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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Prodesse, Inc 5/11/09

From: FDA Center for Devices and Radiological Health
(FDAFLUTASKFORCE-CDRH@fda.hhs.gov)
Date: May 11, 2009
To: ashrago@prodesse.com


Prodesse, Inc.
W229 N1870 Westwood Dr.
Waukesha, WI 53186


Subject: Urgent Message from the Food and Drug Administration Regarding an 2009 H1N1 Flu Virus-Related Product Marketed by Your Firm


UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION ROCKVILLE, MD 20855


TO: www.prodesse.com / ashrago@prodesse.com
FROM: Food and Drug Administration
RE: Unapproved/Uncleared/Unauthorized Product Related to the 2009 H1N1 Flu Virus
DATE: May 11, 2009


WARNING LETTER


This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.prodesse.com (specifically, www.prodesse.com/USA/news/article71.html and www.prodesse.com/USA/news/article72.html) on May 8, 2009. The FDA has determined that your website offers a product for sale that is intended to diagnose, mitigate, prevent, treat or cure the 2009 H1N1 Flu Virus in people. This product has not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the 2009 H1N1 Flu Virus. This product is the Prodesse ProFlu+ Assay. The marketing of this product violates the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. §§ §§ 331, 351, 352. We request that you immediately cease marketing this unapproved, uncleared, or unauthorized product for the diagnosis, mitigation, prevention, treatment, or cure of the 2009 H1N1 Flu Virus.


Some examples of the claims on your website include:


•    “ProFlu+™ Detects Swine Flu: Multiple CDC Confirmed Cases Initially Detected by ProFlu+”
•    "ProFlu+ sequences are a nearly perfect match to every known swine flu sequence, meaning that users can have high confidence that swine flu will be detected by ProFlu+."
•    “Prodesse, Inc. announced today the results of in silico testing of its ProFlu+ Assay that demonstrate the Assay detects the currently circulation swine flu virus.”
•    “Prodesse is currently attempting to procure isolates so that reactivity with the swine flu strain can be confirmed.”


The Secretary of Health and Human Services, under section 319 of the Public Health Service Act, 42 U.S.C. § 247d, has determined that a public health emergency exists nationwide involving the 2009 H1N1 Flu Virus that affects or has the significant potential to affect national security. Following this determination and in response to requests from the U.S. Centers for Disease Control and Prevention, FDA issued letters authorizing the emergency use of certain unapproved and uncleared products or unapproved or uncleared uses of approved or cleared products, provided certain criteria are met, under 21 U.S.C. § 360bbb-3. The marketing and sale of unapproved or uncleared 2009 H1N1 Flu Virus -related products that are not authorized by and used in accordance with the conditions of an Emergency Use Authorization, is a potentially significant threat to the public health. Therefore, FDA is taking urgent measures to protect consumers from products that, without approval or authorization by FDA, claim to diagnose, mitigate, prevent, treat or cure the 2009 H1N1 Flu Virus in people.


You should take immediate action to ensure that your firm is not marketing, and does not market in the future, products intended to diagnose, mitigate, prevent, treat or cure the 2009 H1N1 Flu Virus that have not been approved, cleared, or authorized by the FDA. The above is not meant to be an all-inclusive list of violations. It is your responsibility to ensure that the products you market are in compliance with the FFDC Act and FDA's implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that the claims you make for your products do not adulterate or misbrand the products in violation of the FFDC Act. 21 U.S.C. §§ 331, 351, 352. Within 48 hours, please send an email to FDAFLUTASKFORCE-CDRH@fda.hhs.gov describing the actions that you have taken or plan to take to address your firm's violations. If your firm fails to take corrective action immediately, FDA may take enforcement action, such as seizure or injunction for violations of the FFDC Act without further notice. Firms that fail to take corrective action may also be referred to FDA's Office of Criminal Investigations for possible criminal prosecution for violations of the FFDC Act and other federal laws.


FDA is advising consumers not to purchase or use 2009 H1N1 Flu Virus-related products offered for sale that have not been approved, cleared, or authorized by FDA. Your firm will be added to a published list on FDA's website of firms and websites that have received warning letters from FDA concerning marketing unapproved/uncleared, and unauthorized 2009 H1N1 Flu Virus-related products in violation of the FFDC Act. This list can be found at http://accessdata-test.fda.gov/scripts/h1n1flu/. Once the violative claims and/or products have been removed from your website, and these corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken appropriate corrective action.


If you are not located in the United States, please note that unapproved, uncleared, or unauthorized products intended to diagnose, mitigate, prevent, treat, or cure the 2009 H1N1 Flu Virus offered for importation into the United States are subject to detention and refusal of admission. We will advise the appropriate regulatory or law enforcement officials in the country from which you operate that FDA considers your product(s) listed above to be unapproved, uncleared, or unauthorized products that cannot be legally sold to consumers in the United States.


Please direct any inquiries to FDA at FDAFLUTASKFORCE-CDRH@fda.hhs.gov