Coronavirus (COVID-19)

The FDA and Pharmacy Weekly Digest will continue to provide weekly coverage of the FDA and the pharmacy sector during the current public health emergency. 

We have a separate alert for the FDA and state boards of pharmacy reactions to the coronavirus that will be updated periodically. Since the most recent publication, the FDA has issued updated guidance on diagnostic tests for the coronavirus during the public health emergency. The “unprecedented policy” outlines that the FDA does not intend to object to “commercial manufacturers distributing and labs using new commercially developed tests prior to the FDA granting an EUA [emergency use authorization], under certain circumstances.”

Food/Dietary Supplements

FDA Launched New Nutrition Facts Label Campaign – The new label bolds information for serving sizes and calorie counts. Additional changes include added sugars, vitamin D and potassium, and a dual-column version of the label for food packages that contain two to three servings that can be reasonably consumed at one time. Manufacturers with $10 million or more in annual food sales had until January to begin using the new label. Most manufacturers with less than $10 million in annual food sales have an additional year, until Jan. 1, 2021, to start using the new label.

FDA Reopened Comment Period for Cannabis-related Products – In the notice, the FDA announced that it reopened the comment period indefinitely for scientific data and information about products containing cannabis or cannabis-derived compounds. The agency is specifically interested in data that may help it address uncertainties and data gaps related to cannabidiols.

Drugs

FDA Issued Guidance on Competitive Generic Therapies – The guidance provides a description of the process that applicants should follow to request designation of a drug as a competitive generic therapy. The guidance also provides information on how the FDA implements the statutory provision for a 180-day exclusivity period for certain first-approved applicants that submit abbreviated new drug applications for drugs designated as competitive generic therapies.

FDA Extended Comment Period for Drug Products Labeled as Homeopathic Draft Guidance – This is the second extension to the comment period. The draft guidance describes how the FDA intends to prioritize enforcement and regulatory actions for human drug products labeled as homeopathic and marketed in the United States without FDA approval. Comments are now due May 23.

Medical Devices

FDA’s Efforts Are Focused on Coronavirus Disease 2019 (COVID-19) Outbreak – The FDA issued a letter to healthcare providers on surgical mask and gown conservation strategies. For more coverage, see our COVID-19 alert.

Tobacco

FDA Issued Final Rule on New Cigarette Health Warnings for Packages and Advertisements – The final rule implements a provision of the Tobacco Control Act that requires the FDA to issue regulations on warning statements appearing on cigarette packages and advertisements. These new cigarette health warnings consist of textual warning statements accompanied by color graphics. The rule is effective June 18, 2021. The FDA will issue a small-entity compliance guide on this final rule shortly.

Pharmacy

Compounding Pharmacist Convicted in $21 Million Fraud – During a trial in Houston, evidence was presented that the pharmacist and others billed the federal government approximately $21.8 million for medically unnecessary compound gels and creams that were predicated on illegal kickback payments.

CMS Announced New Part D Model – Through the CMS Innovation Center, beginning Jan. 1, 2021, “Part D sponsors participating in the Model will offer beneficiaries plan choices that provide broad access to multiple types of insulin, marketed by Model-participating pharmaceutical manufacturers, at a maximum $35 copay for a 30-days’ supply in the deductible, initial coverage, and coverage gap phases of the Part D benefit.” CMS will make available to Part D sponsors the list of pharmaceutical manufacturers participating in the Model for Contract Year 2021 on or around March 20.

DEA Proposed an Increase in Registration Fees – In the Notice of Proposed Rulemaking, the DEA proposed amendments to increase registration fees for business activities involving controlled substances, as well as Schedule I chemicals and drug products containing ephedrine, pseudoephedrine or phenylpropanolamine. The DEA estimates that the total proposed fee increase will be $318 million over a three-year period.

Florida Passed Two Bills Advancing Pharmacy Practice – CS/HB 389 allows pharmacists to enter into collaborative practice agreements with physicians and authorizes pharmacists to test for and treat influenza streptococcus. CS/CS/HB 599 creates licensure for consultant pharmacists. Consultant pharmacists advance the practice of pharmacy and are authorized to order and evaluate laboratory or clinical tests; conduct patient assessments; and modify, discontinue or administer drugs under certain conditions.

United States Pharmacopeia (USP) Issued Final Decisions on Appeals to General Chapters – The USP Appeals Panel granted the appeals for General Chapters <795> and <797>. USP denied the appeal for General Chapter <825>. This means that the currently official chapters of <795> (last revised in 2014) and <797> (last revised in 2008) remain official. General Chapter <825> may take effect, but USP must provide at least another six-month implementation period for this chapter. As of now, if implemented, General Chapter <825> will be informational unless otherwise required by a regulatory body.