• Regulatory NewsRegulatory News

    Government Report Slams DEA for Oversight of Drug Production Quota System

    Shortages of some pharmaceutical products could be alleviated if the Drug Enforcement Administration (DEA) coordinated its efforts to control the supply of some drugs more closely with the US Food and Drug Administration (FDA), a new government report has found. Background In the US, drug products are primarily overseen by two federal agencies: FDA and DEA. The former regulates drugs in accordance with their efficacy, safety and quality. For example, FDA might approve a...
  • GAO Says FDA Doing (Almost) All It Can to Alleviate Drug Shortages

    The US Government Accountability Office (GAO) has released a follow-up report on the national problem of drug shortages, lauding the US Food and Drug Administration (FDA) for making efforts to alleviate drug shortages. Background "The number of drug shortages remains high," begins the report, released on 10 February 2014. While GAO noted significant progress in confronting new drug shortages in 2013 compared to 2012, its data portrayed the stubbornness with which some o...
  • GAO Report Gives Credence to FDA's Pharmaceutical Compounding Claims

    A new report just published by the Government Accountability Office (GAO) confirms what US Food and Drug Administration (FDA) officials have long argued: They simply don't have sufficient authority to regulate compounding pharmacies with the same level of vigor as they do traditional pharmaceutical manufacturers. Background In the waning months of 2012, a massive outbreak of fungal meningitis was linked to supposedly sterile versions of methylprednisone acetate manufact...
  • Government Report Finds Mixed Opinions on Proposed Drug Labeling Overhaul

    A new report published by the Government Accountability Office (GAO), an intra-governmental watchdog agency, has found that the US Food and Drug Administration's (FDA) efforts to substitute three types of paper- based prescription drug labeling with an electronic-based labeling system is being met with strongly mixed reactions, indicating that the effort may not work as intended. Background FDA currently regulates the content and layout of prescription drug labeling, in...
  • Are Medical Countermeasures Meeting the Potential Needs of Children?

    Is the US government doing enough to protect children from the threat of a medical emergency caused by a chemical, biological, radiological or nuclear accident? Not as much as it could be, concludes a new report just published by the Government Accountability Office (GAO), an intra-government watchdog that regularly assesses programs for deficiencies. Background Since the events of September 2011, federal agencies, and particularly the US Food and Drug Administration (F...
  • Government Report Says FDA Could Do a Better Job at Leveraging Adverse Event Data

    A new report published by the US government Accountability Office (GAO), a intra-government watchdog that assesses programmatic weaknesses, has informed the US Food and Drug Administration (FDA) that it could be doing a better job at utilizing the information it collects on adverse events for dietary supplement products. Background The 18 March 2013 report reflects a complicated regulatory area for the agency, in which products-some of which contain pharmaceutical or ph...
  • Study: Agencies Falling Short on Regulatory Transparency

    Federal agencies in the US, including the US Food and Drug Administration (FDA), could stand to do a better job at responding to public comments, claims a report out from the Government Accountability Office (GAO). GAO's report, " Agencies Could Take Additional Steps to Respond to Public Comments ," comes in response to a review initiated to probe how agencies seek public comment on proposed regulations. In advance of final regulations, agencies are supposed to issue a n...
  • Government Investigators: FDA Must Assess Medical Devices for Hacking Risks

    Government oversight officials are sounding the alarm over what they say is the potential for US Food and Drug Administration-regulated medical devices to be hacked, saying FDA needs to establish new safeguards to ensure unguarded devices don't exhibit easily exploited vulnerabilities. The report, " FDA Should Expand Its Consideration of Information Security for Certain Types of Devices ," was authored by the Government Accountability Office (GAO), an investigative servi...
  • Could Radiation Exposure Recommendations Affect an Impending App Guidance?

    The US Food and Drug Administration (FDA) may be in the midst of increasing cellphone use by developing its mobile medical application guidelines, but at least one government agency and a US legislator are calling for additional research on the effects of radiation emitted from the phones themselves. In a 24 July report released by the Government Accountability Office (GAO), the government's internal program watchdog, the agency said a reassessment of the effects of ra...
  • 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 ...
  • FDA Receives Small Funding Boost In Senate Appropriations Bill

    The US Food and Drug Administration (FDA) could see an addition $24 million in funding under a bill cleared by the Senate Appropriations Committee on 26 April. The bill, The Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act of 2013 , would increase overall FDA appropriations to $2.54 billion, or a 1% increase over its Fiscal Year 2012 appropriated amount. BioCentury notes the increase is greater than the amoun...
  • Report: FDA Meeting Review Goals Under PDUFA

    The Government Accountability Office (GAO), the government agency tasked with reviewing and auditing government programs, has found the US Food and Drug Administration (FDA) to be meeting its performance goals for reviewing applications under the terms of the Prescription Drug User Fee Act (PDUFA) . GAO's report to Congress notes FDA has generally "met performance goals for priority and standard New Drug Applications (NDAs) and Biologic License Applications (BLAs) recei...