Washington Editor

WASHINGTON - The FDA is expected to publish a proposed rule later this year requiring that all medication packages carry an identifying bar code.

But manufacturers will have plenty of time to adjust. Typically, when a rule is published, the agency builds in a 60-to-90-day comment period, and if approved, implementation takes several months to a year.

Already, the agency has solicited comments from the health care and pharmaceutical industries, and as expected, health care professionals viewed mandatory bar coding as a good idea while business people approached the subject more cautiously in an eight-hour public hearing held late last month in Bethesda, Md. (See BioWorld Today, July 30, 2002.)

The type of information that would be contained within the bar code also remains a subject of debate. At the public hearing, speakers generally agreed that information in the code should include the National Drug Code (NDC), the lot number (a code that identifies when and where the product was made) and the expiration date.

Government officials began considering a bar code requirement on release of the Institute of Medicine's 1999 report "To Err is Human: Building a Safer Health System," which said more than 100,000 people die every year in U.S. hospitals due to preventable medical errors, often related to drugs.

Tommy Thompson, secretary of Health and Human Services, will make the final decision whether to require bar codes on drugs, biologics and possibly medical devices.

Tufts Says User Fees Decrease Approval Times

The average time it takes the FDA to approve a biopharmaceutical has dropped 4.6 months since the mid-1990s, according to a recently released study from the Tufts Center for the Study of Drug Development in Boston.

And Tufts credits the decade-old Prescription Drug User Fee Act (PDUFA) with shortening the review periods.

According to the study, the average approval times for priority-reviewed new chemical entities (NCEs) and new biopharmaceuticals decreased by 40 percent and 37 percent, respectively, between fiscal years 1994-1997 and fiscal years 1998-2000. The average approval time declined from 11.9 months to 7.1 months for NCEs submitted in fiscal 1994-97 compared to those submitted in fiscal 1998-2000, and dropped from 12.6 months to eight months for biopharmaceuticals during the same period.

Furthermore, in 1998-2000 the average approval times for priority-reviewed NCEs and new biopharmaceuticals were 59 percent and 64 percent shorter, respectively, than those for standard-review products, Tufts' said late last month.

Initially approved in 1992, and reauthorized five years later, PDUFA allows the FDA to charge biotechnology and pharmaceutical companies a fee when they file drug applications. PDUFA II (reauthorized in 1997) expires in September, and already it has been reauthorized for another five years.

Under PDUFA III, the cost of drug applications will increase from the current rate of about $300,000 to about $400,000 in the first year. The agency's income from the fees will increase from roughly $160 million in 2001 to $223 million in 2003, with the amount expected to reach $260 million by 2007. Fees collected through PDUFA help the FDA pay salaries of additional scientists needed to review applications.

Congresswoman In Patent Debate Loses Seat

Rep. Lynn Rivers, a Democrat from Michigan who introduced legislation that would allow scientists to conduct research using patented genetic sequence information without obtaining permission from the patent's owner, will not return for another term in the House of Representatives.

Elected in 1994, Rivers lost her seat in the Democratic primary to Rep. John Dingell (D-Mich.), who has served in Congress for 47 years. Redistricting forced the Democrats to run against each other.

Introduced in the spring, Rivers' bill (HR3967) also would allow medical practitioners to freely use patented genetic diagnostic tests without fear of lawsuits. (See BioWorld Today, April 1, 2002.)

The legislation was co-sponsored by Rep. Dave Weldon (R-Fla.), who also faces re-election in November. The Florida primary is Sept. 10.