Food and Drug Admininstration Amendments Act of 2007

Floor Speech

FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007 -- (Senate - September 20, 2007)

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Mr. DURBIN. Mr. President, today, the Senate will send a bipartisan bill to the President that will improve the FDA's ability to assure the safety of drugs in our medicine cabinets and the food in our kitchens.

The FDA is an essential guardian of the public's health and safety. In recent years, FDA's reputation has been marred by drug safety incidents and questions about its scientific independence.

In 2004, the public learned that taking Vioxx, a heavily marketed pain medication, increased your risk of a heart attack and stroke. The revelation raised serious questions about how the drug manufacturer responded to signs of a problem and how FDA handled disagreements among its staff.

The Vioxx episode and problems with other FDA-approved drugs in recent years exposed significant weaknesses in our Nation's drug-safety system.

This year, Congress decided to do something about it. In addition to reauthorizing user fee programs for prescription drugs and medical devices, we have engaged in a serious effort to improve drug safety.

The bill gives the FDA more tools to detect the safety problems of drugs after they are available to consumers. It also creates an active surveillance system that will help detect problems that were not apparent during the clinical trials conducted prior to a drug's approval and it promotes greater openness by requiring disclosure of clinical trials performed by drug companies. Lastly, the FDA is given greater authority to require drug companies to add warning labels and to conduct safety studies.

I note the provisions in the bill that give FDA the authority to compel a drug company to make changes to a drug's labeling. That authority should not be seen as an absolution of the companies' responsibility regarding drug labeling. Consumers should be made aware of a drug's risks at the earliest possible moment, and drug companies remain responsible for ensuring that consumers are provided with prompt and adequate warning of a drug's risks.

We have noticed a creeping trend in recent years towards implied and agency preemption of state laws. Last week, a Senate Judiciary Committee hearing looked at techniques that Federal agencies, including FDA, have recently used to assert that agency rulemakings preempt state liability laws. The drug labeling provisions in today's legislation include a rule of construction that makes clear that Congress does not intend to preempt state requirements regarding drug companies' responsibilities. Rather, this legislation recognizes that State liability laws, including liability laws for improper drug labeling, play an essential role in ensuring that drug products remain safe and effective for all Americans.

The bill addresses two other issues of particular interest to me, new restrictions on conflicts of interest for FDA advisory committees and important provisions related to food safety.

I have been troubled by the large number of waivers of conflicts-of-interest rules that FDA issues to members of its advisory committees. The public depends on these committees to make independent assessments about the safety and effectiveness of drugs. Including members with financial conflicts can erode the public's trust in the process.

When the Senate debated this bill in May, I offered an amendment with Senator Bingaman that would have limited the number of waivers to one per advisory committee meeting. While the amendment was defeated on a 47-47 vote, the House included the language in its FDA bill.

The final bill includes a 25-percent reduction in waivers over the next 5 years. I would have preferred more of a reduction, but this compromise moves us in the right direction and I commend the conferees for addressing concerns raised in both chambers around conflicts of interest.

On the issue of food safety, I am happy to report that the bill includes food safety language that I originally offered on the floor of the Senate. The language passed on the Senate floor by a 94-0 vote.

The language creates a new reporting requirement for food companies that determine there is a significant adulterated food product in their supply chain. Previously, companies consulted trade associations and attorneys to determine when to report significant adulterations to the FDA. Uncertainty about reporting requirements and an incentive to keep products on store shelves resulted in uneven, delayed reporting of significant incidents to FDA.

Under this new policy, companies will now be required to report these types of incidents to FDA within 24 hours of determining the presence of such an adulteration. These reports will trigger an FDA review and, depending on the findings of the review, FDA would then have the authority to require further action from the company, including an investigation, submission of additional information, and the sending of notifications to affected parties in the supply chain. Companies would be required to maintain records of reports and notifications for a period of 2 years. Failures to report incidents, falsify reports, or comply with follow-up FDA requirements would be subject to civil and criminal penalties.

The effect of this language will be to involve Federal regulators in the review process earlier, resulting in faster recalls, alerts, and notifications through the supply chain. Contaminated products will be tracked and removed from the supply chain earlier and faster. Recalls will be more targeted to specific lots and batches of contaminated products. We will minimize some of the uncertainty around the extent of contaminations once they are discovered.

This provision is an important step forward for food safety.

In addition to this provision, the language directs FDA to establish pet food ingredient, processing, and nutrition labeling standards. Previously, these standards were completely voluntary and did not carry the weight of law. This section also directs FDA to establish an early warning and surveillance system to identify pet food adulterations and outbreaks of disease. In addition, the language directs FDA to improve its outreach and coordination with professional associations, universities, and state and local authorities during recalls. The agency is also asked to enhance the display of recalls on its website.

The bill directs FDA to strengthen its coordination with states to ensure the safety of fresh and processed produce and requires the Department of Health and Human Services to submit more detailed reports to Congress on the number of inspections conducted each year and the number of violations and adulterants discovered through inspections.

Lastly, it includes sense-of-Congress language that commits this Congress to working on comprehensive food safety reform.

On that note, I want to emphasize one thing--the food safety provisions in this legislation are only the starting point for more comprehensive efforts to improve our Nation's food safety system.

For too long we have gone without updating the resources and authorities for our food safety efforts, and a broad coalition of stakeholders understands that our system is broken. We need to close the gaps in our current system.

Several months ago, Robert Brackett, Director of the FDA's food arm said this in response to the pet food recall, ``These outbreaks point to a need to completely overhaul the way the agency does business. We have 60,000 to 80,000 facilities that we're responsible for in any given year. We have to get out of the 1950s paradigm.''

Also in response to this recall, Dr. Stephen Sundlof, Director of the Center for Veterinary Medicine of FDA, implied the same when he said, ``We're going to have to look at this after the dust settles and determine if there is something from a regulatory standpoint that we could have done differently to prevent this incident from occurring.''

I agree with their sentiments and look forward to making more progress on the issue of food safety.

I would like to thank my colleagues, Chairman Kennedy and Senator Enzi, for their cooperation and willingness to work on this language. I would also like to highlight the efforts of the following members of their staffs: David Noll; Amy Muhlberg; David Dorsey; and David Bowen. I look forward to working with the Senate HELP Committee on future food safety efforts. I would also like to thank Senators HARKIN, BROWN, HATCH, and CASEY for their assistance with this language.

In particular, I also would like to thank Chairman Kennedy and Senator Enzi for their extraordinary leadership and hard work on this overall bill.

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