The Pharmaceutical Company's
Information on the company's that manufacture vaccines.
Vaccine Manufacturer Loses Proxy Vote to Pro-Life Advocates May 8, 2003
Crucell and Merck & Co. Sign PER.C6 Licensing Agreement for Therapeutic Protein Production
Warning Letter-December 18, 2003, Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine, Comvax (Merck & Co, Inc)
Warning Letter-June 27, 1997 FDA inspection of veterinary drug manufacturing facility, Merck Sharp & Dohme Quimica P.R., located at Rd. #2, Km. 56.7, Cruce DaviJa, Barceloneta PR conducted from March 20 to May 13, 1997. Merck& Co, Inc.
Warning Letter-February 9, 2001 FDA inspection of facility located at Sumneytown Pike, West Point, Pennsylvania, between August 14 and October 11, 2000. Merck& Co, Inc.
Letter-November 1, 2000 FDA inspection of manufacturing facility located
#2, Km 60.3 Sabana Hoyos, Arecibo, Puerto Rico. Merck& Co, Inc.
Warning Letter-September 17, 2001 promotional activities and materials for the marketing of Vioxx. Merck & Co. Inc.
Warning Letter-June 16, 1998 FDA inspection at West Point. PA manufacturing facility from April 6 through May 12, 1998. Merck & Co. Inc.
Warning Letter-June 27, 2000 inspection of manufacturing facility located at 126 East Lincoln Avenue, Rahway, New Jersey from February 1 through March 16, 2000. Merck & Co. Inc.
Use of the false discovery rate for evaluating clinical safety data. Biostatistics and Research Decision Sciences, Merck Research Laboratories, Blue Bell, PA 19422, USA
Report: Mercury Levels in Vaccines Eyed-Tue Feb 8, LOS ANGELES - A MEMO from the drug maker Merck & Co. shows that its executives were concerned about high levels of mercury in children's vaccinations nearly eight years before health officials disclosed a similar finding, the Los Angeles Times reported Tuesday.
Letter-July 22, 2005, Merck-FDA inspection of Merck and Co., Cherokee
Plant, 100 Avenue C, Riverside, Pa., from February 15-18, 2005
Vaccines and Related Biological Products Advisory Committee March 7, 2001FDA Briefing Document for SmithKline Beecham Biologicals DTPa-HepB-IPV Vaccine
Warning Letter-August 18, 1999 television advertisement of Flonase is lacking in fair balance or otherwise misleading Glaxo Wellcome, Inc.
Warning Letter-September 19, 2000 inspection of pharmaceutica1 manufacturing facility in Verona Italy during the period of May 22 to 29, 2000. Glaxo Wellcome, Inc
Warning Letter-July 17, 2001 promotional activities for the marketing of Avandia Glaxo Wellcome, Inc
Warning Letter-July 6, 2004, Advertising and Promotional Labeling - false or misleading statements regarding the live attenuated influenza vaccine and fails to reveal material facts regarding specific risks associated with the use of Engerix-B, Havrix, and Twinrix,GlaxoSmithKline Biologics S.A
Warning Letter-January 31, 2005, GlaxoSmithKline-The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a convention panel displayed as a stand alone panel at the 2004 American Society of Health-System Pharmacists (ASHP) conference held June 19-23, 2004, Las Vegas, Nevada. The panel is false or misleading because it omits material risk information and overstates the efficacy of Coreg.
Warning Letter-November 21, 2007, three Dear Healthcare Practitioner letters part of the launch campaign for Tykerb, are misleading in that they omit and minimize the most serious and important risk information for Tykerb and selectively present efficacy information for Tykerb, thereby overstating the efficacy of the drug. GlaxoSmithKline
Warning Letter-June 30, 2006, Zovirax Ointment false or misleading claims. GlaxoSmithKline
Acambis acquired Berna Products Corporation in August 2003
Warning Letter-June 24, 2004 Violative Advertising and Promotional Labeling Letter Typhoid Vaccine Live Oral Ty21a (Vivotif) (Berna Biotech Ltd)
Warning Letter-inspection of Swiss Serum and Vaccine Institute conducted from August 18 through August 28, 1997.
Warning Letter-CBER-01-021, April 09, 200l, FDA inspection of Aventis Pasteur, Inc. Swiftwater, Pennsylvania January 29-February 16, 2000 ---VAERS report on Tripedia® lot number U0356B VAERS report on Yellow Fever-Single dose unit lot number UA071AA
Warning Letter-01-ATL-57, June 29, 2001, FDA inspection of Seramed, Inc. d.b.a. Aventis Bio Services Greenville, South Carolina on 4/19-20& 5/30-6/6/01
Warning Letter-SEA 01-64, July 13, 2001, FDA inspection of Aventis Bio-Services d.b.a. SeraMed BioCenter Salem, Oregon May 7-11, 2001
Warning Letter-February 6, 2002, FDA inspection of Aventis BioServices, Inc. Milwaukee, WI, between December 12 and 19, 2001
Warning Letter-NO. 2003-NOL-03, November 5, 2002, FDA inspection of Aventis Bio-Services, Inc. plasmapheresis center Monroe, Louisiana on July 15 - 19, 23 - 27 & August 9, 2002
Warning Letter-February 24, 2004, Violative Advertising and Promotional Labeling Letter- Rabies Immune Globulin (Human), Imogam Rabies-HT and Rabies Vaccine, Imovax Rabies (Aventis Pasteur Inc.)
Warning Letter-January 13, 2004, Violative Advertising and Promotional Labeling Letter BCG Live (Intravesical), TheraCys (Aventis Pasteur Inc.)
Warning Letter-January 23, 2003, Violative Advertising and Promotional Labeling Letter Immune Globulin Intravenous (Human), Gammar-P IV (Aventis Behring, LLC)
Warning Letter-January 22, 2001, FDA of Aventis Behring Gmbh, located at Emil von Behringstrasse 16, Postfach 1230,35401 Marburg, Germany, between August 8 and September 13, 2000.
Warning Letter-Nov. 24, 1999 FDA inspection of manufacturing facility located at 1541 Avenue Marcel Merieu Marcy LEtoile, France, between July 19 and August 5, 1999. (Pasteur Merieux Serums et Vaccins) ---VAERS Report on Typhim Vi lot P0323---VAERS Report on Rabies Vaccine lot M0475---VAERS Report on Rabies Vaccine lot N0018---VAERS Report on Rabies Vaccine lot M0162---VAERS Report on Typhim Vi lot P0482
Warning Letter-April 2, 2004 Violative Advertising and Promotional Labeling Letter - Typhim Vi (Typhoid Vi Polysaccharide Vaccine) Aventis Pasteur Inc.
Aventis Pasteur, Ltd. obtained product ownership from Connaught Laboratories, Inc effective February 24, 2000 the following vaccines: BCG Live-Mycobax®, Diptheria & Tetanus Toxoids Adsorbed-no trade name, Poliovirus Vaccine Inactivated (Human Diploid Cell)-Poliovax®-not available.
Aventis Pasteur, Inc obtained product ownership from Connaught Laboratories effective December 9, 1999 the follwing vaccines: Diptheria & Tetanus Toxoids Adsorbed-no trade name, Diptheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed-Tripedia®, Influenza Virus Vaccine, Trivalent, Types A and B-Fluzone®, Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined-Menomune®, Tetanus & Diptheria Toxoids Adsorbed for Adult Use-no trade name, Tetanus Toxoid-no trade name, Tetanus Toxoid Adsorbed-no trade name, Yellow Fever Vaccine-YF-Vax®.
Aventis Pasteur, SA is the new corporate name for Pasteur Merieux Serums et Vaccins, SA effective February 4, 2000,which effects the following vaccines: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)-ActHIB®, Poliovirus Vaccine Inactivated (Monkey Kidney Cell)-IPOL®, Rabies Vaccine-Imovax®, Typhoid Vi Polysaccharide Vaccine-TYPHIM-Vi®.
Supporting Existing Products and Developing Novel Agents - Michel De Wilde, Ph.D.Executive Vice President, Research and Development Aventis Pasteur
Warning Letter-October 12, 2004-Office of Compliance and Biologics Quality in the Food and Drug Administrations Center for Biologics Evaluation and Research CBER) has reviewed convention panels for Zemaira submitted by Aventis Behring L.L.C. The convention panels are false or misleading under sections 502 (a) and 201 (n) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 352(a), 321(n)) because they omit risk information.
Warnig Letter-August 16, 2004-FDA Inspection of Aventis Pasteur SA located at 1541 Avenue Marcel Merieux, F679280 Marcy Letoile, Lyon, France, between March 9 to Match 18, 2004, and April 26 to April 30, 2004-Rabies vaccine, Thymoglobulin, Haemophilius b Conjugate Vaccine
Warning Letter-October 23, 2007, objectionable conditions found during the FDA investigation into Aventis Pharmaceuticals' role as sponsor of study HMR3647A/3014entitled "Randomized, Open-Label, Multicenter Trial of the Safety and Effectiveness of Oral Telithromycin [Ketek] and Amoxicillin-Clavulanic Acid [Augmentin] in Outpatients with Respiratory Tract Infections in Usual Care Settings" of the investigational drug, Ketek (telithromycin).
Warning Letter-June 30, 2006, FDA inspection of Sanofi Pasteur, Inc. (Sanofi), Discovery Drive, Swiftwater, Pennsylvania, between April 18 and April 28, 2006. Significant deviations from current good manufacturing practices (CGMP) in the manufacture of licensed biological products and Fluzone® monovalent concentrate batches
Several licensee companies are engaged in Phase I or Phase II clinical trials with PER.C6-based products in therapeutic areas including HIV (Merck & Co., Inc) and angiogenesis (Genvec, Inc.). Other licensees include GSK, Centocor/J&J and Aventis.
Crucell: Malaria vaccine testing program in collaboration with three leading rersearch organisations.
Aventis Pasteur Press Release-Aventis and Crucell Announce Strategic Agreement to Develop and Commercialize Novel Influenza Vaccines: Agreement covers pandemic and inter-pandemic influenza vaccines
Wyeth Experiencing Temporary Interruption in Prevnar Shipments 11/06/2003
Warning Letter-99-PHI-36, September 28, 1999, FDA inspection of Wyeth-Ayerst Laboratories West Chester, PA March 8 through May 5, 1999
Wyeth-Ayerst Laboratories Signs Consent Decree with FDA
Warning Letter-February 2, 2004 Violative Advertising and Promotional Labeling Letter Antihemophilic Factor (Recombinant), ReFacto (Wyeth Pharmaceuticals Inc.)
Wyeth Laboratories, Inc is the new corporate name for Wyeth-Ayerst, Inc effective July 1, 1980.
Warning Letter-January 16, 1998, FDA Inspection of Wyeth-Ayerst Laboratories November 18, 19,20,25 and 26, 1997
Warning Letter-March 27, 1998, FDA pre-approval inspection of A. H. Robins facility located at 2248-2300 Darbytown Road, Richmond, Virginia, on March 17-20, 1998. Wyeth-Ayerst Laboratories, Inc.
Warning Letter-October 14, 1997, FDA inspections of A. H. Robins Company at 1407 Cummings Drive and 2248-2300 Darbytown Road, Richmond, Virginia, on September 9 through 19, 1997, and September 17 through 19, 1997. Wyeth-Ayerst Laboratories, Inc.
Acceptance speech by Mark Livingston for the Joe A. Callaway Award for Civic Courage on December 20, 2004. Mark is a former employee of Wyeth.
Warning Letter-December 10, 2007, FDA review of professional journal ad submitted by Wyeth Pharmaceuticals Inc. for Effexor XR Tablets. Journal ad is misleading because it overstates the efficacy of Effexor XR, makes unsubstantiated superiority claims, in addition to other unsubstantiated claims, and minimizes the risks associated with the use of Effexor XR.
Warning Letter-May 8, 2006, FDA inspection of Wyeth manufacturing facility located at State Road #3 km 142.1, Guayama, PR 00784, conducted between November 7, 2005 and December 15, 2005 revealed that your firm's manufacture, processing, packing or holding of the human drug products Triphasil-21 & 28 tablets, Prempo 0.62512.5mg & 0.45/1.5mg tablets, Advil (liquid Gels, Caplets, Gel Caplets), Effexor tablets, Duofeln tablets, Gestodene tablets, Caltrate 600 mg + D tablets and Inderal LA 60 mg tablets violated the Current Good Manufacturing Practice.
MedImmune Info from Business.com
New Medicines in Development at MedImmune
Product Approval Information FluMist-Influenza Virus Vaccine, Live, Intranasal
Meeting Minutes-Center for Biologics Evaluation and Research The Advisory Committee Meeting on FluMist
Warning Letter-June 21, 2005, MedImmune-The Office of Compliance and Biologics Quality in the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has reviewed the Vaccine Assessment Tool Flyer for FluMist® (Influenza Virus Vaccine Live, Intranasal) This consumer-directed flyer is misleading because it fails to reveal material facts regarding the risks associated with the use of FluMist.
Warning Letter- May 24, 2007, FDA conducted an inspection of Medlmmune U.K. Ltd, between March 21 and March 29, 2007, FluMist bulk monovalent lots used to manufacture In fluenza Virus Vaccine Live, Intranasal
BioPort Corporation acquired product ownership on November 12, 1998 from the Michigan Biologic Products Institute, formerly under the Michigan Department of Public Health the following vaccines: Anthrax Vaccine Adsorbed-Biothrax-available only thru Department of Defense(DoD) programs and Rabies Vaccine Adsorbed-no trade name-not available.
Press Release-October 5, 2004
Evans Vaccines is a wholly owned subsidiary of Chiron Corporation
Warning Letter-December 9, 2004-FDA Inspection of Evans Vaccines, an affiliate of Chiron Corporation, Gaskill Road, Speke, Liverpool L24 9GR, United Kingdom, between October 10 and October 15, 2004-Influenza Virus Vaccine, Fluvirin®
Warning Letter-June 11, 2003, Roche-FDA inspection of Disetronic Medical Systems, AG located in Burgdorf, Switzerland, on January 27 - February 5, 2003, an inspector collected information that revealed serious problems involving the manufacture of external insulin infusion pumps
Warning Letter-September 2, 2004, Roche-FDA inspection of establishment located in Indianapolis, IN, on May 11-26, 2004 inspection was conducted in response to FDA's receipt of a Medical Device Report (MDR) concerning the potential for mismatch of patient identification with sample results in the analysis for Chlamydia trachomatis and Neisseria gonorrhea infective agents.
Warning Letter-May 11, 2004 Polygam® S/D Immune Globulin Intravenous (Human) professional print advertisement Baxter Healthcare Corporation
Powderject obatined product ownership from Evans Medical Ltd. Effective 2001 on the following vaccine: Influenza Virus Vaccine, Trivalent, Types A & B-Fluvirin®.
In 2003, PowderJect was acquired by Chiron Corporation.
Warning Letter-October 15, 2002, FDA inspection of drug manufacturing facility located in Austin, Texas, conducted August 19-28, 2002 (Abbott Laboratories, Inc.)
Warning Letter-July 19, 2002, FDA inspection of 100 Abbott Park Road Abbott Park, IL 60064 from January 7 through January 28, 2002, and March 21 through April 3, 2002 (Abbott Laboratories)
Warning Letter-September 24, 2002, FDA Inspection of pharmaceutical manufacturing operations in Building AP- 16,located at Abbott Park, IL from June 18 through July 24, 2002 (Abbott Laboratories, Inc.)
Warning Letter-March 25, 2004, FDA Inspection of Hospital Products Division (Abbott HPD) located at 600 N. Field Drive, Lake Forest, IL, from April 22 to May 1, 2003, and from May 28 to September 2, 2003
Letter-August 7, 2000 FDA Inspection of Hospital Products Division (Abbott
March 20 to April 10, 2000
Warning Letter-July 9, 1999 FDA Inspection of Hospital Products Division (Abbott HPD) at 14th& Sheridan Rd, North Chicago, Illinois, from February 24, 1999, through May 26, 1999
Warning Letter-November 5, 1998 FDA Inspection of Abbott Laboratories Diagnostics Division July 5 through August 19, 1998
Warning Letter-June 26, 1998 Abbott Laboratories promotional materials reviewed by the Division of Drug Marketing, Advertising, and Communications
Warning Letter-March 19, 1999 Abbott Laboratories "Dear * Customer" Letter disseminated via Western Union Mailgram on March 16, 1999
Warning Letter-March 17, 1999 FDA Inspection of Abbott Laboratories, Abbott Diagnostics Division (ADD), Abbott Park, Illinois, from September 8, 1998 to November-4, 1998
Warning Letter-March 17, 1997 FDA Inspection of Abbott Laboratories Hospital Products Division (HPD), located at 1400 Sheridan Road, North Chicago, Illinois, from January 13, 1997 to February 14, 1997
Warning Letter-January 30, 2002 FDA Inspection of Abbott Laboratories at 4455 Atherton Drive, Salt Lake City, Utah between November 5 - 20, 2001
Warning Letter-February 7, 2000 FDA Inspection of Abbott Laboratories medical device manufacturing facility located in Irving, Texas, from 10/26/99 to 12/22/99,
Warning Letters-July 6, 2000 FDA Inspection of Abbott Laboratories Inc. located at 14th Street and Sheridan Road North Chicago, Illinois between March 13 and 22, 2000
HUMIRA®-Abbott Immunology-IMPORTANT DRUG WARNING
Warning Letter-April 28, 1998 FDA inspection of facilities located at 305 South Street, Jamaica Plain Boston, MA between January 22 and March 4, 1998. Massachusetts Public Health Biologic Laboratories
buying North American: $390 million deal seen enhancing market for vaccines
Warning Letter-Oct. 8, 1999, FDA inspection of North American Vaccine, Inc., located at 12040 Indian Creek Coti, Beltsville, MD, between Jme 1, 1999, and July 2, 1999---VAERS Report on lot number C010
DTAP and Manufacturer NORTH AMERICAN VACCINE-VAERS Report on Certiva
Notice to Readers: Update on the Supply of Tetanus and Diphtheria Toxoids and of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine.
Warning Letter- September 29, 2003, FDA Inspection of drug manufacturing facility located at 375 Mt. Pleasant Avenue, West Orange, New Jersey April 24 through June 27, 2003 (Organon USA Inc.)
Warning Letter- January 8, 2001 inspection of Boxtel, Netherlands facility from September 11 through 14, 2000 to determine compliance with the Postmarketing Adverse Drug Experience reporting. Organon Teknika BV
Warning Letter-September 19, 2000 FDA inspection of manufacturing facility located at 375 Mt. Pleasant Avenue, West Orange, NJ, between July 17 and August 23, 2000. Organon, Inc.
Warning Letter-Oct. 30, 2001, FDA and CBER inspection on April 19, 2001, to May 25, 2001, of AVAX Technologies manufacturing facility located in Philadelphia, Pennsylvania.
Warning Letter-Oct. 21, 1999 FDA inspection of facility located at M Gaskill Road, Speke, Liverpool, UK, between JuIy 13 and July 21, 1999.
Warning Letter-Question and Answer document distributed at a promotional booth in connection with the 4th Annual Federal Biodefense Research FY 2006 meeting, October 17-19, 2005, in Washington, DC entitled, "Questions and Answers About VaxGen's Anthrax Vaccine Bioshield Contract," Question and Answer document contains false or misleading statements (VaxGen Inc.)
Warning Letter-January 6, 2005, webpages on www.nabi.com for your product Nabi-HB® [Hepatitis B Immune Globulin (Human)] webpages are misleading because they fail to reveal material facts regarding the risks associated with Nabi-HB
AlphaVax Announces a New NIH Vaccine Grant for Influenza
Vaxin Inc.-an emerging vaccine company using non-invasive means to elicit immune responses
Oxford BioMedica-Delivering Gene-Based Medicines
GenVec Inc.-emerging biopharmaceutical company developing gene-based medicines for the treatment of major diseases, such as cancer and cardiovascular disease
Warning Letter-September 22, 1997 inspection of Greer Laboratories, 639 Nuway Circle, NE, Lenoir, NC, conducted on August 11-15, 1997 Plague Vaccine
Warning Letter-June 24, 2005 Inspection of Greer Laboratories, 639 Nuway Circle, NE, Lenoir, NC, conducted between February 14 and March 3, 2005
New England Journal of Medicine-Financial Conflicts of Interest in Physicians' Relationships with the Pharmaceutical Industry Self-Regulation in the Shadow of Federal Prosecution
New England Journal of Medicine-Registration of Clinical Trials Voluntary or Mandatory?
Science for Sale? - Transcript - NOW WITH BILL MOYERS
Center for Vaccine Development-University of Maryland School of Medicine An Organized Research Center of the University of Maryland, Baltimore
Annual Report-National Immuniation Program 2002
Research sponsored by drug companies is biased. This week in the BMJ Volume 326, Number 7400, Issue of 31 May 2003.
Pharmaceutical industry sponsorship and research outcome and quality: systematic review
Evidence b(i)ased medicineselective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications
Characteristics of general practitioners who frequently see drug industry representatives: national cross sectional study.
1: Entanglement - Who pays for the pizza? Redefining the relationships between doctors and drug companies-In this two part article, a journalist based in Washington DC explores the brewing conflicts at one of the world's leading medical campuses as it joins the wider global debate about how to redefine relations with big pharmaceutical companies
2: Disentanglement - Who pays for the pizza? Redefining the relationships between doctors and drug companies
How to dance with porcupines: rules and guidelines on doctors' relations with drug companies - Interactions between doctors and drug companies can lead to ethical dilemmas. This article gives an overview of the guidance and codes of practice that aim to regulate the relationship
Medical journals and pharmaceutical companies: uneasy bedfellows - Many medical journals have a substantial income from pharmaceutical companies from the purchasing of advertising and reprints and the sponsoring of supplements. Is this funding corrupting journals?
Unhealthy spin - Public relations companies are experts at "third party technique"helping the drug industry separate the message from what could be seen as a self interested messenger. But most journalists have a sketchy idea about how the public relations industry works, and thereby are vulnerable to uncritically accepting the disguised messages of the drug industry
Relationships between the pharmaceutical industry and patients' organisations - Pharmaceutical companies and patients' organisations are unequal partners in a collaboration that has developed over the yearsand this raises serious questions
BMJ Reviews-Website Of The Week:Doctors and the drug industry
June 23, 2004-Drug Industry and HMOs Deployed an Army of Nearly 1,000 Lobbyists to Push Medicare Bill, Report Finds - Study Shows Special Interests Spent $141 Million in 2003, Hired 431 Lobbyists With Revolving Door Connections to Congress and the White House
The availability of references and the sponsorship of original research cited in pharmaceutical advertisements