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In the News: August 2021 Regulatory and Development Updates

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

Some Drugs May Require Reclassification to Devices

On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices. This is in response to the decision from the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA. Genus contested the FDA’s classification of its barium sulfate contrast imaging agent as a drug rather than a device. For some time, the FDA has asserted its authority to decide on the classification of a product which met the definition of both a drug and a device. Genus succeeded in both the District and Appellate courts. The Court of Appeals for the District of Columbia Circuit stated, “Excepting combination products . . . devices must be regulated as devices, and drugs—if they do not also satisfy the device definition—must be regulated as drugs.”

As noted in the Federal Register announcement, the FDA has decided not to appeal. The notice provides detail on how the FDA plans to handle the transition process. If you are in doubt regarding what classification your product falls into, Camargo can assist.

FDA Creates Public Docket to Address Challenges Around PANDAs

Prior to the enactment of the Hatch-Waxman Amendments, which established the current abbreviated new drug application (ANDA) and the 505(b)(2) application, some drug products were approved through an ANDA that was in many ways a less rigorous NDA: These pre-Hatch-Waxman applications are now called PANDAs. The drugs approved via PANDAs are often used as the reference listed drug (RLD) for ANDAs under 505(j), and they can also be used as the listed drug for 505(b)(2) applications.

PANDAs have historically been overseen by the FDA’s Office of Generic Drugs and thus regulated more like a generic than an NDA. For example, the holder of a PANDA may not be held to the same strict requirements for labeling updates as traditional NDA holders. Camargo has encountered numerous instances in which directly referencing PANDA labeling in a 505(b)(2) application is not scientifically defensible in light of current knowledge, and we have often taken the lead for sponsors in Pre-IND meetings to find ways to successfully use PANDAs.

In addition, duplicating these products can prove difficult, given the number of studies required for ANDA approval for PANDAs with minimal nonclinical, pharmacology, or clinical information. Because of this, many PANDAs have enjoyed little or no competition, possibly because of the regulatory challenges. For instance, the first generic version of the PANDA Estrace® (estradiol vaginal cream, USP, 0.01%) did not appear until 2017, allowing the innovator to enjoy no competition for more than 30 years.

The FDA has been aware of these issues for many years and recently created a public docket soliciting comments on how to treat PANDAs, open through the end of 2021.

Final Regulation Issued for “Intended Use”

On August 2, the FDA issued a final rule on the intended use of medical products, amending its existing regulations at 21 CFR §§ 201.128 (drugs) and 801.4 (devices):

This final rule amends FDA’s regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), and FDA’s implementing regulations, including whether a medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification is intended for a new use.

The regulation has been in flux since 2015. Of particular concern was a component in the previous iteration that placed product sponsors at a potential compliance risk if the sponsor simply had knowledge of an off-label use of their product. Under the final rule, that risk has been mitigated but remains a factor.

PDUFA Fees for Fiscal Year 2022 Announced

The FDA announces the Prescription Drug User Fee Act (PDUFA) fees for the coming fiscal year each August in a Federal Register notice. This year, the fee structure was published on August 13, six pages wherein the FDA analyzes its expected expenses and resource allocation In short, the fees for the coming year are as follows:

Fee category and fee rates for FY 2022

  • Application requiring clinical data: $3,117,218
  • Application not requiring clinical data: $1,558,609
  • Program: $369,413

These changes will make applications more expensive for sponsors in 2022.

Further Reduction of the Already Skinny Label Coming?

Back in October, we noted the outcome of GlaxoSmithKline Beecham Ltd. v. Teva Pharmaceuticals USA, Inc., case as an erosion of the protection the “skinny label” affords to generic manufacturers seeking approval of a drug product where some but not all patents on the RLD have expired.

Now, another case, Amarin Pharma, Inc. et al v. Hikma Pharmaceuticals USA Inc. et al in the Delaware district court is dealing with much the same question: Is a generic product sponsor still liable for patent infringement when it uses the skinny label? The case was filed in December of 2020 and is ongoing. In August, the generic trade organization the Association for Accessible Medicine filed an amicus brief urging the court to reject a report filed in the case supporting continuation of the suit.

The skinny label approach has been used extensively by generic manufacturers since it was enacted via the Hatch-Waxman Act in 1984. If this approach were essentially eliminated, many in the industry predict a sharp decline in generic competition through ANDAs. In many situations, an alternative to an ANDA may be a product approval via the 505(b)(2) regulatory pathway.


Ken Phelps
President and Founder

Bill Stoltman, JD
Vice President, Regulatory Operations