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Articles Posted in FDA

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The FDA has put forth proposed guidelines for implementing the salient portions of the Patient Protection and Affordable Care Act of 2010 (“PPACA”) that requires certain restaurants (20 or more locations) and vending machines to disclose nutrition information.

Critics like Walter Olson, Wes Siegner, and Susan J. Matthees are upset by the impact this is putting on small businesses. Although I think a restaurant with 20 locations is a little bigger than a small business, I get their point. No doubt, there are unnecessary burdens that government places on small businesses.
But I think the world is changing and things need to change with it. Obesity is not a problem you can legislate directly. But indirectly maybe by requiring people serving us food to tell us what it is? I’m in favor of it and I think in 20 years we will be amazed it was any other way.

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In just an hour, the FDA’s Office of Compliance, Division of New Drugs and Labeling Compliance (DNDLC) will present a webinar entitled, “Marketed Unapproved Drugs.” The webinar will discuss (1) the history of drug regulation in the United States, (2) the public health risks associated with unapproved drugs in the market and FDA’s Unapproved Drug Initiative, (3) and will identify tools to help determine the approval status of prescription drug products.

No word yet on whether Johnson & Johnson will require everyone at J&J who has ever even heard the word “Topamax” to attend.

Okay, that was a weak effort at a joke. I was trying to slide in a “marketing Topamax for everything but the common cold” jab but it does not really fit. You sometimes can’t fit in the joke with the story. But check out the webinar.

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In an article about what the FDA does not tell you, Smart Money tells us that 90% of medical devices approved by the FDA go through what is called a “510(k)” which allows device manufacturers to skip testing a device before putting it on the market if there is already a “similar device available.”

I’m not saying necessarily that every medical device that has the slightest modification should have to jump through the full FDA approval process. I think few people really say that. The question is simply where do we draw the line and it seems fairly clear that we are drawing it in a way that makes it far too easy on medical device manufacturers.

The FDA recently took a shot at making the 510(k) device clearance process “more predictable and smarter” but has not made any real progress. Again, I understand their trepidation. We want to get products with slight improvements in the market quickly. I just think we have to (1) better define what qualifies for 510(k) and (2) intensify the requirement – something in the middle of full-blown testing and “bring it on through.”

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American Regent has recalled seven lots of injectable dexamethasone sodium phosphate because the agent may form particulates before its labeled expiration date. The recall involves 30-mL multiple-dose vials at 4 mg/ml. American Regent was silent on whether there have been any injuries or problems reported from this injectable steroid. This can mean they don’t want to say or it can mean absolutely nothing. But the best thing to do is to just tell us from jump street whether anyone has reported injuries and whether those injuries were significant. Because if we are taking a drug or using a product, it is something we really want to know.

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With tossed to the trash heap of history, there is a void in the market for a new diet drug. That void apparently will not be filled by Arena Pharmaceuticals’ new drug lorcaserin. The FDA rejected the drug last week. The problem with lorcaserin was a big one: it caused the formation of cancer in rats, albeit in high doses.

There is obviously a big demand for a diet drug that works and has limited side effects. Eventually, modern science is going to produce such a drug and extreme obesity will be a thing of the past. Arena Pharmaceuticals probably would tell you that while not a panacea, we are getting closer with lorcaserin and they will be able to prove it is both safe and effective. History gives us doubts.

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The Huffington Post has an interesting blog post about how little the government is doing in spite of the fact that MRSA – the drug-resistant staff infection that kills thousands every year – is being found in random samples of raw pork, beef, and chicken. The biggest culprit seems to be pork.

The CDC acknowledged the presence of MRSA in some meat but does not seem overly concerned because the levels of MRSA are low. That may well be true. I doubt anyone at the CDC would want their kids to eat meat that they knew had any level of MRSA in it. I’m not sure I would want to use the “would I let me kid eat it?” standard for a recall. But the CDC tells us that there were 76 million new cases of food-related illnesses that were reported – reported – in 2009 causing over 5,000 deaths. So we need to make sure we are minding the store on food safety because we cannot rely on the food producers to balance the costs and benefits of what is safe to put on our plate.

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The FDA posted a graphic on Adverse Event Reports–where they come from, what’s done with them, and the potential fallout. It’s not very sophisticated (graphically speaking), but it is functional.

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Lettuce-05-13-10.jpgThe new romaine lettuce recall is the latest in a series of dangerous fruits and vegetables. The impact of clean agricultural practices first really hit public consciousness in 2006 with the massive E.Coli outbreak in Dole spinach. And then in 2008 with the tomato recall. And then in 2009 with the peanut butter recall.

Now, the FDA is telling us that Freshway Food’s bagged romaine lettuce, potentially with sell-by (not use by) dates of May 9 and May 10, can contain E. coli O145, which is harmful. The outbreak has likely harmed at least 19 people in Michigan, Ohio, and New York. The FDA believes a farm in Yuma Arizona may be the source. Injuries include hospitalizations and hemolytic uremic syndrome (a disease that destroys red blood cells and may be indicated by bloody diarrhea and acute kidney failure). Adults typically recover quickly, but it can be life-threatening to children, the elderly, and people with impaired immune systems.

The lettuce at issue was sold to wholesalers, food service outlets, and some stores with salad bars or delis, and may include pre-packaged salads from Kroger, Giant Eagle, Ingles Markets, and Marsh stores. Other states where the salad was sold include Alabama, Connecticut, the District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, West Virginia, and Wisconsin. Importantly, Freshway Foods does not produce prepackaged salads for supermarket sales.