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  • Regulatory NewsRegulatory News

    Gottlieb: Immediate Release Opioids to be Subject to REMS

    FDA Commissioner Scott Gottlieb on Thursday said that immediate-release (IR) opioids will be subject to the same risk evaluation and mitigation strategy (REMS) as extended-release and long-acting (ER/LA) opioids. The agency first required a REMS for ER/LA opioids in 2012. "This week, we issued letters notifying 74 manufacturers of IR opioid analgesics intended for use in the outpatient setting that their drugs will now be subject to a more stringent set of requirements,...
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    Balancing Hatch-Waxman: Stakeholders Weigh in After FDA’s Meeting

    Following a US Food and Drug Administration (FDA) meeting in July on generic drug competition, various stakeholders are offering written comments on reforms FDA and Congress could make to ensure the Hatch-Waxman amendments are not abused. Like others, California Attorney General Xavier Becerra submitted comments calling for pay-for-delay agreement reforms, including legislation to make the deals "presumptively unlawful," reforms to FDA’s citizen petition process a...
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    FDA Transparency: Gottlieb Outlines What’s Coming

    FDA Commissioner Scott Gottlieb has been at the forefront of the Washington, D.C. conference circuit this week discussing new work that the agency he leads will undertake, with discussions Thursday at a Politico event, a speech Wednesday at the Friends of Cancer Research, a speech Monday at RAPS' Convergence and a speech last week at the National Health Research Forum. On Thursday, Gottlieb highlighted a few upcoming moves that the agency plans to make in terms of t...
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    Novo Nordisk Pays $58M to Settle REMS Allegations

    Danish drugmaker Novo Nordisk on Tuesday agreed to pay $58 million to settle allegations that the company failed to follow the risk evaluation and mitigation strategy (REMS) for its blockbuster diabetes drug Victoza (liraglutide). Victoza, Novo's top-selling drug, brought in more than $1.8 billion in sales in the first half of 2017 , accounting for 20% of the company's overall sales. The allegations stem from a federal investigation into Novo's marketing practices that...
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    E-Submissions of REMS Documents: FDA Offers Draft Guidance

    The US Food and Drug Administration (FDA) on Friday released draft guidance describing how FDA plans to implement the requirements for the electronic submission of Risk Evaluation and Mitigation Strategies (REMS) documents in certain submissions under new drug applications, abbreviated new drug applications and biologics license applications. The agency said the implementation will begin no earlier than 24 months after issuance of the final guidance. The 7-page dr...
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    Senators Ask FDA Commissioner What Help He Needs to Tackle REMS Abuse

    In a letter sent to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb last week, a bipartisan group of senators say they want to know what FDA can and cannot do to address certain tactics used to delay generic drug competition. Gottlieb, who last week announced plans for a public meeting to gather insight on these practices, has signaled an interest to increase generic drug competition to reduce high drug prices in the US. In the letter, the senators f...
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    Gottlieb Looks to Boost Generic Drug Competition

    As the US continues to grapple with the high cost of prescription drugs, the Food and Drug Administration (FDA) on Wednesday announced plans to stop drugmakers from gaming the system to block generic competition. "We know that sometimes our regulatory rules might be 'gamed' in ways that may delay generic drug approvals beyond the time frame the law intended," FDA Commissioner Scott Gottlieb said, just days after FDA released new draft guidance on priority reviews for ge...
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    FDA Commissioner Vows to Eliminate Backlog of Orphan Drug Designation Requests

    At a Senate hearing on President Donald Trump's FY2018 budget request for the US Food and Drug Administration (FDA), Commissioner Scott Gottlieb vowed to eliminate the backlog of orphan drug designation requests and said he will soon release "modern and risk-based" tools for assessing new treatments, especially for rare diseases and conditions with no effective treatments. "Right now we have a backlog of about 200 orphan drug designation requests where we haven't respond...
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    House and Senate Revive Bill Targeting Generic Drug Delays

    Leaders of the Senate and House Judiciary Committees, led by Sen. Patrick Leahy (D-VT), on Thursday re-introduced legislation to combat anticompetitive practices that can block the market entry of lower-cost generic drugs.  Known as the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, the resurrected bill targets sample sharing (when brand-name drugmakers prevent generic firms from obtaining samples of the branded products so the generic ...
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    ‘FAST’ Generics Act Seeks to Thwart Abuse of FDA Safety Programs

    A bipartisan House bill introduced on Friday seeks to stop pharmaceutical companies from blocking generic competitors by abusing US Food and Drug Administration (FDA) safety programs. The “Fair Access for Safe and Timely Generics Act of 2017,” or “FAST Generics Act of 2017,” introduced by Reps. David McKinley (R-WV) and Peter Welch (D-VT) would amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible generic and biosimilar developers have competitive acce...
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    House Committee Probes Restricted Distribution Systems Delaying Generics

    • 24 March 2017
    The House Committee on Oversight & Government Reform on Wednesday heard testimony on how pharmaceutical companies use restricted distribution systems to delay generic drug competition. In his opening statement, Subcommittee on Health Care, Benefits and Administrative Rules Chairman Rep. Jim Jordan (R-OH) said that some drugmakers are manipulating the regulatory framework to block competitors from accessing the reference drugs they need to conduct bioequivalence testing t...
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    When is a REMS Necessary: FDA Explains in Draft Guidance

    The draft guidance from the US Food and Drug Administration (FDA), unveiled earlier this month, tries to further explain the application of its risk evaluation and mitigation strategy (REMS) regulatory paradigm, which can delay generic drug competition. A REMS, which may be a medication guide, a patient package insert, and/or a communication plan is a required risk management strategy to help FDA ensure that the benefits of a drug outweigh the risks. FDA may require a ...