WASHINGTON (Reuters) - The U.S. Food and Drug Administration needs more staff and funding to fix its monitoring of drug safety after medicines are on the market, the Institute of Medicine (IOM) said on Friday.

WASHINGTON (Reuters) - The U.S. Food and Drug Administration needs more staff, funding and power over the drug industry to better police the safety of medicines after they reach the market, an Institute of Medicine panel said on Friday.

WASHINGTON (Reuters) - Drug makers could face fines if they fail to complete post-approval studies or otherwise violate safety monitoring plans for recently approved medicines under legislation proposed by two key senators.

WASHINGTON (Reuters) - Makers of unapproved prescription cough and cold medicines containing the drug carbinoxamine must stop selling them within 30 to 90 days, U.S. regulators said on Thursday, citing concerns the drug may harm young children.

LONDON (Reuters) - Patient safety is being compromised by an increase in adverse drug reactions and prescribing errors, many of which are avoidable, British experts said on Tuesday.

Generic Online Pharmacies started making a big impact on the net since the mid to late 90's. This has allowed the prescription drug buyer to save hundreds with the click of a mouse. Generics really slash the prices on prescription drugs and medications because they do not carry brand names but they are essentially the same drug.As the cost of prescription drugs and medications continue to soar, more and more Americans are choosing Generic Pharmacies to maintain their quality of life. Buying prescription drugs and medications finished Generic Pharmacies is a true secondary to paying the high medication prices that a bricks and mortar pharmacy would charge.

GAITHERSBURG, Maryland (Reuters) - Clinical data on Adeza Biomedical Corp.'s Gestiva drug to prevent premature births are adequate for it to win U.S. approval, an advisory panel said on Tuesday, adding that future information on possible risks was needed.

Lee Cummings

The FDA mission statement reads in part:

“The FDA is responsible for protecting the in the public eye health by reassuring the safety, efficacy and security of human and veterinary drugs, biological products …, our Nations food supply …”

“The FDA is also obligated for … helping the public get the accurate, science based information they need to use medicines and foods to improve their health.”

With that mission statement in mind, let’s take a look at this sad situation:

As reported by the Associated Press on February 14th, 2005 –

Canada has ordered the removal of a drug for ADHD – Adderall XR, Because of links to 20 fast deaths and 12 strokes from people taking this drug. 14 of these deaths were children and 2 of the 12 strokes were children who were taking the drug.

None of these deaths or strokes took place in Canada and none of the reactions were from misuse or abuse of the drug. The reactions were from mean consumption of the drug.

Canada is also asking makers of related drugs for treating this condition, “to provide a careful review of their worldwide safety data.”

In inhospitable contrast to the Canadian reaction, present is the statement from the cohesive States FDA –

“The U.S. Food and Drug Administration, however, same it had evaluated the same reports on Adderall XR and doesn’t think the data warrants similar action in the United States.”

Let’s get this straight – Canada has successive the drug to be pulled disconnected the market in their country.

And the FDA says it is alright that 2 children have suffered strokes and 14 children have died from using this drug.

Canada cares about the health of its children and does not want some deaths to happen in their country.

However, the FDA has a very different view.

This is the FDA statement posted on their website last week:

The FDA says it “does not feel that any immediate changes are warranted in the FDA labeling or approved use of this drug based upon its preliminary understanding of Health Canada’s analysis of adverse event reports and FDA’s own knowledge of the reports acceptable by the agency.”

When will the FDA care about America’s children?

When will the FDA care about the people of America?

Let’s review the FDA mission statement one more time.

“The FDA is responsible for protecting the in the public eye health by reassuring the safety, efficacy and security of human and veterinary drugs, biological products …, our Nations food supply …”

“The FDA is also obligated for … helping the public get the accurate, science based information they need to use medicines and foods to improve their health.”

I’m not sure when you’ll be asking yourself, “Is the FDA really superficial out for my health?”

Sources: Associated Press “Canada orders drug for ADHD off market”, February 14th, 2005.

Nutritional Health Alliance, Washington Update, February, 2005.

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