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    GAO Survey of State Regulation of Drug Compounding Offers Mixed Results

    Among the local drug compounding regulators for 50 states, Washington, DC, Guam, Puerto and the US Virgin Islands, many say they are working with and appreciate the help of the US Food and Drug Administration (FDA), but only seven out of 50 respondents could differentiate all data on drug compounding for human use versus animal use. Building on a 2016 report , the new survey  results released by the US Government Accountability Office on Friday on the state regulatio...
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    GAO: Drugmakers Want More Clarity on Antibiotic Incentives

    Despite some improvements, drugmakers say the US Food and Drug Administration (FDA) has not fully clarified its expectations for developing new antibiotic drugs or detailed how to access new incentives, according to a new report by the Government Accountability Office (GAO). Specifically, GAO says that FDA has issued 14 updated or new guidances focused on antibiotics since the Generating Antibiotic Incentives Now (GAIN) Act was passed as part of the Food and Drug Admi...
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    GAO: FDA's Ability to Monitor Drug Shortages Remains a Concern

    The US Food and Drug Administration's (FDA) oversight of medical products remains a high-risk area for the federal government, particularly with regard to the agency's oversight of drug shortages, according to a report from the Government Accountability Office (GAO) released Wednesday. Despite commitment from FDA leadership to improve drug availability, GAO says it no longer considers FDA's action plan to be effective. As a result, GAO has downgraded its assessment of F...
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    GAO: Adverse Event Reporting Limitations Delayed FDA Action on Power Morcellators

    The Government Accountability Office (GAO) on Wednesday released the results of its year-and-a-half long investigation into the US Food and Drug Administration's (FDA) handling of laparoscopic power morcellators following reports that the devices spread cancer in patients being treated for uterine fibroids. In August 2015, a bipartisan group of 12 US Representatives wrote to GAO calling on it to investigate the FDA's handling of the issue. The report finds that FDA may ...
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    GAO: FDA's White Oak Campus Poses Security Risk

    According to a new report from the Government Accountability Office (GAO), parking and cramped offices at the US Food and Drug Administration's (FDA) White Oak campus in Maryland pose a security risk for the agency. In its report, GAO calls on FDA to implement a parking security system in line with the Department of Homeland Security's Interagency Security Committee standards for high risk facilities. The report also calls on the agency to work with the General Services ...
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    GAO Report Highlights Ongoing Challenges in Oversight of Drug Compounders

    A new report by the Government Accountability Office (GAO) finds that while the US Food and Drug Administration (FDA) has taken steps to improve its oversight of drug compounders, challenges at both the state- and FDA-level remain. Background Unlike traditional drugmakers, drug compounders are exempt from certain requirements of the Federal Food, Drug and Cosmetic (FD&C) Act . These exemptions allow compounders operating under section 503A of the act to produce drugs w...
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    What Drugs Really Cost: GAO Wants CMS to Find Out

    In order to help ensure the accuracy of Medicare Part B drug payment rates, the US Government Accountability Office (GAO) on Monday urged Congress to require all manufacturers of Part B drugs paid at average sales price (ASP) to submit sales price data to the Centers for Medicare & Medicaid Services (CMS). What’s more, GAO is calling on Congress to ensure that CMS has the authority to request source documentation to periodically validate drug companies’ pricing data, wh...
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    FDA Commissioner Calls for Better National System to Track Device Safety

    The US needs a better system to quickly detect and understand medical device issues when they arise, US Food and Drug Administration (FDA) Commissioner Robert Califf and Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), wrote in a viewpoint published Monday in JAMA . The call for better postmarket tracking of devices comes as professional societies have developed registries with details on clinical circumstances, procedures and outco...
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    GAO Offers Sharp Critique of FDA’s Lack of Measurable Regulatory Science Goals

    The Government Accountability Office (GAO) on Wednesday released two reports criticizing the Food and Drug Administration (FDA), one that says FDA lacks measurable goals to assess its progress in advancing regulatory science, and another that says FDA should better coordinate between its medical product centers. On the regulatory science front, GAO notes that FDA issued strategic planning documents in 2011 and 2013 to guide its regulatory science and identify priority...
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    FDA Official Testifies on Lab Safety After Smallpox, Anthrax Incidents

    At a Congressional hearing on Wednesday, an official from the US Food and Drug Administration (FDA) said that the agency has taken "direct and definitive actions" to improve laboratory safety after a new report highlighted deficiencies at a number of federal agencies in their oversight of bioresearch laboratory safety. The report, issued by the Government Accountability Office (GAO), comes after recent incidents involving the mishandling of dangerous biological materials...
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    House Panel Calls on GAO to Study FDA’s Approval Pathway for Complex Generics

    Chairman of the House Committee on Energy & Commerce Fred Upton (R-MI), ranking member Frank Pallone (D-NJ) and other representatives on both sides of the aisle are calling on the Government Accountability Office (GAO) to assess the US Food and Drug Administration’s (FDA) approval pathway for generic drugs that have complex active pharmaceutical ingredients (APIs). The request for GAO action follows the introduction of HR 1576 in March, which also calls on GAO to study...
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    GAO Finds Majority of Postmarket Surveillance Studies FDA Ordered for Devices are Inactive

    Nearly 90% of the postmarket surveillance studies the US Food and Drug Administration (FDA) ordered over the past seven years were categorized as inactive, though some of these studies were added to other ongoing studies, according to a new Government Accountability Office (GAO) report. Rep. Rosa DeLauro (D-CT) requested the GAO look into the postmarket studies of devices ordered by FDA, and this latest report investigates the types of devices for which FDA has ordered a...