Court Backs FDA’s Approval of the Anthrax Vaccine

October 1, 2009

By William T. Koustas

The United States Court of Appeals for the District of Columbia Circuit (“Court”) recently issued an opinion affirming the FDA’s (or “Agency”) approval of the anthrax vaccine for all known routes of infection and rejected the Plaintiffs’ efforts to enjoin the Defense Department from administering it.  Eight servicememebers (“Plaintiffs”) brought suit against FDA claiming that the Agency’s approval of the anthrax vaccine as effective was arbitrary and capricious as it relied on a study that could not “support a finding of effectiveness against anthrax contracted by inhalation” nor could the study support FDA’s findings that the current version of the anthrax vaccine is effective.  Rempfer v. Scharfstein, No. 08-5117 at 8 (D.C. Cir. Sept. 29, 2009).  The Court noted that the Plaintiffs did not contest the vaccine’s safety, only its effectiveness.  See id. at 8.

Plaintiffs’ first argument is that the main study relied on by FDA for approval of the current vaccine, the Brachman Study, included very few cases of inhalation anthrax and thus cannot support the Agency’s conclusion that the vaccine is effective against all routes of exposure.  See id. at 10.  However, the Court found that FDA used its scientific judgment to determine that the route of exposure is irrelevant to determining the efficacy of the anthrax vaccine.  See id. at 12.  Therefore, it was reasonable for FDA to determine the vaccine’s effectiveness based on all cases of anthrax exposure in the Brachman Study and FDA did not need to determine the vaccine is effective for inhalation routes of exposure separately.  As the Court stated:

…the plaintiff’s claim that the Brachman Study establishes nothing in regard to “inhalation anthrax” relies on the proposition that route of exposure is scientifically relevant.  But FDA’s contrary determination is a scientific judgment within its “area of expertise,” the kind of judgment to which this court gives a “high level of deference.”

Plaintiffs’ second contention is that the Brachman Study used an earlier version of the anthrax vaccine, so the results of that study cannot be applied to the current generation of vaccine. See id. at 13.  Again, the Court rejected this claim, noting that FDA has an established protocol for analyzing changes in the manufacturing process and that the new version of the vaccine has been tested in animals and in clinical studies demonstrating that the antibody response between all versions of the vaccine is similar.  2005 Final Order, 70 Fed. Reg. 75,180 (Dec. 19, 2005).  Therefore, the determination by FDA that the new version of the vaccine is just as effective as the version used in the Bachman Study is a scientific judgment which, as the Court previously explained, is entitled to “considerable deference.”  Rempfer at 14. 

With regard to Plaintiffs’ effort to enjoin the Defense Department from administering the vaccine, the Court affirmed the district court’s determination that Plaintiffs do not have standing to ask for such a remedy as they did not suffer an injury in fact.  See id. at 15.  Plaintiffs’ only alleged that military personnel whose vaccination series (the anthrax vaccine is a six-shot series) was interrupted due to a shortage in 2000-2002 were harmed because the Defense Department resumed the vaccinations after 2002 without taking the interim period into account.  See id.  However, the Court reasoned that since none of the plaintiffs are among those personnel whose vaccine series was interrupted, they did not have standing to ask for an injunction.  See id.

Categories: Drug Development