[Congressional Record Volume 148, Number 69 (Friday, May 24, 2002)]
[Extensions of Remarks]
[Pages E930-E931]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




CONFERENCE REPORT ON H.R. 3448 PUBLIC HEALTH SECURITY AND BIOTERRORISM 
                 PREPAREDNESS AND RESPONSE ACT OF 2002

                                 ______
                                 

                               speech of

                            HON. BART STUPAK

                              of michigan

                    in the house of representatives

                        Wednesday, May 22, 2002

  Mr. STUPAK. Mr. Speaker, I rise today to speak out against the 
procedure used by the majority to consider and pass the Prescription 
Drug User Fee Act also known as PDUFA.
  Yesterday we passed the conference report on bioterrorism almost 
unanimously.
  I voted for it.
  However, I did so over my unhappiness with the procedure used to 
consider PDUFA.
  Through PDUFA, the drug industry pays fees to the Food and Drug 
Administration for timely review of drugs and biological agents.
  We have heard a lot about how PDUFA works, but at what cost? What 
have we sacrificed?
  What we have sacrificed under PDUFA is honesty, accuracy, and 
informative labels. These are the duties and responsibilities that 
affect every American consumer. Therefore, we must be very careful to 
make sure that we do not compromise safety or effectiveness that the 
American public has come to expect.
  The FDA reached this agreement in closed-door negotiations with the 
very industry they are supposed to regulate!
  I have many concerns with PDUFA, but I was not able to address them 
because we in Congress were not allowed to bring these concerns to the 
floor for a full and open public debate.
  We weren't even allowed to have a committee markup on it.
  Well, for the record my concerns are as follows.
  First of all, the FDA is financially dependent upon an industry it 
regulates, and because under the new agreement user fees are 
dramatically increased, dependence will grow dramatically.
  Instead of using industry funds, Congress should appropriate enough 
money to ensure FDA's regulatory authority is completely independent, 
above reproach, and free of undue pressure from the drug industry.
  Second, it is more than clear that the approval of a drug or device 
based on relatively short-term information does not always give us 
complete information about a drug.
  The number of drugs pulled off the market in the last 4 years is 12.
  Now, I agree that 3 were pre-PDUFA but that leaves 9 drugs that raced 
through an accelerated PDUFA approval process with incomplete 
information.
  This brings me to my third point.
  Phase IV studies, also known as post-marketing surveillance, are 
nightmarishly inadequate and neglected to a shameful extent by both the 
FDA and the drug manufacturers.
  The 1997 reauthorization of PDUFA--called PDUFA 2--ordered a study 
from FDA that would summarize how well the industry complied over the 
past 5 years with mandates to do phase IV studies.
  The results of this study show the vast majority of drug companies do 
not do their mandated post-marketing surveillance studies.
  Now I understand PDUFA 3 comes a long way towards addressing major 
concerns with post-marketing surveillance, but without any enforcement, 
there will be no post-marketing surveillance, as we saw in PDUFA 2.
  So I suggest that we put civil monetary penalties pegged to the sales 
of drugs as one option that we should consider.
  Another area of concern is the ability of the drug manufacturers to 
game the system.
  While awaiting requested and required information from a 
manufacturer, FDA should be able to ``stop the clock'' on the time 
constraints PDUFA imposes.
  Due to extremely tight decision deadlines in PDUFA, manufacturers 
know they can delay their response to FDA's requests for information 
long enough so FDA is forced to make a

[[Page E931]]

decision without being able to thoroughly review and doublecheck data.
  We had one breast cancer drug, and the FDA got the information one 
and a half weeks before the PDUFA deadline would run.
  My final concern today is that of subpoena power.
  The FDA is one of the only health and safety regulatory agencies that 
does not have subpoena power.
  Subpoena power would give FDA the authority it needs to inspect 
manufacturers' documents.
  This is an issue we need to explore, but we couldn't because we 
weren't allowed to.
  And last but not least, safety, adequate labeling, and compliance 
with federal regulations always seem to fall by the wayside when we 
rush through PDUFA or whatever it might be.
  We did pediatric exclusivity here recently, and we are still waiting 
for studies.
  I recently wrote a letter to Bristol-Myers Squibb in February about a 
drug called Serzone.
  Sixteen other members joined me.
  That was a drug that the FDA did a pediatric exclusivity study 
request in 1994. We are still waiting for the results of that study.
  We have young people who have suffered liver damage from this drug, 
and we can't even get anyone to tell us what the results of that study 
were, eight years ago. That's ridiculous, and it has to stop.
  We want to make sure that drugs are safe, and we want to make sure 
that we have adequate labeling, and we want to make sure that the FDA 
has adequate information.
  Therefore, Mr. Chairman, from subpoena power to enforcement power, 
the pediatric labeling under the pediatric exclusivity issue--all these 
issues we were not allowed to bring up before the House.
  I will continue to work to make safety, accuracy, honesty, and 
labeling is put back in the Food and Drug Administration.
  I voted for the bioterrorism conference report because it is too 
important to not implement.
  But what about the terror facing people everyday when they take 
medications that are not established to be safe?
  Mr. Speaker I hope issues as important as this one will be debated 
fully in the future and not subject to such underhanded tactics in the 
future.

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