
successful.
  Finally, I thank our colleagues from the House of Representatives. 
Chairman John Dingell of the Energy and Commerce Committee and Chairman 
Frank Pallone of the Health Subcommittee steered this legislation 
through the House. They worked in close partnership with the Ranking 
Members, Representative Joe Barton and Representative Nathan Deal. 
Other House members made major contributions to the bill, as well, and 
I particularly commend Representatives Henry Waxman and Ed Markey for 
their leadership.
  Finally, I thank the dedicated staff members who worked so long and 
hard and well on this legislation:
  Shana Christrup, Amy Muhlberg, Keith Flanagan, and Dave Schmickel 
from Senator Enzi's office; Liz Wroe with Senator Gregg; Jenny Ware 
with Senator Burr; Tamar Magarik and Jeremy Sharp with Senator Dodd; 
Ann Gavaghan with Senator Clinton; John Ford, Bobby Clark, Ryan Long 
and John Little of the House Energy and Commerce Committee; and my own 
staff: David Dorsey, David Bowen and Michael Myers.
  They all spent long hours over many months on the many complex 
provisions in this bill. Our efforts could not have been successful 
without them, and millions of Americans will benefit from their ability 
and dedication in the years ahead.
  I thank the Chair and thank the Senator from Indiana for his 
courtesies.
  The PRESIDING OFFICER. The Senator from Wyoming is recognized.
  Mr. ENZI. Madam President, I thank you, and I especially thank the 
Senator from Indiana who has been waiting an hour and a half to speak 
and was kind enough to let us fit into the schedule. We needed to do 
this because so often around here, when something is done in such a 
bipartisan manner that it passes unanimously, nobody ever hears about 
it.
  This isn't something we are trying to force through, this isn't 
something that there are a lot of arguments about, but it is something 
essential to the American people: their food and drug safety. We are 
the best country in the world at doing it. We can do it better. This 
bill lets us do it better. Is it a perfect bill? That never happens 
around here. Is it a big victory for patients and children? Absolutely.
  This actually incorporates four reauthorizations and one massive 
reform. We take care of a lot of things in this package that normally 
would take a lot of hours on the floor, but because of the 
participation from both sides of the aisle, and from everybody 
intensively on the committee, we were able to put together a bill that 
solves a lot of problems.
  The FDA's choice before was to pull a drug off the market or to leave 
it on. If it had some kind of a problem that could be solved some 
simple way, it wasn't an option; pull it off or leave it on. We gave 
them a toolbox, a whole bunch of different things that they can now do 
so that drugs will be approved faster, and then when that clinical 
trial that we call the whole population of the United States kicks in, 
there is a mechanism for following all of those and finding small 
samples of problems, solutions to those small samples of problems, and 
the drug that is working for people across this Nation doesn't have to 
be pulled off the market. It can still work for the people who aren't 
affected by an adverse reaction. That is a major change we have been 
able to make.
  I wish to thank all the people involved, particularly the people on 
the committee who took separate parts of this and dug into it and came 
up with solutions--not solutions that would polarize us but solutions 
that would bring us together. The American people don't get to hear 
much about the solutions that bring us together. They get to hear hour 
after hour after hour of the things that have been polarized and that 
drive us apart. I want them to know there are things that get solved 
around here such as food and drug safety, a big thing for this country. 
It was done, and it was done unanimously. Now that means the House's 
version that was negotiated with the Senate's version was put together 
in such a way that we agreed with it. America needs to know that.
  The FDA is the gold standard among public health regulators the world 
over. For the past century, the FDA has protected the public--from 
filthy conditions in meatpacking plants to thalidomide, which caused 
thousands of birth defects in Western Europe. The FDA's constant 
vigilance is something we have come to depend on every day to protect 
us and our children.
  Beginning in January 2005, the Senate Committee on Health, Education, 
Labor and Pensions conducted a top-to-bottom review of the FDA's drug 
safety and approval processes. Given the limitations we identified 
during our review of FDA, I strongly felt it was necessary to correct 
those problems and ensure that FDA has the right tools to address drug 
safety after the drug is on the market. New authorities were clearly 
needed, and H.R. 3580, the Food and Drug Administration amendments of 
2007, provides those authorities.
  The changes made in the drug safety components of this legislation 
are critical to restoring peace of mind to

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Americans who want to be assured that the drugs they take to treat 
illnesses and chronic medical conditions can be relied upon and 
trusted. The broad new authorities in this legislation are the most 
significant change to FDA in at least a decade. The sweeping new 
authorities provided by this bill will only strengthen the agency's 
ability to safeguard the American people.
  This bill gives FDA a full toolbox of options for dealing with 
potential safety problems, even if they are discovered after a drug is 
first marketed. FDA will be able to proactively react to additional 
safety information whenever that safety information is discovered, even 
after the drug is on the market. FDA will have the ability to identify 
side effects through active surveillance, and the authority to request 
a study or clinical trial to learn more about a potential safety 
problem. But perhaps most significantly, FDA will be able to obtain 
timely label changes in response to that safety information.
  The label is the most important communication mechanism for patients 
and providers about a drug's benefits and risks. Patients and doctors 
need to know that they can rely on the drug label for accurate 
information. To ensure that science is the guiding principle for all 
information with the drug label, the FDA must be the sole arbiter of 
what is and is not in the label. This legislation provides one strong, 
clear pathway to update a drug label in response to new information. We 
rely on FDA to get the label right, and this bill provides broad 
authority to do that, significantly strengthening FDA's hand in 
securing changes to the label. By providing this single, expedited 
pathway for safety labeling changes, it is clear that Congress intends 
there to be one standard for protecting all Americans the FDA gold 
standard. We should not be second-guessing the FDA and its science-
based decisions but continuing to rely on the agency to provide 
accurate information regarding a drug's benefits and risks.
  I thank the Senator from Indiana for letting us take a few minutes to 
voice this so there would be some knowledge out there of something 
happening that is good and in a bipartisan way and gets accomplished. I 
wish I had time to name all the people and the contributions they made 
to this. I hope people will take a look at the record and see all of 
these people, not just Senators, not just House Members, but the staffs 
who worked on this overtime, for hours at night, for hours on the 
weekend, to be able to resolve it by today. Why is today important? 
Because if we didn't get this finished today and assure that the 
companies which help fund the efforts of the FDA would come in, there 
would have had to be RIF notices to about 2,000 Federal employees today 
who would be laid off. So we were up against a tight time deadline and 
we met the time deadline and did it in a very bipartisan way.
  Mr. GREGG. Madam President, I rise today to speak about the passage 
of the Food and Drug Administration Amendments of 2007. This bill 
includes the reauthorizations of the Prescription Drug User Fee Act, 
PDUFA, and the Medical Device User Fee and Modernization Act, MDUFMA, 
both of which provide an essential source of funding to the FDA to 
ensure faster review times and enhanced patient access to safe and 
effective drugs and devices.
  The bill also reauthorizes two programs that have had a great impact 
on the safety of medicines for children. I support the reauthorization 
of the Best Pharmaceuticals for Children Act, BPCA, and the Pediatric 
Research Equity Act, PREA, in particular the provision that maintains 
the current 6 months of data exclusivity provided under current law to 
create a meaningful incentive for drug manufacturers to perform 
pediatric safety studies. It is because of the great success of these 
two programs that I am pleased that the bill requires both programs to 
be reauthorized together in 2012. This joint sunset date allows for 
further reauthorizations to continue balancing the incentives and 
authorities that drive pediatric study.
  Most of all, I am pleased that the drug safety portion of the bill 
contains provisions from my Safer DATA Act. This language requires the 
FDA to establish and maintain an active surveillance infrastructure to 
collect and analyze drug safety data from disparate sources, such as: 
adverse events reports, Medicare Part D and VA health system data, and 
private health insurance claims data. The private sector and many 
academic institutions have had these capabilities for years. With this 
legislation, the FDA will finally have access to the best information 
possible.
  The legislation also directs the FDA to establish drug safety 
collaborations with private and academic entities to perform advanced 
research and further analysis of drug safety data once the surveillance 
system detects a serious risk.
  And finally, to enhance risk communication, the language establishes 
a one-stop shop web portal to give patients and providers better access 
to drug safety information, including aggregate information from the 
surveillance system.
  I congratulate Senator Kennedy and Senator Enzi for their support of 
the inclusion of this provision and for their efforts to get this bill 
finalized before the September 21 deadline.
  We have consistently heard from HHS Secretary Leavitt and 
Commissioner Von Eschenbach over the past few months that if we failed 
to complete the reauthorizations of PDUFA and MDUFMA by September 21, 
they would be required to issue reduction-in-force--RIF--notices to FDA 
drug and device reviewers--the key staffers who are on the front lines 
of ensuring the safety and efficacy of FDA approved products. In 1997, 
when Congress failed to reauthorize PDUFA on time, the 1 month delay 
caused departures to the extent that it took 18 months for FDA to 
return to full staffing levels. Not only would the issuance of RIF 
notices this year have affected nearly 2,000 FDA employees and their 
families, but it would have essentially obliterated the ability of the 
agency to fulfill its public health mission.
  So it may be surprising to some, that the key obstacle to finishing 
this bill over the last few weeks was the House Democratic leadership's 
insistence on a provision that they included on behalf of their most 
precious constituents--not the FDA employees, not the scientists, not 
even the patients, but the trial lawyers.
  Yes, included deep in section 901 of this bill is a one-sentence rule 
of construction that makes the obvious statement that, notwithstanding 
the new authority granted to the FDA under this bill to require 
labeling changes; it is the responsibility of the drug company to 
comply with other regulatory requirements regarding the drug's label. 
This so called ``gift to the trial lawyers'' merely restates current 
law, and is not such a gift at all. Regardless of whether or not the 
drug company or the agency initiates a labeling change, it is the FDA 
that continues to have the express authority to approve, reject or 
modify the labeling of a drug.
  Not only is this rule of construction meaningless, but it pales in 
comparison to the expansive authority given to the FDA throughout the 
rest of the bill's 422 pages. What this bill does at the majority's 
insistence is expand the reach of the FDA's regulatory authority over 
prescription drugs, devices, food, and even tanning beds.
  In addition to the bill's many other provisions, section 901 gives 
the HHS Secretary explicit authority to request certain safety labeling 
changes. If the Secretary becomes aware of new safety information that 
the he or she believes should be included in the labeling for a drug, 
the Secretary may notify the drug company and begin a process to modify 
the label.
  Under existing preemption principles, FDA approval of labeling under 
the Food, Drug, and Cosmetic Act preempts conflicting or contrary State 
law. The determination of whether or not labeling revisions are 
necessary is, in the end, squarely and solely the FDA's. Given the 
comprehensiveness of FDA regulation of drug safety, effectiveness and 
labeling under the Food, Drug, and Cosmetic Act, additional 
requirements for the disclosure of risk communication do not 
necessarily result in positive outcomes for patients,

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but create differing standards that heighten confusion.
  If we had intended through this legislation to give State courts and 
State juries the authority to second guess the scientific expertise of 
the FDA, we would have done so. In fact, based on the totality of the 
bill's 422 pages we have done the opposite. The intent of this 
legislation is explicitly clear. One FDA. One gold standard. One expert 
Federal agency charged by Congress with ensuring that drugs are safe 
and effective and that product labeling is truthful and not misleading.
  The PRESIDING OFFICER. The Senator from Indiana is recognized.
  Mr. LUGAR. Madam President, I unanimous consent to speak as in 
morning business.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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