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Kennedy As The Bipartisan FDA Bill Is Debated

Press Release

Location: Washington, DC


I thank my colleagues for being ready with their amendments so the Senate can make progress on this important legislation. Today, we will deal with several major issues.

First, our colleague from Michigan, Senator Stabenow, and our colleague on the HELP committee, Senator Brown, will offer an important proposal to end the abuse of what are known as citizen's petitions. They are joined in this bipartisan proposal by Senator Lott and Senator Thune.

FDA has a common sense policy to allow ordinary citizens or medical experts to submit comments and petitions to the agency about drugs that it is considering approving. This procedure should be used to protect public health, but too often, it is subverted by those who seek only to delay the entry onto the market of generic drugs.

At the 11th hour, drug companies suddenly discovered a range of supposed safety problems with a generic competitor. These alleged concerns might have been known for months preceding the filing of the petition, but they are delayed and delayed until the very day or week that the generic is to be approved. Only then is a mountain of paper delivered to the FDA with a demand that the agency review it before approving the generic.

With inadequate resources, it can take months for FDA to review the claims in the petition, even when they are patently false. Even if the petitions are found to be meritless, they will have accomplished their mission, delaying access for consumers to safe and lower cost medicines.

To be sure, some citizen's petitions do present legitimate public health concerns, and FDA should not ignore them, but fewer than 1 in 10 of these petitions have been found to raise legitimate concerns. The critical test of any proposal on citizen's petition is that it strike a balance so that the abuse of citizens petitions is prohibited, but those petitions that have genuine safety information are reviewed.

The proposal before the Senate today strikes that balance. It rightly states that the mere filing of a citizen petition should not be cause for delay, but, and this is crucial, it allows FDA to delay the approval of a generic application if it determines that doing so is necessary to protect public health.

This is the right approach. It prevents abuse, but protects health. I commend my colleagues for having struck the right balance on this major issue, and I urge the Senate to approve their proposal.

We will deal with another issue this morning, but this is an amendment I urge my colleagues to reject. One of the major elements of the FDA bill is a program to provide incentives for developing new drugs for children. Senator Dodd, Senator Clinton, Senator Alexander, and many others have been champions of this program, as was our former colleague, Senator DeWine.

A reauthorization of an effective program is an opportunity to strengthen those aspects that work well and improve those that need adjustment. Senator Dodd took up this challenge, and reviewed the information about how the program had worked over the years since Congress last reviewed it. He found that companies were sometimes rewarded with billions of dollars in additional sales in return for doing studies that cost them only tens of millions.

Clearly, we must provide incentives to develop new drugs for children, but we must be responsible in doing so. That is why Senator Dodd included in this reauthorization a proposal to adjust the period of market exclusivity for drugs that generate over $1 billion in sales. These blockbuster drugs will receive only three months of exclusivity instead of the six available to other drugs.

The Allard amendment would delete this sensible provision and give all drugs the full six months. That can be worth billions of dollars to a major medication. Those extra six months don't just apply to sales for use in children, they apply to all sales. A heart drug tested in children would get six months protection from competition, so it can rack up big returns.

The amendment we face embodies a policy that has no proportionality. It gives the same reward to a Lipitor or a Xanax as to a drug for specialty antibiotics that might be helpful in treating ear infections in children. Senator Dodd's proposal has that sense of proportional reward, but the amendment overturns it. That's the wrong approach and I hope the Senate will reject it.

Later today, I hope we will have an opportunity to consider an amendment to improve food safety that we have been working on with many colleagues, including Senator Durbin, Senator Enzi, Senator Allard, Senator Hatch and Senator Harkin. Our HELP committee will take a comprehensive approach to food safety in the days to come, but the current amendment is an important first step of measures we should take right away in terms of increased surveillance, better reporting of adverse events, especially from food importers, and stronger quality standards. We need to take steps both for the food we give our families and the food that our pets are fed.

I will speak in greater detail to this legislation at another time, but I wanted to alert my Senate colleagues that we plan to continue to work in this area.

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