Statements on Introduced Bills and Joint Resolutiions
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS -- (Senate - January 31, 2007)
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By Mr. GRASSLEY:
S. 461. A bill to amend title 28, United States Code, to provide an Inspector General for the judicial branch, and for other purposes; to the Committee on the Judiciary.
Mr. GRASSLEY. Mr. President, I ask unanimous consent that the text of this bill be printed in the RECORD.
There being no objection, the text of the bill was ordered to be printed in the RECORD, as follows:
S. 461
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By Mr. GRASSLEY (for himself, Mr. DODD, Ms. MIKULSKI, and Mr. BINGAMAN):
S. 468. A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes; to the Committee on Health, Education, Labor, and Pensions.
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Mr. GRASSLEY. Madam President, I am pleased to have bipartisan sponsorship of two very important bills with Senator Dodd of Connecticut that are being introduced today, the Food and Drug Administration Safety Act of 2007 and the Fair Access to Clinical Trials Act of 2007.
These bills are part of a sustained effort to restore public confidence in the Federal Government's food and drug safety program and to make sure the agency does all it can to protect the public.
Enactment of those two bills would provide doctors and patients with more information about the risks and benefits of their medicines and bring about greater transparency and accountability of the Food and Drug Administration.
I am sure my colleagues realize I have been involved in oversight of the Food and Drug Administration for now at least 3 years, and it has been in response to concerns about the reluctance of the Food and Drug Administration to provide information to the public about the increased suicide risks for young people taking antidepressants.
In November 2004, I chaired a groundbreaking hearing on drug safety involving the Food and Drug Administration and the drug Vioxx. That hearing and other critical drug safety concerns that have come to light since then highlight the need for comprehensive and systematic reforms as well as more stringent oversight of the Food and Drug Administration.
Over the past 3 years, it has become increasingly apparent that the Food and Drug Administration has repeatedly failed to protect the public from an industry that focuses all too often on profits, even when those profits come at the expense of ``John Q. Public.'
In 2005, then, and because of this, Senator Dodd and I introduced almost identical companion bills to advance serious reforms at the Food and Drug Administration. In the 2 years following the introduction of those bills, however, the Food and Drug Administration failed to take comprehensive and systematic steps toward restoring public confidence in that agency, as well as the necessity of strengthening public safety.
Yesterday, the Food and Drug Administration released its response to the Institute of Medicine's 2006 report on drug safety. The two safety bills introduced today are not intended to supplant the plans articulated in the Food and Drug Administration's response but, rather, to augment those plans and to provide the FDA with additional enforcement tools, something they now lack.
In fact, one of our bills is intended to specifically address a serious problem that was also identified by the Institute of Medicine. Dr. Alta Charo, a member of the Institute of Medicine committee that wrote the report on drug safety, stated in the newspaper USA Today:
I have to confess I'm disappointed that they--meaning the FDA--ignored one of our most critical recommendations.
According to the USA Today article, she was referring to the Institute of Medicine's recommendation that the Food and Drug Administration give more clout to the office that monitors drugs after they go to market. I want you to know I agree with Dr. Charo.
The Food and Drug Administration Safety Act of 2007 would then establish an independent center within the Food and Drug Administration. The name of the center would be the Center for Postmarket Evaluation and Research for Drugs and Biologics. The director of this center would report directly to the Food and Drug Administration Commissioner and would be responsible for conducting risk assessments for approved drugs and biological products.
The new center would also be responsible for ensuring the safety and effectiveness of drugs once they are on the market. Unfortunately, the problem we are trying to solve is that now at the FDA, the office that reviews drug safety postmarketing is a mere consultant and under the thumb of the office that puts the drugs on the market in the first place.
Even more troubling is the fact that those who speak out of line are targeted. Whistleblowers, as we call them, are targeted. They are very helpful to Congress in ferreting out wrongdoing, that laws are not being faithfully executed, that money is not being spent according to congressional intent. So they speak out at the FDA and point out a lot of things that are wrong. And what do they get for it? They are treated like a skunk at a picnic. They are targeted.
So this legislation we put before us would provide the new center with the independence and authority to promptly identify serious safety risks and take necessary actions to protect the public, and I hope eliminate some of the intimidation against whistleblowers.
At the same time, the intra-agency communication is essential in addressing drug safety. So this legislation would encourage communication between the center and other centers and offices, or let's say subagencies at the Food and Drug Administration that handle drugs and biological products, to do what is best for the consumer and not have big PhRMA having undue influence.
The second bill we are introducing would expand an existing Web site, www.clinicaltrials.gov, to create a publicly accessible national databank of clinical trial information. The databank would be comprised of a clinical trial registry and a clinical trial results database of all publicly and privately funded clinical trials so that everything is out there for the public to consider, not letting somebody choose: Well, if this is a little negative toward our drug, we will not make that public. All the positive stuff, of course, we will make public.
So I think this legislation is going to foster transparency. But it is going to bring about a great deal of accountability in health research and development and ensure that the scientific community and, most importantly, the general public whom we are trying to protect have access to basic information about clinical trials, about new drugs going out on the market.
The legislation would also create an environment that would encourage companies from withholding clinically important information about their products from the Food and Drug Administration and from the public.
By the way, the information that is coming out now about Vioxx in the newspapers today will even tell you that a long time before Vioxx went on the market there were scientists within the company who were raising questions about whether it was going to cause harm to the heart. All of this information should be out there. The public ought to know it. Your doctor ought to know it. Transparency and accountability should not hurt anybody in an open society such as we have in America. Oh, there might be some legitimate reasons for intellectual property privacy, but nothing beyond that.
If we have learned anything over the last few years, it is that the Food and Drug Administration is a troubled agency that lost sight of its fundamental function. That fundamental function is to protect the safety and the efficacy of new prescription drugs.
Two very important things for them to answer: Are the drugs safe for you? Are they effective?
Unfortunately, the public has good reason to doubt the Food and Drug Administration's ability to do its job. And experts from all over the country have expressed concern. These two bills, then, that Senator Dodd and I are introducing--and let me parenthetically say for the public, people are always thinking that Democrats are hitting on Republicans and Republicans are hitting on Democrats. There is a lot going on around here you never see on evening television that is bipartisan because there is not controversy about it, or at least there is no controversy between Republicans and Democrats. But what they want to put in the news media every night is when some Republican is fighting some Democrat. So our constituents get a view about this Congress that is very distorted.
I would like to have people read on a regular basis about how Senator Baucus and I meet on a regular basis to determine the agenda for the Finance Committee. I would like to have them read about how he and I have put out bipartisan bills for the last 6 years--whether he was chairman or I was chairman--and that every one of them got to the President to be signed. But you do not hear those things.
So I want to emphasize, this is a DODD--and Senator Dodd is a Democrat from Connecticut--and a GRASSLEY bill--and GRASSLEY is a Republican Senator from Iowa. So this bill is being introduced to ensure the safety and efficacy of new prescription drugs, not to do something new for the FDA, just to give them the tools to do what they have had a responsibility to do for several decades.
So the public has doubts about the FDA's ability to do it. These two bills will help put the FDA back on the path to fulfilling its mission and, most importantly, put the American consumer first.
So, Madam President, in closing, I ask unanimous consent that my statement in the Record that I give today be coupled with the statement of Senator Dodd, which will be given later today, regarding the introduction of these important bills.
By giving me this unanimous consent, it will assure the public, when they read about these bills, knows that DODD is a Democrat, GRASSLEY is a Republican, and they are bipartisan bills.
The PRESIDING OFFICER. Without objection, it is so ordered.
There being no objection, the text of the bill was ordered to be printed in the Record, as follows:
S. 468
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