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  • Regulatory NewsRegulatory News

    Product Hopping: E&C Hearing Addresses Restrictions to Generic Competition

    A subcommittee of the House Energy & Commerce Committee held a hearing on Thursday raising questions around some of the tactics pharmaceutical companies use to block competition, including the controversial use of product hopping. Product hopping, which involves companies reformulating drugs to restrict competition, can include many different types of reformulations, such as a change from a capsule to a tablet, a change in dosing or strength or a reformulation to an ext...
  • Regulatory NewsRegulatory News

    FDA Warns Drug Manufacturers as FTC Warns CBD Advertisers

    The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent to South Korea-based drug manufacturer Enprani Co. and China-based drug manufacturer Hangzhou Badi Daily Use Chemical Company. Meanwhile, the Federal Trade Commission (FTC) on Tuesday said it sent warning letters to three unnamed companies for illegal advertising of products containing cannabidiol (CBD). The letter for Enprani, which follows a five-day inspection last March, shows how...
  • Regulatory NewsRegulatory News

    FTC Backs FDA Draft Guidance to Stem the Tide of Abusive Citizen Petitions

    The Federal Trade Commission (FTC) has offered its support for revised US Food and Drug Administration (FDA) draft guidance that will use additional criteria to determine if a citizen petition was submitted to delay the approval of a competing drug. The revised draft offers new considerations for FDA when reviewing citizen petitions, including if a petition was submitted near the expiration of known patent or exclusivity, if a petition was the same or substantially simi...
  • Regulatory NewsRegulatory News

    FTC Settles Complaint Over Deceptive Marketing of Unapproved Cancer Products

    The US Federal Trade Commission (FTC) on Thursday announced it has reached a settlement with CellMark Biopharma related to the company's claims about marketing efforts to sell two of its unapproved products. The settlement comes less than a year after FDA sent CellMark an advisory letter notifying the company that it must remove claims from its website and other materials indicating that CellAssure could treat or prevent cancer. FDA said that the company would need to ...
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    FTC Seeks Comments on Competition in Prescription Drug Markets

    Ahead of a November workshop in which FDA Commissioner Scott Gottlieb will give a keynote address, the Federal Trade Commission (FTC) is seeking comments on a variety of questions related to competition issues in the US prescription drug market. The free and public workshop on 8 November will explore considerations that may stop the entry of generic drugs even after relevant patents have expired on brand-name products, including factors related to prices and other i...
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    FTC Sues Drugmakers for Not Marketing Authorized Generics

    The Federal Trade Commission (FTC) for the first time ever filed a complaint in federal district court this week alleging that an agreement not to market an authorized generic – often called a “no-AG commitment” – is a form of reverse payment and violates antitrust laws. The complaint alleges that Endo Pharmaceuticals and several other drug companies violated antitrust laws by blocking access to generic versions of the pain drug Opana ER (oxymorphone) and the local anest...
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    FTC: Pay-For-Delay Deals Decrease Significantly After Supreme Court Ruling

    The number of pay-for-delay settlements decreased significantly in 2014 after a Supreme Court decision in 2013 found that a branded drug manufacturer’s reverse payment to a generic competitor to settle patent litigation can violate antitrust laws. The findings from the Federal Trade Commission (FTC) note although the number of settlements slightly increased last year – 160 in FY 2014 vs. 140 in FY 2013, 145 in FY 2012 and 156 in FY 2011 -- the number of potential pay-for...
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    US Government Agencies Crack Down on Dietary Supplement Manufacturers

    In partnership with the Department of Justice, Federal Trade Commission and others, the US Food and Drug Administration (FDA), announced that after a yearlong sweep of dietary supplement makers, the agencies have filed civil injunctions and criminal actions against 117 manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements. Among the cases announced, an 11-count indictment unsealed Tuesday against Dallas-bas...
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    Clinton Urges FDA, FTC to Take Action Against Drug Price Hikes

    In two letters sent Monday, Democratic presidential hopeful Hillary Clinton called on the US Federal Trade Commission (FTC) and US Food and Drug Administration (FDA) to take action against pharmaceutical companies that inflate drug prices and keep generics off the market. In her letter to FDA acting commissioner Stephen Ostroff, Clinton echoes a number of similar calls by politicians such as those by Rep. Elijah Cummings (D-MD) , that Turing Pharmaceuticals' 5,000% pric...
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    FTC Takes Action Against Pharmaceutical 'Product Hopping'

    The Federal Trade Commission (FTC) on Thursday criticized the way brand-name drug manufacturers often tweak products' formulations shortly before a generic's entry to market, thereby delaying competition. The practice, commonly known as "product hopping," can end up harming consumers as it impedes competition "from would-be generic entrants, which have sought FDA approval to sell a generic version only of the original formulation but not the replacement,” FTC says in an ...
  • Regulatory NewsRegulatory News

    FTC Asks FDA to Reevaluate Framework for Homeopathic Products

    The US Food and Drug Administration (FDA) recently announced it was considering changing the way homeopathic products are regulated and asked for input on whether its current regulatory framework for homeopathic products was sufficient. Now, the Federal Trade Commission (FTC) is weighing in, calling on FDA to "consider amending or repealing its framework for homeopathic medications." Background In March 2015, FDA announced a public hearing to evaluate its regul...
  • RAPS' LatestRAPS' Latest

    Experts to Offer Ad, Promo and Labeling Advice at RAPS Virtual Event

    Advertising and promotion of healthcare products in the US are strictly regulated by the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). As the Internet and social media have become increasingly powerful forces in our everyday lives and important sources of information on personal healthcare decisions, regulators, marketers and healthcare companies all have had to contend with a slew of new challenges. On Wednesday, 3 June, RAPS...