Government Regulation & Oversight

The Food and Drug Administration has proposed replacing a 30-year-old system for classifying prescription medications in order to provide women with far more detailed information about a medication’s risks and benefits during pregnancy and breast-feeding. Should the proposal be approved, new prescription drug labels would list the potential risks and benefits for both the mother and the fetus when taking the medication and how those risks might change during pregnancy. The new labels will help women become better informed about their prescription drugs, and doctors will be better able to counsel patients about using prescription drugs.

Any parent can tell you that when a child has a cold, the entire household suffers. Not only baby are awake all night, but so are Mom and Dad. Now, cold syrups have been ruled as a potential source of easy overdosing for children, and stores have voluntarily pulled them from the shelves. What are Mom and Dad to do? Plenty. Below are several actions recommended by Pediatricians.

Humidifier

Controversy over the proper authority for supplementals has been in existence for generations. However, the heat has really been turned up in the past few years, as consumer awareness of drug interactions with supplements has surfaced. Additionally, findings of a prescription drug being used extensively in a common supplement for cholesterol occurred only a few months ago. Safety, Safety, Safety!!!!

Americans have seen an insidious trend for more and more drugs to be sold over the counter (OTC). Sometimes, the only difference between the OTC drugs and prescription drugs is the dosage. For instance, Motrin is sold OTC at 200 mg. Prescription doses are 800 mg. However, it doesn’t take an active imagination to know that we could take 4 Motrin OTC of 200 mg to have the same dose as provided by our physicians.

The World Health Organization has stated we are now in the 3rd phase of a 6 phase wait for the expected bird flu pandemic.

Products advertising red yeast rice products have been on the web for a long time. Along with diet and exercise, the manufacturer’s claim these products will help to reduce one’s cholesterol. Purportedly, this product has been used in Asia for almost 3000 years (and we all know Asians are petite and thin and healthy, right?).

The manufacturer’s are commended for placing warning labels on all of their products which state:

Gastroesophageal reflux (GERD) is a common condition that often occurs without symptoms after meals. In some people, the reflux is related to a problem with the lower esophageal sphincter, a band of muscle fibers that usually closes off the esophagus from the stomach. If this sphincter doesn't close properly, food and liquid can move backward into the esophagus and may cause the symptoms.

FDA Permits Restricted Use of Zelnorm for Qualifying Patients

The U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines.

FDA Announces Program to Enhance States’ Food Safety Programs
Goal is to Strengthen Safety of Food Facilities Overseen by States

The U.S. Food and Drug Administration today launched a national program to bring about the adoption of more uniform, equivalent, and high quality regulatory programs by state agencies responsible for regulating facilities that manufacture, process, pack, or hold food under FDA’s jurisdiction.

Congress is currently considering a bill to States will be required to provide the FBI with information on their Residents and Mental Health Care they may have received. This bill is a response to the devastating catastrophy at Virginia Tech in which a student killed 32 people. The student had a history of mental health care prior to purchasing a gun.

The National Instant Criminal Background Check System (NICS) Improvement Act (HR 297) has a high possibility of passing Congress this year. In addition to the above mandate it is also expected to provide grants to States to help them establish their data bases. Data bases would not only include Mental Health Care received, but any convictions of domestic violence or subjects of mental health adjuciations and commitments.