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.
Déjà Vu All Over Again: OPDP Sends Another Letter Regarding Website Promotion of an Investigational New Drug
By: Seth S. Ray and Alan G. Minsk
On November 1, 2019, the Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) sent an Untitled Letter to the sponsor of an investigational new drug that is being studied to treat brain cancer. According to OPDP, the sponsor’s corporate website represented in a promotional context that the investigational new drug was safe and effective for the treatment of brain cancer, in violation of 21 C.F.R. Section 312.7(a). OPDP found this website to be concerning because of the seriousness of this disease and the relatively few available treatment options. More >
A Day Late and a Dollar Short: After Repeated Notices from FDA about its Contract Manufacturers, FDA Sends Warning Letter to Distributor for Receiving and Distributing Adulterated OTC Drugs
By: Carolina M. Wirth and Seth S. Ray
On November 6, 2019, the Food and Drug Administration sent a Warning Letter to an over-the-counter drug distributor for receiving and distributing OTC drugs produced by foreign manufacturers found to have serious violations of federal law. In the Warning Letter, FDA lists a number of violations of current good manufacturing practices by the contract manufacturers that the company used to produce private-label OTC drugs sold at its retail stores. These cGMP violations caused the drug products to be adulterated. The company’s receipt in interstate commerce of adulterated drugs, and the delivery of such drugs, was a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More >
A Very Fine Line — Split Decision: FDA Issues Draft Guidance on Clinical Decision Support Software
By: Alan G. Minsk and Genevieve M. Razick
From his 1986 “Back in the High Life” album, Steve Winwood sings, “It’s a fine line, a very fine line – split decision.” In fact, that’s what many medical device companies will face as they review the Food and Drug Administration’s recently-issued draft guidance document on “Clinical Decision Support Software” (CDS). The draft is a continuation of the agency’s efforts to define how it intends to regulate this type of software and includes recent changes to the Federal Food, Drug and Cosmetic Act (FDC Act). The 21st Century Cures Act amended the FDC Act to exclude certain software functions from the statutory definition of a device. Comments are due to FDA by December 26. More >
Is it a Conventional Food, a Dietary Supplement, or a Drug?
By: Robert Durkin
When clients seek out legal assistance about regulatory issues concerning one of their products, frequently, the first task is to determine exactly what the product “is.” Most would assume that this determination is made by simply reviewing the product’s ingredient and basing a conclusion on the ingredient’s stated purpose. In reality, it is rarely that simple nor should it be if the client is being properly advised. More >
CMS Expands Open Payments Reporting
By: Jennifer Downs Burgar and Genevieve M. Razick
The “National Physician Payment Transparency Program: Open Payments” requires certain manufacturers of drugs, devices and certain other products to disclose annually to the Centers for Medicare and Medicaid Services (CMS) payments or other transfers of value made to physicians or teaching hospitals. It also requires certain manufacturers and group purchasing organizations (GPOs) to disclose physician ownership or investment interests held in those entities, as well as provide information on payments or other transfers of value made to such owners or investors. The Open Payments program was designed to increase transparency and public awareness of the financial relationships between manufacturers and healthcare providers. Reports are required to be submitted annually. More >