• Regulatory NewsRegulatory News

    HHS moves to end FDA’s unapproved drugs initiative

    Following an announcement by outgoing President Donald Trump on Friday, the Department of Health and Human Services (HHS) is moving to end the Food and Drug Administration’s (FDA) unapproved drugs initiative, which the agency claims has led to increased drug prices for some older drugs. FDA’s unapproved drugs initiative can be traced back more than a decade to the agency’s 2006 compliance policy guide (CPG) on marketed drugs without approved new drug applications (NDAs...
  • Regulatory NewsRegulatory News

    Millions of Drugs, Medical Devices Detained in 116-Country Operation

    A total of 465 websites are the target of a global operation led by Interpol to crack down on the illegal sale of drugs, including opioids and cancer medications, and has resulted in the detainment of more than 10.1 million illegal dose units of drugs and medical devices.   The US Food and Drug Administration (FDA) also posted seven warning letters on Tuesday as part of the international collaboration dubbed Operation Pangea X, FDA spokesperson Jeremy Kahn confirmed wi...
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    New California Law Requires Posted Notices of Non-FDA Approved Stem Cell Products

    California Gov. Jerry Brown this week signed into law a bill that requires health providers to post notices in their offices when they are administering stem cell treatments that have not been approved by the US Food and Drug Administration (FDA). The law is part of efforts to crack down on the use and sale of unapproved stem cell treatments, some of which are being hawked as cures for a range of diseases with few or no treatment options, like ALS, autism and spina...
  • Regulatory NewsRegulatory News

    Study Finds FDA Action on Unapproved Drugs Led to Higher Prices, Longer Shortages

    A new study finds that the US Food and Drug Administration's (FDA) 2006 initiative to get manufacturers selling unapproved drugs to submit the drugs for approval or remove them from the market led to higher prices and longer shortages for those drugs. Background Today, drugs must be reviewed by FDA for safety and efficacy or in some cases conform to an over-the-counter (OTC) monograph before they can be marketed in the US. However, in the years between the 1938 Food, D...
  • After Supply Chain Breaches, FDA Looks to Better Communicate Risks of Counterfeits

    An upcoming advisory committee of the US Food and Drug Administration (FDA) is set to discuss how the agency can engage in best practices for communicating with health care professionals and others about the risks of counterfeit and unapproved drugs. Background US regulators have been seeing an influx of counterfeit products in recent years, testing both the limits of the security of the pharmaceutical supply chain and the ability of regulators to stop products before t...
  • 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...
  • Repeat Deficiencies Form Basis of Warning Letter to Veterinary Pharmaceutical Manufacturer

    • 13 December 2012
    A number of recurring deficiencies form the basis of a warning letter sent to a St. Louis veterinary drug manufacturing facility. The company, Performance Products Inc (PPI), was accused of "significant deviations of Current Good Manufacturing Practice (CGMP) regulations" in the 20 November 2012 letter. PPI manufactures a number of products aimed at bovine and equine species, with most of those products being probiotic in nature. The company's website boats about it...
  • US Regulators Give Final Shot to Owners of Unapproved Drug Products

    Don't have approval for your drug product? For a small number of manufacturers covered by unusual circumstances, the US Food and Drug Administration (FDA) is granting one last shot to obtain a request for a hearing and potential approval. In a 23 July Federal Register notice, the agency highlights certain drug products that could have been marketed extensively under now-outdated provisions in federal law. Between the passage of the 1938 Federal Food, Drug and Cosmet...
  • FDA: Stop Manufacturing Unapproved Oxycodone Products

    US regulators said they intend to take enforcement action against manufacturers of unapproved oxycodone products, saying the products constitute a "high public health priority" and have a high potential for misuse and abuse. Oxycodone, an opioid commonly used as a painkiller, is a schedule II narcotic under the Controlled Substances Act (CSA) , meaning it has a high probability of abuse despite its therapeutic uses. FDA said it was made aware of unapproved single-ingr...
  • US Regulators Debar Man for Marketing Unapproved Products

    The US Food and Drug Administration (FDA) has issued a debarment order against a man convicted of introducing two pharmaceutical products into interstate commerce in violation of federal law after he claimed his unapproved products could treat a range of ailments including cystic fibrosis, SARS and tuberculosis. In its 29 June 2012 Federal Register posting, FDA recounted what it called the "factual basis" for its debarment order, starting with a warning letter sent to ...
  • Warning Letter Analysis: Medical Device Companies Cited for Marketing Unapproved Products

    • 06 June 2012
    The US Food and Drug Administration's (FDA) latest batch of Warning Letters, released 6 June, cites three companies who are alleged to have violated current good manufacturing regulations and, in two cases, federal law by marketing unapproved products. Siemens Healthcare Diagnostics (Medical Device) In a 29 May warning letter sent to in medical device manufacturer Siemens Healthcare, FDA alleges the company's ADVIA Centaur iPTH immunoassay products manufactured at it...
  • J&J Announces Planned Cessation of Vaginal Mesh Sales

    Johnson & Johnson subsidiary Ethicon announced on 5 June 2012 it will cease sales of a controversial line of vaginal mesh implant products after being hit with a series of lawsuits alleging the products cause internal bleeding. Bloomberg Businessweek reports the company has requested approval from the US Food and Drug Administration (FDA) to end sales of the product within the next 120 days so consumers and doctors can find alternate suppliers or other treatment op...