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Articles Posted in FDA Procedures

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FDA is poised to limit the sale and distribution of “Research Use Only” (RUO) and “Investigational Use Only” (IUO) products, issuing draft guidance to that effect on Tuesday.

RUO products are usually in the laboratory research phase of development or are used as basic scientific research. But some companies sell these products when they know or should know that they are being misused diagnostically. Now, the FDA will require that companies only sell their RUO or IUO products if they know or have reason to know that the product is actually being used diagnostically. In other words, no more turning a blind eye to what you know or assume the company’s purpose for a product. The “hey, we make no diagnostic claims are being made” skirt is off.

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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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The FDA’s Center for Devices and Radiological Health (CDRH—you can follow them on Twitter) will hold a free public meeting to address concerns and discuss strengthening of the 510(k) process. The agenda includes:

  • Issues related to predicate devices;
  • Issues related to new technologies and scientific evidence;
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Some noteworthy news items to start your week:

    • Tylenol: Tylenol drug recall expanded to include other Johnson & Johnson/McNeil products (Motrin, Benadryl, Rolaids, Simply Sleep, St. Joseph). See the manufacturer’s press release.
    • Radiation: Philadelphia Veterans Administration acknowledges that incorrect dosages of radiation were given to 114 veterans for prostate cancer. See the Legal Blog of Shrager, Spivey & Sachs.
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In a move that persuaded reporters everywhere to use quotation marks, the FDA yesterday asked media to stop using the common term for the most serious warning the FDA can require–“black box” warnings. Instead, the FDA apparently prefers the term “boxed warning.”

A little background–the black box warning is a thing that drugmakers, drug distributors, and investors of pharmaceutical drugs hate. It’s bad for business. The reason is clear–if you put a prominent warning on your latest smoking cessation drug (just to invent a hypothetical drug; you understand), saying it may cause consumers to become suicidal, that will hurt sales. Reasonable people might say to themselves: “Gee, I want to quit smoking, but a side effect of suicide is something I just can’t live with.” Then they move over to your competition, a good self-help book.

So, why are these warnings bad for business? They hurt profits. The FDA says that “Black Box carries the implication, ‘don’t you dare use this.'” What they fail to recognize is that the warning itself is supposed to jump out and, well, warn you. There’s not much special about the warning itself–it is in bold, and it is surrounded by a thin black box. But it’s still tiny print, and most people picking up prescriptions from their pharmacy may still ignore it. A rose by any other name is still a rose, but here any additional incentive to read the warning is a good thing. You’d think the FDA, which should be on the side of the consumers and safety, would want to encourage that line of thinking. . . .