Inspections, Compliance, Enforcement, and Criminal Investigations
VaxGen Inc. 24-Mar-06
Department of Health and Human Services
Public Health Service
Center for Biologics Evaluation and
March 24, 2006
VIA FACSIMIIE AND CERTIFIED MAIIL
RETURN RECEIPT REQUESTED
Ms. Carmen Betancourt
Senior Vice President, Regulatory Affairs
1000 Marina Boulevard, Suite 200
Brisbane, CA 94005
Bacillus anthracis Recombinant Protective Antigen 102 (rPA102) (anthrax vaccine) with Alum
Dear Ms. Betancourt:
The Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) has reviewed a Question and Answer document distributed by your firm's sales representatives at a promotional booth in connection with the 4'h Annual Federal Biodefense Research FY 2006 meeting, October 17-19, 2005, in Washington, DC (copy enclosed) entitled, "Questions and Answers About VaxGen's Anthrax Vaccine Bioshield Contract," for your investigational product Bacillus anthracis Recombinant Protective Antigen 102 (rPA102) (anthrax vaccine) with Alum. The Question and Answer document contains false or misleading statements that represent your product as safe or effective for the purposes for which it is being investigated . As a result, this material misbrands your investigational product under section 502(a) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(a), and violates sections 312.6(b) and 312.7(a) of Title 21 of the Code of Federal Regulations (CFR).
Bacillus anthracis Recombinant Protective Antigen 102 (rPA102) (anthrax vaccine) with Alum is a drug under section 20i(g) of the Act [21 U.S.C.§. 321(g)] and a biologic as defined in section 351(i) of the Public Health Service Act, (PHS Act) [42 U.S.C. § 262].
False or Misleading. Statements
The following statements in your Question and Answer document, which promote the efficacy and safety of your investigational product, are false or misleading:
"Modem recombinant technology has allowed VaxGen to consistently produce the vaccine at nearly 100 percent purity -- significantly higher than what can be obtained using older technologies such as Bioport's. . . . Bioport's product is less consistent and has greater impurities than VaxGen's rPA102."
"It is false or misleading for you to make any claims about the consistency. of your vaccine production at this early stage of product development. You have not yet [redacted]. Consequently, it is simply premature for you to claim that you can consistently produce this product "at nearly 100% purity."
"Phase I data from humans indicate that VaxGen's anthrax vaccine induces an - immune response that is comparable to the ones induced by BioPort's vaccine. . . . The immune responses generated by rPAl 02 in humans were comparable to the ones that protected animals from inhalation anthrax."
This is false or misleading in that during the referenced Phase 1 study [redacted] doses of VaxGen's vaccine resulted in immune responses comparable to those elicited by only [redacted] doses of Bioport's vaccine. An accurate dose comparison would, at a minimum, be based on testing the same number of doses of each product.
"VaxGen's vaccine requires significantly fewer doses for protection, and people receiving it will achieve the immune response in a far less time than they would with BioPort's vaccine."
That statement is false and misleading because it is premature to make any comparative claims about dosages or effectiveness at this early stage in your vaccine's development.
The material mentioned above, generated and disseminated by VaxGen, is labeling for your product. 21 U.S.C. 321(m). Consequently, by bearing false and misleading statements about your investigational product, the material misbrands your investigational product under section 502(a) of the Act and also violates 21 CFR 312.6(b).
In addition, your product is an investigational drug currently under review by the FDA subject to an IND that is in effect. Consequently, the product's labeling "shall not represent that the investigational new drug is safe or effective for the purposes for which it is being investigated." 21 CFR 312 .6(b). Furthermore, you may not promote your investigational product. Specifically, under the investigational new drug regulations, a sponsor or investigator, or any person acting on behalf of a sponsor or investigator, "shall not represent in a promotional context that an investigationa.l new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug." 21 CFR 312.7(a). While that provision "is not intended to restrict the full exchange of scientific information concerning the drug," its intent is "to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation . . . ." Id.
Conclusion and Requested Actions
Your material misbrands your investigational anthrax vaccine within the meaning of section 502(a) of the Act and violates 21 CFR 312.6(b) because it is labeling that contains false or misleading statements about the product. The material also violates 21 CFR 312.6(b) because it represents that your product is safe or effective for the purposes for which it is being investigated, and violates 21 CFR 312.7(a) because it promotes your investigational product, and represents in a promotional context that it is safe and effective for the purposes for which it is under investigation.
OCBQ requests that VaxGen, Inc. immediately cease the dissemination of violative material for your investigational anthrax vaccine such as described above. Please submit a written response within ten (10) business days of the date of this letter, stating whether you intend to comply with this request, listing all violative materials for your investigational anthrax vaccine such as those described above, and explaining your plan for discontinuing use of such materials. Because the violations described above are serious, we request, further, that your submission include a plan of action to disseminate truthful, non-misleading, and complete information to the audience(s) that received the violative material. Please direct your response to me at the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, HFM- 600, 1401 Rockville Pike, Rockville, Maryland 20852-1448. In all future correspondence regarding this matter, please refer to the IND number and to CBER-06-004. We remind you that only written communications are considered official responses.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your materials for your investigational anthrax vaccine comply with each applicable requirement of the Act and FDA's implementing regulations. Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.
Mary A. Malarkey
Director, Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research