Recent Blog Posts
- Up in Smoke: The Countdown on Vape Enforcement Discretion Begins On July 11, 2019, a Federal judge for the U.S. District Court for Maryland ruled that manufacturers and importers of products such as e-cigarettes and other electronic nicotine delivery systems (“ENDS”) have ten months to submit applications for marketing to the U.S. Food and Drug Administration (“FDA”). The ten-month deadline is applicable to new tobacco products on the market as of the August 8, 2016 deeming rule that extended FDA’s regulatory jurisdiction to include all tobacco products. Accordingly, manufacturers of... More
- Whether Worth Less or Worthless, Quality of Care Issues Under the FCA Are Worth Noting On February 27, 2019, Tennessee-based holding company Vanguard Healthcare, LLC (“Vanguard”), agreed to pay over $18 million to settle a False Claims Act (“FCA”) action brought by the United States and the state of Tennessee for “grossly substandard nursing home services.” The settlement stems from allegations that five Vanguard-operated facilities failed to do the following: (1) administer medications as prescribed, (2) provide standard infection control resulting in urinary tract and wound infections, (3) attend to the basic nutrition and hygiene... More
- Not Business as Usual: The Government Shutdown’s Impact at FDA The federal government entered into a partial shutdown at midnight on Saturday, December 22, 2018. The implications of the ongoing shutdown are far-reaching, but its impact on the Food and Drug Administration (“FDA”) is of particular concern to members of FDA-regulated industries and those with a role in ensuring the public health. Thousands of FDA employees considered non-essential were furloughed and, consequently, routine regulatory and compliance activities at FDA were put on hold. On his Twitter account (@SGottliebFDA), Scott Gottlieb,... More
- FDA to Overhaul Medical Device Approval Process On November 26, 2018, the U.S. Food and Drug Administration (“FDA”) announced the process for clearing most medical devices for marketing is being updated to incorporate changes the FDA laid out in an April draft guidance. For over forty years, most medical devices have entered the United States market through the 510(k) clearance process. The 510(k) process offers an expedited approval process available only for products that are substantially equivalent to products already on the market (known as predicate devices).... More
- The SUPPORT for Patients and Communities Act: President Trump Signs Sweeping Opioid Law On October 24, 2018, President Trump signed sweeping bipartisan legislation to combat the opioid epidemic. The Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, or the SUPPORT for Patients and Communities Act (“H.R. 6” or “the Law”), aims to “reduce access to the supply of opioids by expanding access to prevention, treatment, and recovery services.” Congress has already appropriated $8.5 billion to implement this “landmark legislation” in 2018 and 2019.
In a series of Client... More
- New Federal Laws Banning “Gag Clauses” in the Pharmacy On October 10, 2018, President Donald Trump signed into law the “Know the Lowest Price Act” and the “Patients’ Right to Know Drug Prices Act,” which aim to improve consumer access to drug price information by banning gag clauses. The Trump administration previously announced its intention to enact this legislation in its May 2018 Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs and will likely point to these new federal laws as affirmation of its commitment to drug pricing... More