The recent Supreme Court decisions of SEC v. Jarkesy and Loper Bright Enterprises v. Raimondo have the potential to meaningfully impact the implementation and enforcement of the Drug Supply Chain Security Act (“DSCSA”) as...more
In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more
The Drug Supply Chain Security Act (DSCSA) (Title 2 of the Drug Quality and Security Act, P.L. 113-54 (Nov 27, 2013)) amended Chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding subchapter H —...more
Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more
The Drug Enforcement Administration (DEA) recently issued a new regulation codifying provisions of the Veterinary Medicine Mobility Act of 2014 (VMMA). The VMMA, which was signed into law in 2014, allows a veterinarian to...more
On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising 42 CFR Part 8, which regulates opioid treatment programs (OTPs). The final rule is the first update to...more
This week, DEA announced it has entered into a settlement agreement with Morris & Dickson Co., LLC (“Morris & Dickson”), resolving the protracted dispute born out of a May 2, 2018 Order to Show Cause (“OTSC”) and Immediate...more
In December 2023, the Food and Drug Administration (FDA) issued a final guidance, “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs,” explaining the agency’s interpretation of the...more
In 2020, over 142 million prescriptions for opioid medications were filled in the U.S. That same year, 16,416 people died from overdoses on prescription opioids—a 376% increase from 1999....more
With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing...more
Although 340B-participating covered entities likely don’t need the reminder, numerous manufacturers continue to significantly restrict 340B pricing available via traditional “bill to/ship to” contract pharmacy models, with...more
The U.S. Food and Drug Administration (FDA) recently published a guidance for immediate implementation, Enhanced Drug Distribution Security Requirements Under Section 582(g)(1), that provides a one-year reprieve from certain...more
The DSCSA, enacted in 2013, requires entities in the pharmaceutical supply chain to implement security measures to prevent the introduction of counterfeit and illegitimate drugs into the market. One of these measures is the...more
The Food and Drug Administration (“FDA”) released additional guidance documents on Wednesday, August 30th pertaining to the enhanced drug distribution security requirements under the Drug Supply Chain Security Act (“DSCSA”). ...more
On Wednesday, August 16, the Fifth Circuit Court of Appeals issued a ruling upholding parts of a Texas district court’s decision that would, if it becomes effective, severely limit access to mifepristone, one of two pills...more
On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more
On August 4, 2023, the Drug Enforcement Administration (“DEA”) announced plans to host two public listening sessions, scheduled to take place on September 12 and 13, 2023 at DEA’s headquarters in Arlington, VA, to collect...more
On June 14, the Drug Enforcement Administration (DEA) released an updated Practitioner’s Manual, the first new version of the manual since 2006. The Practitioner’s Manual provides guidance for all DEA registrants handling...more
On March 16, 2023, the Food and Drug Administration (FDA) released final guidance regarding definitions of "suspect product" and "illegitimate product" as part of a continued effort to prepare trading partners for the...more
The Big Picture - On February 24, the Drug Enforcement Administration (DEA), in consultation with the Department of Health and Human Services (HHS), issued two proposed rules that address the prescribing of controlled...more
On February 17, Daniel Russo, a Long Island resident, pleaded guilty in federal court in Brooklyn to multiple charges in connection with illegally distributing oxycodone. Russo faces decades in federal prison when he is...more
Ten years in the making, and full implementation is finally coming. In about a year—beginning on November 27, 2023—prescription drug manufacturers and their supply chain partners will be required to fully trace and verify...more
In one year (plus a few days, as of this writing), regulation of the U.S. drug supply chain will be historically changed. On November 27, 2023, the final phase of the Drug Supply Chain Security Act (DSCSA) goes into effect....more
While critics keep throwing up a false narrative about “ambulance chasing,” self-enriching lawyers, their labors and the civil legal system have proven yet again their effectiveness in wringing financial justice for those...more
The United States Department of Justice (DOJ) has recently emphasized that Maine, New Hampshire, and Vermont are priorities for health care investigations and anticipated significant enforcement. Even well-managed (and...more