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    More Competition: Senator Proposes Priority Reviews for Some Generics, New Voucher Program

    In looking for ways to create more competition in the US pharmaceutical industry and drive down rising prices, a new Senate bill proposes to prioritize certain generic drug applications and to create a priority review voucher program to incentivize the development of new generics. Sen. Susan Collins’ (R-ME) bill, known as “A bill to increase competition in the pharmaceutical industry,” would amend the Federal Food, Drug, and Cosmetic Act to require the US Food and Drug A...
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    FDA Calls for End to Priority Review Vouchers as GAO Says Too Early to Gauge Effectiveness

    The US Government Accountability Office (GAO) said Wednesday in a new report that it’s still too early to assess whether the Food and Drug Administration’s (FDA) three-year-old pediatric priority review voucher (PRV) program has stimulated the development of drugs to treat or prevent rare pediatric diseases. The PRV program offers vouchers that companies can win for gaining approval of new rare pediatric treatments affecting fewer than 200,000 people, more than half o...
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    Sanofi Redeems $245M Priority Review Voucher for Type 2 Diabetes Treatment

    The US Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for Sanofi’s investigational type 2 diabetes treatment on Monday and granted the use of another Priority Review Voucher (PRV), which speeds up FDA’s decision by four months. In redeeming the voucher, Sanofi had to pay a $2.7 million fee in addition to the standard new drug filing fee of $2.4 million. Retrophin sold the PRV to Sanofi last May for one of the highest amounts eve...
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    Congress Considers Priority Review Vouchers for Medical Countermeasures

    Members of the House Energy and Commerce Oversight and Investigations subcommittee were briefed on recommendations at a hearing Friday for improving the nation's biodefence strategy against natural and man-made threats. The recommendations are particularly timely as legislators and public health officials scramble to mount a response to the Zika virus outbreak across Latin America and the Caribbean. Many of these recommendations come from the Blue Ribbon Study Panel on ...
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    US, EU & WHO Launch Efforts to Accelerate Zika R&D

    One week after the World Health Organization (WHO) declared a public health emergency in response to Zika-linked clusters of microcephaly, it and authorities in the US and EU are mobilizing to accelerate the development of treatments and diagnostics for the disease. Obama Calls for $1.8 Billion in Funding On Monday, the White House announced it will ask Congress for more than $1.8 billion to establish an emergency fund to combat the Zika virus in the US and abroad. N...
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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 Propose New Exclusivity Voucher, Priority Review Voucher Programs

    Senators on both sides of the aisle are trying to incentivize the development of new drugs for newborn babies and medical countermeasures via a new exclusivity voucher and a priority review voucher system that are similar to the voucher programs already linked to tropical and rare pediatric disease treatments. Neonatal Exclusivity Voucher Last month, Sen. Robert Casey (D-PA) introduced a bill, known as Promoting Life-Saving New Therapies for Neonates Act of 201...
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    Harvard Professor Questions Success of FDA's Priority Review Voucher Program

    As the Senate debates whether to extend or make permanent the US Food and Drug Administration's (FDA) priority review voucher (PRV) program, a Harvard medicine professor says that so far, at least for tropical diseases, there's "little reliable evidence" that the program has spurred novel drug development. Background Since 2007, the FDA has issued seven PRVs (the most recent of which came earlier this month), which allow sponsors to speed the review of any one...
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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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    FDA Raises Fee Rate for FY16 Tropical Disease Priority Reviews

    The US Food and Drug Administration (FDA) has raised the tropical disease priority review fee rate for fiscal year 2016 to about $2.73 million, which is effective from the beginning of next month through 30 Sept, 2016. The new rate is about $200,000 more than last year's rate , but more than $2m less than the rate for fiscal year 2012. Back in 2008, FDA issued guidance for industry on tropical disease priority review, detailing the way in which the vouchers can be sol...
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    Sanofi Bets Nearly a Quarter Billion on Voucher for Faster Drug Approval

    An unusual regulatory incentive used to accelerate the review of a small number of drug products has just sold to the French pharmaceutical giant Sanofi for the record-setting sum of $245 million. Background The incentive, known as a Rare Pediatric Disease Priority Review Voucher (Pediatric PRV), is an integral part of a program meant to spur the development of new therapies of rare pediatric diseases. The Pediatric PRV program was established under the Food and Dru...
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    Bill Would Make Permanent FDA's Rare Pediatric Voucher Program

    New legislation introduced this week would reauthorize the US Food and Drug Administration's (FDA) rare pediatric disease priority review voucher program, which is currently set to end after triggering a sunset clause in its authorizing statute. Background Priority review vouchers are incentives meant to catalyze the development of new therapies for historically under-served disease areas, such as rare pediatric diseases affecting fewer than 200,000 children in the US...