Bioterrorism Preparedness Addressed On Capitol Hill, At FDA

Any facility that manufactures, processes, packs or holds food for consumption in the U.S. would have to register with HHS within 180 days of the enactment of a bioterrorism bill passed by the House Dec. 12.

The "Public Health Security & Bioterrorism Response Act" (HR 3448) would require all food facilities to submit "the identity and address of each facility at which, and all trade names under which, the registrant conducts business and...the general food category" of the products held there. Foreign drug manufacturers who import their products into the U.S. would have to register annually as well.

HHS or one of its agencies "shall compile and maintain an up-to-date list" of registered facilities and exempt establishments "only if [HHS] determines that the registration of such facilities is not needed for effective enforcement" of the legislation, the bill notes.

Sponsored by Commerce Committee Chairman Billy Tauzin (R-La.) and ranking Democrat John Dingell (Mich.), the bill aims to "improve the ability of the [U.S.] to prevent, prepare for and respond to bioterrorism and other public health emergencies." It was introduced in the House Dec. 11 and passed the next day by a suspension vote of 418-2.

Any firm seeking to import components of drugs or dietary supplements for further processing and export would have to identify the "chain of possession" of the article from manufacturer to importer, the bill notes.

The measure also gives "high priority to increasing the number of inspections...with greatest priority given to inspections to detect the intentional adulteration of food." The bill would provide FDA with $100 mil., some of which would go toward hiring more inspectors and developing methods to detect contaminated foods.

While Tauzin anticipated the bill would clear Congress by year-end, National Nutritional Foods Association Executive Director & CEO David Seckman said that "given the high volume of last-minute bills introduced before the holiday recess...it is unlikely a Senate version of HR 3448 will be introduced this year." The Senate has added $3.1 bil. in bioterrorism funding to its defense appropriations package, passed Dec. 7.

If the legislation does become law, "it may still be possible to obtain exemptions from regulatory mandates," Seckman added.

Another provision in the bill - the stockpiling of potassium iodide (KI) to prepare for a possible nuclear accident - also is addressed in an FDA guidance published in the Dec. 11 Federal Register. The guidance recommends KI be predistributed to individuals who potentially could be affected by radiation exposure.

"State and local governments choosing to incorporate KI into their emergency response plans may consider... predistribution of KI to those individuals who do not have a medical condition precluding its use," it states.

"As time is of the essence in optimal prophylaxis with KI, timely administration to the public is a critical consideration in planning the...response to a radiation accident and requires a ready supply of KI," the document adds, noting "the overall benefits of KI far exceed the risks of overdosing, especially in children."

Persons with known iodine sensitivity should avoid KI, as should individuals with dermatitis herpetiformis and hypocomplementemic vasculitis.

An update of a 1982 document, the guidance contains new dosing recommendations based on an analysis of data from the 1986 Chernobyl accident. The guidance generally recommends that people over 18 take 130 mg KI per day, while children over three take 65 mg/d and children under three take 32 mg/d to protect against the effects of radioactive iodine.

Companies that sell KI tablets include Palm Harbor, Fla.-based Anbex.com ( IOSAT ) and Littleton, Colo.-based U.S. Disaster Preparedness Institute ( Rad Block ). While Anbex primarily provides its OTC tablets to government agencies, USPDI sells 200-count bottles for $16.95 on its Web site, www.uspdi.org.

The guidance follows legislation (HR 3279) introduced Nov. 13 by Rep. Ed Markey (D-Mass.) that would require stockpiling potassium iodide at public facilities within 200 miles of nuclear power plants.

In addition to issuing the guidance, FDA's Center for Drug Evaluation & Research is developing a strategic plan for counter-terrorism initiatives. In a Dec. 7 memo, CDER Acting Director Steven Galson, MD, said he would be working on the report for the next two months with Division of Pulmonary & Allergy Drug Products Director Robert Meyer, MD.

Meyer's absence at the division could affect the timing of an FDA decision regarding the Rx-to-OTC switch of the antihistamines Claritin (Schering-Plough), Allegra (Aventis) and Zyrtec (Pfizer).