All posts by Administrator


FDA to Conduct Evaluation of Pharmacovigilance Systems

By Daniel R. Matlis

On January 12th, I reported on FDA’s request for Pharmaceutical companies to confirm or repeat all pharmacokinetic studies conducted by MDS Pharma Services from 2000 through 2004.

This week the Agency announced that it will be conducting market research on commercially available pharmacovigilance risk management and product safety computer system products. 

Is this a coincidence?  I think not.

According to FDA’s own data, Corrective And Preventive Action (CAPA) findings represent 50% of the 483s issued to companies during inspections. It would be refreshing to hear that FDA is holding itself to the same standards it holds the industry.

I hope this study represents the first step in the agency’s CAPA process triggered by the MDS findings.

If your company provides pharmacovigilance and product safety systems, or you are already using these systems within your organization, the FDA would like to hear from you.  All requests must be submitted no later than January 31, 2007.

Submit your request to:
Food and Drug Administration
5600 Fishers Lane
Rockville, MD  20857
Attn: Ms. Smale/PKLN RM10B31 HFD-70



How Soon Can You Get Me That 6 Year Old Data?

By Daniel R. Matlis

The Food and Drug Administration (FDA) announced that it has asked pharmaceutical companies to confirm or repeat all pharmacokinetic studies conducted for them by MDS Pharma Services (MDS Pharma) from 2000 through 2004.

MDS Pharma performed pharmacokinetic testing services for a number of pharmaceutical companies. These studies are used to measure the level of drug in a patient’s blood. The results of these studies are required for the approval of a drug by the FDA.

The action is a result of FDA inspections of two MDS Pharma Canadian facilities that raised questions about the validity and accuracy of test results from studies conducted by MDS Pharma from 2000 through 2004. FDA has worked with MDS Pharma to address these issues concerning its test results and is now following up directly with all pharmaceutical companies with marketed drugs or pending drug applications that may be affected by these testing issues.

The Agency sent over 1,000 letters to sponsors of pharmaceutical products for both brand-name and generic drugs

As you can imagine, drug companies affected by this notification want to review these studies as expeditiously as possible. However in some cases it may take weeks to just find the study data, let alone review and analyze it.

Why, you ask?

Some of these studies are six years old and are most likely collecting dust at archive facilities like Iron Mountain, or if you are lucky they are on a backup tape in a vault.

In either case it will take hours, days and in some cases weeks to find the right box or tape, retrieve it, parse it and find the pharmacokinetic study in question.  Only then will scientists be able to analyze the impact of the study on the drug and the patients.

According to a recent article, the amount of data required to support compliance activities in the Life-Sciences Industry has increased by 400% from 376 PetaBytes in 2003 to 1644 PetaBytes in 2006 (a PetaByte equals one quadrillion bytes).  This data is in Data Islands often connected by Sneaker-net across the enterprise.

This incident highlights the need for our industry to implement technologies that not only ensure that data is stored, archived and protected, but more importantly can be quickly and reliably retrieved to meet ever increasing business, regulatory and litigation discovery requirement.


Democrats First 100 Hours May Have a Big Impact on Life-Sciences

By Daniel R. Matlis

The Democrats are coming in full force with a very ambitious agenda for their first hundred hours in control of the senate and house.

During the first 100 legislative hours of the 110th Congress, Democrats plan to bring to the floor the following issues:

  • Tuesday, January 9 – Implement the 9/11 Commission Recommendations
  • Wednesday, January 10 – Increase the Minimum Wage
  • Thursday, January 11 – Expand Stem Cell Research
  • Friday, January 12 – Allow Negotiation for Lower Prescription Drug Costs
  • Wednesday, January 17 – Cut Interest Rates on Student Loans
  • Thursday, January 18 – End Subsidies for Big Oil and Invest in Renewable Energy

From a Life-Science perspective two of these stand out. Stem Cell research and Lower Prescription Drug Costs.

A Republican Executive and Democratic Legislative are going to make for an interesting two years for our industry. But as a Zen master would say:”Who is to know what is a blessing and what is a curse?”


Top 7 questions for Pharma and Biotech in 2007

It’s that time of the year.  Mike Huckman, CNBC Pharmaceutical Industry Reporter, shares his outlook on the industry as part of CNBC’s top 7 for 07 series.

Here are Mike’s top 7 Questions on Medicine and Money in 2007:

Could the next diet pill craze start in 2007?

Will big Pharma keep doing deals with BioTechs?

Will Pfizer have to think big and do another huge deal?

Could Bristol-Myers Squibb and Sanofi-Aventis loose the patent on Plavix?

Will Generic Drug competition continue to threaten big Pharma’s profits?

Will the new Congress legalize prescription drug importation?

Will the new Congress let the government negotiate lower drug prices?

Want to know his predictions?  See the complete CNBC story


My Body, My Choice?

By Daniel R. Matlis

No, it’s not what you think; I’m not going “pro” this or “anti” that on you.

I am referring to the Food and Drug Administration’s (FDA) proposal to make experimental drugs widely and easily available to seriously ill patients.

According to Dr. Andrew C. von Eschenbach, Acting FDA Commissioner “This proposed reform is carefully designed to balance several objectives.” von Eschenbach added “One goal is to enable many more patients who lack satisfactory alternatives to have access to unapproved medicines, while balancing the need for safeguarding the individual patient. Another equally important goal is to ensure the continued integrity of the scientific process that brings safe and effective drugs to the market.”

The proposed rule is a direct response to a 2 to 1 decision by the U.S. Court of Appeals for the District of Columbia Circuit overturning a lower court’s ruling in a case brought by the Abigail Alliance for Better Access to Developmental Drugs.

The court ruled that “barring a terminally ill patient from the use of a potentially life saving treatment impinges on the right of self-preservation.” Further, the court held that once drugs have passed safety trials, they should be made available if they might save someone’s life.

Judge Judith W. Rogers wrote “If there is a protected liberty interest in self-determination that includes a right to refuse life-sustaining treatment, even though this will hasten death, then the same liberty interest must include the complementary right of access to potentially life-sustaining medication, in light of the explicit protection accorded ‘life’.”

Dr. Janet Woodcock, FDA’s Deputy Commissioner for Operations stated “FDA hopes this proposal will increase awareness in the healthcare community of the range of options available for obtaining experimental drugs for seriously ill patients,” she added that “By clarifying and streamlining the processes, FDA also hopes to encourage companies to make such drugs available, and reduce barriers for healthcare practitioners in obtaining them.”

The proposed rules, which are open for comment for 90 days, are described in detail at the following FDA web address:

I hope and pray that none of us ever face such a choice, but if we do, it should be our choice to make.