FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for June 2017

Posted on Wednesday, June 14 2017 at 3:26 pm by -

U.S. Supreme Court Finds that Dancing with Biosimilars is NOT Mandatory

By: Alyson L. Wooten, Pharm.D.

imagesThe U.S. Supreme Court had a busy day on Monday (June 12, 2017) issuing four unanimous decisions in recently argued cases.  Of particular note is the final decision in the Supreme Court’s 2016 term – the consolidated case of Sandoz Inc. v. Amgen Inc. and Amgen Inc. v. Sandoz Inc., which interpreted the Biologics Price Competition and Innovation Act (BPCIA).  As we reported here, this case originated out of the U.S. District Court for the Northern District of California where Amgen sued Sandoz for failure to engage in the BPCIA’s patent dance[1] and for inadequate notice of commercial marketing of Sandoz’s biosimilar version (Zarxio®) of Amgen’s Neupogen® product.

The Supreme Court decided that Sandoz had not violated the BPCIA by failing to engage in the patent dance. The justices found it compelling that the BPCIA expressly sets forth the consequences for failure to provide a copy of the FDA application and manufacturing information as required under 42 U.S.C. § 232(l)(2)(A).  This initial exchange of information sets into motion the patent dance.  The consequences, found in 42 U.S.C. § 232(l)(9)(C), permit the sponsor to bring an immediate declaratory judgment action for patent infringement.  Thus, the Supreme Court found the BPCIA does not require a biosimilar applicant to share its abbreviated biologics application and associated data, and, in the absence of voluntary sharing, a branded biologics developer must use injunctive relief to enforce its patents.  As such, the Supreme Court determined there is no requirement that a biosimilar applicant participate in the patent dance.  However, the Court remanded to the Federal Circuit to determine whether California state law may provide for injunctive relief to enforce 42 U.S.C. § 232(l)(2)(A) based on failure to comply with California’s unfair competition statute.

Read the rest of the entry…

Posted on Tuesday, June 13 2017 at 7:41 pm by -

FDA Announces Intent to Extend Compliance Date for Changes to Nutrition and Supplement Facts Labels and Serving Sizes – Federal Register Notice to Follow “At a Later Date”


Following last month’s announcement that the Food and Drug Administration (FDA or agency) had decided to delay the compliance deadline for the menu labeling regulations (see our previous blog post here); today, the agency announced its intent to extend the compliance dates for the Nutrition and Supplement Facts Labels and Serving Size Final Rules.

As you may recall, in May 2016, the FDA issued Final Rules making the most significant changes to the food labeling regulations since they were initially adopted in 1993. The details of the changes are discussed in our May 27, 2016 blog post found here.  Since the Final Rules were published, the agency has been working on providing additional guidance to industry on how to implement the changes (e.g., changes with regard to dietary fibers).  However, in March of this year, the food industry sent a letter to U.S. Department of Health And Human Services Secretary, the Honorable Thomas E. Price, MD., expressing concern with the current compliance deadline of July 2018 for manufacturers with more than 10 million dollars in annual food sales (and July 2019 for those with less than 10 million dollars), and requesting it be extended until May 2021, arguing that the current timeframe for implementation did not “sufficiently account for the time, resources, and complexity involved in label changes of this magnitude.”

After several months of speculation as to whether the Agency and its new Commissioner would be delaying the compliance dates for the new Final Rules, FDA announced that after careful consideration, it had determined that “additional time would provide manufacturers covered by the rules with necessary guidance from FDA, and would help them be able to complete and print updated nutrition facts panels for their products before they are expected to be in compliance.”

While the FDA will be issuing a Federal Register Notice outlining the details of the extension “at a later time;” it noted that “the framework for the extension will be guided by the desire to give industry more time and decrease costs, balanced with the importance of minimizing the transition period during which consumers will see both the old and the new versions of the label in the marketplace.”

Given that the U.S. Department of Agriculture (USDA) is mandated to issue GMO labeling rules in the near future, it is possible that FDA will delay the changes to the nutritional facts labels to coincide with those rules ( potentially until 2021) in order to avoid having industry update their labels twice.  However, we will need to wait until that future Federal Register Notice to see what the agency decides to do.


Posted on Thursday, June 8 2017 at 8:25 pm by -

FDA Extends the UDI Compliance Date for Certain Class I and Unclassified Devices

By: Carolina M. Wirth

UpdateWith the deadline for compliance with the unique device identification system[i] (UDI system) requirements for certain Cass I and unclassified devices other than implantable, life-supporting, or life-sustaining devices (i.e., lower risk devices) over 3 years away (September 24, 2020), the Food and Drug Administration (FDA or agency) issued a letter on June 2, 2017, expressing its intend to extend the compliance date for these types of medical devices until September 24, 2022. In the letter, the FDA acknowledged that there have been some challenges associated with the implementation of the UDI requirements.

Specifically, the agency noted that

after fully considering the time needed to meet UDI requirements, many labelers asked FDA for extensions to comply. In addition, [the agency] identified complex policy and technical issues that need resolution such as how UDI applies to products such as medical procedure trays that contain implantable devices and instruments.  Providing accurate and timely support to labelers has also been challenging due to the sheer number and wide diversity of devices.

In addition to these concerns, FDA noted that in order to “fully reap the public health benefits and a return on investment of a UDI system, high quality UDI data must be available in standardized ways so that the health care community can and will use it with confidence.”

FDA plans to issue a guidance document outlining an enforcement discretion[ii] policy for labeling Global Unique Device Identification Database (GUDID) data submission, standard date formatting, and direct marking requirements for class I and unclassified devices as indicated in the table below.  The agency did not provide a date for when this guidance document will be available to the public and regulated community.

Type of Device Label (21 CFR 801.20), GUDID Submission (21 CFR Part 830, subpart E), and Standard Date Format (21 CFR 801.18) Requirements Direct Mark (21 CFR 801.45) Requirements


Class I devices[iii] September 24, 2020 September 24, 2022
Unclassified devices September 24, 2020 September 24, 2022

[i] The FDA published a Final Rule establishing a UDI system designed to allow adequate identification of devices throughout distribution and use on September 24, 2013.

[ii] Enforcement discretion will not apply to class I or unclassified implantable, life supporting or life-sustaining devices because labelers of these types of devices must already be in compliance with the UDI requirements.

[iii] Class I CGMP-exempt devices are excepted from the UDI requirements per 21 CFR 801.30(a)(2).