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FDA Plans Use of Unapproved Drugs in WMD Events

By Joe Fiorill
Global Security Newswire

WASHINGTON — The U.S. Food and Drug Administration has begun preparing for the use of otherwise unapproved vaccines and treatments in the event of a WMD emergency.
The agency is drafting guidelines on an emergency-use capability authorized in the Project Bioshield law signed a month ago by President George W. Bush, FDA Assistant Commissioner for Counterterrorism Margaret Glavin said last week (see GSN, July 21).
“You can’t anticipate every possible situation, so what we’re trying to do is to lay out a thought process, rather than specific procedures and specific decision rules,” Glavin said in an interview.

The agency, which takes an average of 12 years to approve drugs for use in the United States, is developing the emergency-use guidelines in consultation with other bodies that would be involved in administering the unapproved drugs. The goal, Glavin said, is for the agencies to reach a “common understanding of what the boundaries are.”

The best-publicized component of Bioshield is the creation of a government-guaranteed market for otherwise unprofitable WMD countermeasures, which drug makers do not currently produce in quantities sufficient for a large attack.

A separate provision of the new law allows the health and human services secretary to declare a one-year emergency, in the event of a WMD attack on the United States, during which drugs that lack FDA approval or are approved for other purposes may be used to combat biological or chemical agents or radiation.

Although the health secretary is responsible for formally declaring any emergency under the provision, the determination that the declaration is needed can also originate with the defense or homeland security secretary. The health secretary must also consult with the heads of the National Institutes of Health and Centers for Disease Control and Prevention before authorizing any specific unapproved product for use in a given emergency.

Glavin said her agency would be central in any emergency-use decisions. “We see the authorizations as coming from the [FDA] commissioner under existing … authority. … We would be the operating entity within HHS to do the work on it,” she said.

Liability Questions Remain Unresolved

Even though Bioshield is now law, the legal status of emergency-approved drugs under the legislation remains unclear, potentially limiting the law’s effectiveness in sparking drug development (see GSN, July 26). “Bioshield II” legislation planned for later this year by Senators Joe Lieberman (D-Conn.) and Orrin Hatch (R-Utah) would address matters including manufacturers’ concerns about legal liability for damages from Bioshield-related drugs.

Meanwhile, the FDA is considering the creation of a new regulatory category for otherwise unapproved drugs that are potentially useful in a WMD emergency, according to Bioshield expert Stephen Prior, who directs the National Security Health Policy Center at the Potomac Institute for Policy Studies. Providing such a status to certain drugs could ease liability concerns and smooth the emergency-authorization process in time of need.

The usefulness of a new drug category is clear, Prior said yesterday in an interview. If an attack warranting an emergency-use authorization occurred tomorrow, he said, the current legal uncertainty could necessitate a presidential order accepting total government liability for damages.

“That’s not a good way to go for the government, to just take on unwarranted levels of indemnification, but they will do that in an emergency if there’s no other recourse,” Prior said.

Bioshield stipulates that the health secretary “may” impose conditions on emergency use that include informing patients of the option and possible consequences of refusing emergency-authorized drugs.

Such measures would probably be less cumbersome than those commonly taken for medicines granted an existing investigational new drug status, which allows activities such as transporting unapproved drugs across state lines and testing them on consenting subjects. Bioshield stipulates that authorizing drugs for emergency use does not grant them investigational new drug status.

National Institute of Allergy and Infectious Diseases Director Anthony Fauci last year told a House of Representatives subcommittee that, although investigational new drugs could sometimes be used in emergencies under existing laws, the amount of paperwork they required would prevent large-scale use.

“If you have to vaccinate 10 million people,” Fauci said, “there isn’t a chance that you’re going to be able to do that under an investigational new drug, so what the [Bioshield emergency-use] proposal says is that [there can be] something between a full licensure and something that is an investigational drug.”

According to Prior, the Bioshield emergency-use authorization could lead to storage of unapproved drugs in the Strategic National Stockpile of emergency countermeasures, potentially resolving a long-standing debate over the legality of including investigational new drugs in the stockpile. FDA rules that govern distribution of drugs should not apply to the stockpile, Prior said, since the stockpile “is only used under specific authorization” and “is not a general distribution system.”

“The purpose of the Bioshield legislation is to create an environment in which those products which could become part of the Strategic National Stockpile could be developed and, if necessary, purchased,” Prior said.

Glavin said Bioshield’s usefulness is in providing options for “circumstances where doing something is better than doing nothing.” Existing FDA powers such as the conferral of investigational new drug status, she said, would be of limited use in a large-scale emergency.

“They really don’t contemplate a mass-casualty situation,” she said, “and they don’t contemplate what Bioshield contemplates, which is an act of terror in which some larger number of individuals could be affected and in which time is of the essence.”
A drug authorized in an emergency could carry risks, Glavin said, but the scenario implies that a greater and more immediate danger is already present. An unproven drug could be the only hope in such a situation, she said, “and it might be better to use it than not.”