June 11, 2010
VIA FACSIMILE AND USP
Mr. David Wright
President and CEO
One Park Place, Suite 450
Annapolis, Md 21401
Bacillus anthracis Recombinant Protective Antigen 102 (rPA; E. Coli) (anthrax) vaccine -b(4)---
Dear Mr. Wright:
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 Product Fact Sheet entitled “SparVax™ – Recombinant Protective Antigen (rPA) Anthrax Vaccine-Novel Second Generation Vaccine Technology” for your investigational product Bacillus anthracis Recombinant Protective Antigen 102 (rPA; E. Coli) (anthrax) vaccine -b(4)---. The product fact sheet contains false or misleading statements that represent your product as safe and effective for the purposes for which it is being investigated. This is problematic from a public health perspective because it suggests that SparVax is safe and effective when the product has not yet been approved by FDA and the promotional claims have yet to be demonstrated by substantial evidence or substantial clinical experience. As a result, these materials misbrand your investigational product in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(a)&(n), and 321(n), and FDA’s implementing regulations. (See 21 CFR 312.7(a)).
Bacillus anthracis Recombinant Protective Antigen 102 (rPA; E. Coli (anthrax) vaccine --b(4)------ is a drug under section 201(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]. Additionally, your product is an investigational vaccine currently under review by the FDA subject to an IND that is in effect.
Promotion of an Investigational Product
According to 21 CFR 312.7(a), a sponsor or investigator, or any person acting on behalf of a sponsor or investigator, “shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug." 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.
The product fact sheet contains the following misleading claims that promote either the efficacy or safety of your investigational product:
- “Phase I and Phase II clinical trials involving 770 healthy human subjects have been completed and showed that SparVax™ appears to be well tolerated and induces an immune response in humans.”
- “These studies suggest that three doses of SparVax™, administered over approximately 60 days, should be sufficient to induce protective immunity in humans.”
These claims strongly suggest that the vaccine will be safe and effective. Moreover, the claims are misleading because the product fact sheet reveals that there is no data to support the efficacy and the risks associated with the vaccine.
Conclusion and Requested Actions
For reasons discussed above, the product fact sheet misbrands your investigational anthrax vaccine in violation of the Act, U.S.C. 352(a) & (n) and 321 (n), and FDA’s implementing regulations 21 CFR 312.7(a).
OCBQ requests that PharmAthene 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 SparVax, such as those described above, and explaining your plan for discontinuing use of such materials. Because the violations described above are serious, we further request 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 Lisa Stockbridge, Ph.D., Acting Branch Chief, at the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, Division of Case Management, Advertising and Promotional Labeling Branch (APLB), HFM-602, 1401 Rockville Pike, Rockville, Maryland 20852-1448. In all future correspondence regarding this matter, please refer to the IND number. 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 SparVax comply with each applicable requirement of the Act and FDA's implementing regulations.
Robert A. Sausville
Division of Case Management
Center for Biologics Evaluation and Research
Enclosure: Product Fact Sheet