FDA and Pharmacy Weekly Digest - April 14

Alerts / April 14, 2020

Investigations Are Ongoing Into Recalled Mushrooms – FDA, CDC, and state and local partners are currently investigating a multistate outbreak of Listeria monocytogenes infections linked to enoki mushrooms. FDA recommends that consumers should not eat, and should check their refrigerators and throw away, any recalled enoki mushrooms from three firms. All three firms have recalled the products.

FDA Reopens Comment Period for Ultrafiltered Milk in Certain Cheeses – FDA issued a proposed rule in October 2005 to amend, in its regulations on food, the definitions of “milk” and “nonfat milk” for cheeses and related cheese products. If finalized, the proposed rule for standardized cheeses and related cheese products would “(1) amend the definitions of ‘milk’ and ‘nonfat milk’ in § 133.3 (21 CFR 133.3) to provide for ultrafiltration of milk and nonfat milk and (2) define ultrafiltered milk and ultrafiltered nonfat milk in § 133.3 as raw or pasteurized milk or nonfat milk that is passed over one or more semipermeable membranes to partially remove water, lactose, minerals, and water-soluble vitamins without altering the casein-to-whey protein ratio of the milk or nonfat milk and resulting in a liquid product.” FDA will provide stakeholders an additional 120 days to submit comments.


GAO Report Analyzes FDA Drug Application Review – The report concluded that “application review times largely reflect agency goals.” GAO found that four key features of a new drug application are linked to the time FDA takes to complete an initial review: 1) whether or not the NDA qualified for the priority review program, 2) whether or not the NDA involves a new molecular entity, 3) whether or not the applicant submits a major amendment, and 4) whether or not the application qualified for one or more of three expedited programs for drugs intended to treat serious or life-threatening conditions. GAO’s report is based on analyzing data and interviews with FDA officials.

FDA Issues Final Guidance on Stability Testing for New Veterinary Drugs – This guidance addresses the stability data package for new veterinary drug substances and medicinal products to be included in a registration or application submitted within the regions in climatic zones III and IV.

Medical Devices

FDA Warns COVID-19 Serological Test Developers – In the general warning, FDA states that it “will take appropriate action against firms making false claims or marketing tests that are not accurate and reliable.” Serological testing does not diagnose COVID-19, but it helps identify who may have developed an immune response to the virus. Former FDA chiefs have written that serological testing will play a role in reopening the economy.

Guidance Issued on Developing and Labeling In Vitro Companion Diagnostic Devices – FDA has issued guidance describing considerations for the development and labeling of in vitro companion diagnostic devices. This guidance expands on the policy statement FDA issued in the 2014 guidance. Companion diagnostics inform the development and approved use of precision medicine.


FDA Extends the Comment Period on Vaping Products – The deadline to comment on the “Request for Information on Vaping Products Associated with Lung Injuries” was extended to June 19. FDA seeks to obtain information on product design and potential ways to prevent consumers from modifying or adding substances to these products that are not intended by the manufacturers.


FDA Publishes Compounding Policy Clarifications – FDA clarified discontinued drugs and those no longer marketed are not considered “commercially available” under the “essentially a copy” provision for pharmacy compounders. Also, the agency is planning to issue a revision to the “one-mile radius” rule for compounding pharmacies owned by hospitals and health systems. Lastly, FDA does not intend to enforce the 5 percent limit on interstate distribution of compounded drug products for pharmacy compounders until the Memorandum of Understanding is finalized.

Authorship Credit: Marc Wagner

Baker & Hostetler LLP publications are intended to inform our clients and other friends of the firm about current legal developments of general interest. They should not be construed as legal advice, and readers should not act upon the information contained in these publications without professional counsel. The hiring of a lawyer is an important decision that should not be based solely upon advertisements. Before you decide, ask us to send you written information about our qualifications and experience.