Photo of Andrew J. Sylora

Andrew J. Sylora

Subscribe to Andrew J. Sylora's Posts

Andrew J. Sylora is an Associate in Vedder Price’s Chicago office and a member of the firm’s Health Care & Life Sciences practice group. Mr. Sylora focuses his practice on advising clients in the life sciences and health care industries on a wide range of transactional, regulatory and compliance matters.

Contact:Read more about Andrew J. Sylora
Laptop, stethoscope and doctor writing in notebook for research planning or medical tech innovation in hospital office. Healthcare medic worker, research strategy book notes and online communication

On May 12, 2025, President Donald J. Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.”  This executive order aims to lower the cost of prescription drugs for U.S. consumers by requiring drug manufacturers to sell their products to consumers at a most-favored-nation price through direct-to-consumer purchasing programs facilitated by the Secretary of Health and Human Services (“HHS”).  Under the proposed most-favored-nation approach, consumers would pay no more than the lowest price for a prescription drug sold by a drug manufacturer to customers in comparably developed nations. 

The executive order directs HHS to take steps to implement a most-favored-nation approach to prescription drug pricing.  This includes communicating most-favored-nation price targets to pharmaceutical manufacturers within 30 days.  If “significant progress” towards implementing the most-favored-nation approach is not made, the executive order directs HHS to, among other things, propose a rulemaking plan to impose most-favored-nation pricing.  The executive order does not specify a timeline for measuring “significant progress.” The executive order states that if drug manufacturers fail to implement most-favored-nation pricing, the Administration will take “additional aggressive action.”Continue Reading Trump Administration Issues Executive Order Aimed At Lowering Prescription Drug Pricing

On February 25, 2025, President Donald J. Trump signed an executive order titled “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information” (the “2025 Order”) aiming to provide increased transparency regarding the pricing of health care services.  This executive order builds upon a prior executive order issued during President Trump’s first term in June 2019 (the “2019 Order”) that required hospitals to disclose to consumers pricing information for certain “shoppable” health care items and services and maintain this pricing information in accessible, consumer-friendly formats.  The 2019 Order also mandated the establishment of rules requiring health care providers, health insurance issuers and self-insured group health plans to facilitate consumer access to information concerning expected out-of-pocket costs for health care items and services prior to receiving care.Continue Reading Trump Administration Issues Executive Order Mandating Implementation and Enforcement of Health Care Pricing Transparency

Laptop, stethoscope and doctor writing in notebook for research planning or medical tech innovation in hospital office. Healthcare medic worker, research strategy book notes and online communication

On September 28, 2024, California governor Gavin Newsom vetoed AB 3129, a bill that, among other things, would have required private equity firms and hedge funds to provide 90 days’ prior written notice to, and for some transactions, obtain consent from, the state attorney general prior to proceeding with certain health care transactions.

In a…

Laptop, stethoscope and doctor writing in notebook for research planning or medical tech innovation in hospital office. Healthcare medic worker, research strategy book notes and online communication

Private equity investments in health care to be subject to increased oversight from federal and state regulators, including antitrust officials

Federal and state governmental regulation of health care transactions continues to increase rapidly.  At the federal level, there is increased focus on the role of private equity in health care and the perceived impact on access to care, quality of care and pricing.  At the same time, a growing number of states have passed and continue to propose legislation that increases state oversight of health care transactions.  As a result of this increase in regulatory scrutiny from federal and state regulators, parties interested in conducting health care transactions must consider various regulatory requirements and the factors regulators take into account when analyzing proposed health care transactions. Continue Reading Health Care Transactions Facing Increased Federal and State Regulatory Scrutiny

On April 26, 2024, the Federal Trade Commission (FTC) announced that it had finalized changes to the Health Breach Notification Rule (HBNR). These changes, which go into effect on June 25, 2024, are intended to modernize aspects of the HBNR such that the HBNR applies to entities not covered under the Health Insurance Portability and Accountability Act (HIPAA). The updated HBNR follows the FTC’s previously stated intention in a 2021 policy statement to broaden the interpretation of the HBNR to address the growing number of digital health applications, websites, and consumer-facing technology that were not subject to HIPAA. The scope of the finalized rule therefore aims to apply the HBNR to health care technology and digital health companies that obtain personal health records (PHR) and PHR identifiable health information.Continue Reading FTC Finalizes Broader Changes to the Health Breach Notification Rule

On June 1, 2023 the U.S. Supreme Court vacated and remanded two Seventh Circuit decisions involving the False Claims Act (FCA), holding in a unanimous opinion that the FCA’s scienter element turns on a defendant’s subjective belief and intent, not by an after-the-fact analysis of whether the defendant’s actions were “objectively reasonable.”

The two cases at issue, United States et al. ex rel. Schutte et al. v. SuperValu Inc. et al. and United States et al. ex rel. Proctor v. Safeway Inc., alleged that respondents SuperValu and Safeway separately defrauded Medicaid and Medicare by offering discount programs to their customers while knowingly submitting claims for the higher retail prices exceeding the “usual and customary prices” customers paid. Ruling in favor of SuperValu and Safeway, the Seventh Circuit applied an “objectively reasonable” scienter standard, determining that SuperValu and Safeway would be liable for submitting false claims only if their respective interpretation of the FCA’s “usual and customary” language was not “objectively reasonable.”Continue Reading U.S. Supreme Court Clarifies Usage of Subjective Standard for FCA Scienter Element

The FDA has recently stepped up its enforcement activity with respect to animal and pet food manufacturing. On February 8, 2023, the FDA announced an expansion of a voluntary recall for a Nestlé Purina dog food product. On March 10, 2023, the FDA announced a voluntary recall of cat and dog supplements distributed by Stratford Care USA due to elevated levels of vitamin A found in the supplements. And on March 14, 2023, the FDA published a warning letter issued to Primal Pet Foods, Inc. in relation to the company’s recall of its dog food product, stating the company had not taken sufficient steps to address operational and manufacturing deficiencies found during an FDA inspection of the manufacturing facility.Continue Reading Navigating FDA Manufacturing Guidelines for Animal and Pet Food Products