Prescription Drug User Fee Amendments of 2007

Floor Speech

PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 -- (Senate - May 02, 2007)

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Mr. KOHL. Madam President, I rise today and would like to briefly speak about Senator Durbin's amendment regarding food safety. I was happy to cosponsor this amendment, and I agree with all of the sentiments expressed by the Senator earlier today.

This amendment deals with many of the underlying problems that allow food safety issues, such as the ones we have dealt with in recent months that have affected not only humans, but their pets as well.

It requires the FDA to set standards for pet food and to update them as necessary, and it directs the Secretary of Health and Human Services to establish a system capable of detecting pet food contamination and outbreaks of pet illnesses and death--this will prevent the type of confusion that continues to surround the recent melamine outbreak, and will help detect these problems much earlier. It requires FDA to develop effective communication plans to coordinate with stakeholders during outbreaks of both pet and human foods, so people know what is going on--quickly--and know what to do. It directs the Secretary to work with States to collaborate on activities and programs that assist in improving the safety of raw agricultural products such as spinach, which was the cause of a major food safety recall last fall. Importantly, it requires FDA to establish a registry to collect information on cases of potentially dangerous food adulteration to help get any dangerous food off of the shelves more quickly and to allow FDA to target inspection resources where most needed.

This amendment does many important things--and takes many important first steps. I know that Senator Durbin would have liked this amendment to go a little further, and I agree with his sentiments, but it is important to at least take the first step.

In March of this year, I held a hearing in Madison, WI, on food safety issues at the FDA. The Commissioner of FDA attended, as well as the Director of the FDA's Center for Food Safety. At that time, I pointed out that outbreaks of foodborne illness caused by produce have doubled since 1998. During this same time, the FDA's food budget has suffered. The number of people getting sick is going up, but the number of inspections and food safety tests being conducted is dwindling. So too are the number of food inspectors and overall staff at the FDA's Center for Food Safety. Imports have risen dramatically over the years, but the FDA is only able to inspect less than 1 percent of them.

Events after that hearing seemed to exacerbate what I pointed out. The recent pet food scare, and the ongoing melamine investigation, serve as constant reminders that we have been taking this issue for granted, assuming that the FDA has the authority and funding necessary to do its job, when that is clearly not the case.

Senator Durbin's amendment begins to take care of some of the problems with FDA authority and actions.

As the chairman of the Agriculture Appropriations Subcommittee, which has jurisdiction over the FDA's budget, it is my job to make certain that the FDA has the money to carry out its vital role of protecting our food. The Food Center at FDA doesn't have user fees from industry to boost its funding--it all comes from the Congress, and has been stagnant for far too long.

I have been working diligently to make sure that when the fiscal year 2008 Agriculture Appropriations bill is written, food safety will be one of its highlights. I do not believe the administration has ever requested enough funding for food safety at the FDA, this year notwithstanding. I plan to correct that. It may not happen all in the first year being fiscally responsible can be tough--but it will happen. We will provide a significant increase to the FDA this year, so they can implement some of what Senator Durbin's amendment proposes, and quite simply, so they can hire inspectors where they are needed, to do the necessary research to prevent outbreaks from occurring wherever possible, and so we don't continue to see large recall notices in our newspapers every day. It is not a problem that can be fixed immediately, but I fully intend to meet my end of the obligation in making sure that FDA has the money that it needs, and can use responsibly, to tackle this problem head on.

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AMENDMENT NO. 1011

Mr. KOHL. Madam President, I rise today to join Senators STABENOW, LOTT, BROWN, and THUNE in offering amendment No. 1011. This amendment will help speed the introduction of cost-saving generic drugs by preventing abuses of the Food and Drug Administration citizen petition process.

Consumers continue to suffer all across our country from the high--and ever rising--cost of prescription drugs. A recent independent study found that prescription drug spending has more than quadrupled since 1990, and now accounts for 11 percent of all health care spending. At the same time, the pharmaceutical industry is one of the most profitable industries in the world, returning more than 15 percent on their investments.

One key method to bring prescription drug prices down is to promote the introduction of generic alternatives to expensive brand name drugs. Consumers realize substantial savings once generic drugs enter the market. Generic drugs cost on average of 63 percent less than their brandname equivalents. One study estimates that every 1 percent increase in the use of generic drugs could save as much as $4 billion in health care costs.

This is why I have been so active in pursuing legislation designed to combat practices which impede the introduction of generic drugs. The amendment offered today, includes provisions based on legislation that I first introduced with Senator Leahy in the last Congress, and targets one particularly pernicious practice by brandname drug companies to impede or block the marketing of generic drugs--abuse of the FDA citizen petition process.

FDA rules permit any person to file a so-called citizen petition to raise concerns about the safety or efficacy of a generic drug that a manufacturer is seeking FDA approval to bring to market. While this citizen petition process was put in place for a laudable purpose, unfortunately in recent years it has been abused by frivolous petitions submitted by brandname drug manufacturers, or individuals acting at their behest, whose only purpose is to delay the introduction of generic competition. The FDA has a policy of not granting any new generic manufacturer's drug application until after it has
considered and evaluated any citizen petitions regarding that drug. The process of resolving a citizen petition, even if ultimately found to be groundless, can delay the approval by months or years. Indeed, brandname drug manufacturers often wait to file citizen petitions until just before the FDA is about to grant the application to market the new generic drug manufacturer's solely for the purpose of delaying the introduction of the generic competitor for the maximum amount of time possible. This gaming of the system should not be tolerated.

In recent years, FDA officials have expressed serious concerns about the abuse of the citizen petition process. In 2005, FDA Chief Counsel Sheldon Bradshaw noted that ``[t]he citizen petition process is in some cases being abused. Sometimes, stakeholders try to use this mechanism to unnecessarily delay approval of a competitor's products.'' He added that he found it ``particularly troublesome'' that he had ``seen several examples of citizen petitions that appear designed not to raise timely concerns with respect to the legality or scientific soundness of approving a drug application, but rather to delay approval by compelling the agency to take the time to consider the arguments raised in the petition, regardless of their merits, and regardless of whether the petitioner could have made those very arguments months and months before.''

And a simple look at the statistics gives credence to these concerns. Of the 21 citizen petitions for which the FDA has reached a decision since 2003, 20--or 95 percent of them--have been found to be without merit. Of these, 10 were identified as ``eleventh hour petitions''--defined as those filed less than 6 months prior to the estimated entry date of the generic drug. None of these 10 ``eleventh hour petitions'' were found to have merit, but each caused unnecessary delays in the marketing of the generic drug by months or over a year, causing consumers to spend millions and millions of dollars for their prescription drugs than they would have spent without these abusive filings.

Among other things, our amendment will, for the first time, require all those who file citizen petitions to affirm certain basic facts about the truthfulness and good faith of the petition, similar to what is required of every litigant who makes a filing in court. Our amendment also includes a provision from my bill that directs the HHS that all citizen petitions on generic drug applications be adjudicated within 6 months of filing, which will put an end to excessive delays in bringing needed generic drugs to market because of the filings of these petitions.

While I strongly support this amendment and I am pleased that many of my provisions were included, I do wish the amendment could have gone even farther and include my provision to allow the Department of Health and Human Services--the FDA's parent agency--the power to sanction those who abuse the process. While this proposal would not have an effect on any person filing a truly meritorious citizen petition, this provision would serve as a strong deterrent to attempts by brand name drug manufacturers or any other party that seeks to abuse the citizen petition process to thwart competition. Having said that, I do believe our amendment today is an important step in the right direction to remove a significant obstacle exploited by brand name drug companies to prevent or delay the introduction of generic drugs. I urge my colleagues to support this amendment.

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