Mr. Speaker, I rise today to introduce the Fair Access to Clinical Trials (FACT) act. This bill is designed to ensure that the public has complete and accurate information about the drugs and devices they use.
Recently many people have becomes concerned that the drug industry is hiding important information from the public. The most recent evidence that we do not know all that there is to know about the drugs we are taking and the devices we are using comes from the fact that several pediatric anti-depressant trials that contained important safety information were not released to the public. The public is now demanding to know why these trials never saw the light of day. Although the conversations have focused on the most recent examples of anti-depressants, the problem of selective disclosure and publication is not limited to a specific type of drug or scenario -- the same concern exists whether we are talking about drugs to treat depression, heart disease or arthritis.
I am sure that some trials do not become part of the medical literature for innocent reasons. But we cannot ignore the possibility that some studies were and continue to be intentionally buried by companies worried about the impact of a negative trial on their bottom line. Regardless of the motivation, the fact remains that we don’t know what trials are currently being conducted so it is impossible to determine whether the companies and researchers are actually telling us the whole truth about their drugs and devices or whether painting a distorted picture of their products by picking and choosing which trials they want to reveal.
There are two major problems with this situation. The first is that in order for doctors to make good medical decisions and provide their patients with the best possible care, they need to have access to complete and sound scientific data.
In addition, when people enroll in a clinical trials they give up control of their medical decisions, willingly take experimental drugs and subject themselves to potential harm because they believe that their participation in the studies will add to the advancement of medical knowledge and potentially unlock the secrets of disease. But if a researcher or a company that sponsors a trial does not publicize the results, the knowledge gained from putting those participants at risk remains forever buried in some researcher’s computer.
In order to ensure that clinicians have all the information they need in order to make sound medical decisions, uphold the ethical responsibility to patients and protect public health, I am proud to join with my friend Congressman Waxman to introduce the Fair Access to Clinical Trials (The FACT Act) a bill to create a mandatory, public, federal registry of all clinical trials.
The FACT act will require researchers to register their clinical trials in a federal registry before starting them and report the results of those trials at the conclusion. The database will include both federal-funded and privately-funded clinical trials so that clinicians, patients and researchers will be able to know the universe of clinical trials on a particular drug and have access to the results of those trials. The bill also establishes strong enforcement mechanisms, including monetary penalties of up to $10,000 per day for manufacturers who refuse to comply.
The registry will meet all of the minimum criteria for a trial registry set out by the International Committee of Medical Journal Editors, and will satisfy the American Medical Association’s call for the results of all clinical trials to be publicly available to doctors and patients. The legislation has been endorsed by the New England Journal of Medicine and the Elizabeth Glaser Pediatric AIDS Foundation.
The FACT act will ensure that patients have the tools they need to make informed decisions, maintain the integrity of the medical community, and protect the health of their patients and our families.
I look forward to working with everyone concerned about this important issue so that we end up with a system that preserves a robust system of research and ensures robust system of disclosure.