FDA and Pharmacy Weekly Digest - May 21

Alerts / May 21, 2019
Food/Dietary Supplements

FDA Holds Public Meeting on Dietary Supplements – The FDA held a public meeting titled “Responsible Innovation in Dietary Supplements.” During the meeting, Acting Commissioner Sharpless stated, “The topic of today’s meeting – responsible innovation in dietary supplements – really gets to the heart of the balance between access and safety that is at the core of the Dietary Supplement Health and Education Act. Our multipronged effort to modernize the dietary supplement program is complicated – but so is the industry. I know that our Office of Dietary Supplement Programs is looking forward to hearing your suggestions on how we might reshape our oversight of dietary supplements.”

FDA Releases Guidance on Potassium Chloride – The FDA issued a draft guidance titled “The Use of an Alternative Name for Potassium Chloride in Food Labeling.” The guidance is intended “to advise food manufacturers of our intent to exercise enforcement discretion for declaration of the name ‘potassium chloride salt’ in the ingredient statement on food labels as an alternative to the common or usual name, ‘potassium chloride.’”


FDA Raises Concerns About Homeopathic Products – The FDA issued a warning letter to five manufacturers of homeopathic products, alleging violations of current good manufacturing practices. The majority of the warning letters addressed homeopathic eyedrops purporting to be sterile when they were shown to be nonsterile.

Medical Devices

FDA Warns Consumers About the Use of Certain Diabetes Management Devices – The FDA issued a public warning to patients and healthcare professionals about the risks of unapproved/unauthorized diabetes management devices. These include glucose monitoring systems and insulin pumps. The FDA’s safety communication stated, “Patient use of unauthorized diabetes management devices, alone or along with other devices, could result in inaccurate glucose level readings or unsafe insulin dosing. These inaccuracies may lead to injuries requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis (buildup of acids in blood), and death.”


​Sharpless Addresses Public Workshop on Youth Tobacco Cessation – The acting commissioner stated, “I intend to focus on keeping tobacco products out of the hands of America’s youth. There is no dispute that years of progress to combat youth use of tobacco – to prevent lifetimes of addiction to nicotine – is now threatened by an epidemic of e-cigarette use by kids.”


Justice Department Issues Opinion on Articles for Use in Lawful Executions – In a slip opinion, the assistant attorney general stated, “We conclude that articles intended for use in capital punishment by a state or the federal government cannot be regulated as ‘drugs’ or ‘devices’ under the Food, Drug and Cosmetic Act. The Food and Drug Administration accordingly lacks jurisdiction to regulate such articles intended for that use.”

SC Passes PBM Law – The South Carolina governor signed S 359, which requires licensure for pharmacy benefits managers and prohibits them from penalizing pharmacies for disclosing certain information, like the total cost of pharmacy services.

503A Bulks List Submission – A pharmacy submitted a citizen petition for the inclusion of oxitriptan on the 503A Bulks List “and to allow continued compounding of oxitriptan for the treatment of tetrahydrobiopterin deficiency diseases in the interim.”

CMS Publishes Guidance Aimed at Spread Pricing in Medicaid – The Center for Medicare & Medicaid Services (CMS) stated, “In today’s guidance, CMS is making clear that, for purposes of the [medical loss ratio] MLR regulation, ‘prescription drug rebates’ means any price concession or discount received by the managed care plan or by its PBM, regardless of who pays the rebate or discount. Some possible examples include payments from pharmaceutical manufacturers, wholesalers, and retail pharmacies. Therefore, the amount retained by a PBM under spread pricing would have to be excluded from the amount of claims costs used for calculating the managed care plan’s MLR. The policy underpinning this guidance is that spread pricing should not be used to artificially inflate a Medicaid or CHIP managed care plan’s MLR.” The guidance is available here.

CMS Finalizes Rule To Lower Drug Prices – CMS stated, “After an implementation period, Part D plans will be required to provide access to such a tool that is integrated into clinicians’ electronic prescribing or electronic health records (EHR) systems. CMS is encouraged that some plans are already offering these tools, but today’s policy will require all plans to provide clinicians with access to price information for different prescription drugs. Getting more information on out-of-pocket costs for prescription drugs to patients and their clinicians early in the process is critical, as there should be no surprises at the pharmacy counter. To further promote transparency, after an implementation period, today’s rule will also require the Explanation of Benefits document that Part D enrollees receive each month to include information on drug price increases and lower-cost therapeutic alternatives. As a result of these changes, patients and their clinicians will be able to better understand the cost of prescription drugs and seek out high-value options, helping to increase patient adherence and improving health outcomes. CMS is also codifying a policy that enables beneficiaries to select a Medicare Advantage plan that negotiates prices for physician-administered medicines when beneficiaries are first starting on the medicines.” The final rule is available here.

Authorship Credit: Lindsay P. Holmes

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