QDIS Blog

The AP had a nice report this week related to food safety and the FDA.

FDA cuts food inspections by half

They report that over the last three years, food safety inspections have dropped in half! Here are some other startling facts from their investigation:

- There are 12 percent fewer FDA employees in field offices who concentrate on food issues.
- Safety tests for U.S.-produced food have dropped nearly 75 percent, from 9,748 in 2003 to 2,455 last year, according to the agency’s own statistics.

After Sept 11, 2001 the FDA urged increasing food inspection and that did indeed happen and peaked in 2003 but have fallen back and erased those gains.

I have stated before that given the number of high profile cases in the last year, there will be increased scrutiny in this area, especially from Congress. I would not at all be surprised by a hearing on this sometime before the summer. The problem is, there are many other areas of higher priority now such as the war in Iraq.

The budget for next year does include modest gains for food safety of $10.6 million, but most critics agree this is only a very small portion of what is really needed to do their job properly. Some claim that as much as ten times that amount would be necessary.

The FDA Commissioner had his to say.

“We’re applying resources to targeted areas. So in a way, it’s not a matter of ‘Are you inspecting one out of 100 or 10 out of 100?’ The real issue is if you can define risk. Are you applying the 10 inspectors to the 10 areas of concern? Then it’s essentially you’re covering 100 percent of your problem, which is not covering 100 percent of the universe,” FDA commissioner Dr. Andrew von Eschenbach said.

While this is a good goal and I am a advocate of risk based assessment, it ignores the fact that some risks exist that we do not know about. In the case of the lettuce e.coli problems it may be that a feral pig defecated in the field and that was the source of the contamination. I doubt anyone would have had that on their list of criteria for risk assessment.

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CNN Money reported yesterday that the sentencing of Dr. Lester Crawford, the former FDA commissioner was completed yesterday. He ended up being fined $89,377 and three years of probation as well a 50 hours of community service.

Former FDA chief fined $89,377 - Feb. 27, 2007

Boy did I get this wrong. You may remember I made a prediction back in October that said he would be fined $10,000 and given 2-3 months probation. This was based upon my pessimistic view of high level officials ever being truly held accountable. I am glad to see that the judge thought this was worthy of more punishment than that. It is interesting that the fine is much larger than the agreed amount of $50,000 between Crawford and the prosecutor, but still lower than what could have been handed down.

I personally would like to have seen more hours of community service given out. Fifty hours is just slightly more than one work week.

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LIlly received additional approvals for Cymbalta for treatment of generalized anxiety disorder.

Press Release: FDA Approves Eli Lilly and Company Cymbalta - FierceBiotech:

This brings to three the number of indications for this drug. The others include depression and diabetic neuropathy.

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Seems they knew what they was doing when Shire purchased New River Pharmaceuticals. Now, the FDA has approved Vyvanse for treatment of Attention Deficit Hyperactivity Disorder (ADHD).

FDA approves Shire’s ADHD drug Vyvanse - Yahoo! News:

Here’s the Shire press release. This is big for them and for anyone suffering from ADHD. This drug seems to be better tolerated and longer lasting than other stimulates used to treat this disorder.

Other Resources

lisdexamfetamine dimesylate - Yahoo! Search Results
lisdexamfetamine dimesylate - Google Search
Google Blog Search: lisdexamfetamine dimesylate

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Tomorrow, an expert panel of outside advisors will give their recommendation on a Sanofi-Aventis bird flu vaccine.

FDA experts to vote on America’s first bird flu vaccine - Feb. 23, 2007:

It will be interesting to see what comes out of this meeting. I still think that the concerns over bird flu are currently overstated. Many more will die this year from the standard flu than from bird flu.

As the article point out though, it is impossible to develop a precise vaccine against bird flu unless it actually mutates into a pandemic strain. It is a difficult decision to stockpile a vaccine that may likely do no good whatsoever. However, it is also unconscionable to do nothing. I think the best spending of money would be on technologies that get away from using chicken eggs to produce vaccines. The way the pharmaceutical industry produces vaccines has not changes in many, many years. If bird flu should become epidemic within the chicken population and not affect humans directly, it could still have a major impact on humans since ALL vaccines are made using chicken eggs. This would inhibit the ability to produce any other vaccines. These technologies, if they allowed rapid ramp up of production, could easily be used for other vaccines in the future.

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I’ve always said that pharmaceutical companies that are truly looking at improving their image (and heading off further regulations) with the public, should do better at completing agreed upon post-marketing studies. A recent article shows that 71% of agreed upon post-marketing studies (899 studies) have not yet even been started.

Prescription Drugs | Prescription Drug Makers Have Not Begun Many Pending Post-Market Studies on Newly Approved Drugs, FDA Says - Kaisernetwork.org:

Here is the latest numbers for 2006 from the FDA: Postmarketing Study Commitments 2006 [HTML] [PDF ]

These are studies that pharmaceutical companies agree to as a condition for approval of the drug. The problem is, the FDA has no authority to do anything if companies do not comply. Their only true recourse is to withdrawal approval but that is something they have never done for failure to complete post-marketig studies. It isn’t something I would recommend either as it would hurt too many patients who may truly need a specific drug.

Some in the industry complain that it is hard to recruit patients for some drugs. That may very well be the case, but that doesn’t mean they should not even start trials. It means it may take longer to get them completed. However, that reasoning does not address the extremely high percentage of studies that have not even been started! Also, if there will be a problem getting patients for these studies, then the companies should discuss that with the FDA at the approval and agree to start them but state that it will likely take longer to complete them. It would be interesting to try and determine how many drugs pharmaceutical companies make this sort of claim for and look at how many prescriptions are written for those drugs. One of the problems is, someone in a phase IV study (aka post-marketing studies) will not be generating revenue for the company.

At the heart is the fact that these studies tend to be large and costly and in most cases, the companies will not be achieving anything substantial from them (i.e. a competitive or marketing advantage). They are mainly studies to give the FDA better confidence in the safety of the drug. Therefore, from a strictly business perspective (ignoring safety), it makes sense to put off these trials as long as possible since they are costly and are not likely to bring any benefit for the companies. Also, if there are no consequences than why do them? I would argue that sort of mentality is very shortsighted and not including the potential costs of later legal problems if the drug should have some unintended consequences (i.e. Vioxx).

Also, if this sort of trend continues, there will certainly be more power given to the FDA. I have always found it interesting that the EPA can fine companies in order to protect the environment (and the potential human consequences) but the FDA has no such power to fine companies for failing to complete required pot-marketing studies that have a larger potential to do harm.

Fro another view see Opinion | Delayed FDA Post-Marketing Study Statistics ‘Misrepresented,’ Opinion Piece Says - Kaisernetwork.org

Other Resources (note: some are from 2005)

FDA says too many drug studies delayed - Boston.com
FDA Accused of Dropping the Ball on Post-Marketing Studies of Fast Track Drugs - CME Teaching Brief® - MedPage Today
FDA To Drug Firms: You Promised, Where Are The Post-Marketing Studies? - CBS News
Postmarketing Study Commitments Database (FDA website)
Postmarketing Study Commitments: Introduction (FDA website)

Technorati Tags: FDA, post-marketing studies, phase IV studies

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There was no love for Advancis from the FDA in this article on Feb 14 when the FDA gave them a refusal to file letter. This is the second one now in the last few weeks.

FDA deny drug application from Advancis - Washington Business Journal: :

What is very interesting to me is that Advancis does not have a press release on this on their website. The last press release they have is dated Jan, 12 2007. This day and age, it is amazing to me that companies don’t react quickly to these sorts of situations. It’s been two weeks since this happened with no word from the company on their website. I understand that time is needed to form a response but something should be immediately announced.

Their Amoxicillin PULSYS once daily dosing is the product concerned and according to the company they were surprised just like Pharmacyclics that I posted about previously at the FDA’s response. The FDA, according to the company, is concerned about how they plan to scale up their manufacturing process to make bulk quantities. Previously, the company had failed some phase III clinical trials which had to be repeated and then had to re-file the NDA in Dec 2006.

I’m wondering if this means the companies are not really listening to the FDA or if the FDA is changing their mind midstream. While this may not seem to be much of difference it could have major implications for other companies getting ready to file NDAs. If the FDA is starting to crack down and not even accept applications, then the industry needs to be much more careful about how they prepare their filings. If on the other hand, these two companies just weren’t really listening and picking up on the nuances from the FDA then it may not have much of an effect on other companies.

I do know from personal experience that you have to be very careful in the questions you ask the FDA. Many times at end of phase x meetings, you submit questions in writing ahead of time and depending on exactly how those questions are worded, you may get different answers. I know of some companies that will only ask yes or no questions and try to word the question so as to get the answer they desire instead of asking questions to really learn what the FDA thinking is on a given set of circumstances. I have always felt this was a mistake. Early on, it is vitally important to ask open ended questions before too much time and money is spent going down a regulatory or development route that may lead to failure at a late stage when it is very costly.

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I’ve been meaning to comment on this article for quite some time. The LA Times is reporting that a virus may be responsible for Mad Cow disease (aka bovine spongiform encephalopathy or BSE).

Virus may be the cause of mad cow - Los Angeles Times:

For a long time, scientists have thought prions, misshaped proteins were the cause but according to these new results from Lead author Dr. Laura Manuelidis of Yale University, the prions occur late in the development of the disease in mice. It remains to be proven that these isolated virus particles cause the disease but work is underway to prove just that. They did stimulate the product of the prions fivefold and this did not increase the level of infection. If this does prove to be the case, it is certainly a major turn of events for Mad Cow disease. Other scientists are highly skeptical of this idea.

I personally have always had some doubts about prions being the cause but am really not an expert on the subject. A virus seems to me to be much reasonable explanation. It is curious is to why no one had seen these sorts of particles in previous research. It will be interesting to see if they can prove that these viruses actually cause the disease.

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Earlier this month, DrugResearcher.com had an article on revamping at major pharmaceutical companies.

Roche revamps R&D for speed:

An import part of the article is in the last paragraph. GlaxoSmithkline reorganized their research into seven Centres of Excellence for Drug Discovery years ago and I don’t know that it has increased their overall productivity. It may gets more drugs into development, but the more important issue of making sure the ones that do go into development have the greatest possible probability of success.

I’ve seen this before and I don’t have much faith in these “reorganizations”. Inevitably, these sorts of moves don’t make major contributions to the bottom line and sometimes actually make matters worse. I personally think that the culture and huge bureaucracies are more to blame for the lack of research results. That isn’t to say re-orgs can’t make thing better, that can be. I just think too many times they don’t pay off.

I’ve also said that just moving the bottlenecks of development from one place to another is not the answer. The bottlenecks need to be removed from the system entirely, rather than just moved from place to place without increasing the overall output.

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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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