Drugs

Experts Offer Pharmaceutical Reform Plan

Some 21 health experts are offering what they describe as a comprehensive proposal to ensure universal access to safe, innovative, and affordable medicines, according to a statement from Public Citizen. The plan, published in the British Medical Journal, identifies seven critical areas of reform, with short- and long-term solutions they say will improve the development, approval process, affordability, and marketing of medications. The seven areas are:

access through having the U.S. and Canada establish national formularies of the safest, most effective, and least expensive medications, and providing all residents with full coverage of formulary drugs without copays or deductibles;
affordability by having public agencies negotiate with manufacturers to make branded medications more affordable and, if negotiations fail, issuing a “compulsory license” to allow generic manufacturing;
preclinical development and patent protection limiting patents to medications that provide real innovation and having health agencies find a new public research program to develop and test new treatments outside of the patent system, prioritizing medications with high clinical value and for conditions deemed unprofitable by the industry;
clinical testing through approval agencies increasing standards for clinical trials and increasing transparency by making all trial data publicly available;
approval reform by funding approval agencies exclusive with public funds rather than industry user fees;
postmarketing surveillance so that companies are required to promptly perform and submit safety studies after their products are on the market; and
promotion to improve monitoring and stiffen sanctions for misleading or off-label promotions.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome