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  • Regulatory NewsRegulatory News

    OND Director: New Approval Summaries Will Require FOIAs for Some Currently Available Data

    Closing out RAPS’ Regulatory Convergence on Tuesday afternoon, Peter Stein, director of the US Food and Drug Administration’s (FDA) Office of New Drugs (OND), confirmed to attendees that sponsors and other interested stakeholders looking to retrieve some of the data currently available in FDA-released drug approval packages would need to use the Freedom of Information Act (FOIA) to obtain some of that information under a new plan. While not getting into the specifics of...
  • Regulatory NewsRegulatory News

    Mylan Pharmaceuticals Pledges to Resolve FDA Citations Over Quality Control Failures

    Following the 13 nonconformities that were revealed during a US Food and Drug Administration (FDA) inspection of a Mylan Pharmaceuticals manufacturing site, Focus obtained a copy of the company’s response to the agency via a Freedom of Information Act (FOIA) request. The response to the 31-page Form 483, which was issued after the FDA visit to the plant in Morgantown, WV earlier this year, outlines a total of 77 commitments to address the inspectional observations....
  • Regulatory NewsRegulatory News

    Group Sues FDA, Seeking Access to Ebola Information

    A battle over regulatory documents has led a libertarian-leaning think tank, The Goldwater Institute, to sue the US Food and Drug Administration (FDA) in the hopes of compelling the agency to hand over information related to how several US citizens received drugs to treat the Ebola virus. Background In August 2014, the American public became fixated on an outbreak of Ebola in West Africa after two US missionaries, Dr. Kent Brantley and Nancy Writebol, became infected wi...
  • AIDS Group Wins Bid to Obtain 'Confidential' Data Analysis, Summaries About HIV Drug from FDA

    When it comes to patient groups interacting with the US Food and Drug Administration (FDA), some relationships are more adversarial than others. And while plenty of patient groups have their problems with FDA-its regulatory processes, its standards, its conclusions and its approvals-few do anything to escalate those gripes beyond a letter to the commissioner or a call to their congressperson. And then there's the AIDS Healthcare Foundation (AHF). Background The Washi...
  • Groups Call on FDA to End Transparency Policy They Say Violates Spirit, Letter of Law

    The way in which the US Food and Drug Administration's (FDA) treats some Freedom of Information Act (FOIA) requests-the primary method of extracting non-publicly available information from an agency-has angered more governmental transparency advocates, who say the agency needs to stop its use of a so-called "minor deletion" policy it says is preventing groups from appealing adverse FOIA decisions. Background The policy of "minor deletions" is essentially a loophole in...
  • FDA Scores Legal Victory Against Whistleblowing Case as Lawsuit Continues

    US medical device regulators scored a minor legal victory on 9 November 2012, prevailing at least temporarily against the National Whistleblower Center (NWC), which is representing several current and former employees of the US Food and Drug Administration (FDA) in a lawsuit alleging the agency violated their rights to privacy by engaging in surreptitious surveillance against them. NWC has been fighting FDA in the court system to obtain documents about the case, and ...
  • Group: FDA's Interpretation of FOIA Procedures Illegal

    The public health advocacy group Public Citizen is blasting the US Food and Drug Administration (FDA) for its application of the Freedom of Information Act (FOIA) , saying in a statement that the agency's actions violate both the "letter and spirit" of the law. FOIA , passed in 1966, has been dramatically expanded over the last half century to include numerous provisions requiring federal agencies to release documents relating to many internal decision-making proce...
  • Court Orders FDA to Release Thousands of Documents on Surveillance Program

    The US Food and Drug Administration (FDA) has been ordered by a federal judge to release thousands of documents to an attorney representing former employees of the agency who now allege they were the subject of an illegal surveillance program. Judge James Boasberg of the District Court of DC sided with the National Whistleblowers Center (NWC) at the 23 July hearing, and has ordered the agency to turn over more than 4,000 pages of documents related to the case to NWC by...
  • Brazil: Anivsa Sets Confidentiality Criteria

    A notice ( Ordinance No. 748-B/2012 ) published by Anvisa on 18 May sets forth the criteria the agency will use for classifying materials as confidential and thus ineligible for release under the Access to Information Act, which recently went into effect.  Examples of what would be classified as non-releasable is information relating to: scientific studies and research projects in progress, intelligence activities, ongoing monitoring, and information treated as con...
  • Brazil: Anivsa Implements Freedom of Information Law

    Greater transparency is an integral part of the reorganization of Brazil's national regulatory agency, Anvisa, and the agency will now release upon written request copies of all documents in its possession, other than those classified as confidential.  The Access to Information Law (Law No. 12.527/2011) establishes as a fundamental principle the constitutional right of public access to public information.  The Law is now in effect according to the ordinance ...
  • FDA Gets High Marks for FOIA Request Transparency

    A report by the House Oversight Committee has found many federal agencies to be deficient when it comes to tracking basic information regarding Freedom of Information Act (FOIA) requests, including the US Department of Health and Human Services (DHHS). The report "found that many federal agencies failed or struggled to transparently demonstrate an ability to track basic information about the processing" of FOIA requests. While DHHS-the parent organization of the ...