Food And Drug Administration Amendments Act Of 2007

Floor Speech

FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007 -- (Extensions of Remarks - July 17, 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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