• 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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    FDA Warns 14 Companies for Selling Fake Cancer Treatments

    The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to 14 US-based companies for selling dozens of unapproved cancer treatments online and through social media. The companies, FDA says, have 15 days to respond with plans to address the violations or face possible criminal prosecution, including up to a year in federal prison and fine of $100,000 or twice the companies' gains on the fraudulent products. The agency is also advising patients ...
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    FDA to Texas and Arizona: Destroy or Export Detained Shipments of Execution Drugs

    After a lengthy wait, the US Food and Drug Administration (FDA) has officially told Texas and Arizona that their imported execution drugs cannot be used because they were unlawfully obtained. FDA spokesperson Lyndsay Meyer told Focus via email: “The FDA has notified the Texas Department of Criminal Justice and the Arizona Department of Corrections that their detained shipments of sodium thiopental have been refused on the basis that the detained drugs appear to be...
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    Medical Device Manufacturer Pleads Guilty to Misbranding and Agrees to Pay $36M

    Pennsylvania-based medical device manufacturer Biocompatibles Inc., a BTG subsidiary, pleaded guilty earlier this week to misbranding its embolic device used to treat liver cancer, among other diseases, and will pay more than $36 million due its illegal conduct, the Justice Department (DOJ) said.  Under the terms of the plea agreement before the US District Court for the District of Columbia, Biocompatibles pleaded guilty to a misdemeanor charge in connection with the ...
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    FDA Ad Regulators Cite UCLA Over Development Partner's Website

    The US regulator of pharmaceutical advertising, the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP), has issued a new warning to the University of California for allegedly promoting an investigational new drug for conditions for which it had not obtained approval. A Rare Letter OPDP's letter is exceedingly rare in that nearly all of the office's letters in recent years have been sent to established pharmaceutical companies—not acad...
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    Drug Counterfeiters Could Get Life in Prison Under New Bill

    New legislation introduced in the US House of Representatives just prior to the holiday break would amend the Federal Food, Drug and Cosmetic Act (FD&C Act) to increase penalties on the sale or trade of counterfeit pharmaceuticals and also grant the US Food and Drug Administration (FDA) new authority to recall drugs. Counterfeit Bill Proposed The proposed legislation, The Counterfeit Drug Enforcement Act of 2014 , was introduced on 11 December 2014 by Rep. Steve Is...
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    Final Regulation Makes it Easier for FDA to Seize Drugs at the Border

    The US Food and Drug Administration (FDA) is finalizing without change a proposed regulation introduced last year which would establish an administrative detention process for pharmaceutical products it believes are adulterated or misbranded. Background The rule is borne from the  Food and Drug Administration Safety and Innovation Act (FDASIA) , Section 709 ("Administrative Detention") of which ordered FDA to promulgate a final regulation within two years of the passage...
  • APEC Moving Toward 'Regulatory Convergence' in Effort to Safeguard Drugs, Improve Manufacturing

    An international organization which counts most of Asia as members says it and its members will be committing to a joint, multi-year initiative intended to improve medical product manufacturing and the security of the medical product supply chain. In an announcement on 12 May 2014, the Asia-Pacific Economic Cooperation (APEC) group said its membership had committed to a "greater alignment of policies safeguarding pharmaceuticals, medical devices and biomedical goods"-a c...
  • Cancer Drug Returns, and with it FDA's Willingness to Go After its Manufacturer

    Earlier this week, the US Food and Drug Administration (FDA) made a quiet but important announcement: Supplies of the drug Doxirubicin Liposomal Injection, a widely used cancer drug that has been experiencing massive shortages since 2011, have been resolved. But with the resolution of that shortage has come something else that has been in short supply in recent months as well: regulatory scrutiny for the drug. Background In late 2011, regulators became aware of mounting...
  • Rare Multi-Agency Warning Letter Slams Flu Product

    The US Food and Drug Administration (FDA) has issued a rare multi-agency warning letter to a marketer of a product claiming to give patients protection against the influenza virus. The letter, sent on 24 January 2013 to Flu and Cold Defense LLC ('FCD'), was sent in conjunction with the Federal Trade Commission (FTC). Both FDA and FTC regularly work together on matters related to advertising, but the joint warning letter is extraordinarily rare, as FTC ordinarily defers...
  • Merck Gets Warning Letter After Failing to Complete Postmarketing Safety Study

    Merck Sharp and Dohme Corp.'s global director of regulatory affairs received a warning letter on 17 February from the US Food and Drug Administration warning Merck that it had failed to complete an agreed-upon postmarketing study for its diabetes medications Januvia and Janumet. The products are now effectively misbranded under the Federal Food, Drug and Cosmetic Act (FD&C Act), and the company faces $250,000 in fines, with further fines accruing for continuing vi...
  • FDA Releases Exceptions to Labeling Requirements for Strategic National Stockpile

    The US Food and Drug Administration (FDA) released a new final rule on 6 February 2012 that allows FDA center directors leeway in the labeling requirements for products held at the Strategic National Stockpile (SNS). SNS is a stockpile of drug products to be used in the case of a national emergency, such as an outbreak of disease. Products at the stockpile are frequently overseen by FDA due to the need for continued stability testing and labeling updates. Instead of repl...