[Congressional Record Volume 153, Number 114 (Tuesday, July 17, 2007)]
[Extensions of Remarks]
[Page E1536]
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, July 11, 2007

  Ms. McCOLLUM of Minnesota. Mr. Speaker, I rise today in support of 
the Food and Drug Administration--FDA Amendments Act. This bipartisan 
legislation is an important step toward ensuring that the FDA has the 
authority and the 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 made clear 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 within the FDA to monitor the safety of drugs. Under this 
legislation, the FDA will be able to examine drug safety even after a 
drug has been approved and is on the market. H.R. 2900 also increases 
penalties for companies that violate safety standards.
  To regain the public's trust, the FDA's advisory committees must be 
medically qualified, independent, and acting on behalf of the health 
and safety of the American people. This is why it is important that the 
FDA Amendments Act addresses concerns about the potential for conflict 
of interest because members of FDA advisory committees are frequently 
involved in the drug and device industry. This bill requires each 
member of an advisory committee to disclose financial interests to the 
Secretary of Health and Human Services prior to a meeting on a 
particular matter. It also requires the Secretary of Health and Human 
Services to submit reports to Congress on the membership of FDA 
advisory committees.
  In order to increase transparency and accountability, this 
legislation requires 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.
  Additionally, H.R. 2900 reauthorizes through 2012 both the 
Prescription Drug User Fee Act--PDUFA and the Medical Device User Fee 
and Modernization Act--MDUFMA. These programs are essential in 
expediting FDA's review of new drug and medical device application and 
help avoid backlogs, which negatively impact both patients and 
manufacturers. This bill also reauthorizes the Pediatric Research 
Equity Act to encourage drug manufacturers to develop products to meet 
the specific and unique needs of children.
  I am disappointed that this bill was not able to address direct-to-
consumer--DTC--advertising 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. H.R. 2900 is a 
good step forward, but I look forward to continuing to work with my 
colleagues to 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. 2900.

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