Drugs

Stakeholders Hit Generic Drug Labeling Rule

Some 15 healthcare stakeholders led by the Generic Pharmaceutical Association and including managed care companies, pharmaceutical benefits managers, and leading drug companies have told FDA that a proposed rule to change generic drug labeling requirements could permit multiple, potentially conflicting labels for therapeutically equivalent products that would create provider and prescriber confusion. A 4/12 letter calls on the agency to “use a science-based alternative that relies on FDA to review new safety information for multi-source products. FDA is the only organization in the multi-source environment with full access to complete product safety information from the numerous manufacturers. Therefore, the agency is best positioned to serve as the centralized authority for labeling changes.”

The letter cites a 2014 survey of physicians, physician assistants, and pharmacists co-released by the Generic Pharmaceutical Association and the National Coalition on Healthcare that found that:
81% of respondents said that FDA approval should be required before any safety label information is changed; 75% said that patients would be confused by multiple labels for the same medicine; nearly 80% said that multiple labels would be confusing for themselves; and 60% of prescribers said their willingness to prescribe generic drugs would change.

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