United States: FDA And Pharmacy Weekly Digest - July 9

Food/Dietary Supplements

FDA Revises Advice About Eating Fish While Pregnant – The FDA issued a revised “Advice about Eating Fish for Women Who Are or Might Become Pregnant, Breastfeeding Mothers, and Young Children.” The FDA stated, “The revised advice highlights the many nutritional components in fish, many of which have important roles in growth and development during pregnancy and early childhood. It also highlights the potential health benefits of eating fish as part of a healthy eating pattern, particularly for heart health benefits and lowering the risk of obesity. The advice is intended to help women who are or might become pregnant, breastfeeding mothers, and parents of children over 2 years of age make informed choices about fish that are nutritious and safe to eat.”

Drugs/Biologics

FDA Announces Steps to Make Prescription Drug Labeling More Clear – The FDA released a statement coupled with two guidance documents intended to help “ensure that FDA-approved medication and biological product labeling (often referred to as the ‘package insert’ or Prescribing Information) provides clear, complete information so that health care professionals have the essential information needed to make informed decisions and to facilitate safe and effective use of a medication.” The first guidance is titled Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products – Content and Format. The second is titled Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format.

FDA Warns a Number of Drug Repackagers – The FDA issued warning letters to three drug repackagers that allegedly violated current good manufacturing practices. The FDA stated, “API repackers take bulk API (usually in powder form) from the container in which it was distributed by the original manufacturer and place it into a different container without further manipulation of the drug and distribute it to drug manufacturers, compounding pharmacies or outsourcing facilities. Improper repackaging or lack of supply chain oversight of API can cause serious vulnerabilities in the supply chain and may lead to adverse events in patients.”

FDA Updates a Number of REMS Programs – The FDA released a summary for REMS program updates. The summary is available here.

FDA Plans to Prioritize ANDAs for Treatment of Opioid Overdoses – The FDA announced its plan to focus on approval of ANDAs for the emergency treatment of opioid overdoses. Coupled with this announcement, the FDA also released the “Center for Drug Evaluation and Research’s Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original Abbreviated New Drug Applications (ANDAs), Amendments, and Supplements.”

Medical Devices

FDA Issues Two Guidance Documents on Medical Device Appeals – The FDA published “Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A” and “Center for Devices and Radiological Health (CDRH) Appeals Processes.” The guidance documents describe the appeals process for decisions and actions made by the Center for Devices and Radiological Health related to medical devices.

Tobacco

Acting FDA Commissioner Remarks on the 10th Anniversary of the Tobacco Control Act – Acting Commissioner Sharpless stated, “I see the FDA’s regulation of tobacco products as one of our greatest public health challenges, but also one of our greatest opportunities at the FDA. As we tighten tobacco control, we are having an immense impact on the health of Americans, given that tobacco use remains the leading cause of preventable disease and death in the United States … But while we have made real progress against the older foe of ‘combustible’ cigarettes and other traditional tobacco products, we also have to acknowledge the emergence of a new, very worrying problem in American life: the explosion of children using of e-cigarettes.”

Pharmacy

FDA Releases 503A Compliance Policy – The FDA issued “Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect Guidance for Industry.” This guidance addresses “the conditions under which the Agency does not generally intend to take regulatory action against a licensed pharmacist in a State-licensed pharmacy or Federal facility or a licensed physician using the bulk drug substance oxitriptan (also known as 5-hydroxytryptophan or 5-HTP) to compound oral drug products for patients with tetrahydrobiopterin (BH4) deficiency.”

Trump Announces “Favored-Nation Clause” for Drug Prices – President Donald Trump announced that the White House is “working on a favored-nation clause, where we pay whatever the lowest nation’s price is.” Thus, the U.S. would benefit from the lower drug prices that other countries currently enjoy.

States Continue to Pass Legislation Restricting PBMs – The legislatures in New Jersey and Maine passed legislation aimed at further regulating PBMs. The New Jersey bill limits PBM recoupments against and retroactive reductions in payment to pharmacies. The Maine bills establish PBM licensure requirements and oversight responsibilities, address spread pricing, and establish a Prescription Drug Affordability Board.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.