Political Quotes

“Mr. President, first of all, I congratulate my colleague from Iowa and my colleague from Wyoming for the bipartisanship of this legislation. The FDA amendments of 2007 mandated basic public results reporting for all clinical trials supporting FDA-approved drugs and devices. Clinical trials results help both patients and doctors understand the benefits and efficacy of a particular medical product. Moreover, a July 2011 FDA report stated: Understanding variable characteristics in clinical trial sites is becoming increasingly important because of the international nature of current clinical trials. The sources of differences in efficacy results between the U.S. and foreign clinical trials sites have yet to be determined, but differences rooted in the conduct of the clinical trial should be evaluated. It has been 5 years since the passage of the FDA Amendments Act, and the National Institutes of Health is still in the process of writing proposed regulations. The clinicaltrials.gov program and title VIII of the FDA Amendments Act were considered major reforms and helped science information advances. If they are not being implemented well or adequately enforced, society will fail to reap the full benefits of the billions of dollars in good medical science research. This amendment before the Senate will impose a deadline by which the NIH will finalize both the proposed and final regulations.…”