Drugs

FDA Mulls European Drug Supplies for Generic Testing: Gottlieb

As a means to help bring down rising drug costs, FDA commissioner Scott Gottlieb says he is stepping up pressure against brand drug makers and their tactics to block generic drug market entries. In a 2/15 interview with Kaiser Health News, the agency head expressed his frustration with brand drug makers gaming the system. Specifically, he said FDA is exploring an alternative path for potential generic product makers to obtain brand drug supplies, which are needed to conduct required bioequivalence and other testing, when brand makers block their access.

“[Brands] are adopting all kinds of commercial restrictions with specialty pharma distributors and wholesalers” to prevent sales to generic companies, Gottlieb said, adding that not every branded company is using the tactic, but it is “going on across the board.” He said the agency is currently exploring whether generics makers could buy the drugs they need from European markets without having to do additional work (bridging studies) to prove they are the same, noting that many American and European drug versions are often manufactured in the same plants.

“I have lawyers now looking at this,” Gottlieb said. FDA has been exploring the issue for a couple of months, he said, and he thinks it may be “hard for us to get there without legislation, but we’re not done yet looking at this; we’re still pressing on this.”

In the interview, Gottlieb also discussed a new proposal outlined in the recently released fiscal year 2018 budget plan (see story) to “ensure that ﬁrst-to-ﬁle generic applicants who have been awarded a 180-day exclusivity period do not unreasonably and indeﬁnitely block subsequent generics from entering the market beyond the exclusivity period.” Under the proposal, when a ﬁrst-to-ﬁle generic application is not approved due to deﬁciencies, FDA would be able to tentatively approve a subsequent generic application, which would start the 180-day exclusivity clock. “Triggering the start of the 180 day-exclusivity period for ﬁrst-to-ﬁle applicants who ‘park’ their exclusivity would speed delivery of generic drugs and provide substantial cost savings to American consumers,” the plan says.

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