FDA and Pharmacy Weekly Digest - April 6

Alerts / April 6, 2020

FDA Requested Comments on Information Collection for Cosmetics – FDA announced it is seeking comment on information collection activities regarding FDA’s cosmetic labeling regulations and its Voluntary Cosmetic Registration Program (VCRP). Specifically, FDA is interested in whether the information it collects will have practical utility; ways to enhance the quality, utility and clarity of the information to be collected; and ways to minimize the burden of the collection of information on respondents.

Food/Dietary Supplements

FDA Will Reopen Comment Period for Ultrafiltered Milk in Certain Cheeses – Originally, FDA issued a proposed rule in October 2005 to amend the definitions of “milk” and “nonfat milk” for cheeses and related cheese products in FDA’s regulations on food. The agency will reopen the comment period to solicit any new information on current industry practices regarding the use of fluid ultrafiltered (UF) milk and fluid UF nonfat milk and on labeling of UF fluid milk and fluid UF nonfat milk when used as ingredients. FDA will provide stakeholders an additional 120 days to submit comments when the notice is published in the Federal Register.


FDA Ended the Clinical Data Summary Pilot Program – The program began in 2018 to assess the feasibility of using a different format to provide required summaries of the safety and effectiveness information that is used to make regulatory decisions. FDA identified various inefficiencies caused by increasing transparency in the drug approval process, such as multiregional disclosure requirements, a significant burden considering 60% of the clinical trial participants were located outside the U.S. for new drug approvals in 2019. Additionally, FDA identified a potential approach that could facilitate a harmonized system for disclosing study reports, if legal and regulatory barriers could be removed.

FDA Requested All Ranitidine Products to Be Removed From Market – This request stems from the investigation into a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). Ranitidine is available as a prescription and over-the-counter (OTC) medication for heartburn. The contaminant, NDMA, is a probable human carcinogen that was found to be in ranitidine in the summer of 2019. Because of the market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.

FDA Warned Drug Manufacturing Facility in India for Adulterated Products – The warning letter summarizes significant violations of current good manufacturing practice. The warnings included failed sterility testing, environmental monitoring and data integrity.

Medical Devices

FDA Postponed Public Meeting on Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 – FDA announced that the public meeting originally scheduled for April 7 is postponed to May 5 and will take place remotely. The FDA invites public comment on the medical device user fee program and suggestions regarding the commitments the FDA should propose for the next program. Registration to participate as a speaker at the meeting is open until April 23, and registration for general attendance closes May 4.


FDA Sued Over Required Warnings for Cigarette Packages and Advertisements – The new required cigarette health warnings for cigarette packages and advertisements contain textual warnings and graphic images. The complaint alleges that the required warnings constitute “compelled speech” and violate the First Amendment.


FDA Published a Report on Prescription Drug User Fee Act and Biosimilar User Fee Act – The report provides options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the human drug and biosimilar biologic review programs. FDA is accepting public comment on the report until May 6.

Supreme Court Postponed Oral Argument in Pharmacy Benefit Manager (PBM) Case – In a press release, the Court postponed cases through the end of April, citing COVID-19 as the cause. If circumstances allow, the Court may reschedule the argument before the end of the term or “the Court will consider a range of scheduling options and other alternatives if arguments cannot be held in the Courtroom” before the end of the term The postponed case is Rutledge v. the Pharmaceutical Care Management Association, in which the Court will decide whether Arkansas can regulate PBMs’ drug-reimbursement rates by statute.

Utah Enacted PBM Reform Law – Among other provisions, the new law prohibits PBMs from reimbursing a network pharmacy less than they would reimburse a PBM-owned pharmacy or from retroactively reducing pharmacy reimbursement without providing 30 days’ notice. A PBM may not prohibit an in-network retail pharmacy from mailing or delivering a prescription.

Washington State Increased PBM Oversight – The bill was partially vetoed by the governor, but the remainder was passed and will be effective. The bill requires healthcare managers to register with the insurance commissioner and imposes requirements on PBMs.

Authorship Credit: Marc Wagner

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