FDA advisors declare ‘FDA science and mission at risk’
According to a subcommittee of the U.S. Food and Drug Administration’s Science Board, the nation’s food supply is at risk, as are the regulatory systems that oversee the nation’s drug and device supplies. In a report presented in December, the subcommittee attributed the deficiencies to increased demands on FDA and resources that have not increased in proportion to those demands. Committee members conclude that “this imbalance is imposing a significant risk to the integrity of the food, drug, cosmetic, and device regulatory system, and hence the safety of the public.”
The result of a year-long review by a distinguished panel of experts, the subcommittee’s 300-page report concludes that the state of FDA’s scientific and regulatory programs could not be separated from the lack of resources. It urged funds to support the agency’s scientific base, hire a broadly capable scientific workforce, and build a sophisticated, modern information technology infrastructure.
Upon the report’s release, Don Kennedy, PhD, a former FDA commissioner and editor-in-chief of Science magazine, and also a member of the FDA Alliance, an advocacy organization formed in 2006, commented that “FDA can’t improve its science, prepare for the future, or protect American consumers without significant additional resources. Congress is negotiating FDA’s FY 2008 [current year] budget right now and can start to fix this critical problem.”
The cry for more FDA resources was echoed by the Coalition for a Stronger FDA, which comprises patient groups, non-profit organizations, consumer and public health advocates, and innovative companies
with the goal of working alongside policymakers to bolster and preserve public confidence in FDA. “Over the last decade, complex scientific advances, globalization, and challenging new safety issues have combined to multiply the responsibilities of the FDA. As this new report makes clear, our expectations cannot exceed the resources we give FDA to accomplish its mission. In this regard, more is definitely better,” said Mark McClellan, MD, former FDA commissioner and chairman of the new Reagan-Udall Institute.
compiled by Carrie Meadows
USP <797> revisions now available
The U.S. Pharmacopeia has posted the Revision Bulletin containing changes to General Chapter Pharmaceutical Compounding–Sterile Preparations <797> on its web site at http://www.usp.org/USPNF/pf/generalChapter797.html. The revisions will become official on June 1, 2008, and will be included in USP 32???NF 27 and the upcoming second edition of Pharmacists’ Pharmacopeia. USP says that the revised standards are being published online “to give the compounding community time to implement changes before the official date.”
BASF completes European electronic materials center
The Electronic Materials Center Europe at BASF’s Ludwigshafen, Germany site is complete after approximately 15 months under construction. The production plant will provide process chemicals for the semiconductor industry throughout Europe. The center includes state-of-the-art purification facilities as well as cleanroom filling stations to ensure high purity and consistent quality of the products. After completion of the qualification activities at the end of 2007, routine production was scheduled to commence on Jan. 1.
Microtest expands facilities and services
Microtest, a provider of testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries, has doubled the size of its medical device/pharmaceutical stability storage capabilities, as well as significantly expanding its medical device packaging laboratory and its GMP pharma fill/finish contract manufacturing services at its Agawam, MA-based headquarters. “Package validation is needed to support our medical device clients. We’re also dedicating additional new space to our growing product stability testing laboratories as well as our GMP drug manufacturing services,” says president and scientific director Steve Richter.