FDA ConneKTion

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

Category: Uncategorized

Posted on Tuesday, February 13 2018 at 7:05 pm by
Will Kratom Be Restricted?

By: Alyson L. Wooten, Pharm.D.


Kratom, a popular alternative medicine used as a home remedy for opioid addiction, is now classified by the Food and Drug Administration (“FDA”) as an opioid – a step that may lead to the classification of the substance as a restricted drug under the Controlled Substance Act.

Kratom-e1518403746740-600x350Kratom lies at the intersection of the debate between natural product and drug of abuse. Thousands of people around the world have taken kratom, which grows naturally in areas of tropical Southeast Asia. The plant is part of the coffee family and is commonly crushed for use as an herbal supplement and traditional remedy for pain relief and as a stimulant.

Read the rest of this entry »

Posted on Monday, December 4 2017 at 5:39 pm by
Menu Labeling Update: Plans On-Track for Implementation in May 2018

By: Alyson L. Wooten, Pharm.D.

On November 7, 2017, the U.S. Food and Drug Administration (FDA or the Agency) released the much-anticipated draft supplemental guidance, “Menu Labeling: Supplemental Guidance for Industry” (Draft Guidance). The Draft Guidance provides further details on the Menu Labeling Final Rule (Menu Labeling Rule) and responds to comments the Agency received on the interim final rule, which was released in May 2017.

The Agency’s Menu Labeling Rule has had a long history. The rule requires restaurants and “similar retail food establishments”, such as grocery stores and convenience stores that are part of a chain of 20 or more locations, doing business under the same name, and offering similar food menu items from a menu or menu board to provide: (1) calorie information; (2) a statement on suggested daily caloric intake; and (3) a statement with written nutrition information (which must be provided if requested).

After release of the interim rule in May 2017, which was originally presented in 2015, a number of restaurants and stores in New York City filed suit seeking to prevent New York City from enforcing its substantially similar rule against nutritional information (read here). The City agreed to delay enforcing the rule until March 7, 2018, and the parties reached a settlement agreement contingent upon implementation of the rule by this date. Following the settlement, Scott Gottleib, FDA Commissioner, announced that the Agency planned to release a practical guide on the rule before the end of 2017. The November 7 Draft Guidance seeks to fulfill this promise of a “practical guide”, and appears to continue to suggest that the Menu Labeling Rule will be implemented in May 2018.

While many support the overall goal of the Menu Labeling Rule, many organizations such as the National Restaurant Association are concerned about the patchwork of state and local menu requirements, and the burden created by different store formats attempting to comply with varied rules and regulations. The newly issued Draft Guidance attempts to address these issues has been met with mixed reactions.

As an example of the concerns over this rule, a big issue for many pizza chains is the burden of addressing the thousands of topping combinations people may want on their pizza in calorie counts posted on menu boards in the store. Many pizza chains have been pushing for FDA to allow calorie information to be posted on their website instead of in the store location, with the rationale that the majority of customers order their pizza online rather than in-store. The Agency has rejected this approach in the Draft Guidance, noting that calorie count information may appear online but, if they have in-store menu boards, the calorie information must also appear on the board.

The Agency has indicated that it is willing to continue considering feedback and questions concerning the Draft Guidance. Comments on the proposal are due January 8, 2018.


Posted on Friday, September 22 2017 at 8:51 pm by
Menu Labeling Litigation Between the FDA and Public Interest Groups May Be On Hold

By: Alyson L. Wooten, Pharm.D.

Following the 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), two public interests groups sued the FDA over the decision seeking to have the delay vacated and an immediate compliance date ordered.  Both of these groups, the Center for Science in the Public Interest (CSPI) and the National Consumers League (NCL), have agreed to stay the litigation if FDA will issue additional guidance before the end of the year and confirm that it will not provide another extension to the deadline.

CSPI and NCL sued FDA in June shortly after FDA extended the deadline for compliance asserting that the extension of time was unlawful because the Agency did not provide a rational explanation for the delay or provide for public comments before the delay took effect. In August, the government filed a motion to dismiss for lack of jurisdiction.  A few days later, on August 25, the Agency issued a statement that they would issue “additional guidance” about menu labeling before the end of the year and that the new guidance “should allow covered establishments to implement the requirements by next year’s compliance date.”

On September 15, prior to the deadline for Plaintiffs to file an opposition to Defendant’s motion to dismiss, the parties (CSPI, NCL and FDA) filed a joint motion to stay the case. If granted by the court, the case will be stayed until May 7, 2018, as long as the FDA issued new their guidance by the end of the year and confirmed a compliance date with the Menu Labeling Rule by no later than May 7, 2018.  If FDA does not confirm May 7, 2018 as the compliance date, gives any indication that the compliance deadline could be or will be extended beyond May 7, 2018, or fails to publish the additional guidance before the end of the year, the stay may be lifted and the litigation will proceed with “expedited consideration.”  However, the parties agree that if the compliance date goes into effect on May 7, 2018, the parties will dismiss the case.

Download PDF 

Posted on Thursday, May 11 2017 at 8:34 pm by
New FDA Commissioner Scott Gottlieb, M.D. Sworn in Today

By Carolina M. Wirth

As many of you know, Scott Gottlieb, M.D. was confirmed by the Senate (57 to 42) on Tuesday, May 9, 2017, to serve as the 23rd Commissioner of the Food and Drug Administration (FDA or agency).   Today, he was officially sworn in as Commissioner and begins the task of leading the FDA.

drscottgottlieblHere are a few facts about the FDA’s new Commissioner:[i]

  • Dr. Gottlieb is a physician, medical policy expert, and public health advocate.
  • He previously served as FDA’s Deputy Commissioner for Medical Scientific Affairs and as Senior Advisor to the FDA Commissioner.
  • He worked on the implementation of the Medicare drug benefit when he served as a Senior Advisor to the Administration of the Centers for Medicare and Medicaid Services.
  • He was appointed by the Senate in 2013 to serve on the Federal Health Information Technology Policy Committee, which advises the Department of Health and Human Services on Healthcare Information Technology.

Read the rest of this entry »

Posted on Tuesday, January 26 2016 at 7:38 pm by
Supreme Court Review in Amgen v. Sandoz – Amgen Decides not to Seek Review; Sandoz is Granted Filing Extension

By: Jennifer Giordano-Coltart, Ph.D. and Carolina M. Wirth

Following the Federal Circuit’s denial to rehear the Amgen Inc. v. Sandoz case en banc,1 Amgen and Sandoz had until January 14, 2016 to file petitions for certiorari with the Supreme Court. At the Federal Circuit level, each party won one of the issues in dispute relating to interpretation of the Biologics Price Competition and Innovation Act (BPCIA). Thus, each party had an opportunity to request Supreme Court review of the issue decided adverse to their position. On December 23, 2015, Sandoz submitted a request for an extension of time until February 16, 2016 to submit its petition. The Chief Justice granted Sandoz’s request on December 29, 2015.2 Amgen, on the other hand, did not file for an extension and did not submit a petition by the January 14th deadline. Read the rest of this entry »

Posted on Friday, July 31 2015 at 2:39 pm by
CMS Announces Comprehensive Care for Joint Replacement Model: Agency Includes Waivers for Telehealth

On July 9, 2015, CMS announced the Comprehensive Care for Joint Replacement (“CCJR”) Model. The proposed initiative seeks to hold hospitals accountable for the quality and cost of care provided through the entire hip and knee surgery process. CMS is accepting comments on the proposed model until September 8, 2015.

The proposed two-year model is intended to support better and more efficient care for those patients undergoing hip and knee replacements (also known as lower extremity joint replacements or “LEJR”). The model is designed to test retrospective bundled payment of episodic care for these common surgeries that cost more than $7 billion for hospitalization alone in 2013. Ideally, hospitals, physicians, and post-acute care providers will work together to improve quality and coordination of care throughout the entire surgical and recovery process. Participating hospitals will be held financially accountable for the quality and cost of a beneficiary’s entire episode of care, which continues 90 days after discharge. The hospital will either be financially rewarded or penalized depending on the care provided. Read the rest of this entry »

Posted on Thursday, July 16 2015 at 1:56 pm by
21st Century Cures Act Passed by the House…Next up, the Senate

On July 10, 2015, the U.S. House of Representatives voted with an overwhelming majority in favor of H.R. 6, the 21st Century Cures Act, after a unanimous vote in the House Energy and Commerce Committee in May. The bill is intended to accelerate the pace of medical cures and to provide support for the leading federal healthcare research agencies to discover, develop, and deliver innovative cures to those suffering from incurable diseases. Federal legislators believe that increased support for these research agencies can help spur the current innovation crisis in the pharmaceutical industry, where fewer drugs are being produced per dollar spent on research and development. Read the rest of this entry »

Posted on Tuesday, July 14 2015 at 9:33 am by
CMS Issues the CY2016 Proposed Physician Fee Schedule: the First Proposed Adjustments Following the SGR Repeal

On July 8, 2015, the Centers for Medicare & Medicaid Services (“CMS”) released the proposed Medicare Physician Fee Schedule (“PFS”) for CY 2016 (“Proposed Rule”). The Proposed Rule—which is the first released following the repeal of the Sustainable Growth Rate (“SGR”) formula[1]—calls for a 0.5% increase in physician payments starting on January 1, 2016 and, more broadly, begins implementing the new payment system for physicians and other practitioners—the Merit-Based Incentive Payment System (“MIPS”). The Proposed Rule introduces significant policy changes and finalizes others already in the works to shift physician reimbursement to a system that rewards quality over quantity.[2]

As summarized below, the Proposed Rule proposes changes to the Physician Quality Reporting System, the Physician Value-Based Payment Modifier, and Medicare’s Physician Compare website. Additionally, it proposes two (2) new potential exceptions to the Stark Regulations and clarifications to existing exceptions to resolve common trouble areas identified via the Stark Self-Disclosure Protocol. Read the rest of this entry »

Posted on Thursday, July 2 2015 at 7:18 pm by
The Affordable Care Act Lives On

On June 25, 2014, the U.S. Supreme Court ruled 6-3 to allow millions of Americans to continue to receive subsidies received through federal health insurance exchanges established by the Affordable Care Act (ACA). Read the rest of this entry »

Posted on , July 2 2015 at 12:13 am by
Down to the Wire: FDA Extends Deadline for Dispenser’s Product Tracing Requirements Less than 24 Hours Before July 1, 2015 Deadline

In response to “concern[s] that electronic systems used to exchange, capture, and maintain product tracing information will not be operational” by the July 1, 2015, deadline, the Food and Drug Administration (“FDA”) issued a new guidance yesterday (“Guidance”) indicating they will not begin to enforce dispenser1 (primarily pharmacy) requirements under section 582(d)(1) of the Food, Drug, and Cosmetic Act until November 1, 2015.2 Read the rest of this entry »