BakerHostetler FDA and Pharmacy Weekly Digest - January 14, 2019

Alerts / January 14, 2019

During Shutdown, Commissioner Gottlieb Tries to Reassure Consumers – As the partial shutdown continues, Commissioner Scott Gottlieb tries to reassure the industry and consumers that the FDA will continue to execute its duties. The commissioner tweeted, “The lapse in funding represents one of the most significant operational challenges in [the] FDA’s recent history. But as an agency, we’re committed to fulfilling our consumer protection mandate, to the best of our abilities, under our current configuration.”

Food/Dietary Supplements

FDA Addresses Expanded Food-related Activities During Prolonged Shutdown – Amid concerns of stemmed food facility inspections, Commissioner Scott Gottlieb tweeted, “additional activities may be considered excepted work during a shutdown. Given the prolonged shutdown and compounding risk as time accrues, [the] FDA is working to operationalize additional activities that exceed what we’ve done in past shutdown situations.” The commissioner also tweeted certain activities would be considered, including “Surveillance sampling of imported high-risk foods, drugs and devices, and the logistical coordination and laboratory support for allowable inspections and evaluation” and “Expanded monitoring and analysis by the Coordinated Outbreak and Response Evaluation (CORE) Network to include additional food safety and foodborne illness outbreak surveillance, detection and response activities.”

Industry Continues to Report Food Recalls – A number of food facilities have reported voluntary recalls during the partial shutdown. Recalls include lunchbox sandwiches, milk, potato chips and certain butters.


FDA Plans to Provide Update on User Fee Funding – Commissioner Scott Gottlieb addressed user fee funding questions via Twitter. The commissioner tweeted, “We have many inquiries regarding user fee funding. We’ll update this week with details on remaining balances. We’re also closely evaluating when we will cross a threshold, beyond which we have to declare that we will not be able to meet medical product user fee goals for 2019.”

FDA Announces Record-breaking Generic Drug Approvals – Commissioner Scott Gottlieb announced the 2017-2018 calendar year resulted in 2,048 generic drug approvals or tentative approvals.

Medical Devices

FDA Continues For-Cause Inspections – Commissioner Scott Gottlieb announced that the FDA will be “continuing to conduct for-cause inspections of device facilities when the agency believes an imminent threat to life or health exists, and working to bring back online surveillance inspections of high-risk devices as we have already announced for foods.”

FDA Continues Post-market Surveillance – Commissioner Scott Gottlieb announced via Twitter that the FDA would continue certain post-market surveillance efforts. He tweeted, “With respect to post-market efforts, the agency is currently monitoring ALL medical device adverse events it receives, looking for concerns and signals that need to be addressed. If we find issues, we can and will act to protect Americans from imminent threats to health.” He also tweeted the FDA will “continue to process, review and classify all high-risk (Class I) and moderate-risk (Class II) medical device recalls. We are then ensuring that the necessary steps are taken for those that pose an imminent threat to human life.”


FDA Continues to Focus on E-Cig Flavors – Commissioner Scott Gottlieb tweeted, “Our data continues to demonstrate that flavors are a leading factor in driving youth appeal and use of e-cigs. This use has reached epidemic levels. It should be a concern to all responsible parties, including adults who responsibly benefit from the availability of these products.”

FDA Issues “Tips for Retailers” Video – The FDA invited tobacco retailers to review its latest video to provide them with information and resources to help prevent the sale of tobacco to minors.


FDA Targets Websites for Illegally Selling Drugs – The FDA is taking action against online pharmacies for selling potentially dangerous and counterfeit drugs. FDA Commissioner Scott Gottlieb stated, “The illegal online pharmacies that we’re taking action against are often run by sophisticated criminal networks that knowingly and unlawfully distribute illicit drugs, including potentially counterfeit medicines and controlled substances both on the surface and dark web[s]. Consumers go to these websites believing that they’re buying safe and effective medications. But consumers are being put at risk by individuals who put financial gains above patient safety.”

Pharmaceutical Rate Increases in 2019 – The Wall Street Journal reports that many drug makers raised the prices of medications heading into the new year. The article is available here.

Health and Human Services Advisory Committee Releases Draft Report on Pain Management – The Pain Management Best Practices Inter-Agency Task Force released a draft report outlining preliminary recommendations for pain management that will be finalized and submitted to Congress this year.

PEW Releases Summary of CGMP Guidance – PEW issued a summary of the FDA’s revised guidance on current good manufacturing practices (CGMP), as well as the importance of compounders’ compliance with CGMP.

Authorship Credit: Lindsay P. Holmes

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