• Public Citizen Blasts Draft Compounding Rules, Says New Category Would Skirt Regulatory Requirements

    A US Senate proposal to overhaul the way in which compounded pharmaceutical products are regulated is being slammed by a prominent public advocacy group, Public Citizen, which claims that the proposed legislation is "a major step backward for US drug safety." Background In the US, pharmaceutical products generally fall into two categories: Those that are manufactured, typically for use by a wide audience, and those that are specifically tailored for a specific individua...
  • Citing Confidentiality Troubles, Mystery Firm Petitions FDA to Delay Posting of Warning Letter

    The story has it all: Mystery, intrigue, failures and secrecy. But it's not the latest plot line for a mystery novel-it's the latest out of the US Food and Drug Administration's (FDA) federal register docket, where a prominent life sciences law firm has petitioned the agency to hold off on posting a warning letter to an unidentified pharmaceutical company it represents. Background The petition for a stay of action-in plain parlance, a request to delay an action-was made...
  • Citing Public Health Needs, FDA Alters Labeling Standards for Smoking Cessation Products

    The US Food and Drug Administration (FDA) has, in response to three citizen petitions submitted to the agency, agreed to modify the labeling of nicotine replacement therapies (NRT) to indicate that consumers are allowed to use other NRTs and infrequently smoke when attempting to quit smoking using an NRT. Background Nicotine replacement products have been on the US market for nearly three decades, and are commonly used to wean users of tobacco products off the substance...
  • Delay in Sending Warning Letter to Fat Loss Device Company Hurt Patients, Group Claims

    A new warning letter sent by the US Food and Drug Administration (FDA) to medical device manufacturer RevecoMED regarding the sale and use of its "LipoTRON 30000" device is bringing both praise and scorn from some industry watchers, who say the device and its manufacturer have long flaunted federal regulations without consequence. Background The device, also known as the RFLipo System (Model DETCBF140), is technically a "therapeutic massager." Under FDA regulations, the...
  • 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 Will Continue to Allow Unapproved Drugs to Receive National Drug Code Numbers

    The US Food and Drug Administration (FDA) will continue to grant national drug code (NDC) numbers to pharmaceutical and other drug products not explicitly approved by FDA for a given indication after rejecting a Citizen Petition from Susan Alpert, RAC. Background NDCs were created in 1969 as a response to the difficulties of processing claims in the absence of a standardized product identification system for drug products. The NDCs were intended to provide "an identific...
  • Group Calls for REMS-Like Conditions for Popular Hypertension Drugs

    The public safety advocacy group Public Citizen is calling on the US Food and Drug Administration (FDA) to place additional safety warnings and restrictions on several classes of hypertension drugs due to safety concerns. In a petition sent to FDA Commissioner Margaret Hamburg and Center for Drug Evaluation and Research Director Janet Woodcock on 4 October, Public Citizen said three types of hypertension drugs-angiotensin-converting enzyme (ACE) inhibitors, angiotensin...
  • Study: Regulatory Noncompliance Plays Big Role in Record-Setting Fines

    Regulatory compliance woes have contributed to record-setting fines paid by pharmaceutical companies since 1991-more than $30 billion in total -- claims a new report published by the health advocacy group Public Citizen. The report, " Pharmaceutical industry Criminal and Civil Penalties: an Update ," follows an earlier 2012 report by the same group in which it found that nearly $20 billion had been recovered by federal officials from pharmaceutical companies since 1991, ...
  • 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...
  • Group Sues FDA, Seeking to Compel it to Withdraw Alzheimer's Drug from Market

    Consumer advocacy group Public Citizen has filed a lawsuit against the US Food and Drug Administration (FDA) seeking to compel it to remove a particular dose of the Alzheimer's drug Aricept, which the group alleges is causing dangerous and potentially fatal side effects. The lawsuit stems from a May 2011 Citizen's Petition filed by the group. The letter, addressed to FDA Commissioner Margaret Hamburg, calls for the 23 mg dose of Eisai's drug Aricept to be removed bec...
  • FDA Backs HIV Prevention Drug In Letter Denying Citizen Petition

    The US Food and Drug Administration (FDA) this week published a citizen petition denial to a group seeking to pre-emptively block the approval of a supplemental New Drug Application (sNDA) for Gilead Sciences' Truvada for preventing the transmission of HIV-1. The group, the AIDS Healthcare Foundation (AHF), had filed the petition on 7 March 2012-part of a subsequent campaign by the group to call attention to the drug. In a series of advertisements, AHF asked, "What rotte...
  • Group Calls for Changes to User Fee Bill After Transparency Concerns Emerge

    A group of 20 public interest organizations has written the US Congress to express their displeasure with a measure which would purportedly allow the US Food and Drug Administration (FDA) to hide health and safety inspection information from the public. The group is most concerned about Section 812 of the FDA Reform Act (FDARA) , which they say "allows the FDA to deny the public access to information relating to drugs obtained from a federal, state, local or foreign gov...