• Regulatory NewsRegulatory News

    EMA Contests Two Judicial Decisions Over Clinical Trial Transparency Efforts

    The European Medicines Agency (EMA) on Thursday announced it has appealed two interim orders by the President of the General Court of the EU, which suspended the release of clinical study documents requested by third parties under a new transparency regulation. The first order blocked the release of a study report for PTC Therapeutics’ Translarna (ataluren), a Duchenne’s muscular dystrophy treatment, until a final ruling is provided. EMA says it was planning to provid...
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    Final Rule on Clinical Trial Transparency: Will it be Enough to Encourage More Compliance?

    The National Institutes of Health (NIH) on Friday issued a final rule that its leaders said is expected to result in “rapid increases” in the percentage of trials registered and shared via  ClinicalTrials.gov , though it remains to be seen if the $10,000 per day penalties that can be assessed by the US Food and Drug Administration (FDA) will be strictly enforced. Writing in a JAMA Viewpoint on Friday, NIH Director Francis Collins and other senior leaders said: “Inves...
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    New House, Senate Bills Would Require Companies to Justify Drug Price Hikes of More Than 10%

    US Sens. Tammy Baldwin (D-WI) and John McCain (R-AZ), as well as Rep. Jan Schakowsky (D-IL), on Thursday introduced new bills that would require drug manufacturers to disclose and provide more information about planned drug price increases, including research and development costs. More specifically, the  FAIR Drug Pricing Act  would require drug manufacturers to notify the US Department of Health and Human Services (HHS) and submit a transparency and justification...
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    EU Ombudsman Calls on EMA to Release Redacted Humira Study Data

    The EU Ombudsman is calling for the European Medicines Agency (EMA) to release more information from three clinical trials for one of the most commercially successful drugs of all time, AbbVie's arthritis drug Humira (adalimumab), and says EMA should also make changes to how it handles disclosing information in the future. Specifically, the ombudsman suggests that going forward, EMA should require companies applying for EU marketing authorization to provide the agency wi...
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    Vermont Governor Signs Bill With Possible $10K Fines for Drug Price Hikes

    Vermont Gov. Peter Shumlin (D) on Friday signed into law a bill that would highlight drugs that the state spends significant amounts of money on, and companies owning those drugs could be hit with up to $10,000 in penalties if the wholesale acquisition costs rise too quickly and they fail to disclose the reasons for such hikes. Shumlin said Friday the bill was directed at providing answers on why pharmaceutical companies, like Turing Pharmaceuticals, disproportionately h...
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    EMA Executive Director: Agency Ready for Challenges Ahead

    The newly reinstated head of the European Medicines Agency (EMA), Professor Guido Rasi, on Wednesday outlined his priorities for his new five-year term. In his first press briefing since being reinstated as Executive Director of EMA in November, Rasi says he sees three major factors that will set the tone during his term. First, Rasi says "our understanding of the human body and the underlying science [of medicine] has vastly grown" in recent years. To meet this chal...
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    EMA Management Board Adopts New Framework for Industry Interactions

    The European Medicines Agency’s (EMA) Management Board has adopted a framework that seeks to streamline and structure industry-agency communications, as well as to increase transparency around those discussions. The framework , first announced in early October, comes as the agency has grown in size and scope to the point where its approach to managing interactions with industry have become fragmented. The interactions will cover areas of common interest for the agency a...
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    Senate Committee Advances Bill Redefining When a Drug is Officially Approved

    A bill that would effectively provide manufacturers with more certainty on the marketing exclusivity of approved drugs needing DEA clearance advanced unanimously through a Senate committee Wednesday. Background In order for a drug to be marketed, it must not only be approved by the US Food and Drug Administration (FDA), but the US Drug Enforcement Agency (DEA) must also schedule the drug to a particular class under the Controlled Substances Act (CSA). Under current law...
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    EMA to Publish First Clinical Trial Reports in Mid-2016 Under New Transparency Law

    Following two meetings with drug companies and other stakeholders in July and September, the European Medicines Agency (EMA) says it will publish the first clinical trial reports in mid-2016. The release of the reports comes as EMA's policy on publishing the data came into effect last January. The new policy applies to clinical reports contained in all marketing-authorization applications submitted on or after 1 January 2015, and includes reports where drugmakers hav...
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    FDA Reverses Long-Standing Policy of Not Publicly Posting Individuals' Comments

    As part of its shift to increase transparency, the US Food and Drug Administration (FDA) said on Thursday that beginning 15 October it will publicly post individuals' comments on the regulations docket. The new policy could potentially have an impact on lobbyists or other special interest groups submitting comments as individuals. "In 1995, FDA explained that it routinely reviewed all comments for obvious confidential information before placing the comments in the docke...
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    UK Prime Minister Calls for Greater Clinical Trial Transparency in Emergencies

    In response to the shortfalls in the international response to the Ebola outbreak, UK Prime Minister David Cameron is proposing a plan to boost research and transparency in the hopes of better confronting future public health crises. The Plan Cameron, who spent the past two days with other world leaders from Canada, France, Germany, Italy, Japan, the US and EU at the G7 Summit in Germany, said the world must "be far better prepared with better research, more drug develo...
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    The Untold Compliance Story Behind Sunshine Data

    Under Section 6002 of the Patient Protection and Affordable Care Act (commonly referred to as the Sunshine Act ), data must be reported to the Centers for Medicare and Medicaid Services (CMS) by pharmaceutical and medical device manufacturers regarding promotional, research, consulting and other support activities. 1 These data tell a very public story about those activities and the recipients of any fees or transfers of value behind them. Unfortunately, negative pu...