Given FDA Order, Bush Lawyers Ask Court To Reverse Anthrax Ruling
Inside The Pentagon
Elaine M. Grossman
With a new order in hand from the Food and Drug Administration that supports the use of anthrax vaccine to prevent an inhaled form of the disease, Justice Department attorneys late last month asked a federal appeals court in Washington to reverse "on the merits" a lower court decision banning mandatory shots for military personnel.
Defense Department leaders argue the vaccine is necessary to protect personnel in high-risk areas from becoming infected if an adversary releases anthrax spores into the air.
In October 2004, U.S. District Court Judge Emmet Sullivan issued an injunction against involuntary anthrax inoculations, saying the FDA had not yet completed a longstanding review to formally approve the drug. The court considered the vaccine "investigational" -- in other words, uncertified as safe and effective for protection against inhaled anthrax, according to Sullivan's opinion.
Title 10 of the U.S. Code requires the "informed consent" of military personnel in taking unapproved or investigational drugs. To override that requirement and mandate inoculations, the president could issue a waiver based on national security concerns. But both the Clinton and Bush administrations have insisted the anthrax vaccine is not investigational for such a use, and no presidential waiver has been issued.
Sullivan's finding constituted a win for six anonymous military plaintiffs who filed a lawsuit in March 2003 to stop the mandatory shots.
In December 2004, following Sullivan's summary judgment on the case, the FDA opened a 90-day public comment period on its proposal that the anthrax vaccine is "safe and effective and not misbranded." After reviewing the public comments, FDA last month issued a final rule and order certifying the vaccine.
In the document, the agency said it "agrees" with a March 2002 finding by the National Academy of Sciences' Institute of Medicine "that certain studies in humans and animal models support the conclusion that [anthrax vaccine] is effective" against the disease, "regardless of the route of exposure."
"The FDA's analysis continues to be fundamentally flawed because they have failed to acknowledge that although the mechanism for anthrax [infection] appears to be universal, the widely differing mortality rates based on route of exposure have significant implications for vaccine efficacy," responds one source who is critical of the government position.
The U.S. government has said that more than 90 percent of individuals who contract inhaled anthrax may die of the disease, but fatality rates are less than 20 percent for those who become infected through the skin. Use of antibiotics promptly after exposure to anthrax can significantly lower fatality rates, according to the Centers for Disease Control and Prevention.
The existing FDA-approved label is not specific about the protection the vaccine offers against various types of exposure.
"A vaccine that can protect against low levels of infection may not be sufficient at high levels," asserts the government critic. Advanced efficacy testing that might have gone beyond the contested 1950s-era "Brachman study" in proving the vaccine's ability to prevent inhaled disease was never demanded by FDA and never carried out, this source contends.
"They can't do anything about it now -- it's too late," according to this source, who demanded anonymity while the case remains pending before the court. "The vaccine was improperly licensed from the beginning." For its part, the FDA disputes a 1985 government advisory panel's finding that the vaccine is 93 percent effective against cutaneous anthrax only, saying instead in its new order that the calculation "pertains to both cutaneous and inhalation anthrax."
The contentious debate over vaccine efficacy, however, is not central to the current case, which was decided by the lower court principally on a question of procedure.
Last summer, the Bush administration took Sullivan's decision to the DC Circuit of the U.S. Court of Appeals. Now, following the latest FDA action, government attorneys are asking the three-judge appeals panel to review the status of the case.
"In light of the FDA's Dec. 19 order, the district court's permanent injunction has by its terms expired," the administration lawyers argued two days later in a written motion on behalf of the Defense Department.
The Justice attorneys say the appeals court could now declare the issue moot, vacate Sullivan's decision and lift the ban on involuntary inoculations. But the administration would prefer that the judges go a significant step further -- to decide the case in their favor and explicitly reject the lower court's basis for prohibiting the mandatory shots in the first place.
"We do not believe . . . that the appeal of the [lower court's] final judgment has become moot" because of the FDA action, the Dec. 21 document states. "The final judgment reflects the district court's erroneous conclusion that the 1970 licensure does not encompass use against inhalation anthrax, and there remains a live dispute between the parties regarding the scope of that license."
Rather than replace or supersede the vaccine's original 1970 license, the new agency order instead "completes the FDA's review of the 1970 license[;] confirms the FDA's interpretation of the 1970 license to include inhalation anthrax; and sets forth the FDA's current expert judgment, based on the presently available scientific evidence, that the vaccine is safe and effective for that use," according to last month's brief.
The government attorneys appear concerned that, if left as the decision of record, Sullivan's declaration that the Pentagon's shots program was "illegal absent informed consent or a presidential waiver" implies "that DOD's mandatory program became legal not in 1970, but on Dec. 19, 2005," in the words of the brief.
Beginning in May 1998, more than 1 million military personnel and defense employees were inoculated involuntarily (Inside the Pentagon, Oct. 24, 2004, p1). The Pentagon restarted shots last spring, but only on a voluntary basis (ITP, May 5, 2005, p5).
Since the mandatory shots effort was launched, hundreds of service personnel have faced court-martial or administrative discipline for refusing the order to take the vaccine, which is to be given in six doses over an 18-month period. Some of those cases are currently pending before the U.S. Court of Appeals for the Armed Forces, where oral arguments were heard last month.
If the DC Circuit Court does not reverse on the merits Sullivan's finding that the Pentagon's inoculation program was illegal, that could significantly strengthen the case of military defendants who assert they were resisting an illegal order to take the shots, according to some observers.
One reason the federal appeals court may not simply declare the case moot at this juncture is a pending question the judicial panel raised last month. The judges asked both sides whether the anthrax vaccine must be considered a "drug unapproved for its applied use" under Title 10 because it was originally licensed in a manner that law does not recognize (ITP, Dec. 8, 2005, p2).
In a written argument submitted to the court, the military plaintiffs who brought the suit supported the view that, under Title 10, the vaccine must be considered unapproved.
The Public Health Service Act (PHSA), under which use of anthrax vaccine was initially approved, "holds vaccines to a different and lower standard for licensing," attorneys for the service members argued. Given the Pentagon desire to mandate inoculations using this particular vaccine, "Congress' concern about a lack-of-effectiveness standard was not misplaced," they stated in a Dec. 19 brief to the federal appeals court.
But the government asserted in its own supplemental briefs that all vaccines are approved in the same manner, and "there is no basis for concluding that Congress intended" to prohibit the Pentagon from administering any mandatory inoculations at all, to include not only anthrax but also yellow fever and polio.
In a friend-of-the-court brief filed this week, Connecticut Attorney General Richard Blumenthal disputes that notion as one among "a parade of horribles" the government has alleged would ensue if the appeals panel finds the anthrax vaccine invalid under Title 10.
Administration lawyers "seem to assert that invalidating [anthrax vaccine] would invalidate all other PHSA licenses, and prevent mandatory use of such drugs by the military . . . This is not true," Blumenthal writes. "Though old, PHSA-licensed drugs do not need new licenses, such drugs still must comply" with up-to-date requirements for "safety, efficacy and labeling," he asserts.
The Justice attorneys concede in their latest motion that the supplemental briefing "issue remains live even after the FDA's Dec. 19 order."
They also seek an appeals reversal of the "false premise that worldwide injunctions against the military should be freely available in non-class actions."
In his summary judgment, Sullivan accepted the plaintiffs' argument that the ban on shots should be implemented across the military because the program is not illegal simply for the six individuals who filed the suit.
A principal basis for finding the vaccine was not labeled for inhalation anthrax was that the vaccine manufacturer applied to the FDA for an "investigational new drug" study on that proposed use in September 1996, as the Defense Department was preparing its massive inoculation program. The application remained active at FDA until the government withdrew it in January 2004, shortly after Sullivan issued a preliminary injunction.
Last July, the complainants said a discussion of the application for a license amendment was "inexplicably missing from the government's brief" to the D.C. Circuit Court of Appeals and argued the issue is "absolutely essential to understanding the ultimate success of plaintiffs' claims" (ITP, Aug. 4, 2005, p1).
"In fact," the plaintiffs said later in the same filing, "the district court's preliminary injunction was based on the undisputed investigational new drug status of the vaccine, as established by the defendants' own documents."
Government attorneys argued in August the submission of the application "was not triggered by any regulatory action on the part of the FDA, nor could its filing by the manufacturer purport to speak on behalf of the FDA as to the scope of [the anthrax vaccine] license" (ITP, Sept. 1, 2005, p3).
Elaine M. Grossman
With a new order in hand from the Food and Drug Administration that supports the use of anthrax vaccine to prevent an inhaled form of the disease, Justice Department attorneys late last month asked a federal appeals court in Washington to reverse "on the merits" a lower court decision banning mandatory shots for military personnel.
Defense Department leaders argue the vaccine is necessary to protect personnel in high-risk areas from becoming infected if an adversary releases anthrax spores into the air.
In October 2004, U.S. District Court Judge Emmet Sullivan issued an injunction against involuntary anthrax inoculations, saying the FDA had not yet completed a longstanding review to formally approve the drug. The court considered the vaccine "investigational" -- in other words, uncertified as safe and effective for protection against inhaled anthrax, according to Sullivan's opinion.
Title 10 of the U.S. Code requires the "informed consent" of military personnel in taking unapproved or investigational drugs. To override that requirement and mandate inoculations, the president could issue a waiver based on national security concerns. But both the Clinton and Bush administrations have insisted the anthrax vaccine is not investigational for such a use, and no presidential waiver has been issued.
Sullivan's finding constituted a win for six anonymous military plaintiffs who filed a lawsuit in March 2003 to stop the mandatory shots.
In December 2004, following Sullivan's summary judgment on the case, the FDA opened a 90-day public comment period on its proposal that the anthrax vaccine is "safe and effective and not misbranded." After reviewing the public comments, FDA last month issued a final rule and order certifying the vaccine.
In the document, the agency said it "agrees" with a March 2002 finding by the National Academy of Sciences' Institute of Medicine "that certain studies in humans and animal models support the conclusion that [anthrax vaccine] is effective" against the disease, "regardless of the route of exposure."
"The FDA's analysis continues to be fundamentally flawed because they have failed to acknowledge that although the mechanism for anthrax [infection] appears to be universal, the widely differing mortality rates based on route of exposure have significant implications for vaccine efficacy," responds one source who is critical of the government position.
The U.S. government has said that more than 90 percent of individuals who contract inhaled anthrax may die of the disease, but fatality rates are less than 20 percent for those who become infected through the skin. Use of antibiotics promptly after exposure to anthrax can significantly lower fatality rates, according to the Centers for Disease Control and Prevention.
The existing FDA-approved label is not specific about the protection the vaccine offers against various types of exposure.
"A vaccine that can protect against low levels of infection may not be sufficient at high levels," asserts the government critic. Advanced efficacy testing that might have gone beyond the contested 1950s-era "Brachman study" in proving the vaccine's ability to prevent inhaled disease was never demanded by FDA and never carried out, this source contends.
"They can't do anything about it now -- it's too late," according to this source, who demanded anonymity while the case remains pending before the court. "The vaccine was improperly licensed from the beginning." For its part, the FDA disputes a 1985 government advisory panel's finding that the vaccine is 93 percent effective against cutaneous anthrax only, saying instead in its new order that the calculation "pertains to both cutaneous and inhalation anthrax."
The contentious debate over vaccine efficacy, however, is not central to the current case, which was decided by the lower court principally on a question of procedure.
Last summer, the Bush administration took Sullivan's decision to the DC Circuit of the U.S. Court of Appeals. Now, following the latest FDA action, government attorneys are asking the three-judge appeals panel to review the status of the case.
"In light of the FDA's Dec. 19 order, the district court's permanent injunction has by its terms expired," the administration lawyers argued two days later in a written motion on behalf of the Defense Department.
The Justice attorneys say the appeals court could now declare the issue moot, vacate Sullivan's decision and lift the ban on involuntary inoculations. But the administration would prefer that the judges go a significant step further -- to decide the case in their favor and explicitly reject the lower court's basis for prohibiting the mandatory shots in the first place.
"We do not believe . . . that the appeal of the [lower court's] final judgment has become moot" because of the FDA action, the Dec. 21 document states. "The final judgment reflects the district court's erroneous conclusion that the 1970 licensure does not encompass use against inhalation anthrax, and there remains a live dispute between the parties regarding the scope of that license."
Rather than replace or supersede the vaccine's original 1970 license, the new agency order instead "completes the FDA's review of the 1970 license[;] confirms the FDA's interpretation of the 1970 license to include inhalation anthrax; and sets forth the FDA's current expert judgment, based on the presently available scientific evidence, that the vaccine is safe and effective for that use," according to last month's brief.
The government attorneys appear concerned that, if left as the decision of record, Sullivan's declaration that the Pentagon's shots program was "illegal absent informed consent or a presidential waiver" implies "that DOD's mandatory program became legal not in 1970, but on Dec. 19, 2005," in the words of the brief.
Beginning in May 1998, more than 1 million military personnel and defense employees were inoculated involuntarily (Inside the Pentagon, Oct. 24, 2004, p1). The Pentagon restarted shots last spring, but only on a voluntary basis (ITP, May 5, 2005, p5).
Since the mandatory shots effort was launched, hundreds of service personnel have faced court-martial or administrative discipline for refusing the order to take the vaccine, which is to be given in six doses over an 18-month period. Some of those cases are currently pending before the U.S. Court of Appeals for the Armed Forces, where oral arguments were heard last month.
If the DC Circuit Court does not reverse on the merits Sullivan's finding that the Pentagon's inoculation program was illegal, that could significantly strengthen the case of military defendants who assert they were resisting an illegal order to take the shots, according to some observers.
One reason the federal appeals court may not simply declare the case moot at this juncture is a pending question the judicial panel raised last month. The judges asked both sides whether the anthrax vaccine must be considered a "drug unapproved for its applied use" under Title 10 because it was originally licensed in a manner that law does not recognize (ITP, Dec. 8, 2005, p2).
In a written argument submitted to the court, the military plaintiffs who brought the suit supported the view that, under Title 10, the vaccine must be considered unapproved.
The Public Health Service Act (PHSA), under which use of anthrax vaccine was initially approved, "holds vaccines to a different and lower standard for licensing," attorneys for the service members argued. Given the Pentagon desire to mandate inoculations using this particular vaccine, "Congress' concern about a lack-of-effectiveness standard was not misplaced," they stated in a Dec. 19 brief to the federal appeals court.
But the government asserted in its own supplemental briefs that all vaccines are approved in the same manner, and "there is no basis for concluding that Congress intended" to prohibit the Pentagon from administering any mandatory inoculations at all, to include not only anthrax but also yellow fever and polio.
In a friend-of-the-court brief filed this week, Connecticut Attorney General Richard Blumenthal disputes that notion as one among "a parade of horribles" the government has alleged would ensue if the appeals panel finds the anthrax vaccine invalid under Title 10.
Administration lawyers "seem to assert that invalidating [anthrax vaccine] would invalidate all other PHSA licenses, and prevent mandatory use of such drugs by the military . . . This is not true," Blumenthal writes. "Though old, PHSA-licensed drugs do not need new licenses, such drugs still must comply" with up-to-date requirements for "safety, efficacy and labeling," he asserts.
The Justice attorneys concede in their latest motion that the supplemental briefing "issue remains live even after the FDA's Dec. 19 order."
They also seek an appeals reversal of the "false premise that worldwide injunctions against the military should be freely available in non-class actions."
In his summary judgment, Sullivan accepted the plaintiffs' argument that the ban on shots should be implemented across the military because the program is not illegal simply for the six individuals who filed the suit.
A principal basis for finding the vaccine was not labeled for inhalation anthrax was that the vaccine manufacturer applied to the FDA for an "investigational new drug" study on that proposed use in September 1996, as the Defense Department was preparing its massive inoculation program. The application remained active at FDA until the government withdrew it in January 2004, shortly after Sullivan issued a preliminary injunction.
Last July, the complainants said a discussion of the application for a license amendment was "inexplicably missing from the government's brief" to the D.C. Circuit Court of Appeals and argued the issue is "absolutely essential to understanding the ultimate success of plaintiffs' claims" (ITP, Aug. 4, 2005, p1).
"In fact," the plaintiffs said later in the same filing, "the district court's preliminary injunction was based on the undisputed investigational new drug status of the vaccine, as established by the defendants' own documents."
Government attorneys argued in August the submission of the application "was not triggered by any regulatory action on the part of the FDA, nor could its filing by the manufacturer purport to speak on behalf of the FDA as to the scope of [the anthrax vaccine] license" (ITP, Sept. 1, 2005, p3).
