QDIS Blog

In what could be a nightmare for some pharmaceutical companies, the FDA has notified some pharmaceutical companies that analytical data (primarily bioequivalence) provided in support of some NDAs and ANDA’s may need to be re-evaluated and repeated. Seems during inspections of a Canadian facility of MDS Pharma Services question were raised about the validity of their results.

PharmaLive: FDA Notifies Pharmaceutical Companies to Confirm or Repeat Analytic Studies Used in the Approval of a Number of Drug Products :

FDA Notifies Pharmaceutical Companies to Confirm or Repeat Analytic Studies Used in the Approval of a Number of Drug Products (from FDA website)

Here are the primary areas of concern from the FDA letter.

• Failure to conduct a systematic and thorough evaluation to identify and correct sources of contamination.
• Failure to investigate anomalous results.
• Lack of assay reproducibility between original and repeat results.
• Assay accuracy not assured under the conditions of sample processing.
• Biased manipulation of study data resulting in the acceptance of failed runs (emphasis mine).
• Failure to demonstrate the accuracy of analytical methods with appropriate validation experiments and documentation.

That these were allowed to go on shows a noticeable disregard for cGMP. Most of these are fundamental issues and not even in areas where there is typically disagreement. It is hard for me to fathom how this could go on! Especially troubleing is the bias manipulation item!!

What is even more interesting is it occurred over the course of four years from 2000-2004 but it is only now that the FDA is sending notices to those potentially impacted. What is also interesting to me is that there is no press release about this on MDS’ own news page. The time period covered is four years from 200-2004! While the FDA website has the warning letters they are poor photocopies and in pdf format and hard to read. Here is another source of the FDA letters in a more easily read format.

FDA Warning Letter, MDS Pharma Services (Facility Inspection)
FDA Warning Letter, MDS Pharma Services (BMIS Inspection)

Here is the actual letters the FDA sent to the affected companies:

Letter to sponsor of Pending Abbreviated New Drug Application(s) (ANDAs)
Letter to Sponsor of Approved New Drug Application(s) (NDAs)

On a personal level, one of the drugs mentioned is loratidine the generic name for Claritin. I personally use this and wonder which generic companies are affected. This is the only specfic compound mentioned that I saw but there is likely others.

This should be a warning to many companies when they rely on others for results. I think it will be a blow to MDS Pharma services and find it very confounding that they have yet to get on top of this issue and put out any sort of statement. In light of all this, I certainly would steer any of my clients away from using MDS Pharma Services.

This is also what many refer to as the cockroach syndrome. If you see one, you know there are more in hiding. My question is if this sort of disregard for basic science principals occurs in this instance, there are almost surely other incidents that have not yet been uncovered.

Technorati Tags: FDA, FDA enforcement, FDA inspection, MDS Pharma Services

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The Seattle PI is reporting that a new startup may rise from out of Icos since Eli Lilly has reported they will get rid of all 700 of Icos’ employees.

Biotech startups may pop up in Icos’ wake

The article talks about Calistoga Pharmaceuticals (no website yet) a startup created with technology from Icos. The effort is being led by Michael Gallatin, a former VP and scientific director at Icos who is now part of a venture capital firm.

I hope this happens. I personally think the beginning of the end for biotech in Seatttle happened when Amgen bought Immunex. I do see some signs of hope such as my recent post on the deal between Genentech and Seattle Genetics. However, the article does say that this new startup would have significantly fewer than 700 employees so it still means people will not have jobs.

I’m hopeful for Seattle but I’m not holding my breath. There have been more negatives than positives in recent years regarding biotech and Seattle.

Technorati Tags: Calistoga Pharmaceuticals, Icos, pharmaceutical companies, pharmaceutical deals

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I’ve mentioned Govtrack recently and wanted to highlight what a great resource I think it is. If you want to track and be alerted to specific bills, then this site makes it easy, especially with RSS feeds (web feeds).

Here is a search for all bills containing “drug OR pharmaceutical” in the House of the 110th Congress with any status.

GovTrack: Bill Search House (drug OR pharmaceutical)

This contains links to the full text of bills of 11 bills.

Here is the corresponding Senate bills.

GovTrack: Bill Search Senate (drug OR pharmaceutical)

The Senate currently only has 6 bills before it at this time. Both these links should continue to work and give you all the bills at later dates.

You can also use topics set up by the Congressional Research service (CRS) to monitor topic. As an example, here is the link for the topic Medicines. There is also an RSS feed (web feed).

I encourage everyone who has an interest in what Congress is doing to us this resource.

Technorati Tags: drug cost, drug imports, drug price, Government Information, Govtrack

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I’ve reported on this before but here is an article from Canada about their concerns if the US passes legislation allowing bulk importing of drugs from Canada into the US.

PharmaLive: U.S. Congress Threatens Canada’s Prescription Drug Supply

What is interesting to me is the the Canadian Health Minister has remained silent on this issue although in the past he has said that he doen not expect any impact on the Canadian drug supply. Here are some more articles on this mainly from the UK and Canadian press.

• Open Letter to Minister Clement on Cross Border Drug Trade (pdf)
• Canada pharmacists seek ban on drug exports to U.S.

It is interesting that few if any US based media has reported on this. I think this will be a bigger obstacle to overcome than any other. Between Canadian not allowing exporting of drugs to the US in combination with drug companies potentially limiting the amount of drugs that Canadian pharmacies can purchase, I think drug importing is merely a political ploy.

The article rightly states that this will not solve the problem and will likely create more problems. I think this quote summarizes the issue nicely.

“This is an unsustainable quick-fix for the made-in-America problem of high U.S. drug costs,” said Marc Kealey, CEO of the Ontario Pharmacists’ Association. Kealey added, “Congress is telling Americans it’s okay to cherry-pick the benefits of Canada’s regulated drug system and solve a domestic U.S. problem on the backs of Canadians. Canada cannot afford to become America’s medicine cabinet. That threatens the security of our own drug supply and the health and well-being of Canadians.” Poston noted that Canadians have built a drug supply and pricing mechanism that meets Canadian needs. Buying drugs in Canada as a quick fix to high U.S. drug prices is not a solution. U.S. lawmakers should design a system that responds to the needs of Americans instead of jeopardizing Canada’s drug supply.

I couldn’t agree more! The true issue is affordable health insurance with a drug prescription plan for those Americans who are not covered.

If you would like to track the progress of this US legislation I recommend Govtrack.

• GovTrack: S. 251: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes
• GovTrack: S. 242: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes
• H.R. 380: To amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes.

Technorati Tags: drug imports, drug price, Canadian drug imports

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