Statement of Congressman John D. Dingell, Chairman
Committee on Energy and Commerce

SUBCOMMITTEE ON HEALTH HEARING ENTITLED "DISCUSSION DRAFT OF THE 'FOOD AND DRUG ADMINISTRATION GLOBALIZATION ACT' LEGISLATION: DRUG SAFETY PROVISIONS"

May 1, 2008

Mr. Chairman, thank you for holding the hearing on the drug provisions of the Food and Drug Administration Globalization Act discussion draft. Since last fall, under the leadership of Reps. Stupak and Shimkus, the Subcommittee on Oversight and Investigations uncovered dangerous gaps in the foreign inspection system of the Food and Drug Administration (FDA). What was found, and confirmed by the Government Accountability Office and the FDA’s own Science Board, was a system chronically underfunded, with authorities greatly outdated, based on a lot of trust, but very little verification.

We can no longer allow this important regulatory function to operate on blind faith. That was shown clearly at the hearing on the heparin disaster held earlier this week by the Oversight Subcommittee. The consequences of this system led to the deaths of 81 people who received contaminated heparin.

An important step toward addressing this crisis occurred at the hearing on Tuesday. During that hearing, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at FDA, candidly acknowledged the need for substantial new funding for inspections and stated that at least $225 million would be needed to put foreign facilities inspections on par with inspections of domestic drug firms.

Dr. Woodcock also indicated her agreement with the need for the key authorities proposed by in a Discussion Draft circulated two weeks ago by Reps. Stupak, Pallone, and I.

The Discussion Draft would require FDA to conduct more inspections of foreign drug firms and give the agency authority to deny entry to those imports produced in facilities that refuse or impede an inspection. We would also require drug manufacturing facilities to register with FDA annually, pay a registration fee, and be assigned a unique identifier to provide a more accurate accounting of facilities and allow FDA to move quickly in the event of a safety incident. Finally, we would enable FDA to explicitly require manufacturers to know and to verify the safety of their suppliers.

This is the first time that we have heard a high-ranking Administration official provide with some specificity what FDA needs to do its job, and I appreciate Dr. Woodcock’s candor. To her credit, she has stepped forward in the midst of this public health crisis to tell Congress what her agency needs to better protect the American people from unsafe drugs. I hope we can continue our dialogue today with the same degree of candor.

I am pleased to note the drug industry’s willingness to work with us in addressing these problems. While we may differ on the details, in marked contrast to food manufacturers, the drug industry appears to recognize that a safer drug supply is not only in the interest of the public health, but also in the interest of their bottom line. I appreciate the letters of support that we have received from two generic drug manufacturers – Ranbaxy and Teva – as well as from consumer groups such as Consumers Union and the Center for Science in the Public Interest.

Mr. Chairman, food, drug, device, and cosmetic safety are important issues to American consumers. The Discussion Draft is a good step forward in providing what FDA needs to serve as the premier public health agency of the U.S. Government. I look forward to working with all of my colleagues on the Committee, and with the FDA and interested stakeholders, to craft good, sensible legislation so that the Food and Drug Administration is able to competently fulfill its critical mission.

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