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
Prescription Drug Sampling in the Time of Coronavirus: FDA Issues Temporary Policy Allowing for Drug Samples to be Delivered to Various Locations During the COVID-19 Pandemic
By: Carolina M. Wirth
As the United States tries to find its “new normal” while dealing with the COVID-19 pandemic, the Food and Drug Administration continues to issue temporary policies to allow industry to continue to safely operate during these uncertain times. On June 8, 2020, FDA issued a guidance for industry titled, “Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency,” in order to address questions that the agency has received “regarding FDA’s enforcement of certain requirements relating to the distribution of drug samples under the Prescription Drug Marketing Act of 1987 (PDMA) during the COVID-19 public health emergency [PHE].” More >
FDA Issues Warning Letter for Unapproved Medical Device for Significant Product Quality and Corrective Action-Related Violations
By Alan G. Minsk and Genevieve M. Razick
The Food and Drug Administration issued a Warning Letter to a medical device company after conducting an inspection of the facility’s medical device operations. FDA reviewed the firm’s labeling for the device, the design change assessment, and the response to the FDA Form 483. FDA disagreed with the company’s conclusion that the addition of a device to its 510(k)-cleared device was merely a design change. Rather, FDA concluded that the addition was a new and different device, requiring a new regulatory submission for the whole product. As such, the marketed product was misbranded and adulterated. More >
FSVP: Basics for Importers of Dietary Supplement and Their Components
By: Robert Durkin
Importing dietary supplements and dietary supplement components can present many challenges. Not the least of which are those required to stay in compliance with aspects of the Food Safety and Modernization Act (FSMA). In an effort to assure that imported food products are safe for U.S. consumers, FSMA amended the Food Drug and Cosmetic Act, to add the Foreign Supplier Verification Program (FSVP) 21 U.S.C. § 384a. FSVP requires the importers of food into the U.S. to perform risk-based supplier verification activities. More >
(Maybe) Made in the USA
By: Matthew V. Wilson
On June 22, 2020, the Federal Trade Commission (“FTC”) published a summary of findings from the Commission’s 2019 “Made in the USA” workshop. The workshop report offers experiential, anecdotal and statistical insights into consumer perceptions created by the use of unqualified, “Made in the USA” claims. Importantly, the conclusions drawn from the workshop encouraged the FTC to pursue a formal rulemaking that will govern all “Made in USA” labeling and advertising claims (the “Proposed Rule”). More >
Recent Generics Price Fixing Filing
By: Jeffrey S. Jacobovitz
On June 10, 2020, the Attorneys General from forty-six states, the District of Columbia, and four United States territories filed a lawsuit against twenty-six drug manufacturers, accusing them of a long-standing antitrust conspiracy to fix prices on generic topical drugs. The 543-page complaint accuses some of the largest manufacturers of these products—including Pfizer, Perrigo, Sandoz, and Actavis—of maintaining unlawful agreements not to compete for customers and to coordinate pricing, in violation of the Sherman Act and various state antitrust statutes. More >
