• 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...
  • Public Citizen to FDA: Diabetes Drug Unsafe, Should Be Pulled

    The watchdog group Public Citizen is calling on the US Food and Drug Administration (FDA) to yank Novo Nordisk's diabetes drug Victoza (liraglutide) off the market for safety risks it says "outweigh any documented clinical benefits." After being approved, "the watchdog group says a review of the FDA adverse event database found 200 patients were diagnosed with acute pancreatitis during the first 17 months that Victoza was available, suggesting a larger number of [thyroid...
  • AstraZeneca Sues FDA to Halt Generic Seroquel

    Pharmaceutical manufacturer AstraZeneca filed a lawsuit on 13 March seeking an injunction against the US Food and Drug Administration (FDA) to bar it from allowing generic versions of its blockbuster antipsychotic drug Seroquel to be marketed in the US. FDA denied two Citizen Petitions from AstraZeneca on 9 March that requested FDA delay market entry for any generic products not containing the exact warnings contained on the reference listed drug (RLD). FDA said in its...
  • Petitions to Delay Generic Seroquel Denied

    Two petitions from pharmaceutical manufacturer AstraZeneca that could have delayed market competition to its flagship line of antipsychotic drugs were denied by the US Food and Drug Administration (FDA) on 9 March. AstraZeneca's Citizen Petitions requested that FDA delay market entry for generic products if those products omitted warnings about the risk of developing hyperglycemia. FDA required AstraZeneca to include such warnings on Seroquel and Seroquel XR (quetiapine ...