• Regulatory NewsRegulatory News

    BIO Calls for Increased Emphasis on Patient Perspectives by Biopharma, FDA

    Biopharmaceutical companies should seek out and incorporate the perspective of patients earlier on in the drug development process, a new white paper from the Biotechnology Industry Organization (BIO) argues. Background The call comes in the midst of a sustained shift by both companies and regulators to incorporate the views of patients into the regulatory process. Starting in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) , FDA has begu...
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    FDA Unveils New Website Improvements to Help Industry Keep Track of REMS

    The US Food and Drug Administration (FDA) is making it easier to find information about the controls that police the use of some of the most dangerous drugs approved for use in the US. Background Those controls, known as Risk Evaluation and Mitigation Strategies (REMS), were first created under the 2007  Food and Drug Administration Amendments Act (FDAAA)  and are meant to ensure the safe use of potentially risky products that might otherwise not be approved for use. F...
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    How do you Weigh Benefits and Risks in Medical Device Trials? FDA Guidance Explains

    Which factors should medical device manufacturers take into account when trying to determine whether an investigational device is suitable to begin testing in humans? The US Food and Drug Administration (FDA) has some thoughts on the matter, contained within a new draft guidance document released on 17 June 2015. Background The guidance, Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs) , relates t...
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    EU Committee Confirms Increased Risk with Ibuprofen at High Doses

    A European committee has confirmed that high doses of ibuprofen, a popular over-the-counter (OTC) anti-inflammatory drug, can increase a patient's risk for cardiovascular issues. Background Ibuprofen belongs to a class of drugs, called non-steroidal anti-inflammatory drugs (NSAIDs), which includes drugs such as diclofenac, naproxen and aspirin. NSAIDs already have a warning about increased risk of blood clots included in the information distributed with such products ...
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    FDA Explains how Companies can Modify a Drug Safety Assurance Plan

    A new guidance document issued by the US Food and Drug Administration (FDA) explains the process by which pharmaceutical companies can make changes to policies intended to control the use of, and sometimes access to, potentially dangerous drugs. Background The policies, known as Risk Evaluation and Mitigation Strategies (REMS), were first created under the 2007 Food and Drug Administration Amendments Act (FDAAA) and are meant to ensure the safe use of potentially risk...
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    FDA Plans Huge Study on How Public Understands Drug Risk

    The US Food and Drug Administration (FDA) is out with yet another proposed study on direct-to-consumer prescription drug advertising—its third proposed study in as many weeks—this time focusing on how patients understand the risks and benefits of drug products. Background FDA frequently studies consumer behavior as it relates to drug advertising. An overview of recent studies is as follows: Date Topic Study Summary January 2012 Corrective Advertising Study...
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    In Unusual Letter, FDA Dismantles Company's Drug Superiority Claims

    The US Food and Drug Administration's (FDA) drug advertising oversight division has sent a warning to a pharmaceutical company regarding materials used to promote a drug, saying the materials omitted "important risk information" and contained claims about the drug's superiority that did not hold up to the agency's close scrutiny. The Letter In its so-called " Untitled Letter " to New Jersey-based Sciecure Pharma, FDA's Office of Prescription Drug Promotion (OPDP) said i...
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    Bill Would Close Loopholes Now Preventing Some Generic Drugs From Being Approved

    A new bill introduced last week would seek to limit the use of safety programs required by the US Food and Drug Administration (FDA) to delay and even prevent the introduction of generic drugs into the market. Background REMS were first introduced under the 2007 Food and Drug Administration Amendments Act (FDAAA) , and were meant to act as a regulatory hedge against potentially risky products. REMS typically include the following elements: A communication plan, Medicat...
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    Using Patient Safety Schemes to Delay Generic Drugs Costs Consumers Billions, Study Finds

    A new report sponsored by the generic pharmaceutical industry claims that branded pharmaceutical companies are using Risk Evaluation and Mitigation Strategies (REMS) to great effect—just not the effect that regulators had intended. Background: What are REMS? REMS were first introduced under the 2007 Food and Drug Administration Amendments Act (FDAAA) , and were meant to act as a regulatory hedge against potentially risky products. In plain terms, they are meant to keep...
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    After Quiet Quarter, OPDP Releases New Untitled Letter for Familiar Reasons

    For the first time in nearly three months, the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has released a new Untitled Letter, this time alleging that a company's printed sales aid is misleading in that it does not adequately communicate the risks of the product. The 6 May 2014 Untitled Letter—a type of warning which alleges deviations from FDA's advertising standards, but does not threaten disciplinary action—is addressed to Alv...
  • In Transparency Bid, EU Regulators Unleash More Information About Drug Safety Measures

    In the EU, as in the US, regulators often approve medicines along with measures intended to mitigate risks associated with the use of a drug. Background: What's an RMP? The Risk Management Plans (RMPs), as they're called, include information on how to minimize or prevent risk, plans to initiate postmarketing studies on the safety and efficacy of a medicine, studies to measure the effectiveness of risk-mitigation measures, and general information regarding the known r...
  • Company's Facebook Page Gets it in Trouble with FDA

    The US Food and Drug Administration (FDA) has issued a new Untitled Letter to a pharmaceutical company for allegedly misbranding its hypothyroidism drug on Facebook. Untitled Letters are essentially unofficial warnings from FDA that a practice-Untitled Letters are most often reserved for alleged marketing violations-runs afoul of federal advertising regulations. Unlike a Warning Letter, Untitled Letters do not threaten subsequent enforcement action by FDA. In its latest...