FDA and Pharmacy Weekly Digest - March 19

Alerts / March 19, 2019

FDA Acting Commissioner Announced – It has been widely reported that Ned Sharpless, director of the National Cancer Institute, will be appointed the acting commissioner of the FDA following Commissioner Gottlieb’s announcement of his resignation. This appointment will take effect in April 2019.

Food/Dietary Supplements

FDA Emphasizes the Importance of Agricultural Water Safety – The FDA reiterated the importance of agricultural water for the production of fruits and vegetables through FSMA’s Produce Safety Rule, which has specific requirements related to agricultural water. In 2017, the FDA proposed to delay compliance dates for the agricultural water requirements. FDA announced that those compliance dates would be formally extended to January 2022 for large farms, January 2023 for small farms and January 2024 for very small farms.


FDA Seeks to Modernize Clinical Trials – FDA’s statement indicates that “[n]ew research paradigms are needed to break down barriers between real world data and clinical research, so that evidence can be shared rapidly to improve both domains across a learning health care system.” This statement was coupled with the publication of four draft guidance documents and one final guidance focused on cancer clinical trials.

FDA Approves New Generic Angiotensin II Receptor Blocker – The FDA announced the approval of the drug product and stated it “prioritized the review of this drug application to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of valsartan and other ARB medicines contain nitrosamine impurities.”

FDA Releases Guidance on Nonclinical Development of Drug for Hematologic Disorders – The FDA issued a guidance entitled “Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.” The guidance is aimed at nonclinical study design for certain pharmaceutical products for patients with severely debilitating or life-threatening hematologic disorders.

FDA Issues Guidance Addressing Drug and Biological Product Effectiveness – The FDA released a guidance entitled “Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products.” The guidance is intended to “assist industry in developing enrichment strategies that can be used in clinical investigations intended to demonstrate the effectiveness of drug and biological products. Enrichment is the prospective use of any patient characteristic to select a study population in which detection of a drug effect (if one is in fact present) is more likely than it would be in an unselected population.”

FDA Publishes Guidance on Monitoring Clinical Investigations – The FDA issued a guidance entitled “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers.” The guidance is intended to provide “guidance on risk-based approaches to monitoring investigational studies of human drug and biological products, medical devices, and combinations thereof. This guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results.”

Medical Devices

FDA Approves Device to Help Treat Carbon Monoxide Poisoning – The FDA announced approval for marketing of a device for use in emergency rooms to help patients who have carbon monoxide poisoning. The product “uses a novel method for quickly removing carbon monoxide from the body by increasing a patient’s rate of breathing.”

FDA Seeks to Modernize Review of Certain Medical Device Materials – The FDA released a statement indicating its intention to focus on the review of certain materials used in medical devices as they relate to product safety, including metals, plastics, silicone and animal-derived materials. The FDA intends to “engage the public, scientists and industry stakeholders to gather information and help us determine the current state of the science, critical gaps in the existing science that need to be addressed, what approaches should be considered to further our understanding of medical device materials and improve the safety of devices for patients.” The FDA also released a guidance entitled “Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices).”


FDA Announces New Policies to Stem Youth Access to E-Cigs and Cigars – The FDA released a draft compliance policy and announced that it expects the new policy will have the following results: (1) some flavored e-cigarette products will no longer be sold at all, (2) other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access and (3) some flavored cigars will no longer be sold.


EPA Finalizes Rule on Pharmaceutical Waste – The EPA released its final rule on hazardous pharmaceutical waste. The final rule sets out new regulations pertaining to the disposal of certain hazardous pharmaceutical waste. Specifically, “these new regulations prohibit the disposal of hazardous waste pharmaceuticals down the drain and eliminates the dual regulation of RCRA hazardous waste pharmaceuticals that are also Drug Enforcement Administration (DEA) controlled substances.”

Court Enters Consent Decree Against Texas Compounding Facility – The FDA announced that a federal court entered a consent decree requiring a Texas compounding facility to cease production of sterile compounded products until it corrects violations of the Federal Food, Drug, and Cosmetic Act.

Authorship Credit: Lindsay P. Holmes

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