WASHINGTON — Renewing their commitment to ensuring FDA-approved drugs are safe once on the market, Sens. Chris Dodd (D-CT) and Chuck Grassley (R-IA) are reintroducing legislation to revamp and prioritize the post-market surveillance process within the Food and Drug Administration and to greatly expand public access to information about clinical trials regardless of the outcome of those trials through a clinical trials registry and results database.
Their initiatives are packaged in two bills that will be introduced this week: the Food and Drug Administration Safety Act of 2007 and the Fair Access to Clinical Trials (FACT) Act of 2007. Grassley and Dodd authored nearly identical bills in the last Congress in the aftermath of the Vioxx and antidepressant use in children scandals.
“Both of these bills fill voids in our public health system that I believe need immediate attention,” said Dodd. “Every day, doctors and researchers discover important findings in clinical trials. The FACT Act will help bring these to light, and in doing so, provide consumers, health care professionals, and the FDA with a more complete picture of the safety and effectiveness of drugs, biologics and medical devices so that they are able to make more informed decisions. Additionally, the FDA Safety Act will bring a new level of priority and independence to the postmarket surveillance of drugs. A crisis of confidence in the FDA currently exists. If we are to restore public confidence in the words ‘FDA Approved,’ we must ensure that the men and women who diligently monitor drugs on the market have the resources, the independence, and the authority to do their jobs effectively.”
“A mountain of evidence has amassed about the need to improve the way the FDA operates,” said Grassley, who is Ranking Member of the Senate Committee on Finance. “Congress will act on FDA-related legislation this year, and meaningful structural reforms to the agency need to be a part of what Congress does with regard to drug safety. Consumers shouldn’t have to think twice about what’s in their medicine cabinets. The FDA needs to be more transparent, more accountable and more forthcoming with information for the public
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The Food and Drug Administration Safety Act would enhance the FDA’s drug-safety monitoring system by setting up a new and independent center within the FDA called the Center for Postmarket Evaluation and Research for Drugs and Biologics (CPER) which would be responsible for monitoring the safety of drugs and biologics once they are on the market, in consultation with other existing Centers at the FDA, and would have the authority to take corrective action if a drug or biologic presents a risk to patients. For example, the Center Director can require manufacturers to conduct post-market clinical or observational studies if there are questions about the safety or efficacy of a drug or biologic once it is already on the market. Under the bill, CPER would report directly to the FDA Commissioner.
Grassley and Dodd said the legislation is aimed to change the status quo at the FDA. Sens. Barbara Mikulski (D-MD) and Jeff Bingaman (D-NM) are also cosponsors of this legislation.
"The bill addresses the fact that the office approving new drugs carries too much sway over the FDA's drug-safety apparatus. Today drug makers have the ability to negotiate with the same FDA officials who approved their drugs in the first place, when and if the FDA considers corrective action," Grassley said
The FACT Act is based on legislation authored by Senator Dodd dating back to 2003. It would expand www.clinicaltrials.gov to create a publicly-accessible national data bank of clinical trial information comprised of a clinical trial registry and a database of clinical trial results. The legislation would foster transparency and accountability in health-related intervention research and development and ensure that the scientific community and the general public have access to basic information about clinical trials. Importantly, the FACT Act would maintain and improve clinicaltrials.gov as a registry for patients and physicians seeking information about ongoing clinical trials for serious or life-threatening diseases and conditions. The legislation would also prevent companies from withholding clinically important information about their products.
“Consumers shouldn’t be left in the dark when it comes to the medicines they are taking,” said Dodd. “This measure will help to shine a bright light on information related to clinical trials.”
Bingaman and Sen. Ron Wyden (D-OR) are also cosponsors of the FACT Act.
Dodd is a Senior Member of the Senate Committee on Health, Education, Labor, and Pensions (HELP), which is responsible for overseeing the FDA. He is the Chairman of the HELP Subcommittee on Education and Early Childhood Development. Dodd has worked throughout his career to ensure that drugs are safe and effective for all Americans, including children.
Grassley has conducted aggressive oversight of the FDA for three years and has put pressure on the drug-safety agency to act with more independence and transparency than it now demonstrates in order to restore public confidence and strengthen public safety. He has called the FDA’s relationship with the drug industry “too cozy” and criticized the way that agency leaders have acted to suppress scientific dissent regarding agency actions and drug-safety recommendations.
Floor Speech of U.S. Senator Chuck Grassley
Introduction of the Food and Drug Administration Safety Act of 2007 (S.468)
and Fair Access to Clinical Trials Act of 2007 (S.467)
Wednesday, January 31, 2007
Mr. President, I'm pleased to sponsor with Senator Dodd two important bills 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 agency.Enactment of these 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 at the Food and Drug Administration.
I began my oversight of the FDA three years ago in response to concerns about the reluctance of the FDA to provide information to the public about the increased suicide risks for young people taking anti-depressants.In November 2004, I chaired a groundbreaking hearing on drug safety, the FDA and 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 FDA.Over the past three years it has become increasingly apparent that the FDA 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, Senator Dodd and I introduced almost identical companion bills to advance serious reform at the FDA.In the two 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 the agency and strengthening public safety.
Yesterday, the FDA 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 FDA's response, but rather to augment those plans and 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 IOM committee that wrote the report on drug safety, stated to USA Today, "I have to confess I'm disappointed that they [the FDA] ignored one of our most critical recommendations."According to the USA Today article, she was referring to IOM's recommendation that the FDA give more clout to the office that monitors drugs after they go on the market.I agree with Dr. Charo.
The Food and Drug Administration Safety Act of 2007 would establish an independent Center within the Food and Drug Administration - the Center for Postmarket Evaluation and Research for Drugs and Biologics (CPER).The Director of CPER would report directly to the FDA Commissioner, and would be responsible for conducting risk assessment for approved drugs and biological products.
This new center would also be responsible for ensuring the safety and effectiveness of drugs once they are on the market.Unfortunately, what happens now at the FDA is that the office that reviews the safety of drugs 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.This legislation would provide the new Center-CPER-with the independence and authority to promptly identify serious safety risks and take necessary actions to protect the public.At the same time,intra-agency communication is essential in addressing drug safety, so this legislation would encourage communication between CPER and the other centers and offices at the FDA that handle drugs and biological products to do what's best for the consumer-not big Pharma.
The FACT Act of 2007 would expand an existing website, www.clinicaltrials.gov, to create a publicly accessible national data bank of clinical trial information.The data bank would be comprised of a clinical trial registry and a clinical trial results database of all publicly and privately funded clinical trials.This legislation would foster transparency and accountability in health research and development and ensure that the scientific community and the general public have access to basic information about clinical trials.The legislation would also create an environment that would encourage companies to submit clinically important information about their products from the FDA and from the public.
If we have learned anything over the last few years, it is that the FDA is a troubled agency that lost sight of its most important function-to ensure the safety and efficacy of new prescription drugs.Unfortunately, the public has good reason to doubt the FDA's ability to do its job, and experts from all over this country have expressed concern.These two bills will help put FDA back on the path to fulfilling its mission and most importantly put the American consumer first.
Mr. President, in closing, I ask unanimous consent that my statement be printed into the record and coupled with the statement Senator Dodd will file later today regarding the introduction of these important pieces of legislation.
Summary of the Food and Drug Administration Safety Act of 2007
Senator Charles E. Grassley (R-IA), Senator Christopher J. Dodd (D-CT),
Senator Barbara A. Mikulski (D-MD), Senator Jeff Bingaman (D-NM)
January 31, 2007
The Food and Drug Administration Safety Act of 2007 (FDASA) will establish an independent Center within the Food and Drug Administration (FDA) - the Center for Postmarket Evaluation and Research for Drugs and Biologics (CPER).The Director of CPER will report directly to the FDA Commissioner and will be responsible for conducting risk assessment for approved drugs and biological products and ensuring their safety and effectiveness once they are on the market.
FDASA will:
Authorize the Director to require manufacturers to conduct postmarket clinical or observational studies if there are questions about the safety or efficacy of a drug or biological product.
Authorize the Director to determine whether an approved drug or licensed biological product may present an unreasonable risk to the health of patients or the general public, given the known benefits.
Authorize the Director to take corrective action if a drug or biological product presents an unreasonable risk to patients or the general public - including the authority to make changes to the label or approved indication, place restrictions on product distribution, require physician and consumer education, and require the use of other risk management tools.
Allow the Director to withdraw approval of a drug or biological product if necessary to protect the public health.
Require submission of advertising prior to dissemination, and certain advertising disclosures related to risks and benefits to patients, if one or more of the three following conditions is met: the Director has determined that the product may present an unreasonable risk to patients, the product is the subject of an outstanding postmarket study requirement, or the product was approved within the last two years.
Ensure that the Director benefits from all appropriate resources, including consultation with the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER), and makes all decisions based on a risk-benefit analysis.
Ensure that all findings and decisions made by CPER are transparent.
Establish strong enforcement mechanisms, including civil monetary penalties, for those who fail to comply.
Require a report and recommendations to Congress on postmarket surveillance of medical devices.
Authorize graduated appropriations totaling $500 million over five years to ensure that CPER has the resources to accomplish its goals.
Summary of the Fair Access to Clinical Trials (FACT) ACT
Introduced by Senator Dodd (D-CT), Senator Grassley (R-IA), Senator Wyden (D-OR), Senator Bingaman (D-NM), Senator Durbin (D-IL), Senator Harkin (D-IA)
January 31, 2007
The FACT Act will expand www.clinicaltrials.gov to create a publicly accessible national data bank of clinical trial information comprised of a clinical trial registry and a clinical trial results database.The legislation will foster transparency and accountability in health-related intervention research and development and ensure that the scientific community and the general public have access to basic information about clinical trials.The legislation will also prevent companies from withholding clinically important information about their products.
The FACT Act will:
Maintain a clinical trial registry accessible to patients and health care practitioners seeking information related to ongoing clinical trials for serious or life-threatening diseases and conditions;
Establish a clinical trial results database of all publicly and privately funded clinical trial results regardless of outcome that is accessible to the scientific community, health care practitioners, and members of the public;
Require the Food and Drug Administration (FDA) to make internal drug approval and safety reviews publicly available, including documentation of significant differences of opinion and their resolution;
Build on the successful model of www.clinicaltrials.gov, which was established in 1997.The web site will continue to be run by the National Library of Medicine at the National Institutes of Health, with assistance from the FDA;
Apply to clinical trials for drugs, biologics, and medical devices.All trials must be registered in the database in order to obtain approvalfrom a U.S. Institutional Review Board;
Require that foreign trials that are submitted to the FDA as part of a new drug application or a supplemental drug application or are used in advertising to U.S. physicians be posted in the database in a timely manner;
Require that researchers promptly disclose the objectives, eligibility criteria, sources of funding, and anticipated timeline of clinical trials.The bill's standards will meet all of the minimum criteria for a trial registry set out by the International Committee of Medical Journal Editors on September 8, 2004;
Mandate that the results of clinical trials be available to doctors and patients.Recognizing that the peer review process is the best safeguard for scientific accuracy, the bill provides time for researchers to publish their results.The disclosure of important trial results satisfies the recommendation of the American Medical Association;
Establish strong enforcement mechanisms.The bill will provide for civil monetary penalties of up to $10,000 per day for sponsors who refuse to comply.The bill will also establish penalties for sponsors of a new drug application or a supplemental new drug application for failing to certify that the information they are submitting to the FDA is accurate.Monetary penalties will be earmarked for studies that compare clinical therapies;
Provide authority to audit the completeness and accuracy of the information in the registry; and
Ensure that the Food and Drug Administration has the authority to correct false or misleading statements about the results of clinical trials.