February 28,2005

Chairman Grassley sponsors clinical trial registry legislation

WASHINGTON — Sen. Chuck Grassley today joined Sen. Chris Dodd in introducing legislation that would require drug makers to register clinical trials about prescription medicines.

Grassley said that “by making the clinical trial information publicly available we makethe system for ensuring drug safety more transparent and more accountable. That ultimatelyleads to an even safer system and greater consumer confidence.” He said his support for aclinical trials registry stems from the oversight work he conducted during the last year regardingthe way the Food and Drug Administration has handled information about drug risks.

Grassley’s scrutiny began based on allegations made early in 2004 about an attempt bythe federal agency to withhold information about the findings of an FDA scientist who found apossible link between antidepressants and teen suicide. Grassley continued his investigation ofthe Food and Drug Administration with a hearing in November to explore the FDA’s handling ofthe painkiller Vioxx, which had been pulled from the market due to increased risks for heartattacks and strokes.

Grassley is chairman of the Senate Committee on Finance, which is responsible forMedicare and Medicaid legislation and oversight. Medicaid has spent more than $1 billion onthe drug Vioxx, and Medicare is about to cover prescription drugs for the first time. “There’s nodoubt that the performance of the FDA affects the integrity and effectiveness of these importanthealth care programs,” Grassley said.

The bipartisan legislation introduced today is titled the Fair Access to Clinical Trials orFACT Act of 2005. It is similar to a measure championed by Dodd in the last Congress.Changes have been made to maintain clinicaltrials.gov as a registry for patients and physiciansseeking information about ongoing clinical trials for serious or life-threatening diseases and torequire the Food and Drug Administration to make internal drug approval and safety reviewspublicly available.

The text of Grassley’s floor statement regarding the new measure follows here. Thestatement includes a summary of the bill.

Floor Statement of Sen. Chuck Grassley of Iowa
Fair Access to Clinical Trials Act of 2005
February 28, 2005

 Mr. President, earlier today S.___ was introduced. I’m pleased to sponsor the Fair Accessto Clinical Trials Act of 2005 with Senator Dodd. I’m co-sponsoring this legislation as part of asustained effort to restore public confidence in the federal government’s food and drug safetyagency. Enactment of this bill would be a meaningful step toward greater transparency andaccountability in clinical trials and the scientific process.

The Food and Drug Administration earned its prized reputation through decades of goodwork on behalf of the American people. The FDA’s drug approval process has long beenconsidered the “Good Housekeeping Seal of Approval.” However, the Vioxx disaster and itsaftermath have shaken the public’s confidence. American consumers demand and deserveassurances that the medicines in their cabinets are safe. The health and safety of the public mustbe the FDA’s first and only concern. Unfortunately, reforms at the FDA are necessary to placethat mission front and center once again.

I began my oversight of the FDA last year in response to concerns about the reluctance ofthe FDA to provide information to the public about the increased suicidal risks for young peopletaking anti-depressants. Last November, I chaired a groundbreaking hearing on drug safety, theFDA and Vioxx. That hearing and other critical drug safety concerns of the past year highlightedthe need for reforms and more stringent oversight of the FDA.

Sometimes congressional scrutiny of agency mismanagement can lead to necessaryreforms. Sometimes an agency will act on its own to enhance its credibility. I have beenpressing for reforms – both administrative and legislative – to bring about greater responsivenessand transparency at the FDA. The risks and benefits of prescription drugs should be readilyavailable to patients and doctors seeking to make informed decisions.

The FACT Act would expand www.clinicaltrials.gov to create a publicly accessiblenational data bank of clinical trial information comprised of a clinical trial registry and a clinicaltrial results database. The legislation would foster transparency and accountability in healthrelatedintervention research and development and ensure that the scientific community and thegeneral public have access to basic information about clinical trials. Importantly, the FACT Actwould maintain clinicaltrials.gov as a registry for patients and physicians seeking informationabout ongoing clinical trials for serious or life-threatening diseases and conditions. Thelegislation would also prevent companies from withholding clinically important informationabout their products.

The FACT Act will:

1. Maintain a clinical trial registry accessible to patients and health care practitionersseeking information related to ongoing clinical trials for serious or life-threateningdiseases and conditions;

2. Establish a clinical trials results database of all publicly and privately funded clinical trialresults regardless of outcome that is accessible to the scientific community, health carepractitioners, and members of the public;

3. Require the Food and Drug Administration (FDA) to make internal drug approval andsafety reviews publicly available;

4. 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 NationalInstitutes of Health, with assistance from the FDA;

5. Apply to clinical trials for drugs, biologics, and medical devices. All trials must beregistered in the database in order to obtain approval from a U.S. Institutional ReviewBoard;

6. Require that foreign trials that are submitted to the FDA or used in advertising to U.S.physicians be registered in the database at the time of submission;

7. Require that researchers promptly disclose the objectives, eligibility criteria, sources offunding, and anticipated timeline of clinical trials. The bill’s standards will meet all ofthe minimum criteria for a trial registry set out by the International Committee of MedicalJournal Editors on September 8, 2004;

8. 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, thebill provides time for researchers to publish their results. The disclosure of importanttrial results satisfies the recommendation of the American Medical Association;

9. Establish strong enforcement mechanisms. The bill will provide for civil monetarypenalties of up to $10,000 per day for sponsors who refuse to comply. Monetarypenalties will be earmarked for studies that compare clinical therapies;

10. Provide authority to audit the completeness and accuracy of the information in theregistry; and

11. Ensure that the Food and Drug Administration has the authority to correct false ormisleading statements about the results of clinical trials.

Next month I will also introduce legislation to establish an independent office of drugsafety in the Food and Drug Administration. Today’s legislation is an important step towardreforming the FDA. I urge my colleagues to join me in this effort by cosponsoring this importantlegislation.

-30-