BakerHostetler FDA and Pharmacy Weekly Digest - January 28, 2019

Alerts / January 28, 2019
Commissioner Gottlieb Welcomes Furloughed Staff Back to Work

The Food and Drug Administration (FDA) commissioner tweeted, “We’re making plans to welcome back all our employees who’ve been on furlough. I hope to personally greet many of you tomorrow. Your contributions and work are highly valued; your absence was palpable. #FDA is a singular and historic institution; but it’s strength is it’s people.” In his press announcement, he stated, “I realize there are still challenges ahead. … There will be impacts from this prolonged lapse in funding. But this agency has always faced challenge. And we’ve always worked together to persevere.”

Food/Dietary Supplements

The Food Industry Continues to Issue Recalls – In the past week, the food industry issued recalls related to old-fashioned pimento cheese, fruit puree, unbleached flour, baby spinach, nut butter, certain fruits and specific ready-to-eat products.


FDA Commissioner Comments on Measles Outbreak – Gottlieb responded to the outbreak of measles in the Northwest by encouraging vaccinations. He tweeted, “Measles is a feared & highly contagious childhood malady. Once largely vanquished in U.S., it’s resurgence is an avoidable tragedy. Vaccines like MMR are safe and effective. The shot is perhaps one of the most exhaustively studied products in modern medical history #VaccinesWork.”

FDA Addresses Impurities in Angiotensin II rReceptor Blocker (ARB) Medicines – The FDA became aware of certain ARB medicines that contain nitrosamine impurities, which are “probable human carcinogens.” These medicines do not meet the FDA’s safety standards. The FDA has engaged “with manufacturers of all ARB medicines to recall any product that poses a risk to patients. Because of the way active pharmaceutical ingredients (API) is distributed in the supply chain, one source of contaminated API can impact multiple products.” The FDA also announced the steps it takes to mitigate these ongoing risks.

FDA Releases Two Draft Guidance Documents Related to REMS – The FDA released two draft guidance documents aimed at confirming risk evaluation and mitigation strategy (REMS) programs are working. The guidance documents focus on the REMS assessment plan “in order to improve the quality of the information used to assess the effectiveness of a REMS program and provide post-market evidence that the REMS is meeting its risk mitigation goals.”

FDA Releases Guidance on Immunogenicity Testing of Therapeutic Protein Products – The FDA released a final guidance titled “Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody Detection.” According to the guidance, it “provides recommendations to facilitate industry’s development and validation of assays for assessment of the immunogenicity of therapeutic protein products during clinical trials. Specifically, this document includes guidance regarding the development and validation of screening assays, confirmatory assays, titration assays, and neutralization assays.”

Medical Devices

FDA Permits Marketing of First Mycoplasma Genitalium Diagnostic Tool – The FDA announced that it will allow the marketing of a new testing aid to diagnose the sexually transmitted infection Mycoplasma genitalium. The release states, “According to the U.S. Centers for Disease Control and Prevention, M. gen. is responsible for causing approximately 15 to 30 percent of persistent or recurrent urethritis cases in men in the United States and 10 to 30 percent of cervicitis cases in women. M. gen. is a slow-growing bacterium and is difficult to detect with traditional laboratory methods.”


FDA Requests Comments on Youth E-Cig Use – The FDA announced a public hearing to address youth e-cig use. The hearing was held on Dec. 5, 2018. The hearing covered “efforts to eliminate youth electronic cigarette (e-cigarette) use as well as other tobacco product use, with a focus on the potential role of drug therapies to support youth e-cigarette cessation and the issues impacting the development of such therapies.” The FDA is still seeking comment on this topic. The comment period is open until Feb. 1, 2019.


HHS Is Accepting Comments on the Draft Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations – In November 2018, Health and Human Services (HHS) published the “Draft Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations.” HHS is seeking comments on the report and its recommendations until April 1, 2019.

Authorship Credit: Lindsay P. Holmes

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