BakerHostetler FDA and Pharmacy Weekly Digest - November 19, 2018

Alerts / November 19, 2018
Food/Dietary Supplements

2016 Foodborne Illness Report Released – The Food Safety Analytics Collaboration released a new report titled “Foodborne illness source attribution estimates for 2016 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States.” The report reviewed more than 1,000 foodborne illness outbreaks from 1998 to 2016 to determine which foods resulted in the most outbreaks of certain foodborne illnesses.

Pet Food Recall Expanded – A Missouri company expanded a voluntary recall for a formula of dog food due to elevated levels of vitamin D after receiving complaints from several pet owners.

Registration for FDA Public Meetings on Produce Safety Open – FDA will be holding four public meetings to discuss a draft guidance titled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry.” Registration is now open for these meetings.

FDA Extends Comment Period for Names of Dairy Foods – FDA announced that it plans to extend the comment period for a request for information related to the “Use of the Names of Dairy Foods in the Labeling of Plant-Based Products.” The comment period will be extended for 60 days.


Commissioner Gottlieb Addressed Opioids – FDA released a statement from the commissioner, who indicated that FDA’s focus has turned to clinical practice guidelines for prescribing opioids. The commissioner stated that FDA “want[s] to develop new science where more rigorous evidence is needed on the proper dose and duration of opioid analgesic use for the treatment of pain in some common, acute pain indications. Development of this evidence is needed in many areas when it comes to the treatment of pain.” The commissioner also stated that “[h]aving clear, rigorous, evidence-based guidelines that guide the optimal dosing and duration of opioid analgesic use for the most common indications is the key to” reducing unnecessary exposure and making sure patients have access to necessary medications.

Drugs Added to the Shortage List – Three drug products have been added to the drug shortage list – Ketorolac Tromethamine Injection (Updated – Currently in Shortage), Sterile Water (Updated – Currently in Shortage) and Leucovorin Calcium Lyophilized Powder for Injection (Updated – Currently in Shortage).

Stem Cell Treatment Warned by FDA – FDA issued a press release along with a warning letter to a California laboratory warning it that its marketing of a stem cell product without FDA approval is prohibited. FDA also noted “evidence of significant deviations from current good manufacturing practice requirements in the manufacture of the … product; including unvalidated manufacturing processes, an uncontrolled environment, lack of control over the components used in production, and the lack of sufficient and validated product testing.”

Public Meeting on Drug Development Tool – FDA announced a public meeting to be held on Dec. 11, 2018, to discuss specific commitments FDA made under FDUFA VI and the 21st Century Cures Act. This meeting focuses on “taxonomy for biomarkers and related concepts used in drug development; and planning activities to define a framework with appropriate standards and scientific approaches to support qualification for a specified context of use (COU).”

FDA Issues Two Drug-related Guidance Documents – FDA released a guidance titled “Hypertension: Developing Fixed-Combination Drug Products for Treatment” and another titled “Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry.” The meta-analysis guidance is meant to assist IND, NDA and BLA applicants who plan to utilize meta-analysis of randomized controlled clinical trials to evaluate and support the safety of products.

FDA Issues Rulemaking on IRB Waiver – FDA released a Notice of Proposed Rulemaking titled “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.” This proposed rule “would allow an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects.”

FDA Launches Program to Monitor Social Media – FDA announced that it plans “to use nontraditional sources to explore the social contexts in which substances are being used, as well as to identify potential drugs of concern that may be emerging. These data can provide clues about the dynamics of use, misuse and abuse, and potentially identify changing patterns.”

Medical Devices

FDA Publishes Information Collection for Small Business –– FDA released a notice of information collection related to medical device user fees for small businesses. Written comments are accepted until Jan. 14, 2018.


FDA Announces Plans to Restrict Vape Sales – FDA announced it plans to curb youth access to certain flavored tobacco products. The policy includes a move toward selling all flavored ENDS products in age-restricted, in-person locations and a plan to remove ENDS products marketed to children.

Recently Posted Warning Letter

FDA recently issued warning letters to a drug company for failing to accurately list its products, a compounding pharmacy for preparing and holding sterile products in insanitary conditions, and a medical device company for failing to follow Quality System requirements when manufacturing its products.


ESI and Pharmacy Settle Litigation – ESI settled a lawsuit prior to trial regarding allegations that ESI violated federal antitrust laws by conspiring with other PBMs to boycott compounding pharmacies.

FDA Issues Safety Communication Related to Implanted Pumps – FDA released a safety communication titled “Use Caution with Implanted Pumps for Intrathecal Administration of Medicines for Pain Management: FDA Safety Communication.” This communication is focused on providers, pharmacists, compounders and patients, and discusses “the risks of using medications delivered into the spinal fluid to treat or manage pain that are not approved for use with the implanted pumps.”

FDA to Hold Public Meeting on Drug Shortages – On Nov. 27, 2018, 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. 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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