Senator's Reply to S.1082

[totalyouhealth]

This is the reply I received today reguarding the FDA Revitalization
Act. Make sure to read last paragraph. Kathy

Dear Mrs. Ramsey,

Thank you for taking the time to contact my office about S. 1082, the
Food and Drug Administration Revitalization Act of 2007. Your input
is important to me, and I appreciate the time you took to share your
thoughts.

As you may know, S. 1082 includes reauthorization of four programs:
the Prescription Drug User Fee Act (PDUFA), the Medical Device User
Fee and Modernization Act (MDUFMA), the Best Pharmaceuticals for
Children Act (BPCA), and the Pediatric Research Equity Act (PREA). I
voted for this bill because I believe it will improve drug safety for
American consumers by ensuring that the Food and Drug Administration
can measure and react to safety concerns after drugs are already on
the market. The bill will also continue to incentivize and require
drug companies to conduct clinical trials on pediatric populations to
make sure that drugs are safe for children, help the FDA review
pharmaceuticals and medical devices in a timely manner, and provide
patients with better access to information about new drugs and
devices that are still in clinical trials.

I want to assure you that S. 1082 has nothing to do with dietary
supplements. It is solely focused on drugs and medical devices,
which are defined separately from dietary supplements within the
Food, Drug and Cosmetic Act. This bill does not regulate or restrict
access to dietary supplements in any way. Instead, it gives the FDA
new authority to take swift, appropriate, and decisive action to
protect patients as new information about drugs and medical devices
come to light - ensuring that patients and consumers have access to
the most updated and accurate information about the safety of the
drugs they take.