News & Publications

Mark Schwartz is quoted in the attached article  

Voluminous discovery productions affect every stage of the Department of Justice’s criminalcases. Investigations have become more data-driven, and prosecuting even seemingly simple cases oftenhinges on reliable data management as much as reliable witness testimony. Prosecutors’ obligationsdealing with electronically stored information (“ESI”) have also changed, and …

Many chronic pain conditions are resistant to conventional therapy. Promising new approaches to pain management capitalize on the brain’s own mechanisms for controlling pain perception. This article will demonstrate that cortical neurons directly innervate the brainstem to drive feedforward inhibition of nociceptive neurons. This corticotrigeminal …

Despite being a world leader in the development of digital health technologies, developers in the US are often apprehensive about the often long and detailed process of the Food and Drug Administration’s (‘FDA’) premarket certification review. The FDA’s new Digital Health Software Precertification (Precert) Program (‘Precert Program’), announced …

In September, the U.S. District Court for the Central District of California dismissed a qui tam complaint filed against Medtronic and its subsidiaries alleging violations of the False Claims Act. The relator (an LLC named “The Dan Abrams Company LLC” formed by a former Medtronic employee …

When you think about it, FDA’s general regulatory paradigm for regulating medical devices has enjoyed a tremendous run. The overarching statutory and regulatory foundation was started in 1976 and largely in place in its current form by 1997. (Think 510(k)/de novo/IDE/PMA requirements for the premarket …

Does the Food and Drug Administration’s review of medical devices in the 510(k) program involve a substantial review of safety and effectiveness? The FDA says it does. Device makers and those of us who practice in this area know how burdensome and extensive this process …

The DIA journal, Therapeutic Innovation and Regulatory Science, published the recommendations arising from an effort by the Clinical Trials Transformation Initiative (CTTI) Patient Groups and Clinical Trials team, which included HP&M Attorney James E. Valentine, to identify the elements necessary for successful collaboration between patient …

Without pomp or circumstance, Congressman Morgan Griffith (R-VA) introduced a bill on March 27,2017, that would expand the communications pharmaceutical and medical device companies can have with doctors about their products. The bill, titled the Medical Product Communications Act of 2017, seeks to clarify the …

On January 12, 2017, the US Department of Justice announced it had reached a global settlement with Baxter Healthcare Corporation. The civil component of the settlement was atypical of other False Claims Act (FCA) matters. It was small by comparison -$2.158 million – and it …

Twenty-five years ago, the Food and Drug Administration (FDA) first announced that it believed it had the authority to regulate laboratory developed tests (LDTs). Since then, the topic has generated intense controversy and resulted in the issuance of several draft guidance documents, intense lobbying, draft …

In 2015, FDA proposed revising the so-called A1:I298 use regulation (21 CFR 201.128; id. § 801.4) to remove the famous ‘knowledge’ sentence: But if a manufacturer knows, or has knowledge of facts that would give him notice, that a [drug or device] introduced into interstate commerce …

In 1976, the FDA first began comprehensive regulation of medical devices. Among the new statutory provisions, there was one requiring persons registering with FDA to list all marketed devices. Each device on the list was to be accompanied by a copy of the label and …

Pharmaceutical companies, such as manufacturers, distributors, and pharmacies that dispense, distribute, and sell prescription drugs and devices are subject to state licensing and other regulatory requirements. Corporate transactions involving these companies, including mergers, acquisitions, changes of ownership, or even corporate restructurings, can trigger a requirement …

A problematic decision from the Ninth Circuit appears to impermissibly grant the FDA authority to regulate the practice of medicine, and to further muddy the regulatory morass governing off-label use of products. The court affirmed the felony conviction and 48-month imprisonment of Dr. Michael Stanley …

A 510(k) submission rather than a 510(k) clearance is the threshold that a device firm needs to meet to being advertising or displaying a product under a long-established, one-sentence agency policy. But important questions remain about proper application of this policy by the Industry. This …

The recent issuance of FDA’s draft guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device, which, when finalized, will replace the guidance of the same name issued in January 1997, was undoubtedly met with both excitement and trepidation for companies …

Ricardo Carvajal & Jay Cormier published an article in the JULY/AUGUST 2016 FDLI Update magazine on CRISPR and Gene Editing.

Next generation sequencing (NGS) is playing an increasingly important role in clinical research and clinical diagnostics. This expanding utilization has largely occurred outside of the U.S. Food and Drug Administration’s (FDA’s) regulatory process. In part, this is due to the lack of clear regulatory guidance …

On March 2, 2015, investigators from the U.S. Food and Drug Administration walked into a factory at Zhejiang Hisun Pharmaceutical in China to conduct an inspection. According to the investigators, at one point a lab employee pulled a memory stick from a computer and put …

This year marks the 40th anniversary of the Medical Device Amendments. Some might think that the MDA’s ruby anniversary would be celebrated by stability, predictability, and a general easing of regulatory developments and challenges. Thanks to technological developments in digital health, laboratory testing (e.g., genetic …

For years, the government has threatened to increase the number of criminal charges it brings against executives of companies that have violated the Federal Food, Drug, and Cosmetic Act (“FDC Act”), even in the absence of intent or even knowledge of the company’s wrongdoing. The …

The Department of Justice’s (DOJ) recent criminal prosecution of Vascular Solutions, Inc. (VSI) ended in a spectacular loss for the government. The defense rested without calling even a single witness, but the jury unanimously acquitted VSI and its chief executive officer of, among other things, …

Co-authors of sections on U.S. Regulatory Requirements Edited by Duncan Bucknell Additional information available here.

In the emerging world of regenerative medicine, there is a stark dichotomy in the level of regulation applied to products derived from human cells and tissues, or what FDA calls “human cells, tissue or cellular and tissue-based products” (HCT/Ps).

In the Federal Register of August 28, 2015, the Health Resources and Services Administration (“HRSA”) of the Department of Health and Human Services (“HHS”) published an omnibus guidance document to implement the 340B Drug Discount Program (the “Proposed Guidance”). This program, which was established in 1992 pursuant to …

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The Federal Controlled Substances Act (CSA) and regulations promulgated by the Drug Enforcement Administration (DEA) provide for the adjudication of administrative actions involving entities registered to handle controlled substances. DEA annually adjudicates dozens of matters, the majority of which involve determining whether a party should be …

Thomson Reuters Book: Commercialisation of Health Care, Second Edition, October 2015 Additional information available here.

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Sasinowski, F., Panico, E. & Valentine, J., “Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs: Update, July 2010 to June 2014, Therapeutic Innovation & Regulatory Science, vol. 49(5), 680-697 (2015). The Drug Information Association journal, Therapeutic Innovation and Regulatory Science, published the findings of …

David Clissold and James Valentine* co-authored Chapter 3-1, “FDA Regulatory Scheme” and Alexander Varond authored Chapter 3-7, “Orphan Drugs” in the Food and Drug Law Institute’s guidebook Bringing Your Pharmaceutical Drug to Market. Both chapters cover essential elements of development and approval of pharmaceutical products in …

In this Legal Backgrounder published by the Washington Legal Foundation, HPM authors write a “Warning Letter” to FDA-regulated drug establishments regarding FDA’s inspection practices. This article addresses several of the unresolved questions regarding FDA’s inspection authority and aggressive inspection practices, as discussed in FDA’s …

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Additional information available here.

An interview with Frank Sasinowski was published in a Neurological Rare Disease Special Report, a Supplement to Neurology Reviews. In the interview, Mr. Sasinowski discusses how FDA has consistently exercised reasonable, appropriate, science-based flexibility in its review and approval of rare disease therapies. If you have …

The majority of new medical devices reviewed by FDA enter the market via the 510(k) process. In 2013, FDA cleared approximately 140 510(k)s for every original PMA application approved. For most medical device companies, it is critical to understand the 510(k) process, evaluate the likelihood of …