From all of us at "The Tan Sheet," enjoy a happy and healthy new year. We look forward to 2012, our 20th year of publishing(!), as we continue to provide you with the latest and most insightful coverage of the nonprescription pharmaceutical and nutritional industries.
See below for the top stories from the Dec. 19 issue, our final of 2011. For a complete table of contents, and to sign up for a free trial subscription, click here -- no credit card required.
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"The Tan Sheet," Dec. 19, 2011, Vol. 19, No. 51
Top Stories
Updated Plan B Lawsuit Could Expand EC Switch Targets: The Center for Reproductive Rights plans to revise its 2005 complaint against FDA seeking OTC access to emergency contraceptives. In addition to adding HHS Secretary Sebelius as a defendant, CRR likely will ask for OTC sales of second-generation Plan B One-Step since the original product is available only as generics.
Trade Groups Should Encourage Supplement NDI Compliance – Fabricant: NDI compliance is “taking a back seat to how people feel about the guidance,” FDA official Daniel Fabricant says. Industry leaders ask what more they can do to encourage NDI notification compliance, but also reiterate concerns about FDA’s draft guidance.
Glaxo Subsidiary Stiefel’s Former CEO Faces Securities Fraud Charges: The Securities and Exchange Commission alleges Charles Stiefel, former chairman and CEO of family-owned Stiefel Labs, did not disclose to employee-shareholders material information on the value of the firm’s shares as the firm bought back shares before being acquired by GlaxoSmithKline.
Campaign Targets Unsupervised Pediatric Drug Ingestion: The Consumer Healthcare Products Association, the Centers for Disease Control and Prevention and a public-private safe-medication initiative launch the “Up and Away and Out of Sight” campaign to educate caregivers about how to stop curious children from consuming drugs without supervision.
Chart: FDA Warning Letters Finger Inadequate GMP Inspection Responses: Supplement manufacturers can respond to FDA observations detailed in a Form 483 following a good manufacturing practices inspection. However, recent GMP warning letters the agency posted show that many firms miss the opportunity to detail fully their corrective action plans and forestall an official warning from FDA.
- Dan Schiff (d.schiff@elsevier.com)
