WASHINGTON - Under a new rule, the FDA will begin requiring electronic submission of labeling information for most drug applications.
The agency believes electronic labeling will improve the review process and speed the approval and public dissemination of labeling changes, enabling it to get up-to-date information on medications to doctors and patients quicker. The rule was published in the Federal Register this week and will take effect in June.
It applies to new drug applications, certain biological license applications, abbreviated new drug applications, supplements and annual reports. The rule does not require full applications to be submitted electronically.
Nevertheless, FDA Commissioner Mark McClellan issued a prepared statement saying the use of modern information technology to improve public health is no longer optional at the agency.
"With mandatory electronic labeling, the FDA will be better able to ensure that information provided by products' sponsors is accurate and to communicate information that doctors and patients need in order to use a product," he said.
Electronic submissions will cover the content of the package insert or professional labeling, including all text, tables and figures.
The new labeling system is part of the FDA's larger initiatives involving electronic medical records and electronic health-information systems.
The agency said the final rule is intended to supplement existing requirements, which stipulate that copies of the label and labeling and specimens of enclosures be submitted. Indeed, copies of the package insert still must be submitted in an NDA, and they must be identical to the label and labeling and specimens of enclosures that appear in the package insert, on the immediate container, or in any other form distributed.
The complete rule can be viewed on the Federal Register, accessible via the FDA's website at www.fda.gov.
FDA Dedicates New Life Sciences Lab
The U.S. General Services Administration and the FDA Thursday dedicated the FDA's life sciences laboratory, the first building of the new FDA complex located at the Federal Research Center in White Oak, Md.
Completion of the building marks the end of Phase I for the agency's consolidation onto a single campus. The new facility has 124,000 square feet of laboratory space and is designed to accommodate the Center for Drug Evaluation and Research Office of Testing and Research, the Office of Compliance and certain sections of the Center for Devices and Radiological Health labs.
Approximately 130 people will work in the $43 million facility.
When complete, the new campus will include a number of interconnected buildings large enough to house 7,700 employees. The Center for Biological Evaluation and Research, the Office of Regulatory Affairs and the Office of the Commissioner eventually will be located on the site.
Currently, FDA offices are scattered among 45 leases in 38 buildings throughout suburban Maryland. The agency believes the consolidation will improve the efficiency of operations and enable its employees to use laboratory and office space more effectively, a statement from the agency said.
Medicare Legislation Eases Law On Reimporting Drugs
President Bush signed Medicare legislation this week that legalizes the practice of reimporting FDA-approved drugs from Canada, provided Tommy Thompson, secretary of Health and Human Services, certifies that it is safe. The law does not apply to biologics.
Similar legislation was approved under the Clinton administration, but never was implemented because former HHS Secretary Donna Shalala refused to endorse it, citing safety concerns.
Medicare reform legislation also settles issues surrounding reimbursement based on a drug's average wholesale price (AWP), a practice many believe is arbitrary and unfair because drug companies set the AWP. Under the new law, in 2004 the government will reimburse at 85 percent of the AWP (current reimbursement is 95 percent of AWP). In 2005 and 2006, the government will implement a new system of either competitive bidding or average sales price, plus 6 percent. (See BioWorld Today, Jan. 31, 2003.)
Henceforth, the Centers for Medicare and Medicaid will be forbidden from setting prices on certain drugs and biologics by deeming them as "functionally equivalent" to another product. (See BioWorld Today, Nov. 4, 2002, and Dec. 27, 2002.)
Generic makers get a break under Medicare reform, too, as the legislation stops innovator or brand-name companies from exploiting the Hatch-Waxman Act of 1984. It's been said generics have been stalled from entering the market by companies stacking 30-month extensions on patents.