Drugs

FDA Quality Metrics Program on Hold

Attorney Mark Schwartz (Hyman, Phelps & McNamara) says in an online post in his firm’s FDA Law Blog that the FDA quality metrics reporting program first announced in 2015 now appears to be on hold. Although the agency had said in 11/2016 that it intended to open an electronic portal in 1/2018 to receive voluntary submission of quality metrics data reports, he writes, the agency quality metrics Web site has an update banner that “the portal is not opening in January 2018 for widespread, voluntary reporting. Stay tuned for additional updates.”

Schwartz noted that the program was originally intended to be voluntary, but a 2016 revised draft guidance indicated it would become mandatory and would go through notice-and-comment rulemaking.

“At the time,” Schwartz writes, “we speculated that the agency may have changed course from guidance to rulemaking, in part, because of FDA’s waning confidence in its legal authority for this program since the publication of the initial draft. In addition, we mused about the likelihood that the November 2016 publication had been put in motion prior to the election earlier that month of a president who is decidedly against increasing the regulatory burden on industry writ large.”

Following the 2016 announcement, several industry stakeholders commented that the proposal would be very burdensome and would not yield sufficient benefits to offset the burden.

Given the silence from FDA on the issue since then, Schwartz wonders whether the administration or, more precisely, commissioner Scott Gottlieb, has either decided to end the program or to make it less burdensome and more palatable to industry. “Either way,” he concludes, “we are confident that industry is waiting with bated breath, as whatever doesn’t get finalized in this administration is likely to be finalized in a more burdensome way in the next (Democratic) administration.”

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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