AAM Calls For Congress And FDA To End Shortages By Easing Up On Generics Quality, Pricing
Remote inspection alternatives could allow quicker resolution of quality issues that are holding up US imports, says association for generic drug manufacturers. AAM adds that adjusting a Medicaid inflation penalty could relieve unfair price pressures.
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Drug Shortage Legislation: House GOP Finds Support For Bill While Dems Offer Concerns, Alternatives During Hearing
A proposed 340B rebate exemption for generic sterile injectables appears headed for the final drug shortage bill House Republicans are preparing, despite Democrats’ worries the idea could increase shortages.
The damage at one of Pfizer’s largest injectables facilities could lead to gains for a few Indian companies, analysts feel. However, regulatory risks, litigation pay-outs and other challenges will slow growth for domestic firms and Indian units of multinationals like Abbott and Pfizer in FY24, says rating agency ICRA as Q1 results begin coming in
All Carrots, No Sticks: House Republican Drug Shortage Plan Ups Reimbursement But Lacks Supply, Quality Commitments
New Republican House Energy and Commerce shortage plan is seen as reasonable starting point, though in need of much strength to address root causes of supply troubles. Most changes apply to generic drugs, but a few could impact brands.