Food and Drug Administration Amendments Act of 2007

Floor Speech

FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007 -- (Extensions of Remarks - September 26, 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 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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