Increased Resources and FDA Authority Key to Pharmaceutical Safety

Statement

U.S. Rep. Diana DeGette (D-CO), Vice Chair of the Committee on Energy and Commerce, today offered the following opening statement during the Energy and Commerce Health Subcommittee hearing, Discussion Draft of the "Food and Drug Administration 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 the drug safety provisions included in the Food and Drug Administration Globalization Act discussion draft. It is high time we are moving forward with new legislation to protect the millions of individuals that take pharmaceutical products.

"Late last year the Oversight and Investigations Subcommittee, on which I also sit, held a hearing that looked at the foreign drug inspection program. I remember being stuck by the complete dearth of resources that the FDA has to put towards foreign drug inspections, as well as inherent differences between the inspection process for foreign and domestic facilities. For example, I was shocked to learn that for each overseas facility that exports drugs to the United States, FDA is able to complete an inspection only once every 8 to 12 years. Yet, Good Manufacturing Practices govern that on-site inspections should occur every two years. FDA must inspect domestic facilities every two years—why should the standard be so much lower for foreign drugs than domestic drugs when they are consumed by the same population?

"I am glad that we are taking the first steps towards remedying the current situation and that we are developing legislation that will protect the safety of our pharmaceutical supply. The bill that we are discussing today will require that foreign drug and device facilities be inspected every two years—finally on par with the requirements for domestic facilities. This requirement is long overdue and I commend my colleagues on including this provision in the FDA Globalization Act. However, I would like to reiterate that we will need to make sure to provide adequate resources to enable FDA to complete timely and thorough inspections of foreign facilities.

"The FDA currently has authority to refuse admission of products that appear to violate the Food, Drug, and Cosmetic Act. However, it is my understanding that FDA does not currently have the authority to destroy these shipments, and instead must simply send them back to wherever they came from. This is worrisome in regards to tainted products, but even more worrisome in regards to counterfeit products, as we have no guarantee that the manufacturer won't simply try masquerading them a second time.

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

"I think this is a very strong step towards protecting our citizens from counterfeit and adulterated drugs. I do however want to make sure that there will be sufficient technology and resources available to the Secretary and border officials, that they are able to adequately determine whether the drug in question poses a risk of injury or death. I also want to make sure that any provisions included in the final legislation are strong enough to ensure the safety of high-risk and high-cost drugs that are most likely to be counterfeited. The current system of returning adulterated pharmaceuticals that are refused entry simply does not ensure continued safety of our drug supply. It is vital that we put additional protections into place, such as the authority to destroy adulterated pharmaceuticals.

"The current discussion draft also includes a number of other important provisions, such as improved testing and verification requirements for drug purity and identity, as well as civil monetary penalties for violators. I look forward to hearing from today's panelists about their perspectives on this draft of the ‘FDA Globalization Act.'

"Thank you."

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