[Congressional Record Volume 143, Number 76 (Thursday, June 5, 1997)]
[Senate]
[Pages S5342-S5343]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. JEFFORDS:
  S. 830. A bill to amend the Federal Food, Drug, and Cosmetic Act and 
the Public Health Service Act to improve the regulation of food, drugs, 
devices, and biological products, and for other purposes; to the 
Committee on Labor and Human Resources.


 the food and drug administration modernization and accountability act 
                                of 1997

  Mr. JEFFORDS. Mr. President, today I am introducing legislation to 
modernize the Food and Drug Administration [FDA] and reauthorize the 
Prescription Drug User Fee Act for 5 years. This legislation comes as 
result of over 3 years of consideration by the Congress on steps that 
could be taken by the agency that would contribute to its mandate to 
protect the American public while ensuring that life-saving products 
could be made more readily available.
  FDA acknowledges that its mandate also requires it to regulate over 
one-third of our Nation's products. Within its purview the FDA 
regulates virtually all of the food and all of the cosmetics, medical 
devices, and drugs made available to our citizens. I believe, and 
several members of the Labor Committee share my belief, that in an 
organization the size of FDA there is always room for improvement and 
modernization. Our objective, which this legislation achieves, was 
identify areas where improvements could be made that will strengthen 
the agency's ability to approve safe and effective products more 
expeditiously.
  Last year, both the House and the Senate held numerous and extensive 
hearings on countless proposals for modernizing and reforming the FDA. 
The Senate Labor and Human Resources Committee successfully reported a 
bipartisan bill that sought to accomplish many of those reforms. But 
last year, acrimonious issues remained, time ran out and the bill did 
not receive floor consideration. This year I have resolved to move 
forward. I have been committed to addressing last year's most 
controversial issues. I believe that the legislation I am introducing 
today addresses virtually all of objections raised last year both in 
process and in content. This is a better bill and I believe that upon 
examination, my colleagues will agree that it accomplishes its goal.
  I want to comment a moment on the open, consensus-building process we 
followed in developing this legislation. The Labor Committee held two 
hearings. During the first the committee received testimony from the 
principal FDA Deputy Commissioner, Dr. Michael Friedman, and all of the 
FDA Center Directors. The second hearing included representatives from 
patient and consumer coalitions and from the food, drug, and medical 
device sectors regulated by the FDA. Committee members learned from the 
agency of the administrative reforms and the progress it has already 
undertaken, areas that remain a challenge, and those areas that require 
legislative authority to change. The committee listened to consumers' 
concerns with provisions that were considered last year that they felt 
would weaken the FDA's ability to protect the public health. Finally, 
the committee learned of the ongoing and needless delays and 
frustrations facing health care and consumer product sectors of our 
economy in working with the FDA. The committee learned of the 
frustrated attempts to work through the bureaucratic labyrinth of 
needless regulatory delays. Delays that prohibited people from getting 
access to vitally needed, life saving medical treatments, drugs, and 
devices.
  Since the finish of the committee's hearings we have engaged in an 
open, collaborative process that has given voice to each party wishing 
to be heard. For many of these meetings it is worth noting that the 
agency was a full, cooperating participant and we would not have been 
able to make the progress made without FDA's collaboration. Several 
meetings, essentially roundtable discussions, have occurred with 
bipartisan committee staff, the FDA, and each of the several sectors 
regulated by the agency. These meetings have given all the participants 
an opportunity to discuss problems and potential solutions and have 
been the basis for the consensus bill I am introducing today. Finally, 
committee staff have had numerous meetings to discuss key provisions in 
the bill with a wide range of consumer groups including, among others, 
the Patient Coalition, Public Citizen, the Centers for Science in the 
Public Interest, the Pediatric AIDS Foundation, and the National 
Organization for Rare Diseases. It should be clear that no person or 
group was excluded from this deliberative process.
  Let me turn to the content of this measure and the steps we have 
taken to respond to the controversies raised last year. Five key 
objections were raised against the FDA reform bill that had been 
reported on a strong bipartisan vote from the Labor and Human Resources 
Committee during the last Congress. In that vein, we have sought to and 
have accomplished addressing each of the substantive concerns raised by 
the minority.
  Last year's measure was criticized by some for the number of 
mandatory, but shortened, product review time frames that critics said 
would overburden the FDA and for the hammers that would have required 
FDA to contract out some product reviews or to give priority to 
products approved abroad. Today's legislation eliminates most of the 
mandatory time frames and retains only those necessary to ensure 
collaborative, more efficient reviews or to facilitate quick reviews of 
low risk products. The contracting out and European review hammers that 
would have forced FDA actions have been eliminated.
  Last year's provision allowing for third party, outside expert review 
were criticized for turning central regulatory authority decisions over 
to private industry, creating conflicts of interest, and depriving FDA 
of resources and expertise. Today's legislation adopts FDA's current 
system for accrediting and selecting third-party review organizations. 
The bill expands FDA's current pilot third-party review program beyond 
just the lowest risk devices and FDA retains final approval for all 
devices. Devices that are life-

[[Page S5343]]

supporting, life-sustaining, or implantable are excluded from third-
party review. FDA may allow third-party review for higher risk devices 
at its sole discretion. This approval will allow FDA to retain, 
augment, and focus its expertise, at its discretion, on critical areas 
of its expanding workload.
  Last year's bill would have required FDA to contract out review of 
food additive petitions, medical devices, and drugs. Critics argued 
these changes would weaken consumer protections. We have modified these 
provisions to give FDA express authority to contract out when deemed by 
FDA to be more efficient or to add needed expertise.
  Thsi year the collaborative effort has continued. During our meetings 
FDA identified a number of enforcement powers that the agency believes 
will enhance its ability to protect the public health. We have included 
a number of FDA's specific requests. Many patient and consumer groups 
raised concerns about insufficient safeguards related to the fast-track 
drug approval process and the provision improving accelerated access to 
investigational products and we have adopted several of their key 
concerns.
  I would close by saying that this measure embodies a reasonable, 
moderate approach to balancing the agency's mandate to regulate over 
one-third of our Nation's economy and provide for the public health and 
safety with the compelling need to provide new, improved, safe, and 
effective products to the American public. It is a good bill and I look 
forward to working with my colleagues to improve it even further.
                                 ______