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In the News: July Regulatory and Development Updates

Each month, Camargo’s “In the News” series will highlight important changes and advancements in the regulatory and development space and explore how those changes could impact your program.

FDA announces intention to resume domestic inspections

Camargo recently examined an FDA Complete Response Letter which required the sponsor to complete Pre-Approval Inspections for several facilities before its product application could be approved. As the FDA halted all such inspections earlier this year due to the COVID-19 outbreak, this presented something of a challenge. Thus, the FDA’s announcement that it is resuming domestic inspections is good news for sponsors with pending drug product applications. The situation could change, of course, but we remain hopeful.

The FDA has also indicated a willingness to consider partial work-arounds for on-site inspections of non-domestic firms in several situations in which Camargo has also been involved. Nothing definite has been established, but the idea is worth exploring if an application is “stuck” because of approvals delayed by inspections.

FDA withdraws a DESI product after 39 years of review

The process for the FDA to remove from the market products subject to the Drug Efficacy Study Implementation (DESI) program is long and tortuous; therefore, they are not going away anytime soon. A recent market withdrawal notice illustrates the challenges and opportunities represented by DESI drugs.

The NDA for Vioform Hydrocortisone cream, ointment, and lotion was submitted by Ciba Pharmaceutical Co. (now Novartis) and approved prior to 1962. In 1981, the FDA gave notice that this product lacked substantial evidence of effectiveness and proposed to withdraw the NDA pending a hearing. The hearing, which canvassed the product’s lack of substantial evidence of effectiveness and its failure to meet the combination drug policy, took place in 1985. Still, regulations allow for an appeals process, and now, 35 years later, the FDA believes that all relevant parties have had their say. But perhaps not – July’s FDA notice gives 90 more days for appeals to be submitted by potential interested parties (which are exclusively companies making copies, as Novartis has formally withdrawn the NDA).

Despite this most recent setback, it may be possible to resurrect this product with a deep look at the literature to determine if safety and efficacy can be supported with no clinical studies or with a limited number. Camargo has a great deal of experience in leveraging public information to obtain approvals for former DESI products, with high ROI.

FDA issues draft guidance for cannabis and cannabis-derived compounds

The FDA recently issued the draft guidance “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.” There’s a great deal of interest in these products currently, and Camargo is assisting in the development of several. The guidance outlines the FDA’s current thinking on the development of drugs containing cannabis or cannabis-derived compounds and discusses an appropriate product development pathway at a high level, generally following the expectations for botanical products. It is intended to provide clarity regarding a recent legislative change.

The 2018 Farm Bill (the Agriculture Improvement Act of 2018) changed how cannabis is treated under the Controlled Substances Act (CSA). The bill created a new definition of hemp, which includes cannabis and its derivatives or extracts with no more than 0.3 percent of the compound delta-9 tetrahydrocannabinol (THC) by dry weight. The bill also removed hemp from the definition of marijuana provided in section 102 of the CSA, which means that hemp is no longer a controlled substance under federal law. This creates much more flexibility for sponsors seeking to develop products with less than 0.3 percent THC.

Review process for generic drugs far longer than for new drugs 

Only 12% of U.S. ANDAs are approved in the first review cycle, and an ANDA goes through, on average, three review cycles. Worse, ANDAs for complex products – those with complex active ingredients, formulations, or routes of administration such as combination products, transdermal drugs, etc. – are almost never approved on the first cycle. These results, from a 2019 Government Accountability Office (GAO) report, stand in stark contrast to those of applications for new and repurposed drugs, over 80% of which are approved on the first cycle, the GAO found.

GDUFA and PDUFA, the review commitments between the industry and the FDA for generic and new drugs, respectively, are designed to provide greater certainty of the time to review and approve drugs, a critical factor in ROI. According to the GAO and FDA findings, generic companies still struggle to meet the FDA’s requirements and thus go through multiple review cycles to achieve approval, often extending review times by years.

Generic companies often resemble small biotech companies in that they lack experience with the complex programs. It is important to work with an experienced service provider to identify expedited programs and reduce review cycles.

Co-Authors:

Ken Phelps
President and Founder

Bill Stoltman, JD
Senior Director of Regulatory Compliance and Submissions