Co-Inventor of Zicam a 2 time FDA warning letter loser. Hensley encoraged the public to "stockpile" the bogus bird flu cure.
---------------------------------------------------------
VIRA 38 Production Capacity Increased to Meet the Needs of Bird Flu Afflicted Nations
PRB Pharmaceuticals and Lee's Pharmaceuticals announced today that they have stepped up production capacity of VIRA 38. "As we move closer to the emergence of an influenza pandemic, we find personal stockpiling of VIRA 38 becoming more widespread," said Dr. Charles Hensley, Chairman and CEO of PRB Pharmaceuticals. "In life or death situations, people tend to take matters into their own hands rather than relying on government institutions."
============================================
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
Department of Health and Human Services Public Health Service
Food and Drug Administration
Los Angeles District
19701 Fairchild
Irvine, California 92612-25062
Telephone : (949) 608-2900
Warning Letter
VIA FEDERAL EXPRESS
RETURN RECEIPT REQUESTED
November 23, 2005
W/L 08-06
Charles B. Hensley, Ph.D.
PRB Pharmaceuticals
300 Oceangate
Suite 910
Long Beach, CA 90802
Dear Dr. Hensley:
This letter concerns your firm’s marketing of the product “Vira 38? on your website, www,prbpharmaceuticals.com. According to your website, this product is intended to prevent, treat, or cure serious disease conditions. The statements on your website include, but are not limited to, the following:
Vira 38
“Highly effective flu medication.”
Shown to inhibit and prevent infection of Bird Flu Virus (H5N1) and Type A human influenza in vitro.”
“Human clinical research shows Vira 38 reduces the duration of influenza illness by 78%.”
“One of the anti-viral components is v38 AMF-1 which has been shown to inhabit infections from Type A influenza, SARS virus, Avian influenza virus, Staphylococcus aureus, and Streptococcus pneumoniae (two bacteria primarily responsible for secondary infections seen in influenza).”
“Vira 38 is a favorite among the Hong Kong doctors for the prevention and treatment of influenza.”
“vira 38 is currently used in Hong Kong to protect the live poultry market workers against the bird flu.”
“Vira 38 was used by the major SARS hospital to protect front-line doctors and nurses against SARS during the SARS outbreak of 2003.”
These claims are further supplemented by the metatags that you use to bring consumers to your website. These metatags include “life threatening diseases,” “influenza virus,” “SARS coronavirus.” and treatments”.
Vira 38 is a drug, as defined by Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. 321 (g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Moreover, this product is a new drug, as defined by Section 201(p) of the Act, 21 U.S.C. 321(P), because it is not generally recognized as safe and effective for its labeled uses. Under Sections 301(d) and 505(a) of the Act, 21 U.S.C. 331 (d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of Vira 38 without such an approved application violates these provisions of the Act.
Furthermore, many of the conditions for which this product is offered are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use for these conditions cannot be written so that a layman can use thus drug safely for its intended purposes. (See 21 C.F.R § 201.5). Because your product’s labeling fails to bear adequate directions for its intended uses, it is misbranded under Section 502(f)(1) of the Act, 21 U.S.C., § 352(f)(1).
The above violations are not intended to be an all-inclusive list of deficiencies. It is your responsibility to ensure that the drug products that you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letter about drugs and devices so that they may take this information into account when considering the award of contracts.
You must immediately correct these violations. It you do not immediately correct them, you may be subject to enforcement action against you without further notice. The Act provides for seizure of illegal products and for an injunction against the manufacturers and distributors of illegal products.
You must notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations and the steps taken to assure that similar violations will not occur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Additionally, if your firm does not manufacture the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturing firm. Address your reply to the U.S. Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612, Attention: Pamela B. Schweikert, Director of Compliance.
A description of the new drug approval process can be found on FDA’s Internet Website at fda.gov. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.
Sincerely,
/s/
Alonza E. Cruse
Director, Los Angeles District
FOI Home Page | Most Recent Warning Letters
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility
VIRA 38 Production Capacity Increased to Meet the Needs of Bird Flu Afflicted Nations
PRB Pharmaceuticals and Lee's Pharmaceuticals announced today that they have stepped up production capacity of VIRA 38. "As we move closer to the emergence of an influenza pandemic, we find personal stockpiling of VIRA 38 becoming more widespread," said Dr. Charles Hensley, Chairman and CEO of PRB Pharmaceuticals. "In life or death situations, people tend to take matters into their own hands rather than relying on government institutions."
(I-Newswire) - "People are very concerned about the lack of adequate government stockpiles of anti-viral medications. This is especially true in developing countries, many of which are afflicted with bird flu. Unfortunately, wealthy Western nations were allowed to purchase most of the world's supply of prescription anti-viral medications," added Dr. Hensley. "Starting with this production cycle, we are earmarking 50% of our inventory for people in developing nations. From a humanitarian and world health perspective, keeping these nations supplied with medication is the correct thing to do."
PRB Pharmaceuticals has a strong presence in Southeast Asia and the company has recently started working with Vietnam government officials to help bring the bird flu crisis under control.
VIRA 38 first gained notoriety during the Taiwan SARS outbreak of 2003 when it was used by the Taiwan Presidential staff and doctors at Sungshan Hospital ( SARS management facility ) and again in the spring of 2004 when it was discovered that compounds in VIRA 38 block bird flu virus
( H5N1 ) infections. About VIRA 38
VIRA 38, PRB Pharmaceuticals' over-the-counter broad spectrum anti-viral medication, is known for its effectiveness in treating and preventing influenza. VIRA 38 has recently been shown to contain compounds that inhibit the bird flu ( H5N1 ) virus. Researchers at the Chinese University of Hong Kong have previously discovered these same compounds to be effective against a variety of pathogens, including SARS CoV, the virus responsible for causing severe acute respiratory syndrome.
About PRB Pharmaceuticals
PRB Pharmaceuticals, Inc.
( prbpharmaceuticals.com ) is based in Irvine, California, and Hong Kong. PRB Pharmaceuticals is a fully integrated biopharmaceutical company that develops unique and highly efficacious anti-viral treatments and preventative therapies.
About Lee's Pharmaceuticals
Lee's Pharmaceutical Holdings Ltd
( www.leespharm.com/EN ) ( Hong Kong Exchange GEM
Stock:8221 ) distributes VIRA 38 to the Hong Kong market. Lee's is an integrated research-driven and market-oriented pharmaceutical company engaged in the development, manufacture and sales of quality biopharmaceutical products that focus on combating cardiovascular and viral diseases.
Web sites:
prbpharmaceuticals.com
leespharm.com
For further information:
Vivian Fung
+852-2314-1282, +852-2314-1708 ( Fax )
Charles B. Hensley, Ph.D.
Chairman & Chief Executive Officer
PRB Pharmaceuticals
chensley@prbpharmaceuticals.com
If you have questions regarding information in this press release contact the company listed below. I-Newswire.com is a press release service and not the author of this press release. The information that is on or available through this site is for informational purposes only and speaks only as of the particular date or dates of that information. As some companies / PR Agencies submit their press releases once per week/month or quarter, make sure check the official company website for accurate release dates as our site displays the I-Newswire.com distribution date only. We do not guarantee the accuracy or completeness of information on or available through this site, and we are not responsible for inaccuracies or omissions in that information or for actions taken in reliance on that information.
Published on:
2005-07-18 |
