FDA's Sharfstein Aims for Shades of Gray in Drug Quality Risk Communications
This article was originally published in The Gold Sheet
Sharfstein explains shades of gray in FDA's new enforcement stance
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Hair-trigger enforcement seen as FDA sends in U.S. Marshals and negotiates consent decrees in cases without even first issuing warning letters. The agency is pushing more redacted Form 483 reports onto the web, while the second quarter warning letter rate is back up to Clinton administration levels. Meanwhile, Commissioner Hamburg announces six initiatives to expedite enforcement. Chief among them is a decision to limit Office of Chief Counsel reviews of warning letters. Another is a time clock on Form 483 responses. Additional measures would strengthen ties with other countries' enforcement agencies and establish quicker follow-up and closeout of enforcement cases. Caraco, Clarcon and Teva Animal Health quick-response cases described.
Drug manufacturers are adopting QbD but there are exceptions, especially among some generics firms, McKinsey finds in industry survey. The top challenge to further adoption: misalignment between R&D and commercial operations. Second is a lack of belief in the business case. However, the cost turns out to be low and the financial reward high, McKinsey says.
Using QbD to set specs that make a difference to patients is hard but important work, FDA's Woodcock says. Prasugrel, levothyroxine, pallodone examples explored. How to establish a 'work space.' How to make the right correlations.