Alerts

FDA and Pharmacy Weekly Digest - March 4

Alerts / March 4, 2020
Food/Dietary Supplements

FDA Extended the Comment Period for the Laboratory Accreditation Program Proposed Rule – Once the laboratory accreditation program is established, the FDA will require that the testing of food in certain circumstances be conducted by laboratories that voluntarily become accredited under this program. The proposed rule will establish the framework and requirements for accreditation bodies seeking recognition by the FDA as well as requirements for laboratories seeking accreditation. Comments are being accepted until April 6.

Drugs

FDA Will Present on Advanced Technology in Pharmaceutical Manufacturing – On March 12, the FDA will provide an overview of advanced manufacturing technologies and discuss the steps it is taking to help realize the potential of advanced manufacturing.

FDA Approved First Generic Pyrimethamine Tablets – The FDA approved an application for the first generic of pyrimethamine tablets for the treatment of toxoplasmosis when used with a sulfonamide. Pyrimethamine made headlines in recent years when the sole manufacturer of the branded version increased the price by 5,000% overnight.

Medical Devices

FDA Began Accepting Requests to Participate in the eSTAR Pilot Program – The electronic Submission Template And Resource (eSTAR) is a PDF electronic submission template that guides premarket notification (510(k)) submitters through the process of preparing a comprehensive medical device 510(k) submission. The voluntary eSTAR pilot program aims to improve consistency and efficiency in how the medical device industry prepares 510(k)s and how the FDA reviews these submissions.

FDA Authorizes the Emergency Use of Personal Respiratory Protective Devices for Healthcare Settings During the Coronavirus Outbreak – Under the Federal Food, Drug, and Cosmetic Act, the FDA commissioner may allow unapproved medical products or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions. This authorization will allow healthcare workers to wear disposable filtering facepiece respirators (e.g., N95s), approved by the National Institute for Occupational Safety and Health, to prevent exposure to pathogenic biological airborne particles during the coronavirus outbreak.

Cosmetics

FDA Announced Public Meeting on Cosmetic Regulation – The announcement invites public input on various topics pertaining to the regulation of cosmetics. The meeting will be held on April 14. The FDA may use input from this meeting to prepare for the International Cooperation on Cosmetics Regulation (ICCR) meeting to be held in June. ICCR is a voluntary international group of cosmetics regulatory authorities.

Tobacco

House Passed Bill to Ban Flavored Tobacco Products – The Reversing the Youth Tobacco Epidemic Act would ban the flavoring of tobacco products and electronic nicotine delivery systems. The bill also prohibits the online sale of tobacco products. It is now in the Senate. If the bill is passed, the FDA could approve flavored electronic nicotine delivery systems as a tobacco cessation product or for another therapeutic purpose.

Pharmacy

Kentucky Senate Passed Medicaid Reform Bill – The bill is now in committee in the Kentucky House. Currently, the bill provides that one pharmacy benefit manager (PBM) would administer Kentucky’s Medicaid prescription benefit plan. Interestingly, the Kentucky Medicaid agency would set minimum reimbursement rates a pharmacy could be paid for both the ingredient cost and the dispensing fee. The bill also prohibits the PBM from requiring that specialty drugs come from a PBM-owned or -associated specialty pharmacy.

DEA Proposed to Make Narcotic Treatment Programs More Accessible – The proposed rule would revise the existing regulations for narcotic treatment programs (NTPs) to allow a mobile component associated with the registered program to be considered a coincident activity. An NTP would be permitted to dispense narcotic drugs in schedules II-V at a location remote from, but within the same state as, the NTP’s registered location for the purpose of maintenance or detoxification treatment without having to obtain a separate registration for the mobile component.

The Supreme Court Will Soon Hear Oral Argument in PBM CaseOral argument will take place on April 27. In Rutledge v. the Pharmaceutical Care Management Association, the Court will decide whether Arkansas can regulate PBMs’ drug-reimbursement rates by statute.

Pharmacy Owner Found Guilty of Health Care Fraud and Money Laundering Charges for Role in Billing Scheme – According to evidence presented at trial, the pharmacy owner engaged in a scheme to defraud Medicare by submitting claims for prescription medications that were not actually dispensed to patients. The owner billed Medicare for hundreds of medications that were never dispensed through the pharmacy.

Study Finds That Medicare and Medicaid Spend $2.6 Billion Extra on Extended-Release Drugs – Researchers reported that in 2017, Medicare Part D and Medicaid spent a combined $3.1 billion on 20 extended-release drugs. Switching to immediate-release drug formulations could have resulted in an estimated $2.6 billion reduction in spending in 2017 and a $13.7 billion reduction from 2012 to 2017.

Authorship Credit: Marc N. Wagner

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