FDA Has a New Look for Food

January 28, 2010

Guest commentary by Sid Olufs.

FDA has made a major appointment to oversee food and food safety. Sid Olufs, a professor at Pacific Lutheran University, has written the first of two posts that discuss what is going on at FDA regarding food safety. Sid is also the author of a number of book reviews found on the page at the top of the Blog.

FDA food safety

Consumers buy local in response to food safety concerns about the globallization of the food supply

YOUR comments are always welcome!

Michael R. Taylor appointed Deputy Commissioner of Food
by Sid Olufs, 27 January 2010

The FDA has created a new position, Deputy Commissioner of Food, and has appointed Michael R. Taylor to fill it. The new office is supposed to unify a focus on food safety among the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), and the foods-related activities of the Office of Regulatory Affairs (ORA), plus other staff offices that support them.

This is a significant consolidation of FDA resources toward a mission focused on food safety. The idea has been out there for a while—for example, in May of 2009 the group Trust for America’s Health released a report advocating precisely this move, arguing it is an important interim step in the creation of a single food safety agency. Yet even if all goes well this is going to take a year to bear significant fruit. The several food-related units within FDA have many items on their now-shared plate: inspection and ensuring compliance with rules, coordination with state and local agencies who do much of the work of food safety, responses to “incidents” that hurt people, getting a handle on imported items that find their way into food, sponsoring and organizing the scientific and technical research needed to design a safe food system, including animal feed and veterinary care, and building the information network that helps to knit all of these together. The new Deputy Commissioner’s office is supposed to employ risk-based criteria for the difficult budget and other resources decisions to make all of this happen. It will be a difficult job.

Mr. Taylor clearly has the experience to take on this job, and some of the most knowledgeable people in the food safety world (like Marion Nestle and Steven Grossman) are saying this is very good news. Mr. Taylor’s published writing and congressional testimony may tell us what to expect—these will be the subject of a subsequent note.

FDA food

A single agency for food?

This is all good news. But do not read too much into it. I have two reservations. First, we still have the split responsibility for food between the FDA and USDA. The FDA mission includes much less of the industry cheerleader responsibilities shouldered by USDA, but there is enough wiggle room in the mission language to let a pro-business conservative appointee take the agency in a very different direction. This is the second reservation. A food safety system should not depend on a particular party winning an election. A subsequent blog will compare different models of locking in a mission at an institution like FDA.

Mr. Taylor has written and testified about food safety issues, which provides a record that may tell us what to expect. During his time at Resources for the Future (RFF) he co-edited (with Sandra A. Hoffmann) Toward Safer Food: Perspectives on Risk and Priority Setting (RFF, 2005), and contributed a short summary chapter. The topic of risk analysis is inherently contentious—in general, advocates of a precautionary approach, asfound in several western European countries, do not like it, and advocates of using the business bottom line as a factor in safety issues endorse it. [Disclosure: I personally advocate the use of risk analysis, and am convinced it needs to be part of a precautionary approach—but now seldom is.]

It makes sense to go after the biggest threats to human well-being, and to pursue the policies that produce the most improvement for scarce available dollars. Yet risk analysis comes with a technical vocabulary and measurement techniques that tend to limit participation in debates to those with the skills and experience to speak about and decipher the approach. What I saw throughout Toward Safer Food was a model of analysis

FDA food safety

Risk Analysis & Food Safety

that treated technical innovations as mostly exogenous variables, as the economists call them, which respond to market forces.

Take the example of concentrated animal feeding operations (CAFOs). They produce meat that costs less per pound and brings animals to slaughter many days faster. Markets gave us CAFOs. And yet, they produced public health consequences that have to be paid for through public policy and increased consumer caution—they have killed people. One of the things markets do is to allow some folks to seize the benefits of new technologies while avoiding the costs the new practices impose on others (indeed, many are created for precisely this reason). Risk analysis should include the likely effects of proposed food system technologies to vet them for things like the production of new super-germs, the need for more drugs in animals during production, and so on. None of the authors of the chapters in Toward Safer Food appear to embrace the more robust modeling needed to make risk analysis vigorously support public health.

Another important piece by Mr. Taylor is the 2007 report from Harnessing Knowledge to Ensure Food Safety, coauthored with Michael Batz (Food Safety Research Consortium, 2008). The report focuses on the food safety information infrastructure needed right now. The 9-page executive summary is available at:


It is worth reading. Briefly, we now have a chaotic cloud of food safety information, no widely shared standards for how to develop research, or how to test ideas about food safety, how to collect information at state and local government, in private industry, and in a dozen national government entities. We have to build an information system that supports public health. There are many good ideas in here, as you can see in the executive summary. One key feature of the approach advocated by Mr. Taylor is “the stakeholder model,” (TSM) in which the interested parties discuss challenges and prospects and develop approaches for

food safety FDA

Food Safety Councils?

improvement. Representatives from government, industry, consumer groups, and anyone else with a recognized stake get together (in this report, the gathering will be called a council) to seek consensus among their perspectives. Like the topic of risk analysis, this is a highly contentious idea. TSM has been widely adopted by state and local governments in environmental policy, to cite one example example, because of the political pressures against regulation. Plans that emerge from stakeholder committees or councils emphasize self-financing elements and voluntary compliance. Sometimes a stakeholder has a perspective that harms public health. This fact needs to be part of the institutional design. [Another disclosure: my view on this is probably influenced by personal experience, as described in


A third publication, Stronger Partnerships for Safer Food (coauthored with Stephanie D. David, from GWU School of Public Health and Health Services, 2009) describes the intergovernmental maze of food safety organizations we will have to integrate into an effective system. Nineteen recommendations describe the needed changes, and it is a compelling case.

See the executive summary at:


Among the more difficult features are a clear congressional mandate to the Dept. of Health and Human Services (HHS), a HHS secretary committed to food safety as a main agency priority, and a significant increase in intergovernmental funding. One frequently mentioned feature of the current system is the required visual inspection of all animal carcasses, which do not detect the most dangerous sources of contamination. If they were cut out, perhaps $200 million or so could be saved—at some cost to public health. But this goes at most halfway toward funding the required changes needed at FDA alone, which needs to be supplemented by large increases in intergovernmental funding for state and local food agencies. (The budget estimates I refer to here come from sources like the Congressional Research Service and Congressional Budget Office, not the publications mentioned above.)

Observers of the health care debate over the last half year must be forgiven for their profound skepticism that these obstacles can be overcome. I don’t wish to sound entirely negative. There is much in the latter two documents that need to be put into an effective food safety agency. But more is needed, in my view. To repeat: A food safety system should not depend on a particular party winning an election. The reservations noted above are all things that can be dramatically altered by a shift in party control of Congress or the White House. A subsequent blog will compare different models of locking in a mission at an institution like FDA.

Read more about Food Safety:


Blogroll Pick: Acronym Required In a new feature of the Blog I am highlighting one of the blogs you can find on the Blogroll each time I write a new post. Please take a look at the Blogroll as there are some interesting places to visit. Acronym Required is a recent addition to the Blogroll and discusses issues of food safety, along with other current topics.



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Clinical Trial Compliance & Checklists: The Right Approach?

January 24, 2010

Update: Checklists and clinical trials are points to consider for clinical trial professionals. I am including a link to some resources you may find of interest. Since I wrote this on January 24, 2010 the post has continued to receive a lot of traffic so I am putting a link to some sites that may be of use to you after reading my original post. One link is Norton Audits and they have a number of documents you can access. The checklist is at the bottom right. The links are at the bottom, scroll down.

Original Post: Checklists and complex medical procedures: Some physicians argue that checklists can reduce infection rates during surgery and help manage an increasingly complex medical system. Also, there is a growing use of checklists in clinical trials including the use of “protocol-specific worksheets” to assist a clinical site in protocol compliance. Some QA specialists think checklists are essential. Others ask, “Is this a good thing? Are we missing something in the checklists?”

The New York Times Book Review reports on the medical part of this discussion in a review by Dr. Sandeep Jauhar entitled “One thing after another,” about the book The Checklist Manifesto” by Dr. Atul Gawande (Metropolitan Books/Henry Holt & Company: $24.50). Dr. Gawande is a professor of surgery at Harvard Medical School and a staff writer at the New Yorker. The reviewer, Dr. Jauhar, is a cardiologist and the author of “Intern: A Doctor’s Initiation.” A quick note: His review does not discuss clinical trials. However, I immediately drew a connection.

An example in the book cites “A five-point checklist implemented in 2001 virtually eradicated central line infections in the intensive care unit at Johns Hopkins hospital, preventing n estimated 43 infetions and eight deaths over 27 months.” That is a very impressive result that has been repeated at studies at intensive care units (ICUs) in Michigan, according to the review.

In clinical trials I have seen many quality assurance audit plans and monitoring procedures that rely heavily on checklists. Checklists are something that I should probably use more. I usually use the FDA Clinical Investigator Compliance Program Guidance Manual (CP 7348.811) that I was trained on when I was at FDA (see link on the right under “FDA Stuff”). However, I see a downside of checklists. Although they help make sure you review the necessary documents hey rarely assist the monitor or auditor in determining significance. I have seen cases where a monitor or auditor has hammered away about an item on their checklist that really wasn’t all that important, or maybe not even relevant for that specific study.
checklist clinical trial
In addition, checklists are entirely dependent on who is writing the checklist and if their list, written in an office complex somewhere, is practical in the field where clinical trials actually are taking place. There can be some serious unintended consequences. I have seen recent FDA Warning Letters to clinical investigators that state:

“A. Your site chose to use the sponsor’s standardized forms as source documents to record and document information related to the subjects’ study visits. Per the standardized form, your site was to “Complete the Inclusion/Exclusion Criteria Worksheet to evaluate for study eligibility.” In the FDA investigator’s review of 16 of 65 subject records at your site, there was no Inclusion/Exclusion Criteria Worksheet found for any of these subjects.”

The records kept at a clinical site are the responsibility of the site, of the clinical investigator, not of the sponsor or the employee that wrote them. If the site doesn’t fill out each of the worksheets, and perhaps sign and date them, then FDA will write you up in a Form FDA 483, Inspectional Observations, for inadequate recordkeeping and possibly a protocol violation. In short, the checklists and worksheets have to be practical to use at the clinical site.

Dr. Jauhar does not talk about clinical trials in his book review. But he does give concrete examples of how checklists can be a problem. For exmple he says:

“Today, insurers are rewarding doctors for using checklists to treat such conditions as heart failure and pneumonia. One item on the pneumonia checklist — that antibiotics be administered to patients within six hours of arrival at the hospital — has been especially problematic. Doctors often cannot diagnose pneumonia that quickly. But with money on the line, there is pressure on doctors to treat, even when the diagnosis isn’t firm. So more and more antibiotics are being used in emergency rooms today, despite the dangers of antibiotic-­resistant bacteria and antibiotic-associated infections.”

The book review is very much worth reading. In addition there is access to a podcast featuring Dr. Gawande. You can find a ink under “Interesting Articles” on the right as well as below:





Obtaining FDA Establishment Inspection Reports- EIRs

January 20, 2010

FDA has a policy that allows an inspected organization to obtain a copy of their inspection report before it is available to the general public through the Freedom of Information Act. This policy is called FMD-145 FDA EIR(FMD=Field Management Directive). Since first writing about this last September, the subject continues to be of interest to visitors to the Blog. I checked the FDA website and yes, FMD-145 is still there. Here is the reprint of my original blog post. Please let me know your thoughts with a Comment.

Obtaining your establishment inspection report (EIR) under FMD-145

I frequently talk to people about the difficulties in obtaining an “establishment inspection report” or EIR after a company or clinical site has been inspected by FDA. Inspected parties can wait years before receiving an EIR, if they receive a copy at all. An FDA “Field Management Directive” – FMD 145 – states the following:

“This Field Management Directive (FMD) provides guidance and criteria for releasing a copy of the establishment inspection report (EIR) to the establishment that was the subject of an FDA or FDA-contracted inspection when the Agency determines the inspection to be “closed.”

The Agency … determined that a copy of the EIR should be routinely provided to the inspected establishment once the Agency concludes that the inspection is closed. For the purpose of this directive, the term “closed” will have the same meaning as it has under 21 C.F.R. §20.64 (d)(3).”

A “Field Management Directive” is a method by which senior management at the Office of Regulatory Affairs (ORA), the field organization that conducts FDA inspections, sets ORA policy. This means that FDA should Routinely issue a copy of the inspection report after they close an inspection. You shouldn’t even have to ask although you almost always do. If inspected by FDA you should ask the field investigator about obtaining a copy of the report per FMD 145. If it has been more than 90 days since you have had an FDA inspection and received a letter from FDA saying “no further communication is necessary,” or something like that, then you should ask for a copy of your EIR. You should contact the address listed on your FDA 482, Notice of Inspection, that was issued at the beginning of the inspection.

FDA instituted this policy so an inspected party would receive a copy of their inspection report prior to the report being released to the public at large under the Freedom of Information Act. If you have been inspected by FDA then you have a right to a copy of your inspection report and you should ask for it. FMD-145 is a tool for you to use to improve your compliance with FDA regulations. How did FDA document protocol violations? How did FDA document non-compliance with GxP requirements? The EIR contains important information on how FDA approaches their inspections and, what they think of you. FDA states that they are committed to “Effective Enforcement.” Adhering to FMD-145 is an important component of that. Here is a link to FMD-145:


Blogroll Pick: FDA Transparency Blog. The FDA has a blog to discuss transparency by the Agency. The Transparency Blog also asks, “How Should FDA Inform the Public About Inspection Results” and has 13 comments (including one by me). Check them out and check out the other sites on the Blogroll.



You can read additional posts on FDA Commentaries here:



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Anesthesiologist Accused of Fake Drug Studies

January 18, 2010

Federal agencies including the FDA’s Office of Criminal Investigations and the FBI have joined in an investigation of Dr. Scott Reuben, the former chief of acute pain at the Bay Medical Center in Springfield, MA. Fake drug study FDA clinical trialDr. Reuben was accused of faking clinical trials for pain medications including the Cox-2 inhibitors Vioxx by Merck and Bextra by Pfizer. The Associated Press reports that Dr. Rueben may have agreed to a plea bargain with the U.S. Attorney’s office in exchange for more lenient sentencing. The Journal of Anesthesia and Analgesia and the Journal of Anesthesiology have pulled 13 of Dr. Reuben’s published articles. Read more:



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Mountains Beyond Mountains: The Tragedy in Haiti

January 15, 2010

08 February: The New York Times Book Review reported that Mountains Beyond Mountains by Tracy Kidder was again on the paperback bestseller list for nonfiction at #14. This reflects a continued interest in Haiti and Partners in Health. The book is excellent and I would highly recommend it. Here is a link to Amazon for it:


Remember that Partners in Health has continuing needs to help the people of Haiti. Please contribute:


Here is a slide show that Partners in Health released on 10 February showing the current conditions in Haiti:


15 January 2010: Mountains Beyond Mountains: The Tragedy in Haiti

Given the enormity of the tragedy in Haiti it is difficult for me to write about FDA guidance documents and regulatory compliance. Instead, I am going to ask you to help with the relief efforts. When natural disasters strike it is often difficult to know just where your donations will do the most help. In Haiti I believe it is an organization called Partners in Health. They are already there and have decades of experience in helping the poorest people in Haiti, the people who are most in need Right Now. The link to their website is just below. WOULD YOU PLEASE CONSIDER MAKING A DONATION:


I first learned about Partners in Health and Dr. Paul Farmer, its founder, by reading the book Mountains Beyond Mountains by Tracy Kidder. It is probably the best book on international health issues I have ever read. I strongly recommend it.

Mountains Beyond Mountains: The Quest of Dr. Paul Farmer, a Man Who Would Cure the World (Random House Reader’s Circle) (Paperback) by Tracy Kidder

From the New England Journal of Medicine: “Indeed, Farmer founded a hospital and health center, Zanmi Lasante, in Cange, Haiti, hours from the capital and at the end of a gutted road in a region destitute even by Haiti’s standards, as part of an extensive community-based health network linked to a hospital, Clinique Bon Sauveur. For more than 20 years, Farmer has spent many months every year there, often taking care of patients himself and continually improving the treatments offered by the clinic. These now include antiretroviral drugs. Lasante is supported by a foundation based in Boston called Partners in Health…”

UPDATE: You can read an update from Partners in Health here:

16 January Haiti Update



UPDATE: 02 February: In this morning’s NY Times was an article about relief funds for the crisis in Haiti. It pointed out that when the earthquake hit, the American Red Cross (an excellent organization) had 15 people working in Haiti. In contrast, Partners in Health had 700 doctors and nurses among a staff of nearly 5,000 with one hospital and numerous clinics throughout the country. Yet the American Red Cross has raised almost $200 million for Haiti and Partners in Health about $40 million. People will donate to the best known organizations, not necessarily to the best placed ones.

A colleague of mine who has been following this blog remarked she had been donating to Doctors Without Borders The Nobel Prize winning relief organization. I also strongly support them and contribute on a monthly basis. It is important for relief organizations to have a steady flow of money after the TV cameras have left. I urge that you consider this type of support for an organization you believe is doing good work. Here is a link to Doctors Without Borders/MSF- USA:


Update: Dr. Paul Farmer testifies to U.S. Senate Committee on Foreign Relations, 29 January:


Blogroll Update: Partners in Health Blog- Now you can follow the progress of relief efforts in Haiti firsthand with the Partners in Health Blog:


UPDATE 19 January: FIRSTHAND: Writer Dany Laferrière describes living through Haiti earthquake, the Le Monde interview translated by Mark Jensen:

UPDATE 18 January: Today we celebrate the birthday of Dr. Martin Luther KIng Jr.. What better way to celebrate than by helping the people of Haiti. View Katie Couric interview with Ophelia Dahl of Partners in Health on the current situation:


Update: NIH has provided funding for ten international malaria research centers. Read the 8 July 2010 Press Release


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Analysis of Recent FDA Warning Letters to IRBs

January 12, 2010

A clear pattern is emerging from the recent spate of IRB Warning Letters written by FDA. It appears that IRB registration is working. The Food & Drug Administration is learning just who is approving research in the U.S.

IRB FDA warning letter
The addition to the FDA IRB regulations, 21 CFR Part 56.106(a), requires Institutional Review Boards (IRBs) reviewing FDA research to register with FDA. It is an excellent addition to the regulations and is already paying dividends to improve clinical trials. (FDA could update a few more regulations but that’s a different story.) Formerly, FDA would only find out about an IRB’s existence if there was an application for a product approval that listed the IRB or if there was a complaint.

Here is a link to the FDA guidance document for Frequently Asked Questions regarding IRB registration:

Click to access UCM171256.pdf

The ruling went into effect on 14 July 2009 and came on the heels of the Coast IRB sting where the GAO submitted a fake clinical trial that was unwittingly approved by the now defunct Coast. Since that time some very serious Warning Letters have been written citing some very serious violations of regulations designed to protect human participants in clinical trials. At least two IRBs, the Teneo IRB and the MI Hope Inc. DBA Center for Complex Infectious Disease IRB have been told to stop approving studies and to stop enrolling new subjects in existing studies until FDA approves corrective actions. Is there something seriously wrong with IRBs in this country? Reading the Teneo and MI Hope Warning Letters could lead you to think so. Take a look at MI Hope:

UPDATE: Unfortunately FDA doesn’t appear to keep links to Warning Letters active. The ones inserted into this post no longer work. Thanks FDA. You can find the Warning Letters by going to the FDA Warning Letter Page and searching by company.



And now Teneo IRB:


Although both these Warning Letters are pretty bad I think that they should have been expected. Previously, FDA did not have the authority to require IRBs to register. Although the work of running a good IRB is quite difficult it amazingly easy to start an “IRB.” It takes five people, one of whom is a scientist (they are not required to be a physician), one a non-scientist, and one not affiliated with the institution. Then you toss in some administrative stuff such as a few written procedures and you’re set to go. As a result, organizations such as MI Hope and Burzynski Research Institute could start their own IRBs free from FDA oversight and with serious potential for conflicts of interest. Now that FDA has a list of these IRBs they are conducting inspections and finding a few bad actors. The same thing happened when FDA started inspecting seafood processors and home respiratory care facilities. The first time FDA comes in to conduct inspections, there frequently are problems. FDA isn’t writing Warning Letters to the many established, legitimate IRBs that have been inspected several times in the past


Established institutions, such as the Mayo Clinic, have a long history of IRB regulation

When I was at FDA I inspected over 30 IRBs and found that most IRB members were dedicated, hard working research professionals. Most IRB board members are volunteers, serving for no pay or a small stipend. Few people are getting rich at IRBs. Their purpose is to provide independent review of research to protect clinical trial participants. IRBs are a very good thing. Problems sometimes occur when IRBs become confused between FDA regulations and regulations enforced by the Office of Human Research Protections (OHRP). That is what apparently happened recently when a Warning Letter was written to Florida Atlantic University. They are a small academic IRB that reviews very few protocols under FDA jurisdiction. They are significantly different from Teneo, Burzynski, or MI Hope. Take a look for yourself:


As a result, there is a tendency to heap additional responsibilities onto IRBs. Some in Congress are tempted to do this and some “consumer advocates” are as well. This can lead to a stifling effect on innovative research. One principal investigator I know who conducts non-FDA regulated research, primarily through surveys or questionnaires, described IRBs as the “bane of my existence” because of the overly burdensome administrative procedures. These administrative procedures are frequently enacted because OHRP found problems in the past at some academic research institutions. The American Enterprise Institute, a very conservative policy organization, raised some interesting points last year in an opinion peace published in the NY Times (below). We should give FDA the time to wend their way through the list of newly registered IRBs and not have knee-jerk reactions to the initial results. There will be more Warning Letters in the immediate future but that should just weed out the bad actors. Most IRBs have already been inspected by FDA and are doing their work. We need to make their work easier, not more difficult.

Here is a link to the American Enterprise Institute’s op/ed piece:


The bottom line is we need legitimate IRBs to independently review clinical research in the United States. We also need to understand that we need research vitality. We should resist the impulse to impose too many restrictions on IRBs.

Read about other FDA Warning Letters:

UPDATE: Here is a more recent Warning Letter to an IRB in April 2010. This one appears to be to a smaller IRB that missed a few things. It is different from the ones cited in the story above. Maybe this analysis will need further updating.
This just in: Request for Comments- Exculpatory Language Used in Informed Consent, a joint FDA and OHRP draft guidance document (September 2011)
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The Blog Cleans Up Its Act

January 7, 2010

Welcome to Carl’s Blog on GxP Stuff. I’ve changed the name from “Carl’s Blog on FDA Stuff” to reflect my evolving interest in focusing on a number of issues and not being “FDA-centric.” There many other regulatory agencies in the U.S. and the rest of the world and I would like to give them some attention as well.

Also, its the new year and I’m finally figuring out how to use some of the WordPress blog features. As a result, I have cleaned up the Blogroll so that links once more make sense. I have moved many links to “Interesting Articles” and have created a new category for “FDA Stuff” that are links to the nooks and crannies of FDA’s website. Yes, I will still be discussing FDA.

This allows me to organize and highlight some of the interesting places you can go to research FDA & GxP stuff. I’ve just added Compliance Zen to the Blogroll. The author, John Avellanet, has an excellent post on communication (which I should take to heart). I’ve also moved the Blog’s very own book reviewer’s excellent website for food safety, 1 FDA, Food Safety, and Related Topics, to the top of the Blogroll. Thanks Sid. Another post worth reading is by Lisa Henderson at the Applied Clinical Trials Blog. She has some interesting things to say about when her trade publication’s sales and editorial staff started sharing the same office location.

Finally, I want to recommend some blogs/sites that are not directly related to GxP or FDA stuff. These include France 24 which is an English language news station from France. I think it is important to see things from outside the U.S. We all know about BBC but France 24 is very interesting. Also there are two blogs put out by individuals who take the time to write thoughtfully on topics that you may, or may not, find of interest. They are: Grab & Keel which focuses on current events from the author’s perspective and Monte’s Blog which takes a look at one person’s spiritual journey. Also there is Water: USGS that provides a perspective on government service and one of the most important issues we will face this century, water. Now that I am GxP I can give this issue some thought. Please scroll down and take a look at the various links. There are a number of different perspectives so you can take a look at various viewpoints. Feel free to leave a comment and suggest other sites that you find of interest.

UPDATE: This news is just in from Alan Andersen in an email to members of the FDA Alumni Association:

“FDA has announced Ralph Tyler as the new Chief Counsel. He is currently serving as the Insurance Commissioner of the State of Maryland (01/08/10 is his last day, I think) and will be joining FDA on January 19.

Tyler served as Chief Legal Counsel to Maryland Governor Martin O’Malley and as Baltimore City Solicitor. He was a partner in the international law firm Hogan & Hartson, L.L.P. Prior to that, he served in the Maryland Attorney General’s office from 1982 through 1996, holding the titles of Deputy Attorney General, Chief of Litigation and Assistant Attorney General. Acting Chief Counsel, Mike Landa, will return to his position as Deputy Director for Regulatory Affairs at CFSAN.”

ALSO: Here is the link to an article about clinical trials in the UK that I found interesting:



The Global Drug Supply Chain

January 5, 2010


global drug supply chain

FDA Releases New Guidance Document on Global Drug Supply Chain

FDA released a new finalized guidance document on Standards for Securing the Drug Supply Chain effective March 2010. The guidance document discusses Standardized Numerical Identification (SNI) for prescription drug packages. The new FDA guidance says in part:

“This guidance is intended to address provisions set forth in Section 505D of the Federal Food, Drug, and Cosmetic Act (the Act) regarding development of standardized numerical identifiers (SNIs) for prescription drug packages. In this guidance, FDA is identifying package-level SNIs, as an initial step in FDA’s development and implementation of additional measures to secure the drug supply chain.”

Here is a link to the guidance document:


And now here is the original post:

I think this information about the Global Drug Supply Chain is interesting. We need Good Distribution Practice if we are going to ensure drug safety. Just before the new year I paid WordPress a nominal fee to remove ads from The Blog. As I said in an early post (The Blog Reveals All) I do not receive anything from anyone for what I publish in the Blog. However, that doesn’t mean that there isn’t some good information out there from commercial sources.

A critical issue facing us is the security and integrity of the global pharmaceutical supply chain. The introduction of adulterated and counterfeit drugs is a serious issue and will take some concerted efforts to bring under control. When I was at FDA I would sometimes encounter the difficulties of maintaining the integrity of the supply chain. It is not just a question of internet pharmacies but is a serious public health problem.

I am providing a link to Pharmaceutical Technology for a discussion of this issue. Four supply chain experts from Europe and North America discuss their experiences. Also, you can look on the Blogroll under, “PharmTech Talk.” They have a wide variety of perspectives discussing different pharmaceutical issues. Oh, by the way, Happy New Year!