FDA

Blog entry

FDA Releases ‘Basics’ Consumer Site

1/13/2010 10:16:00 AM

WASHINGTON—FDA released FDA Basics, a consumer Web site directed at explaining agency operations, how it makes decisions and the drug approval process. In a press release, FDA said this is the first phase of its Transparency Initiative.

The new Web-based curriculum includes: questions and answers about the agency and the products it regulates, short videos that explain various agency activities and conversations with agency personnel about the work of their office. According to FDA, senior officials from FDA product centers and offices will answer questions on various topics during future online sessions.More »

FDA, Transparency Initiative

Free

Why is the government giving H1N1 flu shots for free? It is not really free; we the working taxpayers are footing the bill; or our children and/or grandchildren will pay for this. Are we not already a trillion dollars in debt? Why don't they use our hard earn money to eradicate poverty instead?More »

2009 H1N1 Vaccine, FDA, government

Incredulous

Is it possible that the H1N1 vaccine was already formulated years before 2009? Were the manufacturers and government agencies simply looking and/or fabricating an opportunity to bring it to market?

If not, did the manufacturers follow the established FDA protocol to bring it to market? How many months or years does it take to bring a vaccination to market? Why are they (government agencies and manufacturers) pushing so strongly and so fast to get people vaccinated? Does last year lost in Wall Street have anything to do with the push? Is it mainly economics?More »

FDA, government, H1N1, swine flu

Compounding the Problem

I happened to be in West Palm Beach, Florida, one day a few months ago getting ready to attend a pharmacy conference while, in a neighboring town, members of the Lechuza Caracas (Venezuela) polo team were preparing to take the field in the 105th U.S. Open Polo Championship. I later learned the news that 21 elite polo horses had collapsed before the eyes of astonished spectators. Many of the horses were dead within an hour. Initial autopsy results revealed that several of the animals experienced significant hemorrhaging, but it would take some time for the toxicology results to come back.

The deaths were eventually attributed to an overdose of a vitamin compounded by a pharmacy in Ocala, Florida, that specializes in compounding veterinary products. As it turns out, five horses that were not given the drug survived. And while many in the polo community continue to mourn the loss of these well-trained horses, it was a story that lasted only about 3 weeks. But in reality, this is not the end of this story. Unfortunately, the events of that day triggered the FDA to once again become vocal on the risks of pharmacy compounding.More »

compounding, FDA

Why does FDA approve a new drug that increases risk and without benefit?

I received a promotion for Novartis' new antihypertensive, Valturna.
This is a drug that combines Diovan and Tekturna.More »

Cost, FDA, New Drug. Valturna, safety

Mass Hysteria

"The Health Care Reform bill is losing momemtum; let us make up H1N1 flu. Lets us make a vaccination for it. Let us say it is pandemic. We will let the media run with it.More »

2009 H1N1 Pandemic, FDA, government

Price

Tis a well known fact

That one natural act

Of alcohol fueled mirth

Might result in a birth

And alter the courses of two lives.

But help is now here

And FDA clearedMore »

baby, FDA, price, price-matching

Forum topic

Direct to patient advertising.

Should the FDA allow direct to patient advertising of any drug? I say all advertising to patients should be peer reviewed and should be informational only.More »

advertising, doctor shopping, FDA, Patient Safety

GAO Expresses Concern Over FDA's Ability to Meet Its Oversight Reponsibilities

According to a newsletter distributed by the U.S. Government Accountability Office (GAO), 20 years ago it reported that it was concerned that the FDA lacked resources to fulfill its mission, which includes oversight of the safety and effectiveness of medical products, including human drugs, biologics, and medical devices, marketed for sale in the U.S. Now some two decades later, although user fees have added revenue to FDA's coffers, its responsibilites have also increased by the growing number of food and medical products entering the markeplace. The GAO still feels that the FDA needs more resources to do the job it needs to do effectively.More »

FDA, GAO

News Story

FDA Orders Two Companies to Stop Marketing Unapproved Nitroglycerin Tablets

03/16/2010

he U.S. Food and Drug Administration today ordered Glenmark Generics of Mahwah, N.J., and Konec Inc. of Tucson, Ariz., to stop marketing unapproved nitroglycerin tablets. The tablets are placed under the tongue to relieve chest pain or to stop a heart attack and are marketed in 0.3 mg, 0.4 mg, and 0.6 mg dosages.

The FDA does not anticipate a supply problem for these products. Pfizer Inc. markets FDA-approved sublingual nitroglycerin tablets in the same strengths and is able to supply the market with approved products. The FDA also will work with patient organizations and health care professionals to ensure that they are aware that an approved product is available.More »

FDA, nitrogylcerin

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