Drugs

New Opioid Approval Standard Needed: Gottlieb

FDA commissioner Scott Gottlieb told a Senate Appropriations Committee subcommittee 3/28 that a new comparative standard is needed for approving new opioid drugs. Gottlieb made the comment during a hearing into the FDA FY 20 budget request that includes a 5.5% increase over FY 19, one of the largest increases of any HHS agency. He said he believes FDA should be treating opioids as a class different from other drugs and should require sponsors to demonstrate that any new opioid provides a significant advantage in terms of efficacy and safety over existing products. He said he hoped such an approach could incentivize development of non-opioid alternatives and called on Congress to consider other incentives such as exclusivity.

In response to questions, Gottlieb said:

FDA has issued guidance on a new pathway for drugs that are used to wean people from opioids;
the nature of the nation’s opioid crisis is changing from being based on prescribed drugs to stemming from illicit drugs;
rather than considering the volume of illicit drugs flooding the country, regulators need to be looking at the potency of the drugs;
people are becoming adept at disguising illicit opioids, such as sending them in smaller packages or making them look like OTC products;
FDA will take enforcement against CBD (cannabidiol) products if the companies make claims the agency believes are “over the line”;
FDA is expecting that there will be considerable activity for a generic insulin under the biosimilar pathway;
some non-opioid painkillers that are in development look promising and some could be eligible for a breakthrough designation to speed their approval;
FDA is trying to increase drug competition through approval of generic drugs and second-generation branded products but has no way to promote price competition.

Gottlieb’s prepared opening statement is here.

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