[Congressional Record Volume 143, Number 108 (Monday, July 28, 1997)]
[Senate]
[Pages S8205-S8206]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 REAUTHORIZING THE PRESCRIPTION DRUG USER FEE PROGRAM AND CERTAIN FOOD 
                    AND DRUG ADMINISTRATION REFORMS

 Mr. WYDEN. Mr. President, I strongly urge my colleagues to 
support S. 830, the FDA Modernization and Accountability Act.
  This bill deserves support for one primary reason. It preserves the 
FDA's essential mission of validating the safety and effectiveness of 
new drugs and medical devices, while encouraging innovation and the 
commercialization of new, life-saving therapies.
  This bill is the result of much debate, and tremendous consensus 
building over the last two Congresses. I'm proud to have played some 
part in this as a Member of both the House and the Senate, having 
introduced more than 2 years ago H.R. 1472, the FDA Modernization Act 
of 1995, which contains several of the key ingredients of the 
legislation before us today.
  From the time we get up in the morning until the time we go to bed at 
night, we live, work, eat, and drink in a world of products affected by 
FDA decisionmaking.
  Perhaps no other Federal agency has such a broad impact in the daily 
lives of average Americans.
  Food handling and commercial preparation often occurs under the 
agency's scrutiny. Over-the-counter drugs and nutritional supplements, 
from vitamins to aspirin, also are certified by the agency.
  Life-saving drugs for treatment of cancer, autoimmune deficiency, and 
other dread diseases are held to its rigorous approval standards.
  Medical devices ranging from the simple to the complex, from tongue 
depressors to computerized diagnostic equipment, must meet FDA quality 
standards.
  These products overseen by the FDA are woven deeply into the fabric 
of our daily lives, and the agency's twin missions of certifying their 
safety and effectiveness is supported by the vast majority of 
Americans.
  Yet, balancing those missions against the time and expense required 
by manufacturers to navigate the FDA approval system has been difficult 
and controversial. In the last Congress, radical transformation of the 
agency, even ending the agency as we know it and replacing it with a 
panel of private-sector, expert entrepreneurs, became a goal of some.
  At the very least, reforming the FDA at the beginning of the 104th 
Congress looked to be an exercise fraught with partisan political 
turmoil, and destined for gridlock.
  But while there was focus on the extreme ends of the argument, those 
folks arguing for no changes against members demanding wholesale 
dismemberment of the agency, a broader, bipartisan middle developed.
  And with the help of Vice President's Gore's Reinventing Government 
Program, Members of Congress from both political parties developed 
practical, bipartisan solutions to the critical process and management 
problems in the FDA approval process.
  I sought to mobilize this bipartisan movement with H.R. 1472 
introduced in June 1995. Some in my own party thought I had gone to 
far, too fast, But I am gratified that many of the elements of that 
legislation have been retained and strengthened in the legislation and 
managers amendment we expect to have before us this week.
  These include: It streamlines approval systems for biotechnology 
product manufacturing; it allows approval of important, new 
breakthrough drugs on the basis of a single, clinically valid trial; it 
creates a collaborative mechanism allowing applicants to confer 
constructively with the FDA at critical points in the approval process; 
it sets reasonable but strict timeframes for approval decisionmaking; 
it reduces the paperwork and reporting burden now facing manufacturers 
when they make minor changes in their manufacturing process; it 
establishes provisions for allowing third-party review of applications 
at the discretion of the Secretary; and it allows manufacturers to 
distribute scientifically valid information on uses for approved drugs 
and devices which may not yet be certified by the FDA.
  I am especially pleased that Senators Mack, Frist, Dodd, Boxer, 
Kennedy, and I could offer the provisions of this legislation relating 
to the dissemination of information on off-label uses of approved 
products.
  This provision will allow manufacturers to distribute scientifically 
and clinically valid information on such uses following a review by the 
FDA, including a decision by the agency which may require additional 
balancing material be added to the packet.
  Here's why that's important: Manufacturers with an approved drug for 
ovarian cancer may have important, but not yet conclusive information 
from new trials that their drug also may reduce brain or breast 
cancers. That data, while perhaps not yet of a grade to meet 
supplemental labeling approval, may be important for an end-stage 
breast cancer patient whose doctor has exhausted all other treatments.
  That doctor, and her patient, has the absolute right to that 
information.
  This legislation will save lives, not sacrifice them.
  It will mean that more doctors and their patients will have 
meaningful access to life-saving information about drugs that treat 
dread diseases like AIDS and cancer.
  It will mean that biologic products will have a swifter passage 
through an approval process which no longer will require unnecessarily 
difficult demands with regard to the size of a start-up manufacturing 
process.
  It will mean that break-through drugs which offer relief from, or 
curses of deadly disease for which there is no approved therapy will 
get into the marketplace earlier, on the basis of a special expedited 
approval system.
  But legislation, indeed laws, are only words on paper.
  Mr. President, we must also have a new FDA Commissioner who is as 
committed to these changes as former Commissioner David Kessler was 
committed to the war on teenage smoking.
  The pharmaceutical industry is a robust, risk-taking, technology-
driven

[[Page S8206]]

business. But by measure of total U.S. employment growth in this 
industry is stalling out. While sales by U.S.-based concerns continue 
to increase, more of the industry's manufacturing--its jobs--is 
migrating overseas. Part of the reason is rising domestic development 
costs. According to Tufts University, the average development time for 
a new drug is now up to 7 years. And the cost of such developments now 
figures out at something close to $360 million per product. We 
shouldn't kid ourselves about who foots the bill for these high 
development and approval costs--it's the consumer, and it comes via the 
extraordinary high prices we pay on drugs which can spell the literal 
difference between life and death.
  S. 830 significantly reforms that regime, recognizing that we all--
government, industry, and consumers--have a real stake in cutting the 
explosive costs of bringing new medical products to the marketplace, 
and in making available break-through, life-saving therapies more 
quickly, and at a lower price.
  Along with these important reforms, S. 380 also reauthorizes for 5 
years the Prescription Drug User Fee Act, a very successful program 
that has helped swiftly approve scores of new life-saving therapies.
  Let me also point out that while this bill makes substantial and far-
reaching improvements, it distinctly moderates last year's reform 
effort.
  So-called hammers that would have caused the agency to lose 
jurisdiction over the approval process if tight decision-making 
deadlines were not met have been eliminated.
  Also missing is last year's provision requiring the agency to approve 
products previously approved in Europe.
  My colleagues should understand that this bill is the result of 
efforts to reach a true common ground on many tough issues. Many more 
issues were gray, than they were black or white. Extremists on neither 
side of the debate can claim an advantage, or a victory.
  The real victory, I believe, will be realized by the American 
consumer.

                          ____________________