• Regulatory NewsRegulatory News

    FDA and Industry: How Dangerous is the Revolving Door?

    Earlier this week, a former deputy director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) settled charges that he provided tips on drug approvals to three hedge fund managers that made tens of millions off the non-public information. The settlement raises some important questions on the so-called revolving door between industry and FDA, and what it means for patient safety. Is it OK for those in the pharmaceutical and medical device indust...
  • Regulatory NewsRegulatory News

    FDA Hires New Directors, Deputy Directors for Four Foreign Offices

    A big shakeup is underway at the US Food and Drug Administration's (FDA) foreign offices as four new directors and one deputy director were named to the agency's posts in China, Europe, India and Latin America. The shift to new leadership comes as the following employees have moved on: Christopher Hickey, Ph.D., (former director, China Office), Carl Sciacchitano (former acting director, India Office), Michael Rogers (former director, Latin America Office), and Bruce Ross...
  • Bill Delaying Transparency Measures Passed Into Law

    US legislators have delayed the implementation of legislation that would have required dozens of high-ranking officials at the US Food and Drug Administration and other federal agencies to disclose potentially dangerous personal information. The act, known as the Stop Trading on Congressional Knowledge (STOCK) Act was originally brought up by legislators after a CBS 60 Minutes investigation suggested some members of Congress were using insider information to ...
  • Top FDA Officials' Financial Records Could Soon be Made Publicly Available

    Tens of thousands of high-level staff members at all federal agencies, including hundreds at the US Food and Drug Administration (FDA), will soon be required to publicly disclose their financial information under the terms of a recently passed piece of legislation known as the Stop Trading on Congressional Knowledge (STOCK) Act , reports The Washington Post . But the impending deadline has more than a few federal officials, including numerous scientists , cryi...
  • GAO Finds FDA Employee Review Practices Lagging

    The Government Accountability Office (GAO), the government agency in charge of auditing federal programs, has reviewed the US Food and Drug Administration's (FDA) and found its employee performance standards to be lagging behind requirements established in federal law. Under the terms of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) , FDA is charged with meeting certain deadlines for reviewing pharmaceutical and medical device ...
  • Health Canada, Facing Budget Cuts, Lays off Hundreds of Employees

    Health Canada is facing the prospect of dire budget cuts after national austerity measures called for more than $5.2 billion to be cut from the Canadian federal budget, reports The Globe and Mail . Health Canada is facing a budget shortfall of $200 million per year, and notified its staff in early April that it may need to lay off approximately 840 staff to close the gap. Those staff reductions have reportedly already started, with notifications going out to 715 Health...
  • Study of FDA Staff Scientists Finds Lingering Concerns Amidst Improving Outlook

    A study released 7 March by the Union of Concern Scientists (UCS) finds that US Food and Drug Administration (FDA) staff scientists are increasingly upbeat about the direction of the agency. Among the survey's findings : Only 43.5% of staff scientists believes the center or office where they work has the resources it needs to meet its role in fulfilling the mission of FDA Despite a lack of resources, 75% of respondents believe FDA is acting effectively to protect pub...