FDA and Pharmacy Weekly Digest - April 29, 2020

Alerts / April 29, 2020

FDA Extended Comment Period for Rule on Food Standards – The comment period on the proposed rule was extended until July 20. The proposed rule, “Food Standards; General Principles and Food Standards Modernization,” would establish a set of general principles for FDA to use when considering whether to establish, revise or eliminate a food standard.


FDA Published a Revision to the Manual of Policies and Procedures (MAPP) – FDA published a revision (MAPP 5700.1, Rev.1), “ANDA Amendments and Supplements Reviewed by the Division of Filing Review.” This MAPP outlines policies and procedures to determine whether an amendment or supplement should be reviewed by Office of Generic Drugs’ Division of Filing Review. If an abbreviated new drug application (ANDA) is received, FDA has made a threshold determination that the ANDA is substantially complete.

FDA Continues to Refuse Import of Certain Drugs – FDA-regulated products can be refused entry into the U.S. if they do not meet FDA’s laws and regulations. FDA has the statutory authority to refuse entry of products based on the appearance of noncompliance with the Federal Food, Drug, and Cosmetic Act.

Medical Devices

FDA Postpones MDUFA Meeting – The public meeting “Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments” is postponed until further notice. The meeting was originally scheduled for April 7 and then postponed until May 5. The meeting is now postponed until FDA announces a new date.

FDA Issued Guidance for Device Establishments – The guidance explains how a device establishment may request nonbinding feedback from FDA regarding actions the firm has proposed to address certain kinds of inspectional observations documented on a Form FDA 483. Requests should be submitted no later than 15 business days after issuance of a Form FDA 483. FDA’s nonbinding feedback should identify whether the proposed actions to address inspectional observations, if appropriately implemented, appear adequate, partially adequate or inadequate.


FDA Warned Electronic Nicotine Delivery System Retailers and Manufacturers – FDA issued 10 warning letters to electronic nicotine delivery system (ENDS) firms with products targeted to youth or likely to promote use by youth. The products at issue appeal to youth in the way they are designed and labeled because they can be used to conceal product use (which, according to FDA, appeals to kids). Retailers and manufacturers of ENDS products should be aware that FDA continues to aggressively implement its Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization.

FDA Will Close Comment Period on Two Cigarettes – FDA announced the closing date of the public comment period on two modified risk tobacco product (MRTP) applications. Public comments on these applications must be submitted to the docket by May 18, 2020 to ensure they receive consideration by FDA. Anyone can seek approval for an MRTP. If granted, an order permitting the sale of an MRTP refers to a single specific product, not an entire class of tobacco products. An MRTP application must demonstrate that the product will or is expected to benefit the health of the population. The MRTPs under consideration are described as “very low nicotine content” cigarettes.

Premarket Review Submission Deadline for Certain Tobacco Products Extended – In July 2019, a U.S. district court ordered FDA to require manufacturers of e-cigarettes, cigars and other deemed new tobacco products that were on the market as of Aug. 8, 2016, to submit applications for premarket review by May 12. The court granted FDA an extension because of COVID-19. Applications for premarket review for many e-cigarettes, cigars and other new tobacco products are now required to be filed by Sept. 9.


The Supreme Court Will Reschedule Oral Argument in PBM Case – Oral argument will be rescheduled for the October 2020 term. In Rutledge v. The Pharmaceutical Care Management Association, the Court will decide whether Arkansas can regulate pharmacy benefit managers’ (PBMs) drug-reimbursement rates by statute.

Oklahoma Judge Resumed PBM Case – The case was paused so that the Supreme Court could decide Rutledge v. The Pharmaceutical Care Management Association. Because the Supreme Court delayed Rutledge until the October term, the Western District of Oklahoma will continue the Pharmaceutical Care Management Association’s challenge to Oklahoma’s Patient’s Right to Pharmacy Choice Act.

Colorado Board of Pharmacy Ordered to Give DEA Prescription Drug Monitoring Program Data – A Colorado district judge ordered the Board of Pharmacy to give the Drug Enforcement Administration (DEA) prescription drug monitoring data on two pharmacies that the DEA is investigating. The data includes patient identifying data of more than 14,000 patients. The data is to be turned over by May 15.

Authorship Credit: Marc Wagner

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