FDA and Pharmacy Weekly Digest - November 12

Alerts / November 12, 2019

President Trump Announces Nomination for Next FDA Commissioner – The president nominated Dr. Stephen Hahn, chief medical executive at the University of Texas MD Anderson Cancer Center, for the position of commissioner of the FDA.

Food/Dietary Supplements

FDA Publishes Proposed Rule on Laboratory Accreditation Program – The FDA proposed “to establish a program for the testing of food by accredited laboratories as required by the FDA Food Safety Modernization Act (FSMA) as part of a proposed rule published today. The laboratory accreditation program, once established, will require testing of human and animal food in certain circumstances by accredited laboratories. Accredited laboratories would be required to follow model standards and would be subject to oversight by FDA-recognized accreditation bodies to help ensure consistently reliable testing results.”

FDA Releases Microbiology Sampling Summary for Cucumbers – The FY16-17 report covers the FDA’s sampling of cucumbers that was "part of an ongoing effort to help ensure food safety and prevent contaminated products from reaching consumers. The FDA’s proactive approach to sampling is intended to help the agency learn more about the prevalence of disease-causing bacteria in certain foods and identify patterns that may help prevent future contamination.”

FDA Announces Continued Enforcement Discretion for Certain Entities Under FSMA – The FDA stated it will be continuing its enforcement discretion policy for compliance with certain FDA Food Safety Modernization Act (FSMA) supply-chain program requirements applicable to receiving facilities that are co-manufacturers. Three of the rules created to implement FSMA – Preventive Controls for Human Foods, Preventive Controls for Animal Food and the Foreign Supplier Verification Programs – require co-manufacturers that are receiving facilities and/or importers that produce food for the brand owners to approve suppliers and conduct certain supplier verification activities. These requirements are designed to ensure suppliers are addressing hazards requiring a supply-chain-applied control. In November 2017, the FDA announced an enforcement discretion policy until Nov. 6, 2019, for compliance with certain supply-chain program requirements related to supplier approval and supplier verification. The enforcement discretion was intended to “give brand owners more time to work with suppliers to adjust contracts so that supply-chain-related information could be shared with co-manufacturers. Since that time, the FDA has learned of additional challenges the industry is facing in trying to meet the supply-chain requirements. The FDA will continue enforcement discretion policy while advancing its work with stakeholders to better understand these challenges and to consider possible solutions to address these situations. We intend to announce the extension in a forthcoming notice in the Federal Register. In the meantime, co-manufacturers should continue to comply with other applicable requirements for which they are responsible under the Federal Food, Drug, and Cosmetic Act.”


FDA to Hold Public Meeting on Pediatric Therapeutics – The meeting is intended to “obtain input from patient groups, consumer groups, regulated industry, academia and other interested parties on any recommendations or information relevant to the report to Congress that FDA is required to submit to Congress as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA). Some of the issues to be discussed at the meeting will include, but not be limited to: (1) Hearing from patients/parents and patient/parent groups, industry, academia and other stakeholders about the public health impact that pediatric legislation may have had on them or their communities; (2) Understanding the effects of the requirement of pediatric studies under PREA or the incentives under BPCA on drug/biologic development plans; and (3) Understanding if there are any barriers or resource issues preventing undertaking or completing studies under PREA and BPCA.”

FDA to Hold Meeting on Improving Health Equity During the Opioid Crisis – The Office of Minority Health and Health Equity public meeting will be held “to share information and obtain the public’s perspectives on the current opioid crisis and how it specifically affects minority populations across the country, approaches to prevent and treat opioid use disorder, and emerging research as it relates to improving care for racial and ethnic minority, underrepresented, and underserved populations, and how FDA can support those efforts.”

FDA Addresses Patient Safety Through Postmarket Surveillance – The FDA announced its “Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff,” which expands upon those principles. “This draft best practice document outlines our approach for timely postmarket analyses of drugs and biologics, and includes a high-level overview of tools, methods, and signal detection and evaluation activities, using varied data sources, for drug safety surveillance to provide a broader context and a general overview of our overarching effort and commitment in this area. … Our best practices document incorporates the guiding principle that postmarket safety surveillance is a dynamic and constantly evolving field. By using a risk-based approach, the FDA takes into account the nature of the drug, its potential adverse events, the intended population, and the potential for serious outcomes, as well as the impact on individuals and the overall potential impact on the health of the public. When information is uncovered that may change the benefit-risk profile of a product, we will investigate the issue and consider appropriate action, including labeling changes, issuing drug safety communications, requiring postmarketing studies or requiring a Risk Evaluation and Mitigation Strategy. Even when we do not have enough evidence to establish a causal association between a drug and adverse event, we continue monitoring the safety of the product.”

Medical Devices

FDA Announces Webinar About Medical Software – The webinar is intended to discuss and answer questions about the Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act final guidance.

FDA Authorizes Sequencing Test for Detecting HIV-1 Drug-Resistant Mutations – The assay “detects HIV-1 drug resistance mutations in patients taking or about to start antiviral therapy. This assay detects mutations in genes of the HIV-1 virus from a sample of a patient’s blood using NGS. Understanding the mutations in the virus can help healthcare providers select an effective combination of drugs in an ART regimen and indicate which drugs may no longer be effective against the mutated HIV-1 virus. The FDA reviewed data from performance studies, which demonstrated a greater than 95% sensitivity and specificity in detecting 342 HIV drug resistant mutations and determined the … Assay provides a reasonable assurance of safety and effectiveness for its intended use.”


CMS Holds Opioid Treatment Call – On Nov. 12, CMS held a call about opioid treatment programs. Per CMS, “Starting January 1, 2020, under the CY 2020 Physician Fee Schedule final rule, the Centers for Medicare & Medicaid Services (CMS) will pay Opioid Treatment Programs (OTPs) through bundled payments for opioid use disorder treatment services for people with Medicare Part B.” The call addresses the new benefit and how to enroll.

CMS to Hold Call on the Clinical Diagnostic Test Payment System – The call on Nov. 14 will address “how to report data required by the Clinical Diagnostic Test Payment System final rule. CMS demonstrates how to register in the system and submit then certify data. Laboratories, including physician offices laboratories and hospital outreach laboratories, that bill using a 14X TOB are required to report laboratory test HCPCS codes, associated private payor rates, and volume data if they: (1) Have more than $12,500 in Medicare revenues from laboratory services on the Clinical Laboratory Fee Schedule (CLFS), and (2) Receive more than 50 percent of their Medicare revenues from CLFS and physician fee schedule services during a data collection period.”

CMS Releases Final Rule on Durable Medical Equipment (DME) Payment – The final rule “updates payment policies and rates under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to beneficiaries on or after January 1, 2020. This rule also updates the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities to individuals with AKI and finalizes changes to the ESRD Quality Incentive Program (QIP). In addition, this rule finalizes a methodology for calculating fee schedule payment amounts for new Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) items and services and making adjustments to the fee schedule amounts established using supplier or commercial prices if such prices decrease within five years of establishing the initial fee schedule amounts. This rule also revises existing policies related to the competitive bidding program for DMEPOS. This final rule also streamlines the requirements for ordering DMEPOS items, and creates one Master List of DMEPOS items that could potentially be subject to face-to-face encounter and written order prior to delivery and/or prior authorization requirements. Finally, it also includes summaries of responses to requests for information on data collection resulting from the ESRD PPS technical expert panel, possible updates and improvements to the ESRD PPS wage index, and new rules for the competitive bidding of diabetic testing strips.”

Authorship Credit: Lindsay P. Holmes

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