FDA Policy/General

Looking Back at Gottlieb, Ahead to Sharpless

A Health Affairs article assesses FDA commissioner Scott Gottlieb’s nearly two years in office in terms of his efforts to advance policy in three areas relating to prescription drugs, and then looks ahead to how the agency may change under Ned Sharpless. The three drug policy areas considered are speeding generic drugs to market, biosimilar regulation, and changes to the drug approval process.

The article says Gottlieb’s efforts to both speed and prioritize generic drug approvals have been notable for two primary reasons. First, the work has not involved just the agency since Congress provided additional authority and assistance through the 2017 FDA Reauthorization Act. And second, Gottlieb has explicitly discussed the need to accelerate generic drug approvals as it relates to the problem of high prescription drug prices.

With regard to biosimilars, Health Affairs cites the agency’s Biosimilars Action Plan, which is yet to be fully implemented. It notes the plan is focused on biosimilar approval rather than market entry, and says that while 18 biosimilars have been approved, just a handful have actually entered the market.

According to the article, the most controversial aspects of Gottlieb’s legacy on prescription drugs will most likely come from his push to “modernize” the clinical trial process. It says Gottlieb has gotten both praise and criticism for the agency continuing to approve many drugs more quickly on the basis of fewer, smaller trials, particularly in oncology and orphan drugs. It also says there may be a tension between Gottlieb’s stated focus of maintaining the “gold standard” of FDA review and the increasing use of accelerated pathways and real-world evidence.

Health Affairs says it expects commissioner Sharpless to continue to implement many of the agency’s existing priorities. But it also suggests he will have priorities of his own, including development of new oncology treatments and collaborations with other agencies, particularly in HHS.

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

Read more

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