• Regulatory NewsRegulatory News

    Legislation Seeks to Overhaul FDA's Compassionate Use Program

    New legislation introduced in the House of Representatives would makes changes to the US Food and Drug Administration's (FDA) "expanded access"—sometimes called " compassionate use "—policies in the hopes of making it easier for terminally ill patients to access potentially life-saving drugs. Background Under normal circumstances, companies seeking FDA approval for a new drug will first ask regulators for permission to begin a clinical trial using an application known a...
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    Legislation to Increase Regulatory Incentives to Fight Ebola Awaits Obama's Signature

    The US House has quickly passed legislation making changes to the  Neglected Tropical Disease Priority Review Voucher  (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular to those developing new treatments for the Ebola virus. S.2917 , the  Adding Ebola to the FDA Priority Review Voucher Program Act , passed the US House of Representatives by unanimous consent on 3 December 2013, just one day after the same bill was pas...
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    Ebola Voucher Bill Clears Senate, on Course to Become Law

    The US Senate has passed legislation that would overhaul the Neglected Tropical Disease Priority Review Voucher  (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular those developing new treatments for the Ebola virus. S.2917, the Adding Ebola to the FDA Priority Review Voucher Program Act , passed the US Senate by unanimous consent on 2 December 2013. "Today the Senate took a strong step to support that mission by pass...
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    Obama Approves Bill Reforming Regulation of Sunscreen Ingredients, Other Drugs

    US President Barack Obama has signed into law a new bill set to change the way in which some drugs, and in particular sunscreen ingredients long approved in other countries, are regulated by the US Food and Drug Administration (FDA). Background The bill, the Sunscreen Innovation Act (SIA), was signed into law by Obama on 26 November 2014 following its passage in the House of Representatives on 14 November 2014. The bill's passage follows extensive complaints by s...
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    Bill Would Benefit Developers of Drugs for Rare Diseases

    A new bill introduced in the US House of Representatives would grant existing pharmaceutical products an additional six months of marketing exclusivity if a company is able to demonstrate the product is able to treat or prevent a rare disease or condition. Background The bill, the Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014 (OPEN ACT), appears to be loosely modeled off a similar plan in place for pediatric products. Under the US Food a...
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    Bill to Speed up Approvals for Sunscreen Ingredients, Other Drugs Awaits Obama's Signature

    US legislators in the House of Representatives have passed a Senate bill which would overhaul the manner in which the US Food and Drug Administration (FDA) approves sunscreen ingredients and other products through a rarely used regulatory pathway known as the Time-and-Extent process (TEA), all but assuring the bill will be passed into law. Background The bill, known as the Sunscreen Innovation Act (SIA) , follows extensive complaints by several companies that their sun...
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    US Senate Unveils Major Changes to FDA Program in Hopes of Fighting Ebola

    Legislators in the US Senate have unveiled a new piece of legislation meant to incentivize companies to go after the Ebola virus by making critical and long-sought changes to a US Food and Drug Administration (FDA) regulatory program. Background As Focus explained in October 2014 , a recent outbreak of Ebola has led to a scramble for new drugs and vaccines to help treat and prevent the virus. At present, there are no recognized treatments for the disease. Some publi...
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    Senators Call for Expansion of FDA Program to Help Fight Ebola

    Bipartisan members of the US Senate's healthcare oversight committee plan to introduce legislation that would amend a little-used regulatory program in the hopes of spurring the development of treatments for the Ebola virus. Background The program, known as the neglected tropical disease priority review voucher program, was created in 2007 under the Food and Drug Administration Amendments Act (FDAAA) . The voucher program, first envisioned in a 2006 Health Affairs po...
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    After New Drugs Delayed by DEA, Legislators Seek Overhaul of Drug Scheduling Process

    For most pharmaceutical products in the US, obtaining approval from the US Food and Drug Administration (FDA) to market a product means a company can begin selling its product as soon as it wants. But for a subset of products subject to the Controlled Substances Act (CSA ) , the Drug Enforcement Administration (DEA)—not FDA—is the ultimate arbiter of when market access occurs and the extent to which it occurs. Now new legislation wants to make the process by which DEA ...
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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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    Senate Bill Seeks Faster, More Predictable Approvals for Time and Extent Applications

    Senate legislators have released a new iteration of the Sunscreen Innovation Act , a bill which seeks to accelerate the approval of long-delayed new sunscreen ingredients in the US, which would go beyond sunscreen ingredients to overhaul part of the process used to approve over-the-counter (OTC) drugs. Background As explained in our article on the House version of the Sunscreen Innovation Act , the bill has long been focused on the Time and Extent (TEA) application ...
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    House Legislators Clear Sunscreen Innovation Bill, but Questions Remain

    The US House of Representatives has voted in favor of a bill that would require the US Food and Drug Administration (FDA) to speed up its assessment process for new sunscreen ingredients that have been awaiting regulatory approval for as long as a decade in some cases. Background The bill, the Sunscreen Innovation Act (H.R. 4250) requires FDA legislators to speed up their review of sunscreen ingredients submitted under the Time-and-Extent Application (TEA) process. ...