Nearly three months after hearing oral arguments, a divided Fifth Circuit panel issued its decision in Alliance for Hippocratic Medicine v. FDA, upholding the U.S. Food and Drug Administration’s (“FDA”) underlying approval of Mifepristone in 2000, but reinstating the limitations and restrictions under the pre-2016 protocol. Despite rejecting Judge Matthew Kacsmaryk’s blanket suspension of the drug’s approval, the federal appeals court found that the FDA overstepped its authority in expanding access and loosening restrictions on the drug in 2016 and 2021. Specifically, the Fifth Circuit agreed with the lower court’s ruling to invalidate the FDA’s modifications that increased the gestational age and relaxed dispensing requirements such as allowing the drug to be dispensed through the mail and ordered by a non-physician. The 96-page ruling issued by the conservative three-judge panel will likely not have any immediate legal effect, and Mifepristone will remain broadly available due to the Supreme Court’s stay implemented earlier this year.Continue Reading Fifth Circuit Rules to Reinstate Abortion Pill Restrictions

For a brief moment in time last April, the U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Department of Justice (the “DOJ”) asked the Fifth Circuit to grant an emergency or administrative stay of that decision. On review, the Fifth Circuit held that Mifepristone could only be prescribed in the first seven weeks of pregnancy, under a physician’s supervision, and the drug cannot be sent by mail, temporarily suspending more recent modifications to the FDA’s approval. Continue Reading Access to Abortion Pill on the Precipice: A Deep Dive into the Federal Court Rulings that will Decide the Fate of Mifepristone 

The U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Department of Justice (the “DOJ”) asked the Fifth Circuit to grant an emergency or administrative stay of that decision. Although the Fifth Circuit did grant temporary, albeit limited, relief, the court maintained that Mifepristone could only be prescribed in the first seven weeks of pregnancy, under a physician’s supervision, and the drug cannot be sent by mail. Continue Reading Access to Abortion Pill in Limbo: Navigating the Intricacies of Conflicting Federal Court Rulings in Texas and Washington State

The Food and Drug Administration (the “FDA”) has approved a modification to the Mifepristone Risk Evaluation and Mitigation Strategy (“REMS”) Program, increasing the accessibility of mifepristone for patients with a prescription. [1], [2] Continue Reading FDA Approval Mifepristone REMS Program Modification Expands Patient Access to Abortion Care

The United States’ recent False Claims Act (“FCA”) prosecution in United States v. Prometheus Group, et al., is a reminder that the government will use the FCA to target medical device manufacturers for off-label use of medical devices, even where healthcare providers have decided the use is safe and effective. In Prometheus Group, the government alleges that the defendant medical device manufacturer trained providers to re-use disposable rectal probes against U.S. Food and Drug Administration (“FDA”) recommendations, causing the providers to submit false claims for payment to Medicare for the services mis-using the probes. The complaint alleges that Prometheus put vulnerable Medicare patients at risk to gain a marketing advantage by reducing overhead costs associated with its systems. The message to medical device manufacturers is clear: even without submitting claims to the government themselves, manufacturers can face FCA liability for suggesting providers use their devices in any way the FDA has not approved (and in this case, warned against).Continue Reading The Government Seeks FCA Liability for Off-Label Use of Medical Devices

On Thursday, August 6, 2020 President Trump signed an Executive Order, mandating that certain drugs and medical supplies purchased by federal agencies, including the Department of Health and Human Services, Department of Defense, and Department of Veteran’s Affairs must be US-manufactured (the “Buy American Order” or the “Order”). The list of “essential medicines, medical countermeasures and critical input” that fall under this Order will be determined by the Food and Drug Administration (“FDA”). The Order also calls on the FDA to conduct a greater amount of unannounced inspections of overseas drug plants to ensure that production of drugs is compliant with safety standards and to encourage more advanced drug manufacturing techniques.
Continue Reading President Trump’s Executive Order Mandating the Purchase of U.S. Drugs Evokes Criticism

In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing genetic tests for predicting medication response and patient receptivity to drugs (among other things). FDA identified three genetic tests, including one called “MediMap Plus,” which was designed to provide insight into how a patient would respond to drugs used for anesthesia, cancers, infections, attention-deficit/hyperactivity disorder, depression, anxiety, and diabetes. FDA deemed the tests to be adulterated and misbranded because Inova had not sought premarket clearance.
Continue Reading FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests

[1] On January 25, 2018, Associate Attorney General Rachel Brand issued a memorandum on behalf of the U.S. Department of Justice (DOJ) (the “Brand Memo”) which effectively limits the use and enforcement power of guidance documents for the purposes of affirmative civil enforcement cases, a development that could have a significant impact on how certain healthcare cases are handled at the federal level by federal departments, agencies, and administrations, including those that are fixtures of the healthcare marketplace – the Department of Health and Human Services (HHS) and its constituent agencies, including the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA) and the HHS Office of Inspector General (OIG).
Continue Reading New DOJ Guidance Policy Limits Use of Guidance Documents in Federal Civil Actions

On April 7, 2014, the Food and Drug Administration (FDA), in consultation with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC) released a draft report addressing a proposed strategy and recommendations on an “appropriate, risk-based regulatory framework pertaining to health information technology.”
Continue Reading Proposed health IT strategy aims to promote innovation