Posts Tagged ‘ FDA ’

Christmas Comes Early for Medical Device Manufacturers, FDA Plays Santa Claus

January 31st, 2011. By Hunter West

It was recently that the US Food and Drug Administration (FDA), the government agency charged with responsibility over drugs and medical devices in this country, is seeking to further streamline the review, and approval of medical devices.

Can you hear the cries of joy in the medical device manufacturing heartland?

Well, not entirely. The FDA is also thinking of creating a new category of devices that would require more data than is currently required for approval. That would make it tougher for medical device manufacturers to get new products to market.

Oh, but according to a report by Reuters appearing January 19^th in The New York Times, the FDA is going to defer that idea for a period of time. Which is a good thing, I guess, because the device industry was worried that such a change would slow the progress of devices to market. Devices that can now take advantage of an increasingly streamlined process.

That process—which the FDA is looking to expand, while deferring any effort that might make it tougher for device manufacturers—holds that if a manufacturer seeks approval for a new product that is substantially similar to an existing product already on the market, it can take advantage of a streamlined approval process requiring less scrutiny and testing.

Naturally, that’s a win for the device manufacturers. One spokesperson for a major manufacturer called the news of an expansion of streamlined approvals, and the deferral of tougher policy a more ‘balanced’ approach that shows the FDA is engaged, listening and concerned.

Yes—but to whom is the FDA really listening? And about whom are they really concerned?

It sounds to me like the FDA’s greatest role is to assist device manufacturers (and drug companies).

Is the FDA not a government agency, whose mandate is to first and foremost represent and protect Read the rest of this entry »

Tags: FDA, medical devices
Posted in Drugs/Medical | No Comments »

Deadly Medicine, Even More Deadly Oversight…by the FDA

January 26th, 2011. By Hunter West

Anyone with any misgivings about the state of the Drug Union in this country and the role the US Food and Drug Administration (FDA) plays—or doesn’t—would not want to pick up a copy of the January issue of Vanity Fair in their doctor’s office.

Especially if their doctor is about to prescribe yet another drug…

In ‘Deadly Medicine,’ writers Donald Barlett and James Steele reveal troubling aspects of the prescription drug culture in America.

In sum, it is estimated that prescription drugs kill more than 200,000 Americans each year. That figure is based on information from the Institute for Safe Medication Practices that identified 19,551 people who died as a direct result from a prescription medication.

That, in itself is a huge number. However, according to Vanity Fair that figure is low, given the widely held belief that only about 10 percent of such deaths are ever reported. Thus, a ‘conservative’ estimate would be 200,000 deaths a year from drugs that the FDA considers, according to its mandate, as safe and effective and whose benefits outweigh the risks.

When compared against other maladies and behaviors that are known to have life-ending outcomes, that’s three times the number of people who die from diabetes, and four times the number who succumb to kidney disease. Prescription drugs claim more lives than heroin and cocaine. Fewer people die each year in car accidents in America, than those whose lives are cut short from a drug written to their care by a physician.

It gets better…

Clinical trials are moving offshore, where regulatory authority is lax and drug companies have greater control over the outcomes than they otherwise might on US soil.

By the numbers, the Department of Health and Human Services reported 271 clinical trials Read the rest of this entry »

Tags: Big Pharma, Clinical Trials, FDA
Posted in Drugs/Medical | No Comments »

Score One for the FDA as Rest of World Finally Yanks Thelin

January 3rd, 2011. By Hunter West

Time to give credit where credit is due. And this time, the US Food and Drug Administration (FDA) got it right.

Recently it was announced, in a joint statement by Health Canada and Pfizer Canada, that Thelin (sitaxsentan) was being taken off the market in Canada, as well as every country in which it had been sold, due to risk for potentially fatal liver damage.

Never heard of Thelin? There’s a reason for that. Thelin is not available in the US. Never was. That’s because the FDA refused to approve the drug designed to treat pulmonary hypertension. In the view of the FDA, the benefits did not outweigh the risks.

In a bid to win FDA approval for marketing Thelin in this country, Pfizer Inc. launched a series of clinical trials. However, those trials have been abandoned following the deaths of three trial participants.

According to a report in the Globe and Mail, Canada’s national newspaper, liver damage was a known complication of Thelin. However, in announcing that it was abandoning further clinical trials, Pfizer noted that it had discovered a “new potentially life-threatening idiosyncratic risk” of liver injury among patients that is difficult to predict or guard against.

Thus, there will be no further clinical trials, and Thelin will be coming off the market in Australia, Europe and Canada where it had been previously approved. Given the known risks associated with Thelin, Canadians are wondering how Thelin ever won Health Canada approval in the first place.

The FDA has been maligned, chastised, ridiculed and kicked to the curb over the appearance of lax oversight both in the approval, and ongoing supervision of drugs and medical devices. And to be sure, much of that criticism is warranted.

However, on this occasion the FDA stuck to its guns and has been vindicated. There can be Read the rest of this entry »

Tags: FDA, Pfizer, Thelin
Posted in Drugs/Medical | No Comments »

Menaflex: Influence Peddling at the FDA

October 22nd, 2010. By Hunter West

The revelation last week that the US Food and Drug Administration (FDA) would rescind a product previously given FDA approval, is yet another example of why the FDA needs to be overhauled from the ground up and the top down.

That’s because, according to a report October 14^th in The New York Times, a medical device roundly criticized by the FDA’s own scientists and reviewers was approved by the agency largely due to political pressure (read lobbying) and the intervention of the former FDA Commissioner.

Worse, it appears as though this situation was one “of several” at the agency in which outside forces were allowed to be brought to bear over the FDA’s own good scientific counsel.

And this is the agency that ensures the drugs we take, and the medical devices we use are trustworthy?

Oh…my…God…

The issue is over Menaflex, an implantable knee patch manufactured by ReGen. According to an FDA report launched to investigate undue outside influence in its own agency, it was determined that the Menaflex product was given FDA approval in spite of the repeated, and unanimous declarations of FDA reviewers that Menaflex did not meet the criteria for approval.

It should be noted that the FDA employs a fast-track route for approval if it is determined an Read the rest of this entry »

Tags: FDA, implantable knee patch, Menaflex, NJ, ReGen
Posted in Defective Products, Drugs/Medical | No Comments »

Giddy with Glee: FDA Got One Right with SSRI Drug

October 18th, 2010. By AbiK

Or so it appears.

A little bomb just dropped in the form of a report out in the British Medical Journal (BMJ) regarding the antidepressant drug reboxetine. Reboxetine—brand name Edronax—is one of the drugs classified as a Selective Serotonin Reuptake Inhibitor, or SSRI, and it’s manufactured by Pfizer. According to the report, data from industry-sponsored (biased?) trials that have been published in peer-reviewed journals are misleading when it comes to reboxetine’s safety and efficacy.

How did this happen? Well, according to an article over at medscape.com, the BMJ reports that “74% of the data on patients who took part in the trials of reboxetine were not published because the findings were negative and that the data that were published about reboxetine overestimated its benefits and underestimated its harm.”

Huh?

I feel like I’m sitting in a management meeting—not at LawyersAndSettlements.com mind you—where we’ve just received the results of an employee feedback survey—that happen to suck—and we’re all trying to figure out how to save face and mitigate any fallout. What to do? LIE! Or, simply be selective in what information gets revealed…

So re: reboxetine, little bothersome details like the trial revealed that there was no significant difference in remission between reboxetine and a placebo, and that reboxetine was found to be inferior to other SSRIs such as fluoxetine (Prozac), paroxetine (Paxil) and citalopram (Celexa), just never hit the light of day. Until now.

But here is what makes me giddy with glee: reboxetine had been approved for marketing in the UK, Germany and “other European countries” according to the medscape.com article….”but did not win approval in the United States.”

Looks like the FDA got one right! Can it be so…?

Tags: Celexa, Edronax, FDA, paxil, paxil-heart-defects-newborn, Prozac, Reboxetine, SSRI
Posted in Drugs/Medical | 2 Comments »