[Congressional Record Volume 153, Number 144 (Wednesday, September 26, 2007)]
[Extensions of Remarks]
[Pages E1983-E1984]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




          FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007

                                 ______
                                 

                               speech of

                          HON. BETTY McCOLLUM

                              of minnesota

                    in the house of representatives

                     Wednesday, September 19, 2007

  Ms. McCOLLUM of Minnesota. Mr. Speaker, I rise today in support of 
the Food and Drug Administration (FDA) Amendments Act.
  It is critical that the FDA has the authority and resources it needs 
to protect the health and safety of American families. Recent highly-
publicized tragic events linked to prescription drugs, such as Vioxx, 
have highlighted the importance of the mission of the FDA and the 
improvements necessary to ensure its effectiveness.
  This bill strengthens the FDA's oversight of drug safety by 
establishing a new program

[[Page E1984]]

within the FDA exclusively for the purpose of monitoring the safety of 
drugs and allowing the FDA to examine drug safety after a drug has been 
approved and is on the market. It also significantly increases 
penalties for companies that violate safety standards. Additionally, 
H.R. 3580 reauthorizes through 2012 both the Prescription Drug User Fee 
Act (PDUFA) and the Medical Device User Fee and Modernization Act 
(MDUFMA), programs essential in expediting FDA's review of new drug and 
medical device applications and helping to avoid backlogs.
  To regain the public's trust in the drug and device approval 
processes, The FDA Amendments Act imposes strict conflict-of-interest 
provisions to help ensure that FDA's advisory committees are medically 
qualified, independent, and acting on behalf of the health and safety 
of the American people. H.R. 3580 increases transparency and 
accountability by requiring that all drugs, devices, and biologics be 
included in a clinical trials registry and in a results database. All 
registry data on the safety and effectiveness of drugs and devices will 
be posted on an Internet site accessible to the public.
  H.R. 3580 also improves health care and begins to address the high 
cost of prescription drugs by imposing penalties on pharmaceutical 
companies for false or misleading direct-to-consumer advertising (DTC) 
of prescription drugs. Studies have shown that spending on DTC 
advertising from pharmaceutical companies has tripled in recent years 
and plays a role in the unsustainably increasing cost of health care. 
DTC advertising has also changed the doctor-patient relationship with 
an increased number of patients requesting a specific drug or 
treatment, even in cases where a less expensive or different medication 
would be appropriate. I look forward to continuing to work with my 
colleagues to further address DTC advertising of medications.
  The safety of the drugs and devices on which so many Americans rely 
must be a priority for Congress. I urge my colleagues to join me in 
voting for H.R. 3580.

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