FDA Plans Use of Unapproved Drugs in WMD Events

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http://www.nti.org/d_newswire/issues/2004_8_19.html#1443DBD3

> 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. "