Objectives â¢ New drug approval process â¢ Pricing of new drugs â¢ Off ...

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3/15/13% Orphan Drug Act • Orphan Drug Act: • Enacted by US Congress in 1983 • Rewards for developing drugs for patient population fewer than 200,000 • Reward: • 7 year monopoly • 50% tax credit for clinical trials • Consequence: other similar drugs cannot compete unless they can demonstrate higher efficacy Animal Efficacy Rule June 30, 2002 • Drugs and biologics intended to reduce serious and life-threatening conditions • May be approved for marketing based on: • Effectiveness from animal studies • Human efficacy studies are not ethical or feasible • Aim is to protect public from disabling toxic substances and organisms • Need pharmaco-kinetic data to gauge dose 21 CFR Parts 314 and 601 Animal Rule: Examples • Pyridostigmine bromide 2003 • Prophylaxis for soman exposure • Hydroxocobalamin 2006 • Treatment of cyanide poisoning • Levofloxacin 2012 • Treatment of pneumonic plague • Raxibacumab 2012 • Treatment of inhalational anthrax 8%
3/15/13% Prescription Drug User Fee Act V – effective Oct 1 st 2012 • FDA pledges to review 90% of NDAs within 12 months • Expectation is that this increases # of first cycle approvals • Mid cycle and late-cycle review meetings with sponsors • Increased communication & transparency • Pre-submission meeting to ensure NDA/BLA completeness • User fees increase: • Application now $ 1.96 million (6.3% inc) 9%
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