FDA Issues 5 New International Warning Letters

May 15, 2011

FDA international warning letters

FDA's Increased International Presence

The “Most Recent Warning Letters” section of the FDA website lists five Warning Letters to international firms. The Warning Letters were posted on May 10 and will disappear into the Warning Letter labyrinth on the website in a few days (see previous post). They are to firms in both Europe and Asia and come from four different centers: the Center for Devices and Radiological Health; the Center for Drug Evaluation and Research (Active Pharmaceutical Ingredient (API); the Center for Biologics Evaluation and Research; and the Center for Food Safety and Applied Nutrition (two Warning Letters for Seafood HACCP).

The Warning Letters do not state if the inspections were conducted by one of the FDA’s new International Resident Posts- but it is likely that the FDA’s increased global presence contributed to the enforcement actions. FDA now has offices in China, India, Belgium, and Costa Rica. This is addition to FDA’s International Inspection Cadre which is primarily drawn from FDA Field Investigators (Consumer Safety Officers) working for the 20 FDA District Offices across the country. The fact that different offices are issuing Warning Letters around the world at the same time gives a clear indication of FDA’s increased international enforcement efforts.

FDA International Resident Posts

Read the Warning Letters:

Hong Kong – Medical Devices

Spain – Active Pharmaceutical Ingredients

Sweden – Biologics cGMP

Korea – Seafood HACCP

On the Blogroll: Last week we had the FDA Lawyer’s Blog. This week I want to highlight a recent article on the FDA Law Blog on “FDA Warning Letter ‘Close Out’ Process Not Working.”

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FDA Inspections: Will FDA’s New Food Safety Authority Leave Drugs & Devices Behind?

December 5, 2010

FDA authority food safety drug device inspection

FDA Food Safety:
How will it Impact Drug and Medical Device Inspections?

With the passage of the FDA Food Safety Modernization Act by the U.S. Senate, there has been concern that FDA will “choke on food” and not have adequate resources to conduct inspections of medical devices, human drugs, and biological products including vaccines. Although the bill still needs to reconciled between the House and Senate versions, funding is clearly going to be an issue as the new Congress is in a belt-tightening mood. Will FDA’s new food safety authority cut back on oversight of clinical trials and other drug and device inspections? This has been a discussion on the GxP Perspectives LinkedIn Group. My viewpoint is that the new food safety authority will not have an impact on Bioresearch Monitoring inspections (GCP & GLP) but probably will for routine GMP inspections of both pharma and device companies.

Why? The Bioresearch Monitoring (BIMO) program coordinates FDA inspections of Clinical Investigators, IRBs, Sponsors and/or CROs, Nonclinical Laboratories, and Bioequivalence/Bioanalytical research. The BIMO (pronounced bye-moe) inspections are coordinated, and payed for, by four FDA Centers; the Center Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), and the Center for Veterinary Medicine (CVM) located at FDA’s headquarters in Silver Springs, MD. Remember, they have user fees from the Prescription Drug User Fee Act and the device user fee program. So if you are considering an application for approval, expect an FDA inspection.

Those of us in the drug and device development field often think that FDA’s primary authority is the approval of new health therapies. If you are an FDA employee at one of the Centers in Silver Springs, that just might be the case. However, the primary area the new FDA Food Safety and Modernization Act will impact is in the organization and management of the Office of Regulatory Affairs (ORA- the field organization) and the Center for Food Safety and Applied Nutrition.

FDA food authority drugs devices inspections

Bioresearch Monitoring is 5.4% of ORA's Workplan

Bioresearch Monitoring makes up around 5.4% of ORA’s workplan so it has never been their major focus. FDA has fallen behind in the biennial GMP inspection schedule for years, so I would anticipate that to continue, if not worsen. However, the mandated, and funded, inspections of clinical trials should continue unabated. Here are the numbers from the ORA Fiscal Year 2009 Workplan. (The new tobacco program is not included.) They show that food is the largest program. It always has been. ORA is funded by the Centers by the number of FTEs (full time equivalent employees) allocated by the centers to conduct inspections and laboratory analyses.

Food: 1,062 FTEs – 53% of Total
Human Drugs: 339 FTEs- (62.1 BIMO FTEs)
Medical Devices: 238 FTEs- (36 BIMO FTEs)
Vet Medicine: 118 FTEs- (4.4 BIMO FTEs)
Biologics: 115 FTEs- (4.4 BIMO FTEs)

TOTAL: 1,987 FTEs- (106.9 BIMO FTEs) – 5.4% of Total FTEs

These numbers tell an interesting story. ORA has 20 District Offices around the country. They also now have international offices for China, India, Europe, and Latin America. However, the primary focus is food, GMP, and import operations, not BIMO. Think about the amount of expertise and specialization the drug and device development industries require. There are times when one of the Centers will send specialists to work with an FDA BIMO Investigator. That is taking place more and more for sponsor inspections. Still, look at the numbers and do the math.

FDA food safety authority drug device inspections

FDA Needs Adequate Funding for Food, Drug & Device Inspections

I support passage of the FDA Food Safety Modernization Act. It will help FDA take Salmonella off of grocery store shelves and as a consumer I appreciate that. However, it is possible that drug and device GMP inspections might suffer. FDA BIMO inspections will continue at the same rate, but I am one to support a BIMO Modernization Act to help FDA update regulations and reorganize the inspection force. Most of all, FDA needs the funding to carry out the Food Safety Act as well as its other responsibilities, including GMP inspection of drug and device manufacturers and clinical trials.

ORA Workplans FY-2001 thru FY-2009

Update: Read Steven Grossman in FDA Matters on two strategies for FDA legislation in 2011.

>>>>>>>>>>>>>>>>>>>>>>>>>>>>

Two Important New GCP Documents: There is a new Final Rule on required elements of Informed Consent. You can read the Federal Register Announcement here that includes FDA comments in the preamble. The exact change in 21 CFR Part 50 is:

“Sec. 50.25 Elements of informed consent.

* * * * *
(c) When seeking informed consent for applicable clinical trials,
as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be
provided to each clinical trial subject in informed consent documents
and processes. This will notify the clinical trial subject that
clinical trial information has been or will be submitted for inclusion
in the clinical trial registry databank under paragraph (j) of section
402 of the Public Health Service Act. The statement is: “A description
of this clinical trial will be available on
http:[sol][sol]www.ClinicalTrials.gov, as required by U.S. Law. This
Web site will not include information that can identify you. At most,
the Web site will include a summary of the results. You can search this
Web site at any time.”

There is a Draft Guidance on Electronic Source Documentation in Clinical Investigations. The comment period is for 90 day (April 4, 2011 ?)

Please join GxP Perspectives on LinkedIn at:

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Visit the TMF Page at the Top Right of the Blog! I am trying to assemble resources for those of us concerned with the Trial Master File. I welcome any contributions you might have of interesting articles and resource documents.

<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<

In news from GxP Perspectives. I will be participating in the conference, Developing CAPAs in the GCP Environment on January 18-19, 2011 in Arlington, VA.


FDA Warning Letter to API Drug Manufacturer in China

February 19, 2010

The U.S. Food & Drug Administration has sent a Warning Letter to a manufacturer of active pharmaceutical ingredients (APIs) in China for violations of current good manufacturing practices (cGMPs).

The increased globalization of the pharmaceutical industry means that a finished pharmaceutical obtained by a consume at their local pharmacy can have components manufactured in a number of different countries and the finished dosage form manufactured in another country altogether. Problems with heparin and other drugs manufactured abroad have raised imported drug safety high on the list of FDA’s public health concerns.

FDA imports, drug safety, API

Over 90% of active pharmaceutical ingredients (APIs) used in U.S. drug products are imported

The FDA Warning Letter, dated January 28, 2010, does not indicate if the inspection was initiated by one of the new FDA resident posts in China that have been opened to enhance food safety, drug safety, and the safety of medical devices.

On Tuesday, November 18, 2008 The U.S. Department of Health and Human Services issued a press release that stated:

“FDA has selected eight senior experienced FDA officials to work in its offices in China. The employees are inspectors and senior technical experts in foods, medicines and medical devices. The HHS/FDA office in Beijing will be located in the US Embassy. In Guangzhou, it will be located in the U.S. Consulate General, and in Shanghai it will be part of the U.S. consular mission there, but will be situated in the Shanghai Centre, a well-established business complex in the city where several other U.S. government agencies have staff.”

The FDA Warning Letter has serious concerns regarding the testing for the APIs stating:

“For example, your quality control unit failed to detect that IR spectra were being substituted by a laboratory employee and therefore, misrepresenting the actual results of the tested incoming material. Your response is inadequate in that it does not address the ability of your quality unit to control and detect the manipulation or alteration of laboratory documents.”

Here’s the Warning Letter:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm200384.htm

These are serious charges and are a cause for concern by any consumer using drug products. Since 2008 FDA has also issued Warning Letters to a Japanese firm and another Chinese facility for drug safety and failure to follow cGMPs for active pharmaceutical ingredients. This indicates a continuing concern over the quality of APIs. Over 90% of APIs used in drugs in the United States are manufactured abroad. Opening resident posts in China, India, and other countries is part of the effort to ensure their safety.

GxP Perspective:

Regulating APIs is not an easy task. The FDA GMP regulations are for Finished Pharmaceuticals. You will note that most FDA Warning Letters cite FDA regulations found in Title 21 of the Code of Regulations (21 CFR). Warning Letters for APIs however, cite the Food, Drug, and Cosmetic Act and the U.S. Code (U.S.C.). In 2000, when I joined the FDA Foreign Inspection Cadre, FDA headquarters staff actively recruited new API inspectors from the foreign cadre because so few API inspections took place in the United States. When I went to API API Warning Letter FDAschool we were taught to use the International Conference on Harmonization document Q7A as an inspection tool as a replacement for the 1991 “Bulk Pharmaceutical Chemicals” inspection guide. The API Compliance Program Guidance Manual for APIs was issued in 2006 and incorporates Q7A. This is a great step forward, just as the establishment of foreign resident posts improves FDA’s ability to monitor the production of APIs.

I conducted API inspections in Canada, France, Ireland, and the U.S. They are not an easy inspection and should be conducted by specialists. Fortunately I had the opportunity to work with a really great chemist, and that made my job a lot easier.

With the globalization of drug, device, and food manufacturing we want the best inspections possible. Ultimately that will mean increased cooperation and coordination with other regulatory agencies. That is one area that definitely needs improvement. It seems the current FDA leadership senses the need to improve international cooperation. They’ve got a big job in front of them.

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FDA Budget Asks For $4,030,000,000

February 2, 2010

FDA has requested $4.03 Billion, a 23% increase, for fiscal year 2011. (I hope I got all the zeros right.) This would be the largest budget in FDA history. Much of the increase is for the new tobacco program. The largest chunk is for food safety and we have an analysis of that by Sid Olufs, the blog’s resident book reviewer and food safety analyst. research informed consent IRB FDA

However, the issue of the FDA budget request has been lost in the light of the deficit and other news. On the Blogroll FiercePharma, but not FierceBiotech, comments as well as Gooznews on Health. Before we get to Sid’s comments I have a few short, but important items to report. First, here is the FDA press release on the budget:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm199516.htm

UPDATE: This Sunday, the 18th of April, the Pew Research Center released a devastating report on the decline in confidence in government over the past 12 years, including a 17% decline for FDA. Pew says, “The declines have been particularly large for the Department of Education, the FDA, the Social Security Administration, as well as the EPA, NASA and the CDC.” Ouch.

(Original Post):

This Sunday, the 7th of February, is the 10th National Black HIV/AIDS Awareness Day and February is Black History Month. Although African-Americans are only 13% of the U.S. population, they have nearly 50% of the newly diagnosed cases of HIV/AIDS. Here is a statement by Dr. Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Disease that conducts AIDS research world wide:

http://www3.niaid.nih.gov/news/newsreleases/2010/BAAID10.htm

Finally there is an interesting “Frequent Flyer” column in the business section of the NY Times. It is written by a retired physics professor, Robert Kolenkow, who is a diabetic. I am a Type 1 diabetic and a very frequent flyer. I have Travel Too Much status with Alaska Airlines (They call it, “MVP Gold”). I have always found it challenging to manage my diabetes on board a packed coach cabin going across the country so I was interested in what Professor Kolenkow had to say. He participates in a diabetes mentoring group called A1C Champions. They are sponsored by Sanofi-Aventis. Since I use Sanofi insulin I am not sure how happy I am about this. However, you can take a look and judge for yourself.

Here is a link to A1C Champions:

http://www.a1cchampions.com/

Here is a link to the article:

http://www.nytimes.com/2010/02/02/business/02flier.html?ref=todayspaper

Guest Commentary by Sid Olufs:

Paying for a Difficult Job

In an earlier post I briefly described the ambitious agenda facing the new Deputy Director for Food, Michael R. Taylor (FDA Has a New Look for Food). It included these lines describing his responsibilities: “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.”

Others have looked at the costs of building a food safety system that can do all of this adequately. In the most comprehensive outside analysis of FDA responsibilities and capacity, the authors concluded that the FDA FDA Budgetis critically underfunded in its science-based regulation and decision making, so much so as to put public health at risk. (FDA Science and Mission at Risk, Report of the Subcommittee on Science and Technology, Prepared for FDA Science Board, November 2007.) The Congressional Budget Office estimate of the costs of implementing HR 2749, which falls short of the more complete goals of FDA Science and Mission at Risk, came to almost half a billion dollars a year for the first few years of transition, and about a billion dollars per year thereafter. (CBO Cost Estimate, h.r. 2749, July 24, 2009.)

The Obama administration has now released its budget for FY2011. As described in more detail in the agency budget documents submitted to Congress, FDA requested about $220 million in the form of fee-based inspections, plus additional spending over current spending which brought the total food system upgrade request to about $318 million in additional money for 2011. See the attached link for a brief summary:

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM199447.pdf

I spent a little time looking at the documents, and only found about $290 million in budget increases in the documents released by OMB. See their detailed HHS budget description, at:


http://www.whitehouse.gov/omb/budget/fy2011/assets/hhs.pdf

The first three pages are the FDA budget summary (the pagination starts at p. 461).) You will see the $220 million on 09.02 Food Registration and Inspection User Fee, on the third page (page # 463) of this document. The fees are “proposed.”

I found no separate discussion of the resources devoted to upgrading the FDA’s information technology, a critical resource in the needed upgrades. It could be that a separate item is included for this, but I searched in vain in the detailed agency appendices and in the Analytical Perspectives that accompany the Budget.

Judging just by the number referred to here, it does appear the Obama administration is taking food seriously, at about two-thirds to three-quarters of the resource level implied by the panel of experts that assembled FDA Science and Mission at Risk. I for one will find it interesting to read how far down that road this new budget authority will take us.

By Sid Olufs

Blogroll Pick: Gooznews on Health– With every post, I am trying to highlight one of the blogs on the Blogroll to your right. This time Gooznews has some interesting comments on the FDA Budget requests.

http://www.gooznews.com/

REMEMBER, YOUR COMMENTS ARE ALWAYS WELCOME !!!

You can read additional posts on FDA Commentaries here:

https://carl1anderson.wordpress.com/category/fda-commentaries/

You can read additional posts on Food Safety here:

https://carl1anderson.wordpress.com/category/food-safety/

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Blogroll: For those of you interested in the financial aspects of our industry – and others – Check out Hedge Hodge at:

http://www.hedgehogs.net/


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:

http://www.thefsrc.org/FSII/Documents/FSII_Exec_Summary.pdf

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


http://www.plu.edu/~olufsdw/unpleasant.htm

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:

http://www.rwjf.org/files/research/20090417foodsafetysummary.pdf

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:


https://carl1anderson.wordpress.com/category/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.

http://acronymrequired.com/

REMEMBER, YOUR COMMENTS ARE ALWAYS WELCOME !!!

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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:

http://www.ft.com/cms/s/0/2b66d8ae-f570-11de-90ab-00144feab49a.html?nclick_check=1

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FDA Food Safety Bill Advances

November 20, 2009

FOOD SAFETY UPDATE: Check out the website “FDA, Food Safety, and Related Topics” on the link below. Also, Sid’s book reviews on the page above. Also, the new FDA WL page next to Sid’s book reviews.

Congress is moving forward with a bill that will increase FDA’s authority and funding to conduct food safety inspections. Most of us would agree that’s a pretty good idea. With a globalization of the food industry and E. coli becoming a household word, one would wonder why it has taken so long. Well, food is Big Business and there are a lot of the proverbial “special interests” interested in what a food safety bill will or will not allow FDA to do. The current Senate bill is a result of a lot of compromise. Enough concessions were made to allow wide bipartisan support in a political climate where the word “bipartisan” is considered by many to be an obscenity.

The bill, Senate 510, authored by Senators Dick Durbin and Tom Harkin, Chair of the Senate Health, Education, Labor and Pensions Committee, has major bipartisan support as well as support from many food companies and food trade organizations. Republicans are on board including Senator Mike Enzi of Wyoming, the Republican committee leader, who asked for quick approval of the bill. “I’m hoping the bipartisan approach will continue right on through the floor work,” he says.

Unfortunately, the bill doesn’t receive the support of small, local farmers. The San Francisco Chronicle’s newsblog reports that “Small farms and the sustainable agriculture movement raised alarms today about Senate legislation that they say would stifle family farms with ‘heavy-handed and costly attempts’ to battle food-borne illness but in fact would reduce the nutritional value of food.” The small farmers who produce the locally grown fruits and vegetables we find at our hometown farmers’ markets say the bill rigs the system in favor of agribusiness.

In addition, amendments were withdrawn that address major food safety issues. Senator Jack Reed of Rhode Island withdrew an amendment that would have addressed many concerns regarding antibiotics in livestock. Committee chairman Harkin said that more study was needed to determine the risks to human health from the non-therapeutic use of antibiotics in livestock.

“Non-therapeutic use of antibiotics?” Why in the world would anyone use an antibiotic for anything but a therapeutic use? Well it seems that this is a widespread practice in the feedlots that give us our T-bones and Big Macs. When livestock live in close quarters at the feedlots, eating out of bunks and not in a natural habitat, then they get sick. And to keep them from getting sick they receive medicated feed loaded with antibiotics.

FDA has long conducted “tissue residue” inspections to keep antibiotics out of the food supply. There is supposed to be a period of time that animals don’t receive antibiotics and other drugs before slaughter, so the drugs don’t end up in your roast beef. Overuse and misuse of antibiotics is one of the more serious public health problems worldwide. Senator Harkin should know that many people are allergic or sensitive to antibiotics. He should also know about MRSA and drug resistant TB. However, there are a lot of feedlots in Iowa, so the good senator seems to have a different risk/benefit assessment from the rest of us. He should read some FDA Warning Letters on the subject. Here is an excerpt from a 2007 inspection in Muleshoe, Texas:

“Our investigation also found that you hold animals under conditions that are inadequate such that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drug from edible tissues.”

That’s dry, technical language that means they may have slaughtered animals too sick to make it to the slaughterhouse. I’ve heard stories about animals being helped in with a forklift from some Vet Med inspectors I used to work with. This Warning Letter cited a number of drugs in slaughtered animals and it isn’t an isolated circumstance. Go to the FDA website and search for Warning Letters by subject: “Animals for Slaughter / Adulterated,” and you’ll find page after page of similar violations. I have attached a tissue residue Warning Letter at the top on a new page, “FDA WL.”

The food safety legislation being considered by Congress would give FDA broader authority including the ability for mandatory recalls, trace backs of contaminated fresh produce, funding for more food inspections, and new authority over food imports. I think that’s a good thing. However, we need food safety laws that have FDA focusing on agribusiness and the feedlots, not small farmers. We need a risk-based approach that targets well-documented problems, including the overuse of antibiotics. Anytime you have such widespread support from the giants of the food industry for food safety legislation you should take a closer look. A much closer look.


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