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Focus on Regulation

What comes out, must go back in: Court sides with FDA on “same surgical procedure” and “homologous use” definitions governing human cell and tissue products

FDA authority to crack down on illegally marketed stem cell treatments confirmed

On Monday, a federal District Court in Florida issued a decisive blow against US Stem Cell Clinic, LLC, granting the U.S. Food and Drug Administration’s (FDA) motion for summary judgment, and stopping the clinic from offering its stem cell therapy to patients. The court found that the population of stromal and vascular cells in the clinic’s therapy, known as Stromal Vascular Fraction (SVF), constitutes a biological drug product that FDA must review and license before it can be commercially marketed. The court also found that the clinic’s manufacturing procedures and its promotion violated statutory requirements, causing the clinic’s cellular product to be adulterated and misbranded.

Critically, the court rejected the clinic’s argument that because its SVF procedure merely extracts and reinserts cells during the “same surgical procedure,” it is exempt from FDA regulation. Instead, the court adopted FDA’s view that the clinic’s separation of stromal and vascular cells from surgically-removed adipose (fat) tissue disqualified the procedure from this exception. The court held that the exception only applies to a procedure where the human cell, tissue, or cellular or tissue-based product (HCT/P) that is implanted into a patient includes “all” of “the antecedent HCT/P removed from the patient in its original form.” The case is a critical ruling supporting FDA’s increasing enforcement against stem cell clinics. It also clarifies FDA’s authority to regulate SVF therapies in particular, and bolsters FDA’s effort to gain more control over the HCT/P field more broadly.
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The French “PACTE” Law: Growing Space for Social and Environmental Topics in Corporate Management of French Companies

Under the new law on Business Growth and Transformation (the so-called “PACTE Law”), the management of French companies must take into consideration social and environmental issues. Companies are also encouraged to incorporate social objectives into their corporate purpose. This blog looks at the new law and what it means for businesses.

On 11 April 2019, the members of the National Assembly of the French Parliament adopted the PACTE Law. After a decision from the French Constitutional Council on 16 April 2019, the PACTE Law was eventually enacted and then published on 23 May 2019. Continue Reading

OFAC Issues Press Release for a Finding of Violation Against State Street Bank and Trust Co. Where No Penalty was Assessed

OFAC has announced a Finding of Violation –and not a penalty–against State Street Bank and Trust Co. (SSBT) for processing 45 pension payments totaling under $12,000 on behalf of a pension plan participant who was a US citizen with a US bank account but was living in Iran.

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FDA’s ‘Project Facilitate’ Pilot to Collect Metrics on Sponsor Expanded Access Denials

This morning, FDA announced it launched its new expanded access pilot called “Project Facilitate,” a concierge call center under the Oncology Center of Excellence (OCE) to facilitate the Single Patient IND (SPI) request process for oncologists.  Under the new program, FDA staff will help guide physicians through the process of applying for expanded access by answering questions, assisting with completing required paperwork, providing information on IRBs, and facilitating contact with the drug sponsor for submission of the expanded access request.

FDA further announced at a public workshop on May 16, 2019 that as part of its new program FDA will start contacting drug sponsors to collect metrics on whether a request for expanded access was granted, and, if not, the rationale for any denial.  When a sponsor grants an expanded access request, FDA stated it will also collect data from physicians to determine if their patient benefited from the investigational therapy or whether it caused adverse effects. Continue Reading

NHTSA, FMCSA release advanced notices of proposed rulemaking regarding autonomous driving systems

The National Highway Traffic Safety Administration (NHTSA) and Federal Motor Carrier Safety Administration (FMCSA) today each issued an advanced notice of proposed rulemaking (ANPRM) regarding the removal of regulatory barriers to the safe introduction of automated driving systems (ADS) on public roads.

I. NHTSA’s ANPRM

NHTSA’s ANPRM focuses on how to amend its crash avoidance (100-series) federal motor vehicle safety standards (FMVSS) to account for Level 4 and 5 autonomous vehicles (AV) that lack typical manual controls (e.g., steering wheels, foot-controlled accelerator, and brake pedals) but have traditional seating configurations. Continue Reading

DoD Trusted Capital Marketplace

At a press availability on May 10, Under Secretary of Defense for Acquisition and Sustainment, Ellen Lord, discussed the “matchmaking” service the Department of Defense (“DoD” or “Department”) is helping to create, to put small and struggling firms together with trusted sources of capital.  This program may be viewed as a positive step that is an essential complement to the prohibitory actions that have dominated U.S. policy aimed at combatting certain foreign investment in the industries of the future.

This program originated in the fertile mind of a DoD lawyer newly assigned to support the Department’s role in the Committee on Foreign Investment in the United States (“CFIUS”) program.  The lawyer worked on the Department’s efforts to block foreign (primarily Chinese) investment in capital-starved U.S. start-ups and other small companies on the grounds that allowing a takeover of those companies would endanger the national security of the United States. Continue Reading

Update on FCC 5.9 GHz band rule-making

On May 14, 2019, Federal Communications Commission (FCC) Chairman Ajit Pai announced plans to open a rule-making to take a “fresh look” at the 5850-5925 megahertz (MHz) (5.9 gigahertz (GHz)) spectrum band. Initial reports suggested that the FCC would take the issue up in June, but the 5.9 GHz rule-making was not included on the tentative agenda for the commission’s June open meeting. Chairman Pai delayed the rule-making at the request of U.S. Transportation Secretary Elaine Chao. The FCC has not provided a timeline for the rule-making, but we expect release of the rule-making sometime this summer.

Since 1999, spectrum in this band has been reserved for dedicated short range communications (DSRC). DSRC enables vehicle-to-vehicle (V2V) and vehicle-to-everything (V2X) communications that can help reduce traffic fatalities and injuries and reduce traffic congestion. The use restrictions and technical rules applicable to operations in the 5.9 GHz band are a lot more proscriptive than the rules that typically apply to the bands used for commercial wireless services such as Long Term Evolution technology (LTE) and Wi-Fi. As a result, some FCC stakeholders have urged the FCC to use the rule-making to provide more flexibility in the types of services that will be allowed in the band and to promote sharing between services. With a few notable exceptions (e.g., General Motors and Toyota), the automotive industry has been slow to invest in and develop products based on DSRC. In his announcement about the 5.9 GHz rule-making, Chairman Pai described this spectrum as “largely lying fallow” for the past 20 years.

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FDA Chief of Staff: OTC reform remains “top priority” for FDA

Speaking Tuesday, May 21, at the Consumer Health Products Association Regulatory, Scientific, and Quality Conference, FDA Chief of Staff Lauren Silvis emphasized that over-the-counter (OTC) monograph reform remains a “top priority” for FDA.  Based on these comments, FDA is clearly not giving up on monograph reform:

FDA has long engaged in this effort, and we will continue to do so, working with all stakeholders and Congress to make clear that OTC monograph reform is a critical public health priority.  It’s in the best interest of patients to modernize the monograph system.  That means that FDA will continue to engage on this issue, until we have a system for OTC drugs that provides Americans what they need to better manage their own health care.  We know it’s up to Congress to legislate on this issue, but you’ll continue to hear from FDA that OTC modernization will help consumers take charge of their own healthcare, promote safety and innovation, and help Americans lead healthier lives.

FDA’s perseverance on OTC monograph reform is particularly important because on May 16, the Senate passed FDA’s pandemic preparedness reauthorization legislation, S. 1379, after stripping out the monograph reform bill that had been paired with it in the House-passed H.R. 269. Continue Reading

FDA guidance may ease path to biosimilar interchangeability

On Friday, FDA published the final guidance, “Considerations in Demonstrating Interchangeability With a Reference Product,” which is intended to assist sponsors in demonstrating that a biosimilar product is interchangeable with a reference product.  Even as some of the details remain to be hashed out, the guidance makes clear FDA’s desire to minimize the burdens of obtaining a determination of interchangeability.  The guidance summarizes the important scientific considerations for demonstrating interchangeability, including:

  • The data and information recommended to support a demonstration of interchangeability
  • Considerations for the design and analysis of a switching study or studies to support a demonstration of interchangeability
  • Considerations regarding the comparator product in a switching study or studies
  • High-level overview of considerations for developing presentations, e.g., packaging and delivery systems, for proposed interchangeable products

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FDA Doubles Down on MUsT Studies for Sunscreens and Issues Final Guidance on Absorption Studies that Will Likely Be Needed for Continued Marketing

On May 10, 2019, FDA published a notice of availability for a final guidance document on Maximal Usage Trials (MUsT studies) for topically applied active ingredients being considered for OTC drug monographs, including sunscreens.  As FDA has previously explained, the guidance states that MUsT studies can identify the potential for the systemic exposure for a topically-applied active ingredient.  FDA believes that this information is necessary to determine whether additional safety studies are needed to support a finding that the ingredient is generally recognized as safe and effective (GRASE) for its intended use.

FDA’s reliance on MUsT studies has been a subject of controversy with the sunscreens industry.  Industry has argued that MUsT studies are unreasonably expensive and sunscreen products have been marketed in the U.S. and around the world for decades without adverse events or data identifying safety concerns related to absorption.  To support an OTC drug monograph, FDA has said that a MUsT study should evaluate the ingredient in a range of formulations, which further adds to the cost and time needed for such a study.

FDA: Absorption Is Not Just a Theoretical Concern

However, just a few days before the issuance of the MUsT guidance, on May 6, 2019, FDA released a statement reaffirming the agency’s reliance on MUsT studies for evaluating sunscreens.  The FDA statement highlights an FDA-funded study published on the same day in the Journal of the American Medical Association (JAMA), evaluating the absorption of four sunscreen ingredients Continue Reading