Alerts

FDA and Pharmacy Weekly Digest - January 14

Alerts / January 14, 2020
Food/Dietary Supplements

Court Enters Consent Decree Against Food Facility – A Michigan-based food manufacturer will “discontinue selling food products until the company complies with federal regulations and other requirements. This action follows several inspections conducted by the U.S. Food and Drug Administration, which found Listeria monocytogenes (L. mono) in the company’s food preparation area and violations of seafood safety regulations associated with the processing of fish and fishery products.”

FDA Addresses Dietary Fiber – The FDA announced its intention to propose “‘glucomannan’ be added to the definition of dietary fiber” in response to a citizen petition.

FDA Issues Import Alert for Several Foods – The FDA published import alerts for certain French cheeses, seafood products, food with undeclared allergens and food containing illegal or undeclared colors.

FDA, U.S. Department of Agriculture and Environmental Protection Agency Launch Streamlined Biotechnology Site – The three agencies announced the launch of a unified website for biotechnology regulation. “The website streamlines information about the three regulatory agencies charged with overseeing agriculture biotechnology products and is part of President Donald J. Trump’s Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products.”

Drugs

Pharmaceutical Company Recalls Lamotrigine Tablets – A pharma company announced the recall of one lot of lamotrigine 100 mg tablets because it “was found to have been cross-contaminated with a small amount of another drug substance (Enalapril Maleate) used to manufacture another product at the same facility.”

FDA Issues List of CBER-Regulated Product Shortages – The FDA provided an updated list of Center for Biologics Evaluation and Research (CBER) product shortages. The recent shortages are available here.

FDA Releases Recent Drug Shortages – The FDA issued a list of drug products recently in shortage. The list is available here.

FDA Proposes Withdrawal of More Than 200 ANDAs – The notice proposes withdrawing 249 abbreviated new drug applications (ANDAs) and allowing the ANDA holders to request hearings on these drug products. The notice states that the “basis for the proposal is that these ANDA holders have repeatedly failed to file required annual reports for those ANDAs.”

Medical Devices

Company Recalls Defibrillator Device – A company announced the voluntary recall of specific units of its defibrillators because “of an issue that may cause their devices to fail to deliver a defibrillation shock after the ‘Shock’ button on the keypad is pressed.”

FDA Releases Guidance on Peripheral Percutaneous Transluminal Angioplasty and Specialty Catheters – The draft guidance “provides draft recommendations, including bench testing and coating characterizations for 510(k) submissions for peripheral percutaneous transluminal angioplasty (PTA) balloons and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-stent restenosis (ISR) and scoring/cutting balloons). These devices are catheter-based devices intended to treat lesions in the peripheral vasculature. This document provides anatomy-specific testing recommendations and expands on FDA’s current thinking for testing of these devices. FDA is issuing this draft guidance to clarify FDA’s premarket submission recommendations for PTA catheters and specialty catheters and to promote consistency across submissions.”

Cosmetics

FDA to Hold Meeting on Cosmetics Containing Talc – On Feb. 4, the FDA will hold a public meeting “to discuss and obtain scientific data and information on topics related to testing methodologies, terminology, and criteria that can be applied to characterize and measure asbestos and other potentially harmful elongate mineral particles (EMPs) that may be present as contaminants in talc and consumer products, including cosmetics, containing talc as an ingredient.”

Pharmacy

House Energy and Commerce Committee to Hold Cannabis Hearing – The Subcommittee on Health of the Committee on Energy and Commerce will hold a hearing titled “Cannabis Policies for the New Decade” on Jan. 15.

Compounding Pharmacy to Pay $1.9 Million to Resolve FCA Allegations – The complaint alleges that the pharmacy “and its owners submitted false claims to TRICARE, a federally funded health care program for military personnel and their families. The Government alleged that the Defendants, through their ‘sales representatives,’ paid physicians in the form of extravagant dinners and other entertainment perks, to induce prescribing. [The pharmacy] employed a sales force to strategically market pre-printed and pre-formulated topical pain cream prescriptions to prescribers in military populated territories such as Kansas City, Southwest Missouri, and Topeka/Manhattan. Many of these creams contained the Schedule III controlled substance Ketamine. Per the complaint, taking advantage of TRICARE’s per ingredient reimbursement policy, without regard to patient need, [the pharmacy] implemented a high dose refill scheme costing TRICARE over $27,000.00 per claim for medically unnecessary pain creams prescribed without a valid physician-patient relationship. The local pharmacy shipped large quantities of preformulated medication to TRICARE beneficiaries. The U.S. Department of Veterans Affairs (CHAMPVA) also suffered losses from this fraud scheme.”

Florida Legislature Proposes Drug Vending Machines – The House bill would allow community pharmacies to use automated pharmacy systems not located in the same location as the community pharmacy.

Supreme Court Grants Petition Related to PBMs – The Supreme Court of the United States will hear a case to determine “[w]hether the U.S. Court of Appeals for the 8th Circuit erred in holding that Arkansas’ statute regulating pharmacy benefit managers’ [PBMs] drug-reimbursement rates, which is similar to laws enacted by a substantial majority of states, is pre-empted by the Employee Retirement Income Security Act of 1974, in contravention of the Supreme Court’s precedent that ERISA does not pre-empt rate regulation.”

Authorship Credit: Lindsay P. Holmes

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