Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from colleagues in other related life science disciplines. 

In This Issue

• No Product Review for You: FDA Issues MAPP Concerning Failure to Pay PDUFA Fees
• Hello, Teleph(armacy) Line: DEA Seeks Public Comment Concerning Telepharmacy Regulation
• Recruitment Incentives in Clinical Trials
• The HHS OIG Finds Remuneration That Does Not Warrant the Imposition of the AKS or the Beneficiary Inducements CMP
• The Sixth Circuit Dissolves the Fifth Circuit Stay and Revives the OSHA COVID-19 Vaccine and Testing Emergency Temporary Standard
• Georgia Judge Enjoins Federal Contractor Vaccine Mandate in Every State in the U.S.
• Attorney Spotlight
• Industry Activities
• Webinar Recording 
• Happy Holidays 

No Product Review for You: FDA Issues MAPP Concerning Failure to Pay PDUFA Fees 
By: Alan G. Minsk & Laura S. Dona

Many of us remember the Seinfeld television episode where the owner of a soup restaurant refuses to fulfill an order if the consumer talks back or otherwise upsets him, angrily stating, “No soup for you.” Recently, the Food and Drug Administration, while not so harshly, revised Manual of Policies and Procedures (MAPP) 6050.1 (rev. 2) (“Effect of failure to Pay PDUFA [Prescription Drug User Fee Act] Fees), whereby it introduces the phrase, “Unacceptable for filing” (UN)” for new drug and biologics license applications and supplements that are not appropriate for review due to outstanding PDUFA fees. This Bulletin will highlight the MAPP, first introduced in July 2017, FDA’s revisions, and the relevance to drug companies. We will not describe PDUFA here, which dates back to 1992. More >

Hello, Teleph(armacy) Line: DEA Seeks Public Comment Concerning Telepharmacy Regulation
By: Alan G. Minsk & Laura S. Dona

With a nod to the Electric Light Orchestra’s 1976 song, “Telephone Line,” the Drug Enforcement Administration (“DEA”) issued an Advanced Notice of Proposed Rulemaking (“ANPR”) regarding the practice of telepharmacy. The Controlled Substances Act, enforced by the DEA, regulates telepharmacies if they dispense controlled substances. However, the DEA is seeking comments from specific groups involved with telepharmacy, as well as the general public, to better understand the actual practice of telepharmacy. As telehealth and telepharmacies grow nationwide, the agency intends to promulgate requirements concerning the dispensing of controlled substances. The growth of telepharmacies has helped expand access to pharmacy care for rural and other underserved populations that otherwise may not have been able to employ full-time licensed pharmacists. However, the DEA is weighing this benefit against the heightened risks of an absent pharmacist (e.g., no licensed professional physically monitoring the dispensing of controlled substances). More > 

Recruitment Incentives in Clinical Trials
By: Neil W. Hoffman & Laura S. Dona 

Recruiting a sufficient number of trial participants is a common difficulty for clinical trial sponsors. To obtain such numbers, sponsors may offer financial incentives to investigators or study sites or site personnel to identify and recruit participants. Such arrangements are not expressly precluded by the U.S. Food and Drug Administration (FDA), though it does have certain disclosure requirements that could be applicable. But drug and medical device manufacturers that sponsor clinical trials should be cognizant of potential regulatory risks inherent in such recruitment arrangements. Also, various organizations have called for more governmental regulation of recruitment incentives in clinical trials, so it is possible that we may see increased governmental enforcement in this area going forward. More >  

The HHS OIG Finds Remuneration That Does Not Warrant the Imposition of the AKS or the Beneficiary Inducements CMP
By: Sara M. Lord 

In a recent Advisory Opinion, the Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) stated that, although the Arrangement would generate prohibited remuneration, it would not impose administrative sanctions against the Requestor based on certain circumstances. While the Opinion contains the usual disclaimers and restrictions limiting it to the specific Arrangement and individual Requestor, it also provides insight into the kind of circumstances that the OIG considers to pose a sufficiently low risk of fraud and abuse to militate against the imposition either of the Anti-Kickback Statute (“AKS”) or the Beneficiary Inducements Civil Monetary Penalties (“CMP”).  More >

The Sixth Circuit Dissolves the Fifth Circuit Stay and Revives the OSHA COVID-19 Vaccine and Testing Emergency Temporary Standard
By: Ashley S. Kelly, Henry M. Perlowski, & Lindsey E. Hughes  

On November 6, 2021, two days after the Occupational Health and Safety Administration (“OSHA”) issued its highly anticipated COVID-19 Vaccine & Testing Mandate Emergency Temporary Standard (the “ETS”), the Fifth Circuit Court of Appeals (the “Fifth Circuit”) in B.S.T. Holdings, L.L.C. et al. v. Occupational Health and Safety Administration et al., No. 21-60845, granted the Petitioners’ emergency motion to stay the enforcement of the ETS. In that order, described in more detail here, the Court cited to “grave statutory and constitutional issues with the Mandate.” The Fifth Circuit then affirmed that stay in a more detailed order issued on November 12, 2021. In addition to the Fifth Circuit litigation, states, private employers, and trade associations across the country filed similar challenges in virtually every United States Court of Appeals. Due to the number of challenges in different circuits, the Judicial Panel on Multidistrict Litigation, a special body that manages multidistrict, federal litigation, consolidated the cases into one challenge before a single circuit chosen by random lottery. On November 16, 2021, the Sixth Circuit Court of Appeals (the “Sixth Circuit”) was chosen to hear the ETS challenges and all of the various cases were transferred to that court. More >   

Georgia Judge Enjoins Federal Contractor Vaccine Mandate in Every State in the U.S.
By: Tenley A. Carp & Jennifer L. Hilliard  

On December 7, 2021, R. Stan Baker, judge for the United States District Court for the Southern District of Georgia, enjoined enforcement of Executive Order 14042 (“EO 14042”) “in all covered contracts in any state or territory of the United States of America.” EO 14042 requires that contractors and subcontractors performing work on certain federal contracts ensure that their employees and others working in connection with the federal contracts are fully vaccinated against COVID-19. The plaintiffs included the States of Georgia, Alabama, Idaho, Kansas, South Carolina, Utah, and West Virginia; the governors of several of those states; various state agencies; the Associated Builders and Contractors, Inc. (“ABC”), a trade organization; and ABC’s Georgia chapter. In deciding in favor of the plaintiffs, the court cited the Kentucky v. Biden case, No. 3:21-cv-55, 2021 WL 5587446, at *9 (E.D. Ky, Nov. 30, 2021), which stated, “This case is not about whether vaccines are effective. They are.” More >   

Food & Drug of counsel and former Acting and Deputy Director of FDA’s Office of Dietary Supplement Programs Robert Durkin was interviewed by NTD News’ Miguel Moreno on FDA’s seizure of a shipment of Ivermectin, a controversial COVID treatment that FDA opposes. A Notice of FDA Action document stated “the drugs violated two requirements related to misbranding by having a lack of adequate directions for use and not include ‘Rx only’ on its label.” “Essentially that charge just means that the box for the labeling of the drug did not have FDA-approved labeling on it,” said Bob. Bob goes on to explain that FDA has been very clear it does not support the off-label use of Ivermectin. To view the full interview, please click here.

Kevin Bell and Matt Zapadka Presented Knowledge Group Webinar on Cannabis Patent Litigation

AGG Intellectual Property attorneys Kevin M. Bell and Matthew D. Zapadka presented a Knowledge Group webinar titled “Cannabis Patent Litigation Update: Recent Developments You Need to Know” on December 16. Kevin and Matt provided attendees with a comprehensive discussion of recent developments in cannabis patent litigation and notable cases that impact the litigation proceedings. The attorneys covered the challenges and pitfalls of cannabis commercialization. To learn more and play the recording, please click here.

On December 16, AGG Food & Drug practice team leader Alan G. Minsk and AGG of counsel and former Acting and Deputy Director of FDA’s Office of Dietary Supplement Programs Robert Durkin discussed what you need to know to handle a regulatory call or meeting with FDA. To view the on-demand recording, please click here.

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