[Congressional Record (Bound Edition), Volume 153 (2007), Part 15]
[Senate]
[Pages 20988-20990]
[From the U.S. Government Publishing Office, www.gpo.gov]




                            FDA LEGISLATION

  Mr. GRASSLEY. Mr. President, I am here today to speak about S. 1082, 
the Food and Drug Administration Revitalization Act, and H.R. 2900, the 
Food and Drug Administration Amendments Act of 2007.
  The Senate passed S. 1082 in May and the House passed H.R. 2900 
earlier this month. As the House and Senate go into conference and work 
to resolve differences between these two bills, I urge my colleagues to 
keep in mind the public's interest.
  Both bills contain provisions that attempt to address some of the 
problems that have been plaguing the FDA over the past 3 years. Some of 
these issues are better addressed by the Senate bill and others by the 
House bill.
  I am going to spend the next few minutes to comment on what the bills 
don't do and point out some of the provisions that I believe are 
important to improving drug safety at the FDA that will benefit all 
Americans.
  Two months ago, I offered amendment No. 1039 to S. 1082, because I 
believed--and still believe--that S. 1082 does not address a 
fundamental problem at the Food and Drug Administration--the lack of 
equality between the preapproval and postapproval offices of the 
agency, the Office of New Drugs and the Office of Surveillance and 
Epidemiology, respectively. The Office of New Drugs approves drugs for 
the market, while the Office of Surveillance and Epidemiology monitors 
and assesses the safety of the drugs once they are on the market.
  My amendment was intended to curb delays in FDA actions when it comes 
to safety.
  The Institute of Medicine recognized the imbalance between the Office 
of New Drugs and the Office of Surveillance and Epidemiology and 
recommended joint authority between these two offices for postapproval 
regulatory actions related to safety. My amendment did just that.
  While I believe an independent postmarketing safety center is still 
the best solution to the problem, joint postmarketing decisionmaking 
between the Office of Surveillance and Epidemiology and the Office of 
New Drugs at least would allow the office with the postmarketing safety 
expertise to have a say in what drug safety actions the FDA would take.
  Unfortunately, this amendment lost by one vote. But the fact that it 
lost by such a narrow margin demonstrates that many of my Senate 
colleagues also recognize the seriousness of this problem and believe 
action by Congress is necessary.
  I have seen time and time again in my investigations that serious 
safety problems that emerge after a drug is on the market do not 
necessarily get prompt attention from the Office of New Drugs, the 
office that approves

[[Page 20989]]

drugs to go on the market in the first place. We saw this with Vioxx 
and more recently with the diabetes drug Avandia.
  FDA has disregarded and downplayed important concerns and warnings 
from its own best scientists. We saw evidence of that in the way FDA 
treated Dr. Andrew Mosholder's findings on antidepressants and Dr. 
David Graham's findings on Vioxx. The FDA even attempted to undermine 
the publication of Dr. Graham's findings in the journal Lancet.
  My current review of FDA's handling of Avandia has unearthed concerns 
similar to those we have seen in the past--a situation where FDA 
ignored its own postmarketing safety experts and once again left the 
public in the dark regarding potential, serious health risks.
  Not only did the FDA disregard the concerns and recommendations from 
the office responsible for postmarketing surveillance, but I have found 
that it also attempted to suppress scientific dissent.
  As I have said many times before, FDA employees dedicated to 
postmarketing drug safety should be able to express their opinions in 
writing and independently without fear of retaliation, reprimand, or 
reprisal. But in the past 2 months, I have had to write to the FDA 
regarding the suppression of dissent from not one but two FDA officials 
involved in the review of Avandia.
  Last month, I expressed concerns about FDA's treatment of the former 
Deputy Director of the Division of Drug Risk Evaluation. I urged the 
Commissioner to take appropriate corrective actions. That deputy 
director had been verbally reprimanded because she signed off on a 
recommendation that a black box warning be placed on Avandia for 
congestive heart failure.
  This week, I wrote to the Commissioner about a senior medical officer 
in the Office of New Drugs who was removed from the review of potential 
cardiovascular safety problems associated with Avandia. This medical 
officer also believed that there was enough evidence to support a black 
box warning on Avandia regarding congestive heart failure. But I guess 
that FDA management just did not want to hear about drug safety 
problems--again.
  Of the two bills up for discussion, neither the Senate nor the House 
version will give postmarketing surveillance the equal footing it 
deserves with drug approval. But I appreciate the attempt by my 
colleagues in the House to provide some transparency in FDA's 
postmarketing drug safety system. Transparency is the key to 
accountability. In particular, I welcome the provision in H.R. 2900 
that would require FDA to report to Congress on drug safety 
recommendations received in consultation with, as well as the reports 
from, the Office of Surveillance and Epidemiology. If FDA does not act 
on a recommendation from the Office of Surveillance and Epidemiology or 
it takes a different action, the agency would be required to provide 
its justification to Congress.
  In its report released last fall, the Institute of Medicine called 
for specific safety-related performance goals in the Prescription Drug 
User Fee Act, PDUFA, of 2007 to restore balance between speeding access 
to drugs and ensuring their safety.
  I have heard from FDA employees that because of the PDUFA deadlines, 
the staff in the Office of New Drugs is under tremendous time pressure 
to approve new drugs quickly, so safety concerns often needed to be 
``fit in'' wherever they could. This reinforces a point I have 
frequently made in the past--the Office of New Drugs doesn't give 
postmarketing drug safety the attention or priority it deserves.
  The House bill attempts to address this, in part, by requiring that 
postmarketing safety performance measures be developed that are ``as 
measurable and rigorous as the ones already developed for premarket 
review.''
  S. 1082 requires that the Secretary assess and implement the risk 
evaluation and management strategies in consultation with the Office of 
New Drugs and the Office of Surveillance and Epidemiology. It also 
calls for a report to Congress on the assessment of that coordination.
  The requirement that these two offices be consulted doesn't 
necessarily change the status quo. The Office of Surveillance and 
Epidemiology is still just a consultant to the Office of New Drugs, and 
the Office of New Drugs decides--and will continue to decide--what, if 
any, action will be taken to address a safety issue. But I hope that 
requiring that the office responsible for postmarketing surveillance be 
at the table would encourage FDA to better define the role of this 
office on drug safety matters and give this office a greater voice, 
albeit a limited one.
  Last fall, the Government Accountability Office reported that the 
Office of New Drugs typically sets the agenda and chooses the 
presenters at FDA's scientific advisory meetings. The GAO recommended 
that the role of the Office of Surveillance and Epidemiology be 
clarified. After all, this office is the expert on postmarketing safety 
matters.
  This week, Senator Baucus and I sent a letter to the FDA to express 
concerns regarding an upcoming advisory committee meeting on Avandia. 
As usual, the Office of New Drugs is setting the agenda here. We 
pointed out to the FDA that it doesn't make sense that it is the drug 
approval office and not the postmarketing safety office that controls 
the advisory committee meeting convened for the purpose of discussing 
postmarketing safety matters.
  In addition to the provisions I have mentioned so far, both the 
Senate and House bills would give FDA the much needed authorities to 
require labeling changes and postapproval studies; however, the House 
bill includes additional provisions outside of the risk evaluation and 
management strategy process that is established under both bills.
  The House bill specifically enables the Secretary to initiate action 
on drug labeling and postapproval studies. For example, outside of the 
risk evaluation and management strategy process, the Secretary may 
require a manufacturer to conduct postapproval research to assess or 
identify potential health risks.
  Another provision that would improve transparency at the FDA is a 
provision in the Senate bill that requires FDA to post on its Web site, 
the ``action package'' for the approval of a new drug within 30 days of 
approval. That action package would contain any document generated by 
the FDA related to the review of the drug application, including a 
summary review of all conclusions and, among other things, any 
disagreements and how they were resolved.
  Further, in light of the many allegations that FDA safety reviewers 
are sometimes coerced into changing their scientific findings, I 
believe it is critical that the following provision in S. 1082 survives 
the legislative conference process--the provision that states that a 
scientific review of a drug application must not be changed by FDA 
managers or the reviewer once it is final.
  S. 1082 also requires FDA to seek outside expert opinions on drug 
safety questions at least two times a year from its Drug Safety and 
Risk Management Advisory Committee and other advisory committees.
  Another important provision in S. 1082 is a requirement that FDA 
establish and make publicly available clear, written policies on the 
review and clearance of scientific publications by FDA employees.
  Some of the stronger provisions regarding the expansion of the 
clinical trial registry come from the House bill. While both bills 
address clinical trial registration, the House bill adopts a much 
broader definition of applicable clinical trials. ``Thus, information 
about many more trials would be made publicly available through the 
Internet under the House bill.''
  Clinical trial registries serve an important function--they foster 
transparency and accountability in health-related research and 
development by ensuring that the scientific and medical communities and 
the general public have access to basic information about clinical 
trials. Mandatory posting of clinical trial information would help 
prevent companies from withholding clinically important information 
about their products.

[[Page 20990]]

  I have heard from some scientists that they can't disclose the 
findings of their studies because the data belongs to the manufacturer. 
It is up to the manufacturer to decide if and when the results would be 
published, and those results don't always see the light of day.
  But scientists need access to all of the evidence to conduct a full 
and independent review of a product's safety. However, we know that 
relevant data are not always made available for further review by 
independent scientists. While the House bill does not require 
manufacturers to share its data with other scientists, it does require 
the sponsor of a study to report whether or not agreements were made 
restricting individuals from discussing or publishing trial results.
  In addition, for FDA's new authorities to be effective, there has to 
be strong civil monetary penalties. In May, I also offered amendment 
No. 998 to S. 1082. That amendment passed.
  Amendment No. 998 provides for the application of stronger civil 
monetary penalties for violations of approved risk evaluation and 
mitigation strategies.
  While significant monetary penalties may be imposed under the House 
bill for continuous violations, the minimum penalty for a violation 
under the Senate bill would be higher because of my amendment. We need 
to make sure that we're giving FDA, the watchdog, some bite to go with 
the bark. If monetary penalties are nothing more than the cost of doing 
business, you won't change behavior. More importantly, you can't deter 
intentional bad behavior.
  In closing, I would like to thank Senators Kennedy and Enzi and 
Congressmen Dingell and Barton for their tremendous efforts on these 
bills. We have an opportunity to reform, improve, and reestablish the 
FDA as the gold standard for drug safety. If Congress is going to make 
meaningful changes to the FDA to increase transparency and 
accountability, it is critical that the provisions I have discussed 
today make it into the bill that comes out of conference. To do less 
would deny the American people safer drugs when they reach into their 
medicine cabinets.

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