January 31,2007

Senator Grassley’s floor statement and summaries of the FDA Safety Act (S.468) and the FACT Act (S.467)

The text of the floor statement made today by Sen. Grassley regarding his introduction of FDAreform and drug safety legislation with Sen. Dodd is below, along with a summary for both bills.

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 arebeing introduced today, the Food and Drug Administration Safety Act of 2007 and the FairAccess to Clinical Trials Act of 2007. These bills are part of a sustained effort to restore publicconfidence in the federal government's food and drug safety agency. Enactment of these twobills would provide doctors and patients with more information about the risks and benefits oftheir medicines and bring about greater transparency and accountability at the Food and DrugAdministration.

I began my oversight of the FDA three years ago in response to concerns about thereluctance of the FDA to provide information to the public about the increased suicide risks foryoung people taking anti-depressants. In November 2004, I chaired a groundbreaking hearing ondrug safety, the FDA and Vioxx. That hearing and other critical drug safety concerns that havecome to light since then highlight the need for comprehensive and systematic reforms, as well asmore stringent oversight of the FDA. Over the past three years it has become increasinglyapparent that the FDA has repeatedly failed to protect the public from an industry that focuses alltoo 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 advanceserious 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 towardrestoring public confidence in the agency and strengthening public safety.

Yesterday, the FDA released its response to the Institute of Medicine's 2006 Report ondrug safety. The two safety bills introduced today are not intended to supplant the plansarticulated in FDA's response, but rather to augment those plans and provide the FDA withadditional enforcement tools; something they now lack.

In fact, one of our bills is intended to specifically address a serious problem that was alsoidentified by the Institute of Medicine. Dr. Alta Charo, a member of the IOM committee thatwrote the report on drug safety, stated to USA Today, "I have to confess I'm disappointed thatthey [the FDA] ignored one of our most critical recommendations." According to the USAToday article, she was referring to IOM's recommendation that the FDA give more clout to theoffice 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 independentCenter within the Food and Drug Administration - the Center for Postmarket Evaluation andResearch for Drugs and Biologics (CPER). The Director of CPER would report directly to theFDA Commissioner, and would be responsible for conducting risk assessment for approveddrugs and biological products.

This new center would also be responsible for ensuring the safety and effectiveness ofdrugs once they are on the market. Unfortunately, what happens now at the FDA is that theoffice that reviews the safety of drugs is a mere consultant and under the thumb of the office thatputs the drugs on the market in the first place. Even more troubling is the fact that those whospeak out of line are targeted. This legislation would provide the new Center-CPER-with theindependence and authority to promptly identify serious safety risks and take necessary actions toprotect the public. At the same time, intra-agency communication is essential in addressing drugsafety, so this legislation would encourage communication between CPER and the other centersand offices at the FDA that handle drugs and biological products to do what's best for theconsumer-not big Pharma.

The FACT Act of 2007 would expand an existing website, www.clinicaltrials.gov, tocreate a publicly accessible national data bank of clinical trial information. The data bank wouldbe comprised of a clinical trial registry and a clinical trial results database of all publicly andprivately funded clinical trials. This legislation would foster transparency and accountability inhealth research and development and ensure that the scientific community and the general publichave access to basic information about clinical trials. The legislation would also create anenvironment that would encourage companies to submit clinically important information abouttheir 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 agencythat lost sight of its most important function-to ensure the safety and efficacy of new prescriptiondrugs. Unfortunately, the public has good reason to doubt the FDA's ability to do its job, andexperts from all over this country have expressed concern. These two bills will help put FDAback 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 therecord and coupled with the statement Senator Dodd will file later today regarding theintroduction of these important pieces of legislation.

Summary of the Food and Drug Administration Safety Act of 2007Senator 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 anindependent Center within the Food and Drug Administration (FDA) - the Center for PostmarketEvaluation and Research for Drugs and Biologics (CPER). The Director of CPER will reportdirectly to the FDA Commissioner and will be responsible for conducting risk assessment forapproved drugs and biological products and ensuring their safety and effectiveness once they areon the market.

FDASA will:

Authorize the Director to require manufacturers to conduct postmarket clinical orobservational studies if there are questions about the safety or efficacy of a drug or biologicalproduct.

Authorize the Director to determine whether an approved drug or licensed biologicalproduct may present an unreasonable risk to the health of patients or the general public, given theknown benefits.

Authorize the Director to take corrective action if a drug or biological product presents anunreasonable risk to patients or the general public - including the authority to make changes tothe label or approved indication, place restrictions on product distribution, require physician andconsumer education, and require the use of other risk management tools.

Allow the Director to withdraw approval of a drug or biological product if necessary toprotect the public health.

Require submission of advertising prior to dissemination, and certain advertisingdisclosures related to risks and benefits to patients, if one or more of the three followingconditions is met: the Director has determined that the product may present an unreasonable riskto patients, the product is the subject of an outstanding postmarket study requirement, or theproduct was approved within the last two years.

Ensure that the Director benefits from all appropriate resources, including consultationwith the Center for Drug Evaluation and Research (CDER) or the Center for BiologicsEvaluation 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 thosewho fail to comply.

Require a report and recommendations to Congress on postmarket surveillance ofmedical devices.

Authorize graduated appropriations totaling $500 million over five years to ensure thatCPER 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) on January 31, 2007

The FACT Act will expand www.clinicaltrials.gov to create a publicly accessible nationaldata bank of clinical trial information comprised of a clinical trial registry and a clinical trialresults database. The legislation will foster transparency and accountability in health-relatedintervention research and development and ensure that the scientific community and the generalpublic have access to basic information about clinical trials. The legislation will also preventcompanies from withholding clinically important information about their products.

The FACT Act will:

Maintain a clinical trial registry accessible to patients and health care practitionersseeking information related to ongoing clinical trials for serious or life-threatening diseases andconditions;

Establish a clinical trial 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;

Require the Food and Drug Administration (FDA) to make internal drug approval andsafety reviews publicly available, including documentation of significant differences of opinionand 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 NationalInstitutes of Health, with assistance from the FDA;

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 Review Board;Require that foreign trials that are submitted to the FDA as part of a new drug applicationor a supplemental drug application or are used in advertising to U.S. physicians be posted in thedatabase in a timely manner;

Require that researchers promptly disclose the objectives, eligibility criteria, sources offunding, and anticipated timeline of clinical trials. The bill's standards will meet all of theminimum criteria for a trial registry set out by the International Committee of Medical JournalEditors 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 billprovides time for researchers to publish their results. The disclosure of important trial resultssatisfies the recommendation of the American Medical Association;

Establish strong enforcement mechanisms. The bill will provide for civil monetarypenalties of up to $10,000 per day for sponsors who refuse to comply. The bill will also establishpenalties for sponsors of a new drug application or a supplemental new drug application forfailing to certify that the information they are submitting to the FDA is accurate. Monetarypenalties will be earmarked for studies that compare clinical therapies;

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

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