FDA announces progress on steps for avoiding drug shortages
The US Food and Drug Administration (FDA) yesterday announced the release of a strategic plan and expansion of early notification requirements aimed at further enhancing its efforts to avoid drug shortages and to solve them quickly when they do occur.
The strategic plan, called for by the FDA Safety and Innovation Act of 2012, outlines improvements in the agency's response to imminent or existing shortages, such as better communications about shortages and encouraging manufacturers to engage in practices to avoid shortages, the agency said in a news release. The plan also lays out approaches to address the manufacturing and quality issues that most often cause shortages, such as providing incentives for high-quality manufacturing.
A proposed rule on early notification requires manufacturers of drugs and biologic products considered medically important to report to the FDA any planned permanent discontinuation of an agent or foreseeable interruption in manufacturing that could affect supply. Early notification will give the agency time to work with manufacturers to correct problems, find other manufacturers to help fill needs, and speed up processing of other drugs that could mitigate the shortage, the FDA said.
Following an Oct 31, 2011, Executive Order to reduce drug shortages, the FDA helped prevent 195 shortages in 2011 and 282 in 2012, reducing the number of shortages from 251 in 2011 to 117 in 2012, according to the release.
Said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said, "The FDA continues to take all steps it can within its authority, but the FDA alone cannot solve shortages. Success depends upon a commitment from all stakeholders."
Oct 31 FDA news release
Proposed early notification rule
Florida county confirms state's 22nd dengue case
The Rio and Jensen Beach area on Florida's Atlantic coast has undergone the first-ever community survey for dengue fever in that state's Martin County and remains under a health advisory for the disease after 22 residents have had confirmed cases recently, according to reports yesterday.
More than 400 blood samples were drawn from residents. One case was confirmed during that testing, adding to the 21 cases confirmed earlier. An employee of an area business in which 4 of 6 employees had dengue has been hospitalized and may be the 23rd case.
Forty blood samples had inconclusive test results and are undergoing further evaluation, officials said. Results are expected in January. Questionnaires administered during the survey are being analyzed by the Florida Department of Health in Martin County, with results expected in March.
Residents are being told to drain standing water from potential mosquito breeding areas, cover their skin with clothing, use insect repellants outdoors, and make sure window screens are not damaged.
Oct 31 Martin County Department of Health press release
Oct 31 CBS12 News report
