QDIS Blog

The following article gives some interesting insight into the FDA, PUDFA and how the FDA finances their agency.

Amid Doubts, FDA Makes Case for More User Fees (FDA Webview)

I still find it interesting that they loudly proclaim that it doesn’t influence their decisions. This runs counter to the Institute of Medicine report.

Assessment of the U. S. Drug Safety System - Institute of Medicine

And here is the actual report:

The Future of Drug Safety: Promoting and Protecting the Health of the Public

Here is the pertinent section of the IOM report:

An agency whose crucial mission is to protect and advance the public’s health should have adequate resources to do its job. Also, the effect on CDER’s work of CDER’s overdependence on PDUFAfunding with restrictions on how FDA can use the money from user fees hurts FDA’s credibility and may affect the agency’s effectiveness.

To support improvements in drug safety and efficacy activities over a product’s lifecycle, the committee recommends that the Administration should request and Congress should approve substantially increased resources in both funds and personnel for FDA. The committee favors appropriations from general revenues, rather than user fees, to support the full spectrum of new drug safety responsibilities proposed in this report.

I firmly believe that Congress needs to address the funding situation and would like to see the FDA given a reasonable budget and not have them rely on creative funding sources. While it may not actually affect their decisions, I think that even the appearance of conflicts should be avoided given how important the FDA’s job is and how it effects everyones daily lives.

Technorati Tags: drug safety, FDA

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I don’t remember the FDA issuing a “refuse to file” letter in recent memory but Pharmacyclics got one from the FDA recently for their drug Xcytrin (motexafin gadolinium). It is intended to treat non-small cell lung cancer patients with brain metastases. Here is the FDA definition of “refuse to file”.

Pharmacyclics: FDA Won’t Take Filing - Forbes.com:

The stock dropped 46% on the news and is definitely bad news. The FDA said there was not enough in the filings to bother with a substantial review and that too many clinical trials had failed to show statistically significant differences from between treatment arms. This leads me to wonder who is heading up the regulatory group as this sort of situation should never be allowed to happen.

Looking up refuse to file I found that Imclone received one back on Jan 2002 over Erbitux.

Pharmacyclics had a webcast conference call yesterday and is available for one month. I’ve listened to it and not much new was added. They will be having meetings with the FDA to determine where they will be going next. The company basically thought the meetings with the FDA previously went well and they thought highly of this drug and the data and felt they were encouraged by the FDA to go ahead and make the submission. They also used outside consultants who agreed that they should go ahead with a filing.

They only have about a years worth cash on hand and so it will be interesting to see what happens in the next twelve months.. Only three questions were asked and it was a very short call.

Here is the company’s press release.

Other Resuorces

Xcytrin - Yahoo! Search Results
Xcytrin - Google Search
Google Blog Search: Xcytrin
IceRocket Blog Search: Xcytrin

Technorati Tags: Pharmacyclics, motexafin gadolinium, Xcytrin

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With all of these new reports of problems with food safety, I think it is now inevitable that some sort of major reform will occur in the 110th Congress. This time it is not only the FDA but also the USDA since the latest report is of chicken. I’m not sure what will come out of this but there will certainly be changes proposed. My bet is the proposed solution will be to move all the food related problems to a new agency combining the F part of FDA and the USDA as well as maybe parts of CDC. I’m not sure where I come down on that. Until now, I didn’t think the creation f a new agency was needed but I am willing to wait and see what is proposed.

Cooked Chicken Breasts Join Tainted-Food Recalls - Forbes.com

The article has the particulars but it involves Oscar Meyer/Louis Rich chicken breast with rib meat, which is fully cooker and ready to eat. The problem is bacterial contamination, Listeria monocytogenes, which can cause listeriosis, a rare but serious infection.

As the article points out this is the fourth problem within a week. The others were fresh cantaloups, organic baby food and the peanut butter.

Some jars of Earth’s Best Organic 2 Apple Peach Barley Wholesome Breakfast baby food were recalled because they may be contaminated with Clostridium botulinum,, which can cause a life-threatening illness.

FDA Warns Consumers Not to Use Certain Jars of Earth’s Best: “Organic 2 Apple Peach Barley Wholesome Breakfast Baby Food”

The FDA has a web page devoted to the other major food safety problem last week related to Peter Pan brand peanut butter. This has involved more than 290 people in 39 states. At least 46 people were hospitalized. Seems the peanut butter from both Peter Pan brand and Great Value are contaminated with salmonella.

Update on Salmonella Outbreak and Peter Pan Peanut Butter

The cantaloupe info was harder to find but it is also on the FDA website.

Recall of Cantaloupes Due to Potential Health Concerns (FDA web page)

For cat owners the FDA has also warned consumers not to use certain cat foods due to possible salmonella contamination.

FDA Warns Consumers Not to Use Wild Kitty Cat Food Due to Salmonella Contamination

Other Sources

South Carolina Firm Recalls Chicken Breast Strips For Possible Listeria Contamination (USDA web page)

FDA Recalls, Market Withdrawals and Safety Alerts
FSIS Recalls (Meat, Poultry & Egg Products)

Technorati Tags: FDA, food safety

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Wow, this is a major mixup. Seems some people who order drugs over the internet got the wrong drugs! In most cases they were ordering a sleeping pill or an anti-anxiety medication and instead received the schizophrenia drug, haloperidol. Some people actually went to the ER because of complaints such as difficulty breathing, muscles spasms and stffness. It is unclear how many people were affected.

FDA Warns of Dangers of Internet Drugs - Forbes.com:

Seems these were all purchased from commercial websites and the FDA is investigating. It will be interesting to see if and when the web site names come out. The shipments had Greek postmarks and came in clear plastic bags.

Here is the FDA news on the internet drug mixup. Here is the most interesting paragraph to me.

Although the involved consumers have named several Internet Web sites where the products were purchased, identifying the vendors is difficult because of the deceptive practices of many commercial outlets on the Internet. FDA is investigating this illicit trade and plans to release appropriate information when it is available.

If you do have any reports along this line use the FDA’s MedWatch Online Voluntary Reporting Form.
Technorati Tags: drug price, drug safety, FDA

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Pharmaceutical Business Review has a very short article with a few more tidbits about Ranbaxy’s office in New Jersey being raided. Seems no one is commenting about which agency performed the raid but it is thought to be the FDA and that they took not only paper documents but also electronic documents. The FDA has refused to comment.
Technorati Tags: FDA, Ranbaxy

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I listened to the podcast of the Newshour on PBS today and they had a good segment on the FDA looking into irradiation as a way to kill off harmful

FDA Weighs Approval of Irradiating Produce

It is a good piece and worth watching of listening to given the number of such outbreaks in the past year.

Technorati Tags: e coli, irradiation

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I listened to the podcast of the Newshour on PBS today and they had a good segment on the FDA looking into irradiation as a way to kill off harmful

FDA Weighs Approval of Irradiating Produce

It is a good piece and worth watching of listening to given the number of such outbreaks in the past year.

Technorati Tags: e coli, irradiation

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Bloomberg News is reporting that scientist David Ross a former FDA employee, who was one of the players regarding the antibiotic Ketek, is working with Congress to strengthen drug safety rules.

Whistleblowers Help Congress Strengthen U.S. FDA

Along with four other current and former FDA employees they are working with Congress on improving drug safety. I think having some defined process that brings together all potential resources for drug safety definitely needs to be done. However, there needs to be more than just a collection of information and if a new branch of the FDA is created, it may not solve the problem since it would be part of the culture that has created the current circumstances. I’m more in favor of changing the culture within the FDa and get it to focus back on it;s priority of protecting consumers.

I’m all for improving drug safety but think too many times the approach is too stringent or doesn’t address the root cause. Although there have been some high profile cases such as Vioxx and Ketek recently and the FDA really hasn’t done a good job of handling the media, I think that may be changing now that they have a full time Senate confirmed commissioner. I also think too many times there is a knee jerk reaction without thinking through the ever-present “law of unintended consequences”. This is an important issue and one that

If you want to keep up on legislation in Congress regarding pharmaceuticals and the FDA, Mark over at Eye on FDA had a nice posting listing legislation before Congress. I had been meaning to put something together but he beat me to it so I’ll just refer you to his posting.

Technorati Tags: antibiotics, Congress, drug safety, FDA, Ketek, Sanofi-Aventis

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The FDA approved the diet drug Xenical which has only been available by prescription for over the counter distribution. The new name for the lower dose OTC version will be Alli.

FDA Approves Orlistat for Over-the-Counter Use (FDA.gov)

The following Medical News Today article has more information.

FDA Approves Over The Counter Weight Loss Pills (Medical News Today)

I have mixed feelings about this. The article makes clear that this should be used in conjunction with diet and exercise but I think too many people may view it as an easy way to loss weight without any effort on their part. I think it appears to be useful for people in conjunction with diet and exercise and I am all for helping people become healthier. Bit it also seems to play into the American obsession with losing weight without putting forth any effort on their own part. It will be very interesting to see how Roche (the makers of Alli) what kind of advertising they use to promote this drug.

This is the first time the FDA has approved an over-the-conter weight loss drug.

Other Resources
Yahoo! News Search Results for xenical FDA over the counter
xenical FD over the counter - Google News

Google Blog Search: xenical FDA over the counter
IceRocket Blog Search: xenical FDA over the counter

Technorati Tags: Ali, FDA, weight loss, Xenical

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You may remember that I posted about the FDA closing some regional labs back in mid December. Now Some Senator including Ted Kennedy and Arlen Specter s are asking that the FDA not doing anything until it is reviewed by Congress.

Senators Ask FDA to Keep Regional Labs - washingtonpost.com:

They have written to Dr. von Eschenbach and asked that this be reviewed.

“We recognize that FDA faces serious budget constraints that force difficult choices, but it is far from clear that consolidating ORA labs is a reasonable response to these difficult constraints,” they wrote.

It will be interesting to follow up on this since the FDA had said these labs would be closed by April. That is a very short timeframe given how slow Congress usually is.

I am wondering, given the timing with the e.coli problems, if this wasn’t a gamble to increase their budget? I personally doubt it and think it is much more likely to have been a typical bureaucratic response to dealing with an insufficient budget.

Technorati Tags: FDA labs

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