INSIDE COMPLIANCE – Page 41 – Loyola University Chicago School of Law

FDA-USPTO Collaboration Offers Insight on the Future of Generics

March 29, 2022Uncategorized

Following the Biden Administration’s release of the Comprehensive Plan for Addressing High Drug prices in September 2021, the Food and Drug Administration (FDA) responded by opening communication with the United States Patent and Trademark Office (USPTO). On September 10, 2021, the FDA sent a letter to the Under Secretary of Commerce for Intellectual Property and Director of the USPTO seeking to further develop the FDA-USPTO relationship. The letters point out that while “bringing more drug competition to the market and addressing the high cost of medicines by improving access to affordable medications is a top priority” for HHS and FDA, the FDA is constrained by its inability to regulate the price of drugs it approves. While the FDA’s 505(b)(2) hybrid NDA and 505(j) ANDA pathway decrease the cost and time to market entry for generics, the FDA’s authority is concentrated in the pre-market review stage, with post-market authority focused on actions such as product seizure of adulterated or misbranded articles, phase-4 confirmatory trials, and other actions intended to assess the safety and efficacy of drugs.

Journal of Regulatory Compliance

Innovation in Healthcare: Physician Payment and Automation

March 28, 2022Fraud & Abuse

In the fight against COVID-19, healthcare innovation has been unprecedented. New technology, protocols, and laws have changed the way healthcare functions. However, physician compensation remains complex, burdensome, and often contentious. Physician compensation has always invited compliance risks, operational bottlenecks, and administrative burdens, but now, innovative hospitals are simplifying the process with automation.

automationhealth care fraud and abusehealthcare innovationphysician compensation

What Will it Take to Deter Corporations from Violating Environmental Regulations?

March 26, 2022Uncategorized

Beverage corporation Diageo has recently been fined £1.2 million for violating environmental regulations. Diageo is a multinational corporation that owns a variety of liquor brands, including Johnnie Walker, Tanqueray, Smirnoff, Captain Morgan, Don Julio, Crown Royal, and several others. Headquartered in England, it operates all over the world, with its North American subsidiary being one of its most profitable. In violation of UK regulations, the beverage company has failed to report the environmental impacts of some of its sites for the past six years and has failed to secure permits for the relevant operations. The corporation alleges that these omissions were the result of an administrative error.

carbon emissionsconsumer productsenvironmentenvironmental regulationenvironmental regulationsGreenhouse Gas EmissionsJournal of Regulatory ComplianceUK

What the Cluck is Going on? Regulatory Failures Amid a Nationwide Food Poisoning Epidemic

March 25, 2022Uncategorized

In October 2021, ProPublica published an article about a rare and virulent strain of salmonella infantis outbreak that occurred in May 2018, afflicting at least a dozen people across the country. Many who reported being sick reported that they ate chicken, and federal food safety inspectors found the infantis strain in packaged chicken breasts, sausages, and wings during routine inspections at poultry plants.

consumer protectionFDAFood ProcessingRegulation

Critical Infrastructure and Cybersecurity Legislation: America’s Cybersecurity Problem

March 25, 2022Uncategorized

Long gone are the days when cybersecurity concerns existed solely in the domain of technology teams. Various organizations, from schools to government entities (at every level), to private companies alike have fallen prey to cyberattacks. May 2021’s Colonial Pipeline attack caused chaos and a temporary gas frenzy that brought awareness of the vulnerabilities of the technology we rely on to even the least technically minded American. Cybersecurity, and more specifically, the security of critical infrastructure immediately became an issue that the U.S. Government is taking very seriously.

cyber-attacksInfrastructureinternationalInternational AffairsJournal of Regulatory CompliancePrivacy & Security

Stablecoins II: The Stablecoin Innovation and Protection Act of 2022

March 23, 2022Finance & Banking

On Tuesday, February 15, 2022, Congressman Josh Gottheimer released a draft of the Stablecoin Innovation and Protection Act of 2022 (“the bill”). This legislation attempts to both define stablecoins as well as provide a legal framework in which the issuers and users of stablecoins can safely and legally operate. The bill is surprisingly brief, only nine pages long, but Gottheimer claims that it will provide greater direction and certainty to the marketplace in order to boost innovation while also protecting consumers.

cryptoCryptocurrencycryptocurrency regulationfinanceFTCJournal of Regulatory ComplianceLegislationSEC

First Amendment Rights and Florida’s “Don’t Say Gay” Bill

March 22, 2022Uncategorized

Florida’s “Don’t Say Gay” bill, which would bar Florida educators from speaking to students about LBGTQ+ topics that are not considered “age-appropriate or developmentally appropriate for students” has passed in Florida’s House and is likely to pass in the Senate as it now moves to the Republican-controlled Senate floor for a vote. The horrific piece of legislation, formally known as HB 1557, has raised questions as to whether the bill, if passed, would violate the First Amendment rights of teachers or students in public primary schools across the sunshine state.

DeSantis free speachEducationFirst AmendmentfloridagayHB 1557Journal of Regulatory ComplianceLGBTQSchools

The First Cyber War: The Threat of Russian Cyberattacks has Thrust Cybersecurity Compliance into the Spotlight

March 22, 2022Uncategorized

The impact of Russia’s unprovoked attack on Ukraine on February 24, 2022 has not only caused a horrific human rights crisis but has also had a dramatic effect on how the world conducts business, felt well beyond the borders of Russia and Ukraine. Warnings of an imminent Russian cyberattack on critical United States infrastructure has small and large businesses alike brushing up their cybersecurity policies to ensure they are compliant with current best practices in the likely event of a Russian cyberattack and impending federal legislation.

cyber-attackscyber-securityInternational AffairsLegislationPrivacy & SecurityUkraine

Senate Brings Bipartisan Attempt to Update Health Privacy Regulations

March 19, 2022HIPAA & Health Information

On February 9, a group of senators led by Tammy Baldwin of Wisconsin and Bill Cassidy of Louisiana introduced a new bill, the Health Data Use and Privacy Commission Act (the “Act”), in attempt to revitalize current legislation regarding the protection and use of health data. The bill also has the support of a number of representatives from within the healthcare industry, including Epic, IBM, and Teladoc Health, as well as a number of professional associations like the American College of Cardiology, the Association for Behavioral Health and Wellness, and the Association of Clinical Research Organizations.

consumer protectiondata breachDepartment of Health & Human ServicesGDPRHealth InsuranceHIPAAPrivacy & Security

FDA’s Proposed Global Regulatory Harmonization for Medical Devices

March 18, 2022Drugs & Devices, The Marketplace

On February 23, 2022, the Food and Drug Administration (FDA) published a proposed regulation to amend current manufacturing practice requirements of the Quality System Regulation (QSR) (21 CFR Part 820). The FDA first announced such harmonization in 2018, however COVID-19 delayed the proposal. The FDA seeks to align Part 820 more closely with the international specific standard for medical device quality management systems set out by the International Organization for Standardizations (ISO) 13485. According to the FDA, such “harmonization should provide patients more efficient access to necessary devices, leading to improvements of life quality of the consumers.” Part 820 is part of the current mandatory regulations that ensure that all medical devices created and developed within the US market are safe. ISO 13485 is the international standard for a quality management system for medical devices required by certain countries. Therefore, any manufacturer that sells outside the US will likely need to be ISO 13485 certified. With the implementation of this new amendment, manufacturers would be able to assure their products are regulatorily compliant in both the US and international markets.

FDAFDA approvedFDA authorizedFDA regulationsJournal of Regulatory Compliance