Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC office, and articles from members of AGG outside the Food and Drug Practice.

In this Issue

• Rx Drug and Medical Device Advertising & Promotion – Considerations and Predictions for 2019 
• HHS Proposes Rule that Would Impact Drug Manufacturer Rebates to Health Plans, MCOs, and Pharmacy Benefit Managers 
• Pharma Supply Chain Cornucopia: More FDA Guidance on DSCSA Product Identifier and Verification Requirements 
• Over-the-Counter (OTC) Monograph Reform Momentum Strong in 2019:
  Federal Legislation Update in the New 116th Congress
• Boxed Warning Drugs Beware!!
• New Hazardous Waste Pharmaceuticals Rule: Significant changes Coming for health Care Facilities, Particularly Long-Term Care Facilities
• AdvaMed Issues Revised Code of Ethics on Interactions with Health Care Professionals
• Medical Device Landscape: Additional Developments for the 510(k) Pathway
• It’s De Novo All Over Again: FDA Issues a Proposed Rule to Implement the De Novo Classification Process
• Industry Activities and Recognition
• Upcoming Events

PHARMACEUTICALS

Rx Drug and Medical Device Advertising & Promotion – Considerations and Predictions for 2019
By: Alan G. Minsk and Seth S. Ray

AGG recently presented a webinar on “FDA Regulation of Rx Drug and Medical Device Advertising & Promotion: The Year in Review.” The webinar focused primarily on enforcement letters and three guidance documents issued by the Food and Drug Administration (FDA) during 2018 concerning product promotion. We will highlight some considerations and predictions for 2019. More > 

HHS Proposes Rule that Would Impact Drug Manufacturer Rebates to Health Plans, MCOs, and Pharmacy Benefit Managers
By: Jennifer Downs Burgar and Genevieve M. Razick

On January 31, 2019, the Department of Health and Human Services Office of the Inspector General proposed a new rule that would amend the safe harbor regulations under the Federal Anti-Kickback Statute to exclude from the discount safe harbor certain rebates or reductions in price on a prescription drug that are paid by manufacturers to plan sponsors under Medicare Part D, Medicaid managed care organizations, and pharmacy benefit managers. More >

Pharma Supply Chain Cornucopia: More FDA Guidance on DSCSA Product Identifier and Verification Requirements
By: Alan G. Minsk and Christine Kirk 

The Food and Drug Administration has issued four guidance documents regarding the product identifier and verification system requirements of the Drug Supply Chain and Security Act (DSCSA). Among other things, these guidance documents address the end of the product identifier compliance period on November 27, 2018; the grandfathering of certain packages and homogenous cases without product identifiers; and product verification system requirements. More >

Over-the-Counter (OTC) Monograph Reform Momentum Strong in 2019:
Federal Legislation Update in the New 116th Congress
By: Christine Kirk and Carter Cornick 

Recent developments in Congress deserve the attention of companies with over-the-counter drug products. Major legislation addressing comprehensive reform of the OTC drug monograph process, which nearly passed last year in 2018, has been reintroduced and is well on its way toward passage in the current Congress. More >

Boxed Warning Drugs Beware!!
By:  Seth S. Ray 

The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) recently sent three enforcement letters (two Warning Letters and one Untitled Letter) to three prescription drug manufacturers. Both Warning Letters concerned Internet promotion. One Warning Letter and the Untitled Letter were the subject of complaints to OPDP’s Bad Ad Program. All three letters addressed the promotion of drugs with boxed warnings and focused on minimization of risk information. Despite the low number of total letters issued by OPDP this year, these three letters show that FDA has not gone away, particularly where public health risks are presented, such as with boxed warning products. More >

New Hazardous Waste Pharmaceuticals Rule: Significant changes Coming for Health Care Facilities, Particularly Long-Term Care Facilities
By: Brooke F. Dickerson and Jennifer L. Hilliard 

Health care facilities that provide a host of health care-related services or distribute, sell, or dispense pharmaceuticals will need to learn a whole new set of regulations thanks to a finalized new rule promulgated by the Environmental Protection Agency (EPA). The new rule revises management standards for hazardous waste pharmaceuticals (HWPs) for health care facilities, including nursing, skilled nursing, and inpatient hospice facilities, more than three years following the close of comments for the EPA’s initial proposed rule. The revised regulations will take effect six months following publication in the Federal Register. More >

DEVICES

AdvaMed Issues Revised Code of Ethics on Interactions with Health Care Professionals
By: Jennifer Downs Burgar and Genevieve M. Razick

On January 9, 2019, the Advanced Medical Technology Association (AdvaMed) issued a press release announcing approval of an updated Code of Ethics on Interactions with Health Care Professionals (HCPs) in the U.S.. The Code provides voluntary guidelines for interactions with HCPs in the medical technology context. More >

Medical Device Landscape: Additional Developments for the 510(k) Pathway 
By: Alan G. Minsk and Christine Kirk

The Food and Drug Administration announced several actions relevant to the 510(k) premarket notification regulatory pathway. AGG has previously written about some of these, such as the pilot expansion of the Special 510(k) Program. In this Bulletin, we briefly address a few notable developments from late 2018 with potential relevance for 510(k) products. These include ongoing modernization of the 510(k) pathway and related initiatives, particularly FDA’s focus on the use of modern predicate devices. These developments are relevant to determining whether the 510(k) pathway is appropriate for a specific device, and will likely be of particular interest to device companies that: (i) market devices with “older” 510(k) clearances (i.e., those cleared more than 10 years ago), or (ii) are planning to use an older device as a predicate for clearance of a newer device. More >

It’s De Novo All Over Again: FDA Issues a Proposed Rule to Implement the De Novo Classification Process  
By: Alan G. Minsk and Christine Kirk

In December 2018, the Food and Drug Administration issued a proposed rule that would amend the medical device classification regulation to implement the De Novo classification process. In short, the notice explains FDA’s thinking and the rule, if finalized as proposed, would formally implement the law on the submission and withdrawal of requests for De Novo classification. Furthermore, the rule would set the criteria used by the agency when reviewing, approving, rejecting, or withdrawing these requests. FDA will accept comments submitted by March 7, 2019. More >