[Congressional Record (Bound Edition), Volume 153 (2007), Part 4]
[Extensions of Remarks]
[Pages 4619-4620]
[From the U.S. Government Publishing Office, www.gpo.gov]




INTRODUCTION OF THE ``SWIFT APPROVAL, FULL EVALUATION (SAFE) DRUG ACT''

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                         HON. EDWARD J. MARKEY

                            of massachusetts

                    in the house of representatives

                       Friday, February 16, 2007

  Mr. MARKEY. Madam Speaker, I rise today to introduce the Swift 
Approval, Full Evaluation, SAFE, Drug Act. This bill is designed to 
ensure that the FDA can balance the need to get important life-saving 
drugs to the market quickly while ensuring the drugs get the full 
evaluation they need to ensure the safety of those products.
  Earlier this week the Oversight and Investigation Subcommittee of the 
Energy and Commerce held its very first oversight hearing of the 110th 
Congress on drug safety. At the hearing several FDA whistleblowers 
testified about the truly frightening problems at the FDA including: 1. 
a culture of suppression and intimidation, 2. a lack of transparency 
into the review process, 3. the inaction of FDA management in response 
to serious drug risks, 4. a lack of scientific freedom and the 
inability of FDA reviewers to have their concerns heard by senior 
management, FDA advisory committees, and the public.
  Their powerful testimonies add to the concerns raised in the 
Institute of Medicine report, the GAO Report, and the Inspector General 
of HHS report that the FDA's system to ensure that postmarketing 
studies are conducted and completed is broken and the FDA has not made 
reform a priority.
  It is clear from the whistleblowers' testimonies and these three 
major reports that the FDA is a deeply troubled agency that has failed 
time and time again to act in the best interest of the public. The 
failures of the FDA to protect the public have been widely reported by 
the media and the public is losing confidence in the FDA's ability to 
keep us safe.
  According to a recent Wall Street Journal Online/Harris Interactive 
poll, 80 percent of adults say they are concerned about the FDA's 
ability to make independent decisions that will ensure that patients 
have access to safe and effective medicines.
  We need the FDA to be a watchdog for public health, not a lapdog for 
the industry. We need to bring back transparency, accountability and 
scientific integrity to the FDA.

[[Page 4620]]

  That is why today I am reintroducing the Swift Approval, Full 
Evaluation, SAFE, Drug Act to provide greater transparency into the 
approval process and a stronger postmarket safety system.
  The SAFE Drug Act will:
  1. Increase FDA authority with respect to postmarket safety, 
including giving the FDA the ability to mandate labeling and require 
postmarket studies.
  2. Provide FDA greater authority with respect to the Accelerated 
Approval process, by ensuring postmarket study plans are reviewed prior 
to approval; requiring proper labeling until drugs are fully approved; 
and restricting advertising for accelerated approved drugs or biologics 
until full approval.
  3. Provide enhanced whistleblower protections to FDA employees.
  4. Preserve scientific integrity at FDA by prohibiting FDA employees 
from directing other FDA employees to censor or suppress scientific 
research, analysis, opinions or recommendations or directing employees 
to disseminate scientific information that is known to be false or 
misleading.
  5. Require the FDA to provide Advisory Committees with complete 
information.
  6. Ensure scientific freedom at FDA, by guaranteeing FDA and FDA-
sponsored authors the right to publish or present their work.
  7. Increase FDA transparency, by requiring a biennial report to 
Congress on noninferiority studies and a biannual report to Congress on 
postmarket studies system.
  The time to act is now. I look forward to working with my colleagues 
to stop the erosion of public confidence in the FDA, provide greater 
transparency into the approval process, reform the system of 
postmarketing studies, and ensure that FDA balances the desire to speed 
drugs to market with its critical role as the watchdog of public 
health.

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