[Congressional Record Volume 143, Number 128 (Tuesday, September 23, 1997)]
[Senate]
[Pages S9772-S9775]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 
                                  1997

  The Senate continued with the consideration of the bill.
  Mr. KENNEDY. Madam President, we are making substantial progress on 
the FDA bill, and I applaud that progress. We have worked out a number 
of key issues on a bipartisan basis since the committee markup in June. 
We have worked out the issues on fast tracking some innovative 
opportunities for dealing with the special challenges we are facing. We 
built on the fast tracking that we have done on AIDS drugs, and we are 
trying to do more in the areas of cancer and Alzheimer's, following 
what has been an important initiative at FDA for getting drugs out 
faster. We have even worked out differences on the off-label uses of 
various pharmaceuticals and devices and what information and studies 
will be required in terms of safety and efficacy. We have worked out 
the early consultation between device manufacturers and the FDA.
  We have been working toward reducing the total development time. A 
key element in our negotiations has been going upstream and working 
with the pharmaceutical companies, as well as the manufacturers, in 
shaping and formulating their applications so that they will move more 
rapidly through the approval process. Many of these initiatives were 
worked out by Dr. Kessler. We have put them into legislation under the 
leadership of Senator Jeffords and others on the committee. We have 
settled the issues of cosmetics, after good debate and discussion. We 
have also worked our third-party review pilot programs and timeframes 
for some of the drug approvals. Each one of these issues was worked out 
in a way that protects the public health.
  This process continues now with further debate today and tomorrow on 
what I, and others with me, consider to be the most significant threat 
to the public health remaining in the bill. These other areas that are 
complex and difficult, where a wide variety of different positions had 
divided the committee in a significant way. We have

[[Page S9773]]

been able to make important and significant progress in ways that 
advance public health. I believe that we have advanced the interest in 
the public health. This final issue remains and has been identified by 
the President of the United States and the Secretary of HHS as being 
the No. 1 public health risk within this legislation. We had a good 
debate on that issue earlier today and a real engagement of the 
differing ideas. I find that we were able to make important progress. 
The Members realize and recognize what is really at stake. We were 
unable to win the majority of the Members, but we have a substantial 
group of Members who are likewise concerned about the public health 
issues.
  We have heard from the various consumer groups and they are the ones 
that will benefit the most from breakthrough devices. If you read 
through their concern and opposition to the provision in the 
legislation and their strong support for the Reed amendment, you 
understand why we are so concerned about this particular provision.
  The House is in the process of taking up legislation dealing with the 
same subject matter, although they have reached a stalemate with regard 
to the extension on PDUFA. PDUFA, which I certainly support, provides 
the additional resources for the FDA to get the kind of trained 
disciplined personnel that represents the top of our research 
technology to work very effectively in the evaluation of these various 
products.
  As the prime sponsor of that proposal here in the Senate, with my 
friend and colleague, Orrin Hatch, we are clearly strongly in support 
of PDUFA. We tried to take similar action with regard to the medical 
device industry, but we were unable to do that. But we were able to 
accomplish it with the pharmaceutical industry, and it is necessary to 
have this extension.
  The House will take up the FDA. We will continue to work with the 
administration, and with the leaders of the Energy and Commerce 
Committees in the House to make sure the compromises reached in the 
Senate are retained or improved. We will work to make sure that the 
medical device issue that we have been debating on the Senate floor is 
fixed.
  We believe that the Food and Drug Administration should not be faced 
with a situation where a device is submitted with a label that contains 
false and misleading information that would effectively deny FDA an 
opportunity to review the device on its real uses. And deny them the 
authority to require the medical device company to provide information 
relevant to the safety of that medical device.
  There is nothing that we have heard that changes my very view that 
the interests of the American consumer and the American public are best 
protected by strengthening the lead agency for safety--the Food and 
Drug Administration. The agency to which all Americans turn when they 
find that there is tampering with pharmaceuticals, or they are 
concerned about the importation of pesticides on grapes from Chile, or 
they are concerned about drugs and medical devices. We saw that across 
the country this last week with the fen/phen tragedy.
  Now we are being asked to reduce the protections for the American 
people by prohibiting this lead agency, with all its expertise, from 
protecting the public when it comes to medical devices. We are 
handcuffing them from being able to reach out and protect the American 
public when a medical device is falsely labeled. That is a serious 
error on our part.
  A great deal of discussion has taken place in the committee and out 
here on the floor of the U.S. Senate as to the FDA's ability to approve 
medical devices in a timely manner. We heard it expressed this morning. 
We heard. ``Just look how bad the FDA really is.'' We have to accept 
this provision because it is going to make such a difference to the 
patients that need these medical devices.
  Let us look at what the record has been with regard to the FDA.
  If you go through the GAO study on the FDA and its approval record, 
the progress that has been made in the recent time is truly remarkable. 
I have it here. This shows the review times that have been decreasing, 
starting in 1994, continuing 1995, and 1996. This is the General 
Accounting Office.
  The premarket notification 501, the median FDA review time for 
notification as judged to be equivalent devices already on the market 
has dropped consistently from 199 days to 95 days in 1996. Look at that 
difference between 1993 and 1996. The time reduced from 199 days to 
more than half for the medical devices that are the substantial 
equivalent.
  Here is the premarket approvals. Those take longer than the premarket 
notifications because the FDA reviews the substantial amount of 
evidence to determine if the devices are safe and effective. The median 
time for PMA has dropped from 766 days in 1993 to 280 days in 1996. 
Again, a 40 percent reduction of the time--a dramatic improvement in 
the most complicated medical devices that are new; to convince the FDA 
with the range of different new technologies that are coming and that 
are being implanted in people. We have reduced that time for clearance 
on the newest devices that have to be tested carefully and evaluated in 
terms of their safety. We have dropped the time by about 35 or 40 
percent. Approval times have been reduced and we still have the best 
safety record. We are seeing dramatic improvement in approval time for 
the most complicated medical devices, and we are seeing dramatic 
improvement in approval times for the kinds of medical devices that are 
substantially equivalent. And we still have a strong safety record. But 
that isn't enough for the medical device industry. They are refusing to 
support an amendment which would permit the FDA to look at the safety 
features of medical devices that ought to be looked at.

  It would be an entirely different matter if these improvements had 
not been made. At least you would have an argument to say you needed 
dramatic changes in the approval process. But the time it takes for the 
newest kinds of medical devices are improving dramatically.
  We heard on the floor of the Senate, ``Well, we have to be able to 
get these devices out there because all of us are aware of how fast 
those devices are being approved in Europe. If we do not accept this 
provision, all our medical device companies are going to go abroad. We 
are going to lose jobs. This is an issue of jobs. We will take a chance 
with the health of the American people on this so we can keep our 
industry here and protect our public.''
  Well, let's look at the facts on this one. We have just had the GAO 
report of June 1997 showing the remarkable progress that is being made 
in terms of approving these devices while still doing comprehensive 
examinations of the complex safety issues. They can evaluate the new 
kinds of safety information provided by the medical device industry, 
and do it in a timely way, and protect the public. That is what Senator 
Reed and myself believe should be done with regard to this provision.
  Madam President, this is a May 12, 1997 document by the World Medical 
Device Diagnostic News.
  This is April 21, 1997.
  I will include the relevant parts in the Record. But I am reading 
now:

       France calls on EU to tighten device controls. In a letter 
     to the European Council of Ministers, the French government 
     has called for tighter controls over high-risk medical 
     devices. The government is particularly concerned about 
     implantable devices and other products that fall into the 
     high-risk categories, class 3, class 2.

  The letter which was sent to other EU member states has not been 
released publicly. It forms part of the French campaign of ever-
increasing intensity for more stringent relations on medical devices. 
France is also questioning the validity of the European approach to the 
regulation of products that pose a high risk to health.
  Then in another section talking again about the European Union, 
industry experts speculate the French might argue on the basis of the 
results and the question of medical device directors being unable to 
cope with the high-risk products.
  These are storm warnings with regard to the use of high-risk 
products--storm warnings from our European friends about what is 
happening over there with their medical device industry. Then we heard 
here, ``Well, those may be high risk but we are only looking at low 
risk devices.'' Low risk? The list of the products that are being 
suggested as low risk: Ventilators, fetal

[[Page S9774]]

cardiac monitors, imaging devices, MRI ultrasound, x-ray. Who wants to 
take chances about whether the ultrasound that an expectant mother is 
having is going to do the job or not? We think that is a low risk? We 
don't think that mother ought to be able to get satisfactory 
information about the adequacy of the protection and the soundness of x 
rays and CAT scans and ultrasound and MRI's, imaging devices. Low risk? 
Anesthesia machines. Low risk? We have the storm warnings about what is 
happening in our own country.

  Here is the February Business Outlook for the Medical Device Link. 
Here is their cover story February 1997:

       With the improvements in FDA product review performance, 
     despite an ever more challenging domestic market, device 
     company executives are more optimistic than ever.

  They talk about the FDA being cited by many as the leading source of 
their pessimism.
  While nearly as many blamed the disconcerting restructuring of health 
care providers, two years later--that is now. This is going back to 
1994 and 1995.

       ``* * * two years later device company executives report a 
     substantial improvement in FDA's performance, particularly in 
     the 510(k) product approval times.

  This is the medical device industry document. It continues.

       In fact, this year's survey conducted last October marks 
     the highest business climate ratings ever in the 5-year 
     history of the survey.

  The highest degree of approval rating ever in the 5-year history.
  It is going well, my friends. We do not have a Shiley Heart Valve 
tragedy today. We don't have a Dalkon Shield tragedy today. It is 
working in terms of protecting the public. But the industry is 
demanding changes in providing the protection. Why? This is what the 
industry is saying about the FDA. ``The impact of FDA's internal 
reforms and review time is more significant than might appear. The 
agency has not only reduced the approval delays that slowed newer 
products but, perhaps more importantly, has greatly reduced uncertainty 
as to the timeliness of future product introductions.''
  I will include the appropriate amount of this. I will not take up the 
whole record, although it is a fairly short document.
  It continues along: Respondents' rating of the current business 
climate for the medical device. Here are the results. A substantial 
majority of medical device executives said, medical device industry, 
good or excellent.
  Then it has executive ratings of device industry business climate, 
1993 to 1997: 58 percent good or excellent. Last year it was 58 to 11. 
Find me an agency of Government where those who are being covered by 
the regulators are saying 58 percent approval, 11 percent disapproval. 
An examination of this review shows that it was down just in 1995, 37 
to 23--37 percent approval, 23 percent disapproval. Now that 
disapproval has gone from 23 to 12 to 11 in 1997 and the 37 is up to 58 
in 2 years. This is the reflection of those who are involved in medical 
device businesses.
  ``Expectation of respondents for business conditions in the medical 
device and diagnostic industry,'' again, going up, enormously 
favorable.
  ``One important cause of this year's improved outlook is the clearly 
perceived improvement in relations with the FDA. As shown in figure 
5''--that will be in the Record--``the decline in complaints about the 
agency mirrors the increase in positive business outlooks.''
  You could not get a greater endorsement. You could not find better 
support for an agency that is being regulated. You could not see a more 
dramatic improvement in how that agency has been dealing with those 
that it is required to police. And all while still protecting the 
public health, all being done to protect the public health. As the 
Secretary of HHS and the President of the United States said, of all 
the different provisions, this is the one that puts the public health 
at risk. All against a background of a device industry that is saying 
things have never been better.
  Several committee members have expressed concerns that the FDA will 
try to think of every possible off-label use for a device and harass 
the industry to death. There is no justification for that attitude. It 
is good rhetoric, but it just defies any kind of understanding about 
what is happening in the medical device industry today. The medical 
device manufacturers and personnel find that their relationship with 
the FDA is improving significantly in terms of how they are being 
treated, the times that are involved, the way that the agency has been 
considering various applications like the ones we have been talking 
about. The public health is being protected, but we are being asked to 
change it.
  How many times around here do you hear, ``If it is not broke, why fix 
it?'' Well, this is the attempt to try to fix something that is not 
broke. And we are not talking about widgets here. We are talking about 
real health implications to the American public.
  Why should we take a chance on people's health when those medical 
devices are being carefully tailored and designed technologically to do 
something that is different than is on the label? It just defies me. 
That is the issue.
  So, as we go on through this survey report, talking about 
international markets: ``Just as outlooks on business are influenced by 
market segments, so, too, they are affected by geographical markets. In 
fact, large companies have a clear advantage over small ones in 
entering foreign markets. Of the companies surveyed, 91 percent were 
selling to the United States, just over half were doing business in 
Europe and Canada, while 36 to 40 percent were in Latin America. Of the 
largest companies surveyed within the various''--$50 million in annual 
revenues, 90 percent or more were involved in the survey and they show 
here when asked what markets offered them the best prospects in 1997, 
more respondents, 80 percent, named the United States than any other 
market. This are the medical device companies from Central and South 
America talking about what they believe the greatest opportunity for 
market expansion is in the United States, and they are going to have to 
meet the strict requirements that are being put out by the FDA. They 
think, even going through those requirements for safety and ensuring 
the public is going to be protected, that there is this dramatic 
opportunity for growth.

  And it just continues. If we go through the Medical Economics 
magazine of this year, January, it talks about the enormous explosion 
of the various devices, talking of the demand for devices to treat 
arteriosclerosis, enlarged prostates, infertility and many others 
creates a worldwide market of $120 billion, including about $50 billion 
in the United States. That's growing by 8 percent annually. Feeding 
this demand are technologies that offer new ways to treat disease, 
allow doctors to treat illness more quickly, effectively and safely. 
The coronary stint, for example, created a submarket that exploded from 
$220 million globally to more than $1 billion in 1996. Sales of this 
device are growing 30 to 40 percent.
  I used that as one of the examples here the other day. This is a $1 
billion industry. We are talking about the power of this industry to 
put pressure on Congress, with this kind of economic power, that 
pressure is dramatic. To resist that kind of pressure when it is 
contrary to the protection of the public health I think is enormously 
important.
  What we are saying is simple and fundamental. That is, the proposal 
that is being advanced here will permit the medical device industry to 
submit various medical devices to the FDA and the FDA will be limited 
to examining only the uses listed on the label of the medical devices. 
If it is substantially equivalent to a medical device that's been 
approved, all the company has to be able to show is that it has the 
same kind of safety protections that the earlier device had, even 
though--even though--it is the intention of the medical device 
manufacturer to use that medical device for an entirely different 
purpose and market it for an entirely different purpose, the FDA is 
prohibited from examining the safety features.
  Maybe those safety features are such that they will significantly 
improve the health and well-being of the person that is using the 
medical device, but we ought to make sure at least that the agency has 
the information that would justify that utilization. All this is 
happening against a background which demonstrates that the medical

[[Page S9775]]

device industry is happier with the FDA than at any time in the history 
of the 20 years, 23 years, of medical device legislation. Happier that 
there has been a dramatic improvement in approval timeframes, important 
improvement in terms of safety. We are taking that excellent record and 
risking it with this particular provision. It does not make sense.
  This makes absolutely no sense at all. We strongly believe that this 
provision has to be altered or changed. We have missed the opportunity 
to do that on this particular legislation, but we will have further 
opportunities to do so in the near future.
  It is amazing to me, as we went through consideration and as we were 
able to make progress on so many other items while advancing public 
health, but the medical device industry does not want to deal with this 
one. They felt they had the votes. They had them this afternoon. But 
this is a long road. It is a long road, the completion of this whole 
process, and we are going to fight every step of the way. We have seen 
a variety of different options that would attend the kind of concerns 
that the medical device industry has put expressed, which we and the 
FDA and the administration were prepared to deal with, but the device 
industry is unprepared and unwilling to do so.
  So if they are unwilling, we are unwilling at least to roll over. 
There are a variety of different procedures which we will have to 
resort to in order to make sure that this threat to the public health 
of the American people does not go forward over the objections of those 
who are in the best position and do represent the patients and the 
consumers.
  By accepting this change in the protections available to the American 
public at this time, we are not saying that the health of the American 
people is going to be advanced. If this particular provision remains 
unchanged, a provision which effectively handcuffs the FDA, it is the 
bottom line of the medical device companies that will be enhanced. And 
ethical companies and the protection of the American people will 
suffer.
  That makes absolutely no sense. It is basically and fundamentally 
wrong, and we will continue the battle ahead.


                       appropriations ``trigger''

  Mr. COCHRAN. Madam President, as chairman of the Appropriations 
Subcommittee with funding jurisdiction for the Food and Drug 
Administration, I am compelled to state my opposition to the 
appropriations mandate in this bill. While this bill reauthorizes 
prescription drug user fees for the next 5 years, it also states that 
the FDA cannot assess those fees unless the appropriation for FDA 
salaries and expenses is at least equal to the appropriation for fiscal 
year 1997, adjusted for inflation.
  The Appropriations Subcommittee will continue to balance the needs 
and requirements of all agencies and activities under its jurisdiction 
within the total amounts available for discretionary appropriations. 
Any member of the Senate who disagrees with the committee's 
recommendations is free to seek to change the allocation of resources 
proposed in the bill.
  However, annual appropriations decisions should not be predetermined 
by the establishment of arbitrary appropriations ``floors'' and 
``ceilings'' in authorization bills. In this particular case, the bill 
seeks to dictate that FDA's salaries and expenses appropriation be 
``held harmless'' against inflation--that for each of the next five 
fiscal years, the appropriations be at least equal to the current 
appropriations level, adjusted for inflation. If not, FDA cannot assess 
prescription drug user fees.
  Madam President, I am certain that each agency and program which 
receives appropriations would like to secure a similar protection 
against inflation. However, this is unrealistic in the current budget 
environment and inconsistent with the levels available for 
discretionary appropriations under the bipartisan budget agreement.
  Industry paid fees are expected to supplement rather than supplant 
FDA spending for drug approvals. For this reason, I understand the 
industry's desire to make sure that FDA maintains its current level of 
effort relative to the drug approval process. However, as I indicated, 
it is unreasonable to attempt to guarantee FDA protection against 
inflation at the possible expense of other programs and activities. It 
would be difficult for me as chairman of the Appropriations 
Subcommittee of jurisdiction to predict what agency or program 
restructuring might occur over the next 5 fiscal years, what a program 
or agency's future resource requirements might be, or the fiscal 
constraints the subcommittee might face in each future year.
  Mr. President, it could be that the minimum mandated appropriations 
level in this bill is met in each of those years. However, it is just 
as likely that it would not be. The Appropriations Committee will 
continue to do its work by considering the needs of every program and 
agency within its jurisdiction within the total resources available to 
it. It will not feel constrained to meet the proposed appropriations 
``trigger'' for the collection of prescription drug user fees if it 
remains in this bill.
  I do not think it is the intent of the Labor and Human Resources 
Committee or the Senate to set an arbitrary mandate that might result 
in a situation during the course of the next 5 years where these fees 
may not be collected. I believe this would undermine the existing drug 
approval process and run counter to the interests of the federal 
government, the industry, and the American public. The issues and 
concerns I raise are similar to those expressed by Senators Gregg and 
McConnell in the additional views they incorporated in the committee's 
report accompanying S. 830.
  Madam President, I am hopeful that the committee take this issue 
seriously and will work in conference to remove this appropriations 
mandate and possible impediment to the continued success of the 
Prescription Drug User Fee Act.
  Madam President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. JEFFORDS. Madam President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. KENNEDY. Madam President, I am prepared to yield the remainder of 
our time this evening.
  Mr. JEFFORDS. Madam President, we are not prepared to at this time, 
so I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. DASCHLE. Madam President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.

                          ____________________