Hello everyone, yesterday I had the honor of attending the State Arrival Ceremony of Her Majesty Queen Elizabeth II of Great Britain and the Duke of Edinburgh at the White House.

The Queen of England hadn’t visited the United States in 16 years. Her visit comes as we are celebrating the 400th anniversary of the first permanent English settlement in North America at Jamestown, Virginia.

There is great tradition and historical significance of the royal family of Great Britain. It was an honor to be a part of her majesty’s visit.

This week in the senate we are debating the Food and Drug Administration Revitalization Act, S. 1082. Yesterday I offered two amendments to this bill. These two amendments, Amendment Nos. 998 and 1039 are intended to enhance drug safety, promote accountability, and provide the Food and Drug Administration with stronger enforcement tools.

Amendment No. 1039 provides for joint post-marketing decision-making between two offices within the FDA, the Office of Surveillance and Epidemiology and the Office of New Drugs. These offices would address jointly post-marketing drug safety issues. So this amendment only comes into play once the drug is already on the market. This joint post-marketing decision-making is intended to include labeling changes, requiring additional post-marketing studies, and restrictions on distribution or use of a drug. This joint decision-making would give the Office of Surveillance and Epidemiology "sign-off" authority. This is different than its present role of being "mere consultants" to the Office of New Drugs in a post-marketing environment. It's very important to understand that the core of this Amendment was recommended in the Institute of Medicine report last fall.

The other amendment, Amendment No. 998, provides for the application of stronger civil monetary penalties for noncompliance with approved risk evaluation and mitigation strategies. Currently, S. 1082 contains penalties that are insignificant for large companies and amount to nothing more than the cost of doing business. This amendment is intended to give FDA, the watch-dog, some bite along with its bark.

Big Pharma doesn't like my amendments because they shake up the status quo. The status quo includes FDA debacles like Vioxx, and the failure of the FDA to notify doctors and parents of the potentially tragic effects of anti-depressants on children. These amendments would make post-marketing safety concerns a forethought rather than an after-thought at the FDA. These amendments are intended to establish greater accountability, break the strong-hold that big Pharma has on the FDA, and make "post-marketing safety" a meaningful effort at the FDA.