Centra & Teneo IRBs Receive FDA Warning Letters

November 28, 2009

The FDA Warning Letter to the Teneo IRB is an interesting for several reasons. First, the Center for Biologics, FDA’s smallest for human clinical trial regulation, wrote the Warning Letter and they don’t do that frequently to IRBs. Second, the IRB was found to have two sets of meeting minutes in an effort to keep some activities out of the regulatory realm. Third, FDA told the IRB to stop approving studies or having current studies enroll new subjects “until adequate correction is made.” This is about as tough as it gets for an IRB. I am attaching a Thompson link about the Warning Letter. Now I am going to take a break from blogging (I think).

IRB FDA warning letter

Two IRBs receive FDA Warning Letters

Update: Another IRB, another Warning Letter. Centra IRB in Lynchburg, VA received a Warning Letter dated 20 November 09 from the Center for Devices. These folks violated a couple of Big Deals about IRB review of research. First, they forgot to review approved studies after a year. Remember the “Tuskegee Syphilis Study?” What went wrong there was no continuing review of research. Even after they discovered that penicillin worked wonders on syphilis. Then Centra forgot how many people were needed for a quorum. You need a minimum number of IRB members to approve research. Then they forgot to write down what they did. Their minutes didn’t describe what happened at the meetings. If you didn’t document it then its just a rumor. These are basic things that anyone in the IRB business should know about. Read for yourself on the FDA Warning Letter webpage.


Comparing FDA & EMEA Requirements for Clinical Trials & Pharmacovigilance: I will be presenting an audio-conference for Thompson Interactive on this topic on March 3rd. Here is a link for further information:


The Blog is Thankful

November 25, 2009

Thanksgiving is my favorite holiday. It’s always a good thing to be thankful for the many blessings we have. It is also a good thing to be thankful on a full stomach. I’m thankful of life in general. I’m thankful I earn a decent living. I am very thankful that I have decent healthcare although I would be more thankful if others had the same. I’m also thankful for each person who visits this site. If you’ve read this far, thank you. If this is your first visit, please explore a little. I think there are some interesting things posted here and there.

Have a wonderful holiday season, whichever holidays you choose to celebrate. The Blog will be taking a break over the holidays to catch up on paperwork and to enjoy time with family and friends. I’ll see you in 2010. Cheers!

thank⋅ful  [thangk-fuhl]
feeling or expressing gratitude; appreciative.
Origin: before 900; ME; OE thancful.

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.

Paying for healthcare? “Tax the rich,” AP poll says

November 17, 2009

Maybe Al Franken is right. The comedian turned liberal lawmaker raised some eyebrows when he joined conservative Republicans in opposing taxes on medical device manufacturers to pay for healthcare reform. It turns out that an AP poll finds that most Americans also have a different idea on how to raise funds. They agree with Franken on device taxes. Instead, they want to tax the rich (what a novel idea). Here’s what AP says:

Lawmakers also are looking at levying new taxes on insurance companies, drug companies and medical device makers. But the only approach that got majority support in the AP poll was a tax on upper-income Americans. The House bill would impose a 5.4 percent income tax surcharge on individuals making more than $500,000 a year and households making more than $1 million.”

FDA takes on “speedball” drinks

November 14, 2009

First it was candy cigarettes. Now FDA is taking on caffeinated booze. In the old days if someone mixed a stimulant with a depressant it was called a “speedball.” Some companies are now marketing high octane malt liquor with caffeine in yet another way to peddle unsafe products, primarily aimed at younger consumers. Consumer advocates had earlier stopped the big beer companies from the practice, but now it has become a “social network” problem from smaller companies.

Both the caffeinated booze products and candy cigarettes are targeting young people and FDA seems to be fighting back. FDA has taken the first step to outlaw speedball drinks after 18 states’ Attorney Generals urged FDA to take on the caffeinated booze pushers. Letters went out to 30 vendors of speedball drinks expressing serious concerns. To read more look for the L.A. Times story on the Blogroll listed as, “FDA questions caffeinated booze.”

BOOK Review Update: A new review by Sid on the book review page above: Paul L. Conkin, A Revolution Down on the Farm: The Transformation of American Agriculture Since 1929 (Lexington: The University Press of Kentucky, 2008).


FDA Panel discusses “Artificial Pancreas” at Diabetes Technology Meeting

November 12, 2009

The 9th Annual Diabetes Technology Meeting held 5-7 November 2009 in Burlingame, CA drew a number of top diabetes researchers and covered a wide range of topics from the Artificial Pancreas, the Tour de France, FDA Artificial Pancreas DiabetesiPhones, gastric bypass surgery, and FDA efforts to facilitate research. The Blog made a brief appearance at a pre-conference workshop on the topic of current development in Clinical Trials, with an emphasis on Diabetes clinical trials.

Two regulatory scientists at FDA’s Center for Devices and Radiological Health (CDRH) were honored at the conference. Arleen Pinkos MT (ASCP) and Steven Gutman, MD were honored for the First Annual Artificial Pancreas award by conference chair Dr. David C. Klonoff. Dr. Gutman is the past director of the Office of In Vitro Devices (OIVD). He recently retired and now teaches at the University of Central Florida. Ms. Pinkos is the driving force for two FDA working groups on an Artificial Pancreas. One is an inter-agency working group and the other is an internal working group. They were honored for their role in moothing the regulatory pathway for innovative technologies such at the artificial pancreas which is sometimes referred to a “closed loop system.” Many of the presentations and posters covered developments for the artificial pancreas.

Many of the participants, including the Blog, are diabetics, and two interesting points were raised during a special FDA panel that discussed advances in the development of an artificial pancreas. Phil Southerland asked the Tour de France question of an FDA spokesman about advances in technology. It is Southerland’s ambition to particpate in the 2012 Tour. He is the founder of “TeamType 1,” which is found on the Blogroll under “Diabetes: TeamType1.” Amy Tenderich, of Diabetes Mine, mentioned the iPhone technology. Her website is found on the Blogroll at “Diabetes Mine.” In another interesting session, two European scientists discussed using telemedicine for the treatment of chronic health conditions, including diabetes. Telemedicine has yet to become common in the United States, primarily because of our health care structure.

The process of an artificial pancreas is still in the experimental stages. The devil,of course, is in the details, including effective software to determine dosage. Such a system is still years away from being marketed in the United States as safe and effective for its intended use. In fact one scientist speaking at the conference, Roman Hovorka, PhD, from Cambridge Unversity warned against use of the term stating that an artificial pancreas, or closed loop system is, “not a holy grail,” is an “evolving technology” that was not attainable in the immediate future.

The conference is sponsored by the Diabetes Technology Society, which publishes the Journal of Diabetes Science and Technology, whose editor is Dr. Klonoff the conference chair. The next meeting will be in November in Bethesda Maryland on 11-13 November 2010. Their website is on the Blogroll under Diabetes Technology.

You can read additional posts on FDA Commentaries here:



GxP Perspectives on LinkedIn


Special Notice: The Blog was published in the Journal of Diabetes Science & Technology on the topic of Supervisory Responsibilities of Investigators with my colleagues Ann Berenbaum and Patti Young.

Access the Abstract Here


FDA Warning Letters Hit Candy Cigarettes & Clinical Investigator

November 9, 2009

FDA’s new Tobacco center put out 14 Warning Letters to internet purveyors of candy cigarettes. FDA seems very serious about not letting flavored cigarettes onto the market. Now about menthol….

The Center for Drugs also issued a doozy of a Warning Letter to a clinical trial site in Southern California. Among the shortfalls are: failure to supervise the investigation and numerous protocol violations. Also, the investigator failed to have the IRB approve changes in research activity. New protocol amendments showed additional hazards and risks associated with the study drug but the investigator said nary a word to the IRB. That’s a Warning Letter in and of itself. Finally, the investigator was creamed on failure to report Serious Adverse Events as instructed by the protocol. It appears to me that some of these SAEs are disease progression. It may be a case of the sponsor writing violations unnecessarily into the protocol. However, in this case we have a textbook case of the investigator not doing the job.

The FDA & the World Series: Reality Happens

November 7, 2009

Regular readers of the Blog should understand that I hate the New York Yankees. I live in the Puget Sound area and our local ball club, the Mariners, will Never be able to match the Yankees’ Payroll. They will never be able to fork over a multi-million dollar contract for A-Rod the way the Yankees can. A-Rod started with the Mariners, as did Junior and the Big Unit. They went off to more lucrative regions.. and I can’t afford a ticket to the big leagues any more. At least Junior made an attempt at redemption which is more than I can say for others. However, the Yankees are a fact of life. Reality happens.

Recently I spoke at a quality assurance workshop. During the break, an attendee came up and asked about the training of FDA field inspectors. Her company had recently had an FDA inspection and she was shocked at how little the field investigator understood about the clinical trial and the therapeutic area. I explained that FDA didn’t have the necessary training available to their staff and that there was abysmal management by the field organization, the Office of Regulatory Affairs (ORA). In fact, most ORA managers don’t know how clinical trials are run. I’m a big supporter of the mission of FDA. Read the Blog and that’s pretty clear. However, there are simple facts of life. ORA’s poor management of the Bioresearch Monitoring program is reality. It happens. Just like the Yankees winning the World Series.

However, I’m an optimist. I think FDA and ORA can change. I take the same attitude with the Yankees. Wait ‘Till Next Year!

A new book review, by Sid

November 2, 2009

The Blog has been busy and hasn’t had the time to post. However, we have a new book review on the page above of “Doubt Is Their Product,” by David Michaels (NY: Oxford, 2008). Check it out.

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