FederalDaily - April 26, 2006

FDA Needs Better Drug Safety Decision-Making

The Food and Drug Administration (FDA) decision-making process for handling postmarket drug safety issues is unclear and flawed, the Government Accountability Office (GAO) concluded in a March study. GAO found that FDA’s postmarket drug safety process did not have sufficient managerial oversight or criteria to determine when or if certain safety procedures are needed. Further, the report concluded that—due to lack of authority and resource constraints—FDA often could not obtain the necessary data to make postmarket drug safety decisions. Another major hindrance, GAO said, was a lack of communication between the offices involved in the postmarket activities. The study advised FDA to develop a system to track postmarket drug safety issues. GAO also called upon Congress to give FDA authority to require drug sponsors to conduct necessary postmarket drug studies. The report is available online at www.gao.gov/new.items/d06402.pdf.

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2005 Fact Book on Federal Employees

The Office of Personnel Management issued the 2005 Edition of The Fact Book on Monday. This publication contains statistics on federal employee demographics; compensation, payroll and work years; performance management and the Senior Executive Service; retirement and insurance programs; and student employment programs. To access the book, go to: www.opm.gov/feddata/factbook/index.asp.

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“Don’t Ask, Don’t Tell” Challenge Dismissed

A court challenge to the military’s “Don’t Ask, Don’t Tell” policy, which effectively bans gay servicemembers, was defeated in the U.S. District Court for Massachusetts on April 24, according to the Servicemembers Legal Defense Network (SLDN). In the decision, the court accepted the government’s motion to dismiss the complaint on the grounds that SLDN failed to establish that the policy violates the Constitution. Dixon Osborn, SLDN executive director, responded to the dismissal, saying, “We continue to believe the military’s ban is un-American and unconstitutional. There is no reason lesbian, gay and bisexual Americans should be prohibited from serving our country.”

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Government Should Improve Consolidated Financial Statements

As of Dec. 5, 2005, the Treasury Department had not yet addressed 131 out of 154 Government Accountability Office (GAO) recommendations from seven months earlier. The recommendations were to help improve the process for preparing the government’s consolidated financial statements (CFS). In a more recent report, GAO said weaknesses in Treasury’s CFS preparations included internal control monitoring; standard reporting guidance for federal agencies; and reconciliation of intra-governmental activity and balances. According to GAO, Treasury has submitted a proposal to the Federal Accounting Standards Advisory Board to reduce reporting requirements for the CFS under generally accepted accounting principles. Of the 131 outstanding GAO recommendations, GAO concluded that 76 relate to the generally accepted accounting principles. GAO made 12 additional recommendations, and said it will continue to monitor the issue. The report is available online at www.gao.gov/new.items/d06415.pdf.

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