FDA Announces Impact of Ending COVID-19 Public Health Emergency

By Winston S. Kirton, Lee H. Rosebush, Francis Palumbo, Laura Macherelli and Marc Wagner on March 16, 2023 Posted in Alert

Front Line Worker Holding Syringe and Vial Filled with Coronavirus Vaccine or Medicine Silhouetted Against American Flag

On March 13 the FDA officially issued a Federal Register notice to explain how the end of the COVID-19 PHE declaration will impact the Agency’s 72 COVID-related guidance documents currently in effect. The notice comes as the Biden administration plans to end the PHE phase of the pandemic response on May 11.

Of the 72 COVID-19-related guidance documents, 22 will no longer be in effect when the PHE declaration expires, 22 will be revised to continue in effect for 180 days after the expiration, 24 will be retained with revisions after the 180 days, and four will remain in effect after the declaration expires.

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FDA Launches New Directory of Ingredients Used in Products Marketed as Dietary Supplements

By Laura Macherelli, Daniel Kaufman and Marc Wagner on March 13, 2023 Posted in FDA

On March 6, the FDA announced the launch of its new “Dietary Supplement Ingredient Directory.” According to the FDA, the directory is “a one-stop shop of ingredient information that was previously found on different FDA webpages.” It will allow users to search for information on ingredients in dietary supplements and quickly find links to agency actions and communications. Concurrently, FDA is retiring the existing “FDA Dietary Supplement Ingredient Advisory List.”

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FDA’s Center for Tobacco Products Announces Next Steps to Strengthen Tobacco Program

By Lee H. Rosebush, Lance L. Shea and Laura Macherelli on March 6, 2023 Posted in FDA

FDA Commissioner Robert M. Califf, MD, MACC, released a statement on Feb. 24, 2023, announcing next steps the FDA’s CTP plans to take in response to an external evaluation conducted by the Reagan-Udall Foundation. Califf commissioned the external evaluation in September 2022 to analyze the entirety of the Tobacco Program’s operations. The final report contained 15 recommendations stretching across all areas and aimed at strengthening the program by improving communication, transparency and efficiency.

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FDA Issues Guidance on Clinical Research with Cannabis

By Lee H. Rosebush, Randal M. Shaheen, Winston S. Kirton and Laura Macherelli on January 27, 2023 Posted in Alert

On Jan. 23, the Food and Drug Administration (FDA) finalized industry guidance for clinical research using cannabis and cannabis-derived compounds, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. The need for the guidance stemmed from the 2018 Farm Bill, which legalized the production and sale of hemp (cannabis below 0.3 percent delta-9 THC by dry weight) and removed it from the Schedule I substance list.

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FDA Approves Abortion Pill for Sale by Retail Pharmacies

By Amy Fouts and Claire Bass on January 13, 2023 Posted in Alert

Pharmacist and customer discussing prescription in pharmacy

On Jan. 3, the Food and Drug Administration (FDA) finalized a rule allowing more retail pharmacies to dispense abortion pills upon completion of a certification process. The FDA finalized the changes after reviewing supplemental applications from manufacturers of the drug mifepristone requesting modification of the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program.

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Discounted Drugs under the 340B Program

By Lee H. Rosebush, Laura Macherelli and Marc Wagner on December 20, 2022 Posted in Healthcare

The U.S. Court of Appeals for the Third Circuit is currently hearing arguments from pharmaceutical manufacturers Novo Nordisk, Sanofi and AstraZeneca and the Department of Health and Human Services (HHS) on whether the 340B program prohibits pharmaceutical manufacturers from imposing restrictions on how their drugs are distributed.

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Note of Caution to Compounding Pharmacies

By Lee H. Rosebush, Winston S. Kirton, Laura Macherelli and Marc Wagner on December 20, 2022 Posted in Alert

Former co-owner of the now defunct New England Compounding Center (NECC) Gregory Conigliaro may face prison time for conspiring to defraud the U.S. Food and Drug Administration (FDA). Prosecutors argued Conigliaro conspired with more than a dozen others at NECC to deceive and defraud the FDA by misrepresenting the facility as solely a compounding pharmacy dispensing only patient-specific prescriptions while in fact it was also operating as a generic drug manufacturer.

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Georgia 6-Week Abortion Law Is Void Ab Initio

By Amy Fouts and Claire Bass on November 18, 2022 Posted in Alert

Pregnant woman talking a break while working in Roastery

On Nov. 15, the Superior Court of Fulton County issued an order finding that two sections of the Georgia LIFE Act (the Act) – Sections 4 and 11 – were void ab initio. Section 4 of the Act criminalized abortions after the detection of a heartbeat (typically around six weeks into the pregnancy), with exceptions only for certain medical emergencies and in cases of rape or incest where a police report was filed. Section 11 required any physician who performed an abortion after detecting a fetal heartbeat to report to the Georgia Department of Public Health the exception under Section 4 of the Act that applied to justify the otherwise illegal procedure. Spokespersons for the state reported that the state has filed a notice of appeal.

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Allergan Win in Medicaid Drug Rebate Statute

By Lee H. Rosebush, Stephen E. Ruscus and Laura Macherelli on October 21, 2022 Posted in Medicaid

RX pharmacy prescription bottle of pills on a pile of $100 dollar bills and a USA outline Medicaid Drug Rebate

The United States Court of Appeals for the Fourth Circuit decision in US ex rel. Sheldon v. Allergan Sales, LLC, a qui tam False Claims Act (FCA) suit, affirms the complexity of pricing and Medicaid rebates under the Medicaid Drug Rebate Statute, emphasizes the need for government guidance in complex regulations, and further confirms the importance of documenting intentions and reasonable assumptions with respect to the Rebate Statute. The Court was evenly split in upholding the dismissal of the suit brought by a former employee alleging Forest Laboratories LLC committed Medicaid fraud by violating the Medicaid Drug Rebate Statute and unjustly profiting from it.

Federal Judge Blocks Idaho from Enforcing Abortion Ban in Emergencies

By Amy Fouts, Gregory Tanner and Claire Bass on September 1, 2022 Posted in Post-Dodds

On Aug. 24, the United States District Court for the District of Idaho issued a preliminary injunction blocking the enforcement of Idaho’s new abortion law. The law was set to take effect on Aug. 25, 2022. As previously reported, the U.S. Department of Justice (DOJ) filed suit on Aug. 2 against the state of Idaho, seeking to block the recently passed state abortion law. The DOJ alleged the Idaho law violates the federal Emergency Medical Treatment and Labor Act of 1986 (EMTALA) because it does not provide any exceptions for stabilizing treatment in emergency medical situations.

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