Shoosmiths’ mobility head, Jonathan Smart, was a speaker at the SMMT International Automotive Summit 2023, hosted in London. Jonathan moderated a panel discussion focused on the competitive challenges facing the UK’s automotive manufacturing sector. The summit was aimed at addressing the challenges facing the automotive sector, including building resiliency, international collaboration, unlocking potential, competitiveness and innovation ...
“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 ...
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 ...
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 ...
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 ...
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 Supreme Court of Appeal recently handed down a rare trade mark judgment. The protagonists were Adidas and Pepkor, and the main issue was whether Pepkor had infringed certain trade mark registrations belonging to Adidas for its famous three-stripe mark. Adidas was founded by a German called Adi Dassler in 1920 ...
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 ...
Judgement of the European Court of Justice in case C-212/03 – Commission v. France, dated 26 May 2005 The Commission acted against France on the grounds that certain French rules on the importation of medicines are contrary to Article 28 of EC Treaty on the free movement of goods. The relevant national rules and administrative practice required a licence for the importation of medicines for personal use in France ...
The HHS Office for the National Coordinator of Health Information Technology issued an interim final rule on October 29, 2020, extending the compliance date for the information blocking rule under the 21st Century Cures Act to April 5, 2021 ...
It is evident that the current lockdown is having an unprecedented slowdown in the movement of persons between EU Member States. This is not due to a restriction which was imposed by the EU itself but because of the restrictions which the Member States themselves imposed through their respective Public Health officials. It is noticeable that the legal restrictions on immigration were driven by the Member States' individual rules rather than by a general guideline from the EU ...
April 17, 2023 By: Meghna Parikh ALERT: Recent guidance from the Food and Drug Administration (“FDA”) clarifies a procedural issue for premarket submissions related to cybersecurity of medical devices and emphasizes the importance of collaboration between the FDA and medical device manufacturers. Providers using medical devices in their practice should pay attention to these rulings because they impacts the providers’ ability to educate and engage their patients ...
Activists are recasting risk in a way that can only damage industry Last August, a California jury awarded plaintiff Eva Echeverria a total of $417m in compensatory and punitive damages in a lawsuit against Johnson & Johnson (J&J). Her case was that the company should have warned consumers that studies had found an inconclusive correlation between ovarian cancer and talcum powder ...
The Food Standards Agency (FSA) has launched a campaign highlighting the risks of food labelled as vegan to people with allergies. Research from the FSA has shown that 62% of consumers with an animal-based allergy were confident that products labelled as ‘vegan’ were safe to eat. The FSA says this confidence is incorrect and is putting people at risk ...
This year, the Federal Trade Commission (the “FTC”) and the Department of Justice (the “DOJ”) have been modifying antitrust guidance related to healthcare, and recently enacted three notable changes. First, the FTC and DOJ jointly issued updated Draft Merger Guidelines (the “Draft Guidelines”) to address the way the agencies evaluate a merger to determine its effect on competition ...
Rohit Chopra, the head of the Federal Trade Commission, recently issued a statement regarding private equity roll-ups in connection with the FTC’s annual report to Congress related to the Hart-Scott-Rodino (HSR) Act. The full text of the statement can be found here ...
