Food Drug Administration and Prescription Drug Manufacturer Partnership

The Prescription Drug User Fee Act (PDUFA) was passed into law by Congress in 1992 and allows the Food and Drug Administration (FDA) to collect feeds from Prescription drug Manufacturers to fund the new drug approval process.

The PDUFA declares that the FDA is allowed to collect a fee, called an application fee, from these Prescription Drug Manufacturers whenever a new drug is introduced through a new Drug Application (NDA). The fee was up to $250,000 per new NDA.

Note: Kinda looks like the FDA is now working for the Prescription Drug Companies. In fact, a comment from the Public Citizen’s Health Research Group stated “The review of new drugs is too important to leave to ‘user fees’ and likened the drug industry’s financial support of the FDA review process “similar to criminals paying user fees to the police department.”

Originally a short term experiment slated for 5 years, it was “improved” by The Food and Drug Administration Modernization Act of 1997 (FDAMA). This act extended user fees for NDA’s for another 5 years and introduced three amendments: Off Label Use of Drugs; Drug Labeling for Children: and, Fast Track or Accelerated Approval of new drugs.

Off Label Use pertains to using drugs for other than it was approved for. The FDA did away with thus prohibition on the Drug Companies promoting other than approved uses for their drugs, opening the door for Drug Salesman to promote new drugs with no proof of safety or effectiveness for the off label use.

The Drug Labeling for Children amendment. Previously drugs approved for adults were presumed to be safe in children albeit with different doses. This is not always the case. Now drug companies were required to do additional clinical trials to provide information for prescribing to children.

The Accelerated Approval and Parallel Tracking amendment opened up the door for new drug approval based on one “well controlled” Phase 3 clinical trail when the previous standard was two. There is no denying this amendment made drugs available that have saved countless lives, however with much less of a process to ensure safety.

The PDUFA III continued user fees and integrated a Medical Device User Fee as well. PDUFA IV was signed into law in September 2007 represents a significant addition to FDA authority. Among the many components of the law, the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA) have been reauthorized and expanded.

The FDA claims these programs will ensure that FDA staff will have the additional resources needed to conduct the complex and comprehensive reviews necessary to new drugs and devices. However, the FDA and Drug Manufacturers continued to share the same bed.

Allowing the industry to “negotiate” with the FDA on recommendations and “pay” the FDA user fees for new drugs undercuts the agency’s original true role as an independent, drug safety regulator. If the FDA and the prescription drug manufacturers are going to regain the respect and trust of the American public, the FDA must be seen as an objective regulatory entity with a clear and inviolable mission to serve the public, and its reliance on the fees and goodwill of the industry they are supposed to oversee must end.

The bottom line is that the prescription drug consumer needs to live by the old adage “let the buyer beware”. Do your own research and be careful for the drug interactions if you are taking multiple prescriptions, especially from multiple Doctors and Pharmacies.

In a perfect world, you would be able to mitigate much of the problems you are addressing by living a healthy lifestyle, eating low glycemic foods and taking the best nutritional supplements.

Stay Informed!

Charles

Choosing A Herbal Detox Diet

Toxins can include perfume, alcohol, cigarette smoke, pesticides, mercury, food additives, oral contraceptives, and cleaning supplies. Toxins are transformed chemically to less harmful compounds that can be excreted via stools or urine.

Is there anyone who should not try a detox diet?

Consult your primary care provider to find out if a detox diet is appropriate for you. A detox diet should not be used by pregnant or nursing women, children, or people with anemia, eating disorders, heart problems, lowered immunity, low blood pressure, ulcers, diabetes, epilepsy, cancer, ulcerative colitis, unless recommended and supervised by your primary care provider.

There are endless detox plans you can follow, so chose carefully. Some will advocate complete fasting or juice-only days, but beware of the health implications and never start such an extreme plan without consulting your doctor or a qualified nutritionist.

Detox Benefits

1. Improves symptoms of heartburn, constipation and gas and treats digestive disorders.

2. Boosts the immune system.

Allergies or sensitivies?

By and large, conventional health care only deals with masking the symptoms of allergies and food sensitivities, rather than attempting to resolve them. The first step that many alternative practitioners recommend is a change of diet that cuts out wheat and dairy foods, two common allergens.

To do so is also the first step in "detoxing." Higher levels of detoxing, as well as additional immune support through nutritional supplementation, have been known to help many allergy sufferers. Allergies are, however, almost by definition, a very individualized condition.

What happens after the detox?

Many of the foods that were eliminated during this diet can be allergenic. A natural health practitioner can help to systematically reintroduce food groups (wheat, dairy, gluten, corn) and note reactions to identify the food groups that may be aggravating health conditions such as sinus congestion, fatigue, skin conditions, arthritis and bloating and constipation. Flare-ups can occur, so supervision is recommended.

Charles

Is A Vegetarian Diet Safe For Infants?

If, for dietary or ethical reasons, you have decided that you want to put your infant on a vegetarian diet, you should be very careful in choosing formulas and solid food for your child.

If you plan to breastfeed the infant and you are also a vegetarian, you may need to supplement breastmilk with additional sources of nutrition, depending on your dietary restrictions. If you are a vegan, or an ovo-vegetarian, you should add sources of vitamin B-12 to your child’s diet.

Other than the B-12 supplements, your infant should be able to receive all micro and macronutrients through breastfeeding, even if you are on a strictly vegan diet.

If you plan to use formula rather than breastmilk, you should stick to commercial formulas, which contain the proper amounts and ratios of nutrients. If you opt for a homemade formula or soymilk over a commercial product, your child could experience developmental problems from a lack of proper nutrition.

If you want to keep your infant on a vegan diet, you can select a soy commercial formula, as long as it is nutritionally-adequate.

After about a year, you can begin to supplement formula or breastmilk with other sources of nutrition, such as homemade formulas, soymilk, yogurt, and cow’s milk (if you are not a vegan).

Nutritionists suggest that you keep your infant on a full-fat, high protein diet after age one, which includes vegetarian-friendly foods, such as mashed and pureed avocados, soy milk, nutrient-fortified tofu, and yogurt.

When you are ready to switch your infant to solid vegetarian foods, you can introduce solid tofu, pieces of vegetarian burgers, eggs, and cheese.

If you supplement what a nonvegetarian diet lacks, maintain a full-fat diet, and increase your infant’s sources of protein, you should have no problem maintaining a healthful vegetarian diet during your child’s crucial developmental stages.


Charles