Alerts

FDA and Pharmacy Weekly Digest - August 27

Alerts / August 27, 2019
Food/Dietary Supplements

FDA Calls for Improved Practices in the Papaya Industry – The FDA reported trends in outbreaks of Salmonella in fresh papaya. The FDA published a letter to the papaya industry to urge “growers, packers, shippers and retailers in the papaya industry to review their operations and make all necessary changes to strengthen public health safeguards.”

FDA Releases Menu Labeling Fact Sheet – The fact sheet is intended “to inform stakeholders about the agency’s continued efforts to implement menu labeling in chain restaurants and similar retail food establishments. The FDA will continue to support industry to implement the menu labeling requirements, assess implementation progress to further inform education and outreach as well as engage with state, local, tribal and territorial regulatory partners to ensure consistent implementation of the menu labeling requirements.”

FDA Continues Romaine Lettuce Investigation – The FDA released the results of romaine lettuce sampling from the Yuma region. The FDA stated, “During the assignment, the FDA collected and tested 118 samples for each pathogen. The FDA did not detect Salmonella in any of the samples. The agency detected Shiga toxin-producing E. coli (STEC) in a single sample; however, further analysis determined that the bacteria was not pathogenic. The findings of this assignment suggest that there was no widespread STEC or Salmonella spp. contamination of romaine lettuce from the Yuma growing region during the period when the sampling occurred. The FDA is continuing to work with leafy greens stakeholders in the Yuma region to consider a longer-term environmental study to identify and control risks that will prevent future outbreaks, with the ultimate goal of protecting consumers.”

Drugs/Biologic

FDA Issues Warning About Data Integrity Violations – The FDA announced that it warned an over-the-counter drug manufacturer about violations of current good manufacturing practices, including data integrity violations. The FDA stated, “The FDA has uncovered circumstances of drug quality data and information being inaccurate, which can mask problems and failures. Patients cannot be assured of the safety and effectiveness of their medication when data has been altered.

FDA Publishes Guide on Treatments for Male Breast Cancer – The FDA issued a draft guidance entitled “Male Breast Cancer: Developing Drugs for Treatment.” The guidance is intended to make “recommendations to sponsors regarding the development and labeling of cancer drugs, including biological products, regulated by the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) for the treatment of male patients with breast cancer.”

Medical Devices

FDA Makes Remarks at the National Coordinator for Health IT Third Interoperability Forum – The principal deputy commissioner stated, “As Principal Deputy Commissioner, I am focused on a few core components. First, I want FDA to get our own technical house in order so that tech can ‘snap in’ – we can be agile and efficient. We need to be able to have common interfaces with industry so we can pass data between our organizations, have collaborative review, etc. In the same way that ONC is establishing a vision for EHRs that clarifies the interfaces – the APIs – we need to do the same for FDA. Second, we should use examples and use cases that allow us to see what it looks like when we put tech and interoperable data into play. Examples start to show our early steps, such as precision FDA and real time oncology review, which I will describe in more detail in a few moments. And my third area of focus is to update how we interface with the technology community in a meaningful way. As a biomedical community and FDA, we have clear ways of interfacing with the drug and device industries, with patient groups, [and] with trade organizations. But tech companies are largely seen as vendors being told what to do rather than creating critical solutions with collaboration and guidance.”

Tobacco

FDA Announces Public Meeting on Tobacco Product Applications – The FDA will hold a public meeting on Oct. 28 and 29 to “provide information on the agency’s expectations for tobacco product applications with a particular focus on deemed tobacco products (e.g., cigars, water pipe, and Electronic Nicotine Delivery Systems (ENDS) including e-liquids and electronic cigarettes) including product review policies, procedures, and general scientific principles. The information will improve public understanding and assist persons considering submitting marketing applications for tobacco products.”

Pharmacy

Health and Human Services (HHS) Files Appeal in Drug Price Disclosure Rule Case – HHS filed a notice of appeal after a federal judge struck down HHS’s ability to require drug manufacturers to disclose the price of their drugs in TV ads.

Authorship Credit: Lindsay P. Holmes

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