BakerHostetler FDA and Pharmacy Weekly Digest - November 26, 2018

Alerts / November 26, 2018
Food/Dietary Supplements

Romaine Lettuce Investigation – The Food and Drug Administration (FDA) is investigating a multistate outbreak of E. coli likely linked to romaine lettuce.

FDA to Allow Qualified Health Claim for Oleic Acid – The FDA announced its determination that there is evidence to support the qualified health claim that “consuming oleic acid in edible oils, such as olive oil, sunflower oil, or canola oil, may reduce the risk of coronary heart disease.”

USDA and FDA Take on Cell-cultured Food – The U.S. Department of Agriculture (USDA) and the FDA announced that based on public feedback, both agencies should oversee the production of livestock- and poultry-derived cell-cultured foods. The agencies’ agreement will delegate oversight of cell collection, cell banks, and cell growth and differentiation to the FDA. The USDA will oversee the production and labeling of these products.

FDA Takes Action Against Dietary Supplements Containing Tianeptine – In November, the FDA announced that it issued warning letters to two companies marketing dietary supplements containing the ingredient tianeptine, due to adverse events associated with the ingredient, including its addictive nature.

Cheese Recall – An organization has recalled cheese products, due to positive testing for Listeria monocytogenes. The issue was discovered during a routine inspection.


FDA Announces Public Docket for Software Applications – The FDA established a public docket to solicit feedback on a “proposed framework for regulating software applications disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products.” The agency indicates that the “framework that would provide prescription drug sponsors the flexibility to develop and disseminate innovative software, while maintaining appropriate Agency oversight over the sponsors’ communications about their products.” The docket is open until Jan. 22, 2019.

FDA Approves First Drug for Treatment of Primary Hemophagocytic Lymphohistiocytosis (HLH) – The drug is for “the treatment of pediatric (newborn and above) and adult patients with primary [HLH] who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH.”

Medical Devices

FDA Sets New Goal for Device Safety – The FDA announced its plans to implement steps related to the Medical Device Safety Action Plan released earlier this year. The most recent step is to ensure “that the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.”

Materials Available From Patient Engagement Advisory Committee (PEAC) Meeting – The FDA held a PEAC meeting on Nov. 15, 2018. Meeting topics included patient-generated health data, patient-driven registries and digital health technology. The materials from this meeting are now available.

Safety and Effectiveness Summaries for Premarket Approval Applications (PMA) – The FDA published a list of approved PMAs and humanitarian device exemptions (HDE) applications. This list is being made available in order “to inform the public of the availability of safety and effectiveness summaries of approved PMAs.”

Recently Posted Warning Letter

The FDA issued warning letters to a number of vape companies, alleging misbranding, and to a pharma company for alleged violations of current good manufacturing practices.


FDA Updates 503B Bulk Category List – FDA issues an updated version of the Category 1, 2, and 3 bulk list available for use by 503Bs.

FDA Issues Drug Alert – The FDA issued a drug alert for healthcare professionals and patients, warning them not to use sterile drug products from a specific producer due to lack of assured sterility.

NJ Announces Changes to Prescription Monitoring Program (PDMP) – In response to the ongoing opioid crisis, New Jersey proposed changes to its PDMP. The state’s attorney general’s office announced, “The proposed rules broaden conditions under which practitioners are required to look up patient records on the NJPMP prior to prescribing opioid pain medication, adding new requirements for prescriptions written in hospital emergency rooms, after procedures such as wisdom teeth removal, and in other situations. They also expand the types of drugs that trigger lookup requirements. Prescribers would now be required to check the NJPMP before prescribing any opioid, not solely those in the most tightly restricted Schedule II category.”

FDA to Hold Public Meeting on Drug Shortages – On Nov. 27, 2018, the FDA and the Center for Health Policy at Duke University will host a public meeting on drug shortages as part of the agency’s Drug Shortage Task Force. Topics include addressing the root causes of drug shortages and discussion of potential long-term solutions. The FDA also opened a public docket on the topic, which will remain open until Jan. 11, 2019.

Authorship Credit: Lindsay P. Holmes

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