Legislators filed bills before the official start date of the 83rd Texas Legislative Session; many of the bills already filed address healthcare issues. 1. The Budget. Texas legislative leaders recently approved a self-imposed budget cap for the 2014-2015 biennium based on a conservative estimate of growth in the state’s economy, holding lawmakers to not more than a 10 ...
In case you missed it, there was an interesting piece in the January/February issue of Transaction Trends, the Electronic Transactions Association’s official publication. I highly recommend it, as it was a good look ahead. The feature, “Putting the ‘L’ in M-Commerce” was an interview with several prominent industry executives about loyalty cards and programs. Today, however, loyalty card programs are fragmented, to put it politely ...
“Government efforts to manipulate markets and prices on consumer goods never work as intended, and in this case, would be counterproductive.” The waning days of summer signal the approaching midterm election season. Amid inflation, recession and voter discontent, it’s understandable that a group of congress members are anxious to put points on the board with a price-control scheme that they wrongly believe will lower prescription drug prices ...
The Florida Agency for Health Care Administration (“AHCA”) earlier this month fined Humana $3.4 million for failing to promptly report suspected cases of Medicaid fraud and abuse by others, as required by statute and Humana’s Medicaid HMO contract. Though many states have similar laws or regulations, this appears to be the first enforcement action of its kind in the nation ...
On October 10, 2019, the Federal Mine Safety and Health Review Commission (“Commission”) published a notice it would withdraw its simplified proceedings program. The withdrawal of the program becomes effective 45 days after publication in the Federal Register unless adverse comment is received ...
Stay focused on the interest, not on your position. Define the problem; you decide on your position. For every interest there usually exist several possible satisfying solutions to adequately address those interests. Remember that behind opposed positions lie shared and often compatible interests ...
IN OUR JUNE 2005 “FDA WATCH” column, we provided an overview of the regulatory, political, and scientific landscape for follow-on biological products in the U.S. As reported a year ago, the biogenerics debate centers around whether generic biologics are scientifically possible (i.e ...
On Capitol Hill, U.S. lawmakers are considering legislation that would authorize the U.S. Food and Drug Administration (FDA) to approve generic versions of biological products. Representative Henry Waxman (D, CA), of “Hatch-Waxman” fame, has introduced the “Access to Life Saving Medicine Act” (H.R. 1038) to advance this change to U.S. law. In introducing the legislation, Rep ...
The coronavirus pandemic has impacted the food industry, just as it has many others. The good news is that food-to-person transmission of the disease does not seem to be a risk. The challenge remains keeping workers safe from airborne and surface transmission. However, the FDA and the USDA have provided guidance and recommendations to food producers to deal with COVID-19, links to which have been provided below. The guidance focuses on stopping the person-to-person spread of the disease ...
The establishment by the Scottish Government of a food security task force is a necessary and timely response to the war in Ukraine. In addition to the harrowing humanitarian crisis, the conflict has prompted significant concern among food producers. The UK food sector and consumers are currently facing a perfect storm just as we begin to emerge from the pandemic ...
Hospitals and health systems are on the frontlines fighting the COVID-19 pandemic. But, behind the scenes, they are grappling to sustain operations and finances significantly impacted by the state of the economy. In the latest version of our PointbyPoint podcast, Waller’s Ken Marlow and Eb LeMaster, managing director at Ponder, discuss the various factors impacting hospitals and health systems today ...
On November 5, 2020, in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of an Abbreviated New Drug Application (‘ANDA’) occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated.” Slip op. at 3 ...
The ongoing global COVID-19 pandemic is upending regular commercial activity across the United States and around the world, and that disruption is expected to escalate. Among the issues confronting our clients, the effect of public health orders and other measures to address COVID-19 is threatening, impacting, and in some cases, outright prohibiting the performance of material contractual obligations ...
As Hurricane Harvey continues to cause far-reaching disruptions, it is important to understand how to effectively assert or respond to assertions of force majeure. This summary outlines the steps to take to assert force majeure, and initial considerations for those who have received several notices of force majeure from counterparties ...
A case of forced resignation does not automatically amount to an unfair dismissal. In the recent decision of Mohd Rizam bin Ibrahim v Prince Court Medical Centre Sdn Bhd dated 5 June 2020 [Award 716 of 2020], the Industrial Court ruled that although the employee was forced to resign, the same was with just cause and excuse ...
Don't bank just yet on putting your marketing muscle behind the safe and effective off-label uses of your FDA-approved drugs, or defending your next mass consumer class action on First Amendment grounds. But you can start giving those multi-billion dollar prospects some serious thought, because constitutional winds are blowing through the Code of Federal Regulations ...
The February 14 decision in a closely watched Fourth Circuit False Claims Act (FCA) case did not, as initially anticipated, address the issue of the validity of statistical sampling to establish FCA liability. However, it did address another question that has split the circuits—whether the U.S. Department of Justice has the unreviewable right to veto FCA settlements in cases in which it has declined to intervene. See United States ex rel. Michaels v. Agape Senior Community, et al ...
The doctrine of qualified immunity, often invoked by police officers and other government employees in lawsuits alleging civil rights violations, was recently asserted by defendants in a federal False Claims Act (FCA) fraud case. In an interlocutory appeal, a unanimous Fourth Circuit panel has held qualified immunity cannot shield defendants from FCA liability. Citynet, No. 18-1575, 2020 U.S. App. LEXIS 19367 (4th Cir. June 22, 2020) ...
In a defendant-friendly opinion, a split panel held that conduct based on an “objectively reasonable” reading of an ambiguous statute, absent contrary circuit court precedent or agency guidance, cannot constitute “knowing” misconduct under the False Claims Act. In United States ex rel. Sheldon v ...
The United States Court of Appeals for the Fourth Circuit recently decided that claims based on Article 2 of the West Virginia Consumer Credit and Protection Act ("WVCCPA"), including claims based on its FDCPA-like debt collection provisions, do not apply to transactions where the consumer pays at the point of sale. In Hinkle v. Safe-Guard Products Int'l, LLC, Hinkle purchased a new car at a local dealership ...
Recent upheavals sweeping the globe, including significant changes in social and familial structures and technological, political and economic shifts, have quite obviously also stoked the fire of underlying family tensions with incendiary results. Often the next generation fails to conform to the expectations of the wealth-originating generation and their goals and ambitions can diverge quite significantly ...
After the Netherlands, Slovakia, and the UK, it is now France’s turn to impose Sunshine-like obligations on the pharmaceutical industry. Soon, similar obligations will apply to all EU countries, after EFPIA, the European trade association for the pharmaceutical industry, adopts a code of conduct on disclosure of transfers of value between pharmaceutical companies and health care professionals or institutions ...
