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    Senate Committee Considers Priority Reviews to Stem the Tide of Off-Patent Drug Price Hikes

    Sens. Susan Collins (R-Maine) and Claire McCaskill (D-Mo.) hosted a hearing Wednesday to discuss steep price increases for some off-patent drugs and what can be done to ensure patients and hospitals can afford these drugs moving forward. The hearing, which is the first in a series that focuses on companies that, as Collins puts it, “act more like hedge funds than pharmaceutical companies,” follows letters sent to four specific companies – Valeant Pharmaceuticals, Turin...
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    Health Advocacy Groups Call for Changes to Priority Review Voucher Program

    A group of health advocacy organizations are calling on the Senate Committee on Health, Education, Labor and Pensions (HELP) to tighten requirements for obtaining priority review vouchers for drugs for tropical diseases. In a letter addressed to HELP Committee Chairman Lamar Alexander (R-TN) on Tuesday, seven organizations including Médecins Sans Frontières (MSF), Drugs for Neglected Diseases Initiative (DNDi), Center for Global Health Policy, TB Alliance, Treatment Acti...
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    Senators Hint at Confirmation of Califf as Next FDA Commissioner

    Senators on both sides of the aisle offered their support for Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA) at the confirmation hearing Tuesday despite a couple of heated questions on drug pricing and industry’s influence on him. Califf did his best to quell any concerns over industry influencing his decisions as head of the agency and the majority of senators at the hearing seemed confident that his experience makes him the right...
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    Senators Investigate Rising Drug Prices as HHS Plans Action

    The fire stoked by rising drug prices is starting to spread through government, particularly as Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO) on Wednesday announced a bipartisan Senate investigation into pharmaceutical price gouging, with letters to four companies. The letters sent Wednesday follow on the heels of HHS announcing Tuesday that it would dig into drug pricing at an invitation-only forum on 20 November. The forum will feature five panel sessions on t...
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    Bipartisan Clinical Trials Compensation Bill Heads to Obama for Signature

    Late Monday evening, the House of Representatives cleared the final congressional hurdle for a bill that would compensate individuals who participate in clinical trials for rare diseases. If signed by President Barack Obama, the legislation -- the Ensuring Access to Clinical Trials Act of 2015, which passed the Senate in July -- would enable those with rare diseases to receive compensation of up to $2,000 for participating in clinical trials without having the compensati...
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    Senators Question FDA's Authority to Issue 'Placeholder' Name for First Biosimilar

    When the US Food and Drug Administration (FDA) approved the US' first biosimilar product, Zarxio, in March 2015, it gave the drug a unique and temporary nonproprietary name. Now a group of US senators is questioning whether FDA had the legal authority to do so. Background Zarxio is the first drug to be approved under the 351(k) pathway created in 2010 under the Patient Protection and Affordable Care Act . The drug, which is manufactured by Sandoz, is intended to be bio...
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    Senators Seek to Expedite FDA Review of 'Breakthrough' Medical Devices

    Medical device manufacturers may soon benefit from an expedited review pathway now only afforded to "breakthrough" pharmaceutical products if a bipartisan trio of US legislators have their way. Background On 24 April 2015, Sens. Richard Burr (R-NC), Michael Bennet (D-CO) and Orrin Hatch (R-UT) introduced the Advancing Breakthrough Devices for Patients Act ( ABDP Act ) . As written, the law is heavily based on the "breakthrough therapies" section ( Section 902 ) of th...
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    Tougher FDA Approval Process for Opioids Sought by Congress

    New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA). Background The bill, the FDA Accountability for Public Safety Act (FAPSA) , is a response to FDA's regulation of opioid painkillers, and specifically one known as Zohydro. The drug was approved in October 2013 as a pure hydrocodone product lacking any physical characteristi...
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    Senators Call for New Limits on 'Medically Important' Antibiotics

    A new bill introduced this week in the US Senate would restrict the use of "medically important" antibiotics in agriculture in the hopes of reducing the risk of bacteria developing resistance to those drugs. Background The bill, the Preventing Antibiotic Resistance Act (PARN) ( PDF ), was introduced on 2 March 2015 by Sens. Dianne Feinstein (D-CA) and Susan Collins (R-ME), with support from Sens. Kirsten Gillibrand (D-NY) and Elizabeth Warren (D-MA). The legisl...
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    Senate Launches Bipartisan Effort to Assess, Change how FDA Regulates Medical Products

    The US Senate's Health, Education, Labor and Pensions (HELP) Committee is in the early stages of launching its own legislative process intended to help reform the ways in which the US Food and Drug Administration (FDA) regulates drugs and medical devices, it has announced. Background The effort, announced on 29 January 2014, is being led by Sens. Lamar Alexander (R-TN) and Richard Burr (R-NC), and is meant to complement similar efforts by the House Energy and Commerce ...
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    Will FDA Have to Change its Name? New Bill Takes the 'Food' out of FDA

    If a new bill introduced in Congress this week is ultimately passed, the US Food and Drug Administration (FDA) might soon need to change its 85-year-old name—and give up all of its authority to regulate food, including dietary supplements. The bill, known as the Safe Food Act of 2015 , is set to strip several regulatory bodies of their authority to regulate food products and transfer that authority to a new regulator, the Food Safety Administration (FSA), whose sole j...
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    Senator Wants Companies Who Break FDA Regulations to Help Fund NIH

    US Sen. Elizabeth Warren (D-MA) has unveiled plans to introduce new legislation she says will require pharmaceutical companies found guilty of regulatory and legal non-compliance to pay large fines, all in the hopes of providing a new funding stream to the National Institutes of Health (NIH). The Premise: Big Profits Come From Government In a speech at a healthcare conference on 22 January 2015, Warren—a populist Democrat whose meteoric rise to popularity has left some ...