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Increased Resources And Fda Authority Key To Pharmaceutical Safety

May 1, 2008

WASHINGTON – U.S. Rep. Diana DeGette (D-CO), ViceChair of the Committee on Energy and Commerce, today offered thefollowing opening statement during the Energy and Commerce HealthSubcommittee hearing, Discussion Draft of the "Food and DrugAdministration Globalization Act' Legislation: Drug Safety Provisions."Last month, the Committee released its discussion draft on the Food and Drug Administration Globalization Act of 2008. The discussion draft includes a mandatory recall provision built upon legislation introduced by DeGette, H.R. 3484, the SAFER Act.

Below is Ms. DeGette's opening statement as prepared for delivery – entered into the record:

"Mr.Chairman, let me first thank you for holding today's hearing on thedrug safety provisions included in the Food and Drug AdministrationGlobalization Act discussion draft. It is high time we are movingforward with new legislation to protect the millions of individualsthat take pharmaceutical products.

"Late last year theOversight and Investigations Subcommittee, on which I also sit, held ahearing that looked at the foreign drug inspection program. I rememberbeing stuck by the complete dearth of resources that the FDA has to puttowards foreign drug inspections, as well as inherent differencesbetween the inspection process for foreign and domestic facilities. For example, I was shocked to learn that for each overseas facilitythat exports drugs to the United States, FDA is able to complete aninspection only once every 8 to 12 years. Yet, Good ManufacturingPractices govern that on-site inspections should occur every twoyears. FDA must inspect domestic facilities every two years—why shouldthe standard be so much lower for foreign drugs than domestic drugswhen they are consumed by the same population?

"I am gladthat we are taking the first steps towards remedying the currentsituation and that we are developing legislation that will protect thesafety of our pharmaceutical supply. The bill that we are discussingtoday will require that foreign drug and device facilities be inspectedevery two years—finally on par with the requirements for domesticfacilities. This requirement is long overdue and I commend mycolleagues on including this provision in the FDA Globalization Act. However, I would like to reiterate that we will need to make sure toprovide adequate resources to enable FDA to complete timely andthorough inspections of foreign facilities.

"The FDAcurrently has authority to refuse admission of products that appear toviolate the Food, Drug, and Cosmetic Act. However, it is myunderstanding that FDA does not currently have the authority to destroythese shipments, and instead must simply send them back to whereverthey came from. This is worrisome in regards to tainted products, buteven more worrisome in regards to counterfeit products, as we have noguarantee that the manufacturer won't simply try masquerading them asecond time.

"Accordingly, I am extremely pleased that thelegislation we are looking at today takes a first step at remedyingthis potentially disastrous situation, as it grants the Secretary theauthority to destroy any product that appears to pose a risk of injuryor death or had a value of less than $2,000.

"I think thisis a very strong step towards protecting our citizens from counterfeitand adulterated drugs. I do however want to make sure that there willbe sufficient technology and resources available to the Secretary andborder officials, that they are able to adequately determine whetherthe drug in question poses a risk of injury or death. I also want tomake sure that any provisions included in the final legislation arestrong enough to ensure the safety of high-risk and high-cost drugsthat are most likely to be counterfeited. The current system ofreturning adulterated pharmaceuticals that are refused entry simplydoes not ensure continued safety of our drug supply. It is vital thatwe put additional protections into place, such as the authority todestroy adulterated pharmaceuticals.

"The current discussiondraft also includes a number of other important provisions, such asimproved testing and verification requirements for drug purity andidentity, as well as civil monetary penalties for violators. I lookforward to hearing from today's panelists about their perspectives onthis draft of the ‘FDA Globalization Act.'

"Thank you."