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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limit the sale and distribution of “Research Use Only” (RUO) and “Investigational Use Only” (IUO) products, issuing a draft guidance to that effect on Tuesday.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 companies sales of its RUO or IUO products if the company knows or has 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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An editorial in the Carroll County Times (Maryland) provides some information about contaminated food that will surprise some: 300,000 are hospitalized and 5,000 die every year because of contaminated food.
Congress is now looking to give FDA the authority that most people thought they already had: to order food recalls.

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Here are this week’s stories:

  • Medtronic: Medtronic reported that it paid $15.7 million to U.S. doctors in the first 3 months of 2010. Payments were for consulting fees and royalties. This report comes well in advance of the new law requiring disclosure beginning in 2013. See Medtronic’s searchable database of payments.
  • Digitek: A request for a class certification was recently denied in the Digitek MDL. The MassTortDefense Blog has an update.
  • PediaCare Recall: over 100,000 bottles of PediaCare, formerly manufactured by Johnson & Johnson (and, still being manufactured in their facility), have been recalled. This is a precautionary recall, based on the known problems with the J&J manufacturing facility.
  • AstraZeneca and Social Media: Here is AstraZeneca’s take on the transparency/social media issue.
  • Generic Drugs: The Supreme Court asks Obama’s administration for an opinion as to whether generic drug manufacturers can be sued for inadequate labeling that matches labeling of brand-name drugs. Here is the Eighth Circuit’s opinion, deciding that generic drug manufacturers can be held liable.
  • Celebrities in the News: Dennis Quaid is bringing public awareness to injuries caused by pharmaceutical companies. He settled with the hospital on the heparin overdose of his children, but now he’s going after the pharmaceutical company, Baxter Healthcare Corp.
  • More on Whistleblowing: Wyeth (through Pfizer) is accused of illegally promoting its kidney transplant drug for other organs and specifically among African-Americans, who have greater risks associated wit the drug.

Happy Wednesday!

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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;
  • Issues related to practices CDRH has adopted in response to the high volume of 510(k) submissions; and
  • Issues related to postmarket surveillance and new information about marketed devices.

The FDA receives over 3,000 510(k) submissions every year. “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.” After much backlash last year about FDA scientist/employee complaints about corruption, safety problems, conflicts of interest and budgeting, the Institute of Medicine (IOM) was called on to comprehensively study (to the tune of $1.3 million) the 510(k) process. That study is expected to be completed in March 2011, but this meeting is a companion to that study.
Conference Details:

  • Time/Location: 8:00 a.m. to 5:30 p.m.; Hilton Washington DC North/Gaithersburg; 620 Perry Parkway; Gaithersburg, Maryland 20877
  • Live webcast

Related documents:

This meeting is another good step the administration has taken to put patient safety first, and to rigorously watch over the medical device regulatory process.

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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.
  • BPA: FDA to change labeling for bisphenol-A. It has “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children.” See The New York Times.

  • FDA Warning Letters: Publication by Sean P. Wajert, James M. Beck, and Vincent A. Gallo on the “Reduced Legal Oversight For FDA Warning Letters Amplifies Compliance And Liability Risks.” See the Washington Legal Foundation.
  • Faked Drug Research: Federal charges filed against a doctor who allegedly faked research for painkillers, including Vioxx and Celebrex. He received money and other presents from Pfizer. See Yahoo! Finance.

Happy Monday!

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Zyban-Black-Box-07-02-09.jpgIn 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’s going to 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.