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    Consumer Advocacy Group Warns on Orphan Provisions in 'Cures' Act

    Orphan drug provisions in the House-passed 21st Century Cures Act could increase US healthcare spending by billions of dollars over the next decade, consumer advocacy group Public Citizen warns, though the bill still remains in limbo in the Senate. The provisions in question would add an additional six months of marketing exclusivity for approved drugs that later go on to be approved to treat rare diseases. The extended period of exclusivity would apply to all indicati...
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    Johns Hopkins Researchers Call for Orphan Drug Reform

    A team of researchers at Johns Hopkins are calling for reforms to the Orphan Drug Act , saying that loopholes have allowed drug companies to skirt the act's intent by taking advantage of its incentives for non-orphan conditions. Background The Orphan Drug Act of 1983 was passed to spur drug development for rare diseases. The act created incentives for drugs that treat diseases affecting fewer than 200,000 individuals in the US per year. The incentives include seven-...
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    New Bill Directs FDA to Pull Bayer Birth Control Device

    In an unprecedented move, Rep. Michael Fitzpatrick (R-PA) on Wednesday unveiled a new bill that directs the US Food and Drug Administration (FDA) to withdraw from the market Bayer’s birth control implant Essure. The safety of the implantable device, which is used for permanent birth control, has been called into question recently, with FDA holding an advisory panel meeting on the device's safety in September. Rep. Rosa DeLauro (D-CT) also requested FDA pull the produc...
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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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    FDA Raises Fee Rate for Rare Pediatric Disease Priority Reviews for FY2016

    The US Food and Drug Administration (FDA) on Friday announced that it would increase the rare pediatric disease priority review voucher fee rate for FY 2016 by about $200,000. The new rate -- $2,727,000 – is effective on 1 October and will remain in effect for the next year. FDA previously set the fee rates at $2,562,000 for FY 2015 and $2,325,000 for FY 2014. The new rate is based on FDA's estimate that the cost of a standard review for new molecular entity (NME) new dr...
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    Studies Raise New Concerns Over FDA's Expedited Approval Designations, Supplemental Indications

    An increasing number of newly-approved drugs by the US Food and Drug Administration (FDA) have been associated with expedited development or review programs, though many of these approved drugs are not first in class and potentially less innovative, according to two new studies published in the British Medical Journal (BMJ). Background Under the standard regulatory review process, FDA has 10 months to review a potential new drug's safety and efficacy based on a company'...
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    What's in Store for the Medical Device Tax?

    Last month, the US House of Representatives passed a bill that would repeal the medical device tax levied under the Affordable Care Act ( ACA ). Now, the Senate Joint Economic Committee (JEC) has released a report critical of the tax, calling the tax "onerous" and "poorly conceived." Background The medical device tax has been controversial since before ACA was signed in 2010. Under ACA , a manufacturer or importer of a medical device is subject to an excise tax of...
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    Generic Drug Companies Call for Fixes to GDUFA, Citing Few Returns on Investment

    Several of the generic drug industry's most prominent groups are calling on the US Food and Drug Administration (FDA) to make major changes to the program supporting one of its marquee funding sources, the Generic Drug User Fee Act (GDUFA). Background GDUFA is modeled off several other conceptually similar user fee programs, including the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA). The concept behind the programs is relatively st...
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    What Life Sciences Companies Need to Know About the Foreign Corrupt Practices Act

    In 2014, enforcement actions related to the Foreign Corrupt Practices Act (FCPA ) generated fines totaling more than $1.5 billion with the average corporate penalty exceeding $156 million. Also in 2014, the US Department of Justice (DOJ) announced it would hire an additional 300 agents to focus solely on FCPA investigations and enforcement. On 3 March 2015, the director of the Division of Enforcement of the Securities and Exchange Commission (SEC) stated, “…in 2015, th...
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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...
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    FDA Kicks Off MDUFA Reauthorization Process

    The US Food and Drug Administration (FDA) is kicking off the reauthorization process for the Medical Device User Fee Act (MDUFA), a program which funds a significant portion of its medical device regulatory review activities. Background FDA's user fee program began with the passage of the Prescription Drug User Fee Act (PDUFA) in 1992. The law, originally intended to speed up the regulatory review process, wound up being so popular that it inspired several other user ...
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    Congress Eyes Wider Use of Third-Party Medical Device Assessments

    A revised version of the 21st Century Cures Act , a bill being considered by the House Energy and Commerce (E&C) Committee, would allow medical device manufacturers to leverage third-party auditors to assess the state of their quality manufacturing systems. The measure, contained within the "Medical Device Regulatory Process Improvements" section of the bill, was first introduced in the original draft of the 21st Century Cures Act , but was removed without expla...