Alerts

FDA and Pharmacy Weekly Digest - January 22

Alerts / January 22, 2020
Food/Dietary Supplements

FDA Issues Statement on E. coli in Lettuce – FDA issued an update to the E. coli O157:H7 illnesses linked to romaine lettuce. FDA stated it “is lifting the consumer advisory to avoid romaine lettuce from Salinas as the growing season for this region is over, and there is no longer a need for consumers to avoid it. There is also no need to avoid other produce products from Salinas.”

FDA Publishes Two Recent Warning Letters Addressing FSVP – FDA issued warning letters to two companies after conducting Foreign Supplier Verification Program (FSVP) inspections. FDA alleged that one company did not show that it “performed any FSVP requirements for particular products. We also note that the guidelines you have provided are very general and do not reflect all of the requirements in the FSVP rule.” FDA alleged that the second company was “not in compliance with the requirements of 21 CFR part 1 subpart L for the following products that you import from your foreign suppliers: mayonnaise; tomatoes-spice flavored drink; and punch flavored soft drinks.”

Drugs

FDA Speaks on Cannabis Policies – The Deputy Director for Regulatory Programs at CDER stated, “FDA continues to believe the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. The Agency is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug and drug approval process.”

FDA Releases Pediatric Study Plan Guidance – The draft guidance “provide[s] information to sponsors regarding the submission of an initial pediatric study plan (iPSP), as required by section 505B(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), for oncology drugs only. Specifically, this guidance provides FDA’s current thinking regarding iPSPs for oncology drugs in light of the amendments to section 505B of the FD&C Act (also referred to as the Pediatric Research Equity Act, or PREA) made by section 504 of the FDA Reauthorization Act of 2017 (FDARA).”

FDA Updates Preliminary List of Approved NDAs Deemed to be BLAs – FDA published a list of preliminary approved New Drug Applications (NDAs) for biological products that will be deemed to be Biologics License Applications (BLAs) on March 23, 2020. FDA also opened an additional comment period until February 19, 2020.

Medical Devices

FDA Publishes Guidance on Computer-Assisted Detection Devices – The final guidance gives “recommendations to industry, systems and service providers, consultants, FDA staff, and others regarding clinical performance assessment of computer-assisted detection (CADe) devices applied to radiology images and radiology device data.”

Tobacco

Tobacco Purchase Minimum Age Moves to 21 – FDA announced, “Effective immediately, retailers must not sell tobacco products to anyone under the age of 21. FDA recognizes that both the agency and some retailers will need to update current practices to implement this new law as FDA will need time to do outreach and education to retailers and update the Agency’s programmatic work to reflect this change in law. During this period of transition, the FDA expects retailers to follow the law and take measures to ensure an individual purchasing a tobacco product is 21 or older, including manually checking IDs when needed. However, during this ramp-up period, FDA will continue to only use minors under the age of 18 in its compliance check program.”

Pharmacy

ASHP Provides Drug Shortage Statistics – The American Society of Health-System Pharmacists (ASHP) made statistics related to drug shortages available and indicated that the “rate of new shortages is slowing, but long-term active and ongoing shortages are not resolving.”

CMS Issues Guidance on 340B Duplicate Discounts – The CMS guidance “Best Practices for Avoiding 340B Duplicate Discounts in Medicaid” is intended to provide “a number of best practices that states are encouraged to consider to avoid billing manufacturers for Medicaid rebates (also known as receiving a ‘duplicate discount’) for covered outpatient drugs purchased under the 340B Drug Pricing Program (340B Program).”

Authorship Credit: Lindsay P. Holmes

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