FDA and Pharmacy Weekly Digest - July 2020 #1




FDA Is Investigating an Outbreak of Cyclospora in Bagged Salads – The FDA is investigating a multistate outbreak of cyclospora infections potentially linked to salad products. Eight states have reported the illness, with more than 200 people sickened. Multiple recalls are associated with this investigation.


FDA Names Companies Recalling Common Drug Found to Contain Carcinogen – Weeks ago, the FDA announced that testing has revealed levels of the nitrosamine impurity N-Nitrosodimethylamine (NDMA) above the agency’s acceptable intake limit in several lots of the extended-release formulation of metformin, a prescription drug used to control high blood sugar in patients with type 2 diabetes. The FDA contacted five firms to recommend voluntary recalls of the affected drug product. The FDA updated the public by naming the companies recalling product.

FDA Decreased Population Estimates for Cats and Horses for Determination of Minor Uses in Major Species – The FDA decreased the population estimate for cats by 21 percent and the population estimate for horses by 22 percent. Population estimates are used to determine eligibility for drugs for minor uses in major species. New animal drugs that are intended for minor uses in major species or for use in minor species (MUMS) qualify for certain incentives. MUMS designation can provide sponsors exclusive marketing rights, conditional approval for quicker access to the marketplace and waivers of user fees.

FDA Released Report on Pharmaceutical Quality – The FDA’s Office of Pharmaceutical Quality within the Center for Drug Evaluation and Research published its 2019 Report on the State of Pharmaceutical Quality. The report covers Oct. 1, 2018, to Sept. 30, 2019, and contains quality indicators and trends of the U.S. drug supply chain. The report contains an overview of manufacturing site demographics, manufacturing site compliance, inspection findings, indicators of drug product quality, and testing results of sampled products.

FDA Warned Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic – The FDA issued warning letters to four companies for selling unapproved injectable drug products labeled as homeopathic. No currently marketed drug products labeled as homeopathic have been approved by the FDA.

FDA Finalized Patient-Focused Drug Development Guidance – This guidance is the first of a series of four guidance documents that the FDA committed to develop to address how stakeholders can collect and submit information on the patient experience for medical product development and regulatory decision making. This first guidance presents a general overview of methods and approaches for collecting patient experience data. According to the FDA, this series of guidance documents is intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform medical product development and regulatory decision making.

Medical Devices

FDA Granted Marketing Authorization to Game-based Digital Therapeutic Device – This authorization is for the first game-based digital therapeutic device to improve attention function in children with attention deficit hyperactivity disorder (ADHD). The prescription-only, game-based device is indicated for pediatric patients ages 8 to12 years old with primarily inattentive or combined-type ADHD who have demonstrated an attention issue.


FDA Continues to Update Resources for Tobacco Product Applications for Deemed Tobacco Products – Marketing a deemed tobacco product that is new and that was on the market as of Aug. 8, 2016, requires the manufacturer to submit a marketing application by Sept. 9, 2020. The FDA continues to compile information and resources that may be helpful to those preparing and submitting tobacco product applications for deemed products.


The Comment Period for Draft Guidance on Compounding Animal Drugs from Bulk Is Extended, Again – The comment period was extended until Oct. 15, representing the third comment period extension. When finalized, this guidance will describe the circumstances in which the FDA does not intend to take action against drugs compounded from bulk drug substances. Under the draft guidance, only bulk drug substances on the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals can be compounded into drugs for office stock or for antidotes for food-producing animals when no other medically appropriate treatment options exist.

Drug Price Transparency Rule Nixed – The U.S. Court of Appeals for the District of Columbia Circuit affirmed a district court decision to vacate the May 2019 Drug Price Transparency rule published by the Centers for Medicare & Medicaid Services. The rule would have required direct-to-consumer television advertisements of prescription drugs and biological products for which payment is available through or under Medicare or Medicaid to include the Wholesale Acquisition Cost of that drug or biological. Drug manufacturers challenged the rule in court, and the courts vacated the rule.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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