Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice. We are thinking of all of you in these difficult times, and hope all of you and your loved ones are safe.
Industry Insights
Don’t Tune Out OPDP’s Recent Warning Letter For a Violative Radio Advertisement
By: Alan G. Minsk and Genevieve M. Razick
On August 31, 2020, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent a Warning Letter to the sponsor of a drug for a violative direct-to-consumer (DTC) radio advertisement.1 The radio advertisement was submitted to FDA under the cover of FDA Form 2253. According to OPDP, the sponsor’s radio advertisement made false or misleading claims about the risks associated with the prescription drug product and omitted other material facts. Thus, the radio advertisement misbranded the drug within the meaning of the Federal Food, Drug, and Cosmetic Act. We will summarize OPDP’s concerns with the radio advertisement. More >
Houston, We Have A Problem: FDA Confirms That It Will Only Conduct Mission-Critical Inspections and Prioritized Domestic Inspections of Drug and Biological Product Manufacturers During the COVID-19 Pandemic
By: Carolina M. Wirth
In March 2020, FDA temporarily postponed all domestic and foreign routine surveillance facility inspections, as well as surveillance inspections in support of the Bioresearch Monitoring (BIMO) program. Four months later, in July 2020, the agency announced that it was beginning to work toward resuming “prioritized domestic inspections” using its COVID-19 Advisory Rating system to determine the types of regulatory activity that could take place in a given geographic region. FDA determined that it would continue, on a “case-by-case basis, to conduct only “mission-critical” inspections or where possible to do so safely, resuming prioritized domestic inspections, which generally include pre-approval and surveillance inspections.” FDA also announced that prioritized domestic inspections would be pre-announced to FDA-regulated businesses for the foreseeable future. More >
FDA Issues Proposed Rule Seeking to Clarify Evidence Relevant to Its Intended Use Determinations of FDA-Regulated Products
By: Robert Durkin and Seth S. Ray
On September 23, 2020, the U.S. Food and Drug Administration (FDA) published in the Federal Register a proposed rule titled, “Regulations Regarding ‘Intended Uses.’” The goal of this proposed rule is to amend the regulations defining “intended use” – for drugs and medical devices to provide better clarity regarding the specific types of evidence the agency may rely on when making a determination about the intended use of these FDA-regulated products. More >
President Donald Trump Signs an Executive Order Aimed at Lowering Medicare Drug Prices
By: Neil W. Hoffman and Genevieve M. Razick
On September 13, 2020, President Donald Trump issued an Executive Order, “Lowering Drug Prices by Putting America First,” to direct the Secretary of Health and Human Services (HHS) to implement new payment models under Medicare Parts B and D to curb “unfair” and high drug prices in the United States. Under the Executive Order, the Medicare program would not pay more for Part B or Part D prescription drugs or biological products than the “most-favored-nation price.” More >
