FDA Warning Letters Hit Candy Cigarettes & Clinical Investigator

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.

Read them for yourself on the Blogroll. Scroll down to FDA Warning Letters November 2009.

FDA Dose Calculator can make life a little easier

FDA hs put a handy-dandy dose calculator to help make life a little easier. On the Blogroll under FDA Dose Calculator (Thanks to Louise Johnson for pointing it out)

The FDA & the World Series: Reality Happens

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

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.

FDA, CDC face obstacles in H1N1 fight

In Saturday’s NY Times an article discusses the “Shortages, Confusion and Rumors in Flu Fight” (NY Times, page A11, 24OCT09). The Food and Drug Administration and the Centers for Disease Control (CDC) are at the center of fighting the flu outbreak. Despite the difficulties they have been keeping a cool head and doing a good job, which is just what you need during a crisis. As always, there are some who would try to take advantage to make a quick buck from fears about H1N1. This isn’t helped when political “commentators” like Glenn Beck say they want someone with H1N1 to cough in their face so they can do the opposite of what the government recommends. Hogwash. The health professionals at CDC have a webpage with what you should know about H1N1. Listen to CDC, not Glenn Beck and the liberal comic Bill Maher (comedians shouldn’t give out advice during an influenza pandemic). There is a link on the Blogroll, scroll down, under “CDC H1N1 webpage.”

FDA approves the H1N1 vaccine process, which is identical to the seasonal vaccine. They have also taken the lead in warning the public about fraudulent internet “therapies.” In a historical first, FDA has teamed up with the Federal Trade Commission to issue a Warning Letter to fraudulent H1N1 scams. You can access the letter on the page at the top right of the Blog “H1N1 Joint FDA & FTC.” They have also introduced a widget, something I should know more about, to locate H1N1 scams on the internet. The widget, bless its heart, can be found on the Blogroll under “FDA H1N1 Widget.”

In the mean time, cough into your elbow and wash your hands. When you hear a comic or “commentator” babble about H1N1, change the channel. H1N1 is a very real crisis. We need to take it seriously.

How ‘Bout Them Phillies !!!

The Blog would like to acknowledge Jimmy Rollins’ contribution to the field of public health: With two on and two out in the Bottom Of The Ninth !!!

UPDATE: The Phils go on to the World Series blasting the “best record” Dodgers. The NY Times says: “The fans taunted Manny Ramirez all night, and he provided more fodder in the sixth, when Victorino belted a two-run homer to deep left. As the ball soared over his head, Ramirez did not move, not even to give it a courtesy glance. He knew that it was gone, just as he likely realized what everyone in the ballpark Wednesday night long had known. The Dodgers may have posted the best regular-season record in the N.L., but the best team hails from Philadelphia.”

FDA discusses product recalls on new website feature

FDA has started a major campaign to explain product recalls to the public. In an extensive article and video called, “FDA 101: Product Recalls – From First Alert to Effectiveness Checks,” FDA explains the process in clear language for the general public. Go to www.fda.gov to view for yourself.

While FDA discusses that most recalls are voluntary, what isn’t discussed is the fact that FDA currently has limited enforcement authority regarding recalls of hazardous products that FDA regulates. Congress has pending legislation to give FDA increased recall authority, including mandatory recalls for dangerous food products. FDA Commissioner Margaret Hamburg discussed this during her speech to the Regulatory Affairs Professionals Society in Philadelphia (see previous post).

During the time that I worked as an FDA field investigator I would sometimes perform “recall audit checks.” I would go to a hospital, health product distributor, or pharmacy to find out if they had received a recall notice from the manufacturer of the recalled product. Sometimes they had taken prompt action to remove the product from their shelves. Sometimes they would just shrug their shoulders and say they didn’t remember or that they threw away such notifications. There is little FDA can do in that situation because the system is basically voluntary except for the most serious situations. For many, if not most recalls, a voluntary recall system is OK. They are not serious enough to utilize significant agency resources. However, when there are serious public health risks FDA needs the authority to take action.

Hopefully Congress will tmove forward soon with legislation to give FDA the authority it needs to enforce product recalls of significant public health concern.

Obama appointments are pursuing their agency’s mission, including at FDA

The Washington Post reports today that President Obama’s appointments to regulatory agencies such as the Consumer Product Safety Commission and FDA are doing their jobs. The article, on the Blogroll under “Obama appointments…,” points out that qualified appointees are fulfilling the mission of the agencies they oversee, including the two top appointments to FDA. Here’s part of the article:

“In their first few months on the job, FDA Commissioner Margaret A. Hamburg and deputy Joshua M. Sharfstein — both with backgrounds running public health agencies — notified General Mills that it was violating the law with its two-year-old marketing campaign claiming that Cheerios can lower cholesterol by 4 percent. The FDA said the cereal maker was essentially making a drug claim, which would require clinical studies and agency approval before it is put on the market. The food giant has removed that claim from its Web site and a spokeswoman said it is in discussions with the FDA.

While the FDA began looking into Cheerios before Obama’s election, several prominent attorneys who represent food and drugmakers said they believe the agency under Bush would never have taken action against General Mills.”

I think its important to note that among Hamburg and Sharfstein’s first comments about FDA, in an article published in the New England Journal of Medicine, were on the role of public health, not business development. FDA and its importance as a public health agency is a topic the Blog looks forward to exploring.

New website offers “one stop shopping” for FDA stuff & food safety

The Blog’s very own book reviewer, Sid Olufs, has assembled a webpage with links to a number of FDA related websites that include food safety sites that you won’t find here on the Blog. Check it out on the Blogroll under:

“FDA, Food Safety and Related Topics.”

UPDATE: The Center for Science in the Public Interest has released a “Top Ten List” of foods regulated by FDA that can make you sick. They are:1. Leafy Greens
 2. Eggs 
3. Tuna Fish
 4. Oyster 
5. Potatoes
 6. Cheese 
7. Ice Cream 
8. Tomatoes
 9. Sprouts 10. Berries. Fortunately chocolate isn’t listed.

Read about it on the Blogroll as:”Foods that make you sick.”

EU regulators raid drugmakers’ offices: “Restrictive Business Practices”

Not much information yet except that Sanofi Aventis is one of those raided. Read on the Blogroll “AFP Drugs.”

UPDATE: Another viewpoint from Europe on the Blogroll under “Europe Science Business”

Also units of Ranbaxy, Teva, and Novartis AG. See Blogroll under “EU Officials Conduct Raids“

Additional news on Blogroll from PharmaTimes: “EU Raids from PharmaTimes”