Prescription Drug User Fee Amendments of 2007

PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 -- (Senate - May 09, 2007)

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Mr. GRASSLEY. I am going to speak about amendment No. 1039. I ask unanimous consent that Senators MIKULSKI, BROWN, SNOWE, and BINGAMAN be added as cosponsors.

The PRESIDING OFFICER. Without objection, it is so ordered.

Mr. GRASSLEY. This amendment is important because S. 1082 does not sufficiently address the underlying problems I have found existing at the Food and Drug Administration during my tenure as chairman of the Senate Finance Committee looking into the problems of the Food and Drug Administration, with the goal in mind that the Federal Government should only be paying for drugs that are safe. That problem is the lack of equality between the Office of New Drugs, which reviews drug applications and decides whether to approve a drug for marketing, and the Office of Surveillance and Epidemiology, the office which monitors and assesses the safety of drugs postmarketing.

Many times I quote the Institute of Medicine as justification for my amendment. They recognize this problem. The Institute of Medicine recognizes joint authority between these two offices for postapproval regulatory action related to safety. Even the Consumers Union supports this amendment.

Having equality between preapproval and postapproval offices at the FDA is fundamental to real reform. Concentrating on the entire life cycle of drugs
is critical. After all, the vast majority of a drug's life cycle is spent postapproval. In essence, the bill before us promotes the status quo when it comes to the specific role played by the Office of Surveillance. That means the Office of Surveillance and Epidemiology will remain nothing more than a mere consultant to the Office of New Drugs. This is not acceptable.

Amendment 1039 gives the Office of Surveillance sign-off authority. They are experts in postmarketing safety. Even the Institute of Medicine recognized that through their recommendations. Let me be clear: This is not the amendment Senator Dodd and I originally proposed. I still believe an independent postmarketing safety center would be best to solve the problem. But under the process, that is not going to happen. Through this amendment, at least joint postmarketing decisionmaking between the Office of Surveillance and the Office of New Drugs will allow the office with the postmarketing safety expertise to have a say in what drug safety action will be taken by the FDA.

The problem is not only the FDA having enough tools--this bill gives additional tools--it is about FDA managers disregarding concerns raised by its own scientists in the Office of Surveillance and not taking prompt action. This amendment makes common sense when you weigh the evidence I presented over the last 3 years about these problems at the FDA.

Opponents of this amendment say it is unnecessary because the bill includes a dispute resolution process with strict deadlines. But that process is for disputes between the FDA and the drug company, not internal disagreements between FDA offices.

Getting down to brass tacks, when the office that looks at postmarketing surveillance is under the thumb of the Office of New Drugs, and the Office of New Drugs says: This drug is safe, they aren't going to want to get egg on their faces by listening to the advice of the Office of Postmarketing Surveillance. If that had been the case, Dr. Graham, in the case of Vioxx, and Dr. Mosholder, in the case of antidepressant drugs, when kids were committing suicide, would have been listened to, but they weren't until they came as whistleblowers to the Congress.

We have to have it so that we have enough independent decisionmaking within the FDA to make sure these drugs are safe.

This amendment provides an approach with checks and balances between the office that approves a drug for marketing and the office that watches a drug once it is on the market.

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AMENDMENT NO. 998

Mr. GRASSLEY. Madam President, I yield myself such time as I consume on amendment No. 998. I ask unanimous consent that Senators DODD, SNOWE, and BINGAMAN be added as cosponsors.

The PRESIDING OFFICER. Without objection, it is so ordered.

Mr. GRASSLEY. This amendment provides for the application of stronger civil monetary penalties for violations of approved risk evaluation and mitigation strategies. Currently, the bill before us contains penalties, but those penalties won't mean much to large global corporations. In fact, the penalties amount to the cost of doing business. This amendment is intended, then, to give the Food and Drug Administration, the watchdog, some bite along with its bark.

There is opposition to having strong civil monetary penalties, but that does not make sense to this Senator. Even the Consumers Union supports this amendment. The reality is, drug companies provide lifesaving pharmaceuticals throughout the world. The pharmaceutical companies make miracles happen. Before a drug is approved, a drug company has an incentive to provide evidence of a drug's effectiveness to the Food and Drug Administration. Without it, they can't sell drugs in this country. However, once a drug is already being sold in the marketplace, drug companies have almost no incentive to look for and evaluate safety issues. The bottom line is, sometimes market forces guide businesses in a way that may be contrary to the public interest.

We have seen this happen many times. For the Food and Drug Administration's new authorities to be meaningful in this legislation, there must be stronger civil monetary penalties in the underlying bill; hence, my amendment. Fines are nothing more than the cost of doing business, and we can't change behavior. More importantly, we can't even deter bad behavior. If a company does what it is supposed to do, a drug company doesn't need to fear any penalties. It is that simple.

I ask Members of the Senate to support this amendment because it adds real teeth to the FDA's bite.

I thank Senators KENNEDY and ENZI for the tremendous efforts they went to in bringing this bill to the Senate floor. Again, I want to make this bill even better. They have already included several ideas Senator Dodd and I have shared with them.

I reserve the remainder of my time.

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Mr. GRASSLEY. Mr. President, I yield myself such time as I might consume. I only have 2 1/2 minutes.

AMENDMENT NO. 1039

On the very important amendment about making sure there is adequate cooperation and dialog between the Office of New Drugs and the Office of Postmarket Surveillance, I wish to make clear this amendment is not, as some have characterized it, about process. It seems to me this is the ultimate of insurance to do the right thing to protect the American people on the safety of drugs. It is based on so many examples I found over the last 3 years, where there was not the respect for the Office of Postmarketing Surveillance there ought to be from the Office of New Drugs.

A lot of safety issues would not have gotten out if we had not had a lot of red-blooded, patriotic whistleblowers who would come to Congress, such as Dr. Graham, for instance, in the case of Vioxx, such as Dr. Mosholder, in the case of depressants for children who were committing suicide. This ended up with Vioxx coming off the market. This ended up with black-box safety measures in the case of the antidepressants.

The Institute of Medicine has recognized the importance of these two groups within the FDA working very closely together on making a determination on postmarketing surveillance. That is what my amendment does. It makes sure this process works the way the Institute of Medicine indicated it should.

So as you consider voting on this amendment, I ask my colleagues--himself or herself--one basic question before voting: Since the Institute of Medicine recommends equality between the preapproval process--in other words, before a drug is marketed--and the postapproval process at the FDA, why not vote for this amendment and improve postmarketing safety for the American people?

I yield the floor.

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AMENDMENT NO. 1039

The PRESIDING OFFICER. Under the previous order, there will be 2 minutes for debate equally divided prior to a vote in relation to amendment No. 1039.

Who yields time?

Mr. GRASSLEY. Mr. President, I will speak in favor of 1039. I have 30 seconds, did you say, or 1 minute?

The PRESIDING OFFICER. The Senator has 1 minute.

Mr. GRASSLEY. Mr. President, one of the issues that has been very much a shortcoming within the FDA besides lack of respect for the scientific process, but it is involved in the issue of this amendment as well, is whether scientists in the FDA who have the responsibility of postmarketing surveillance get the respect they ought to from the Office of New Drugs that previously had approved the drug. We have found in the case of Vioxx, in the case of antidepressants for children, and in a lot of other areas as well that this has just not been the case.

My amendment will follow the Institute of Medicine recommendation and make sure there is adequate time and consideration given to postmarketing surveillance, the same as there is to the approval of the drug in the first place. So I ask for approval of this amendment. It is backed by the Institute of Medicine.

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Mr. GRASSLEY. Mr. President, the issue is the level of civil and monetary penalties. If the fines are nothing more than the cost of doing business, you can't change behavior and you can't deter bad behavior. My feeling is the levels in this underlying bill are not high enough to get the attention of the drug companies. After all, if a company does what it is supposed to do, a drug company doesn't need to fear any penalties. It is that simple.

I ask my colleagues to support my amendment so it has real teeth.

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