BakerHostetler FDA and Pharmacy Weekly Digest - December 2018 #1


Food/Dietary Supplements

FDA Investigates Multiple Foodborne Illness Outbreaks – The FDA and the CDC have launched a multistate investigation of a Salmonella Concord outbreak linked to certain tahini products. FDA advised consumers not to eat these imported products. In addition, FDA continues to investigate the E. coli outbreak related to romaine lettuce.

FDA Executes MOU With China – FDA issued a reminder that U.S. establishments that are on the dairy, seafood and infant formula export lists for China must obtain third-party certification of compliance with applicable Chinese laws by June 15, 2019, to maintain continued access to the Chinese market. In addition, the FDA issued its updated guidance titled “Guidance for Industry: Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China.”

FDA Issues Warning About Certain Dietary Supplements – The FDA warned dietary supplement marketers that market products containing tianeptine, because a number of these products make claims that the products treat opioid use disorder and pain and anxiety. This warning resulted from reports of serious adverse events associated with tianeptine-containing products.


FDA Warns of Hidden Ingredients in Drug Products – The FDA issued two public notifications about products containing hidden ingredients. FDA warned consumers not to purchase a weight-loss product because it contains sibutramine and phenolphthalein, which have been removed from the market due to safety concerns. FDA also warned consumers not to purchase a product promoting sexual enhancement because it contains undisclosed sildenafil, the same ingredient contained in Viagra.

Large Manufacturer Issues Voluntary Nationwide Recall – A manufacturer issued a voluntary nationwide recall of sodium chloride injections (USP, 0.9%). The “product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain natural rubber latex.”

FDA Announces Grants for Animal Drugs – The FDA opened applications for grants in support of new animal drug development. The grants are focused on treatment of uncommon diseases in major species.

Medical Devices

FDA Issues Draft Guidance Documents Related to Blood Glucose Monitoring – The FDA published two revised draft guidance documents. The guidance documents address design considerations and recommended device standards.

FDA Issues Draft Guidance Documents on CLIA Waiver Applications – The FDA published two draft guidance documents focused on helping manufacturers of in vitro diagnostic devices seeking Clinical Laboratory Improvement Amendments (CLIA) waivers. FDA is also hosting a webinar related to these guidance documents.

FDA Asks for Feedback to Inform Draft Guidance – The FDA is requesting input on its patient engagement discussion document issued after its October Patient Engagement Advisory Committee meeting. The discussion document focuses on patient engagement in medical device clinical trials. Comments can be submitted until Jan. 8, 2019.

FDA Announces Modernization of 510(k) Process – The FDA issued a joint statement from the commissioner and director of the Center for Devices and Radiological Health indicating that the “framework [FDA] propose[s] is aimed at efficiently advancing beneficial technology to patients, while solidifying FDA’s gold standard for safety.” The types of medical devices appropriate for this pathway either use advances in technology or meet more modern safety and performance criteria.

FDA Issues Medical Device Enforcement and Quality Report – The FDA recently released a report detailing its enhanced oversight of medical device firms through increased inspections, development of the Medical Device Single Audit program and its “targeted risk-based approach to addressing concerns with specific devices.”


FDA Warns Company Selling Certain E-liquids – The FDA issued a warning letter to a company for selling e-liquids that resemble kid-friendly food items. This is part of the FDA’s plan to continue to protect children from tobacco products.


HHS Publishes 340B Drug Rule – HHS published the “340B Drug Pricing Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.” HHS changed the effective date of this regulation to Jan. 1, 2019.

CMS Proposes Changes to Medicare Advantage and Part D – CMS announced changes to both Medicare Advantage and Part D to lower drug prices. As part of the plan, CMS announced that it plans to allow step therapy for Medicare Advantage plans and “allow MA plans to offer beneficiaries the drug in Part B, which covers physician-administered drugs, that is most cost-effective before progressing to other options.” CMS is also considering a plan “to require that the price a beneficiary pays at the pharmacy counter reflects the lowest possible cost, so beneficiaries receive the maximum benefit. If adopted, this change would lower cost sharing for beneficiaries by about $12 to $15 billion over 10 years.” The proposed rule also addresses DIR fees.

Georgia Insurance Commissioner Demands Protections Prior to Merger – The Georgia insurance commissioner won a number of protections in order for the merger of CVS and Aetna to gain approval. Such protections include the requirement that CVS/Aetna allow non-CVS healthcare providers (including pharmacies) to join its networks.

US and China Come to Agreement on Fentanyl – News outlets report that President Trump and President Xi came to an agreement over the classification and treatment of Fentanyl in China. If China does in fact go through with the proposed changes, manufacturers, compounders, and other healthcare providers could see potential changes in the availability of the substance.

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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