Publications

When does a single positive adequate and well-controlled study of a new drug meet the statutory requirement to demonstrate substantial  evidence of effectiveness? The answer to this question, particularly with respect to new molecular entities, has been of considerable debate since 1962 when the requirement that new …

On September 13, 2019 FDA issued a final guidance document The Special 510(k) Program (“Guidance”). This Guidance, along with The Abbreviated 510(k) Program, supersedes the 1998 guidance document The New 510(k) Paradigm — Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.

In this white paper, experts from the Digital Pathology Association (DPA) define terminology and concepts in the emerging field of computational pathology, with a focus on its application to histology images analyzed together with their associated patient data to extract information. This review offers a historical perspective …

Interest in and use of telemedicine services appears to be dramatically increasing. According to researchers, telehealth visits by members of one private US health plan rose by 52% annually from 2005 to 2014, and soared by 261% from 2015 to 2017. As more people seek to use telemedicine …

FDA advisory panels meetings to review pre-market applications (PMAs) are high-stakes events. While FDA is not bound by the vote of the advisory panel, it has been long-accepted that the agency typically follows the recommendation of the panel. Which got us thinking: are conventional wisdom and …

This article illustrates how a company’s problems can escalate rapidly from an administrative warning letter to the full weight of the criminal system. The unfortunate subject is ACell, a manufacturer of medical devices derived from porcine urinary bladder material.

FDA recently announced new changes it is making to the Medical Device Reporting (MDR) program as part of its ongoing efforts to increase transparency on device performance, and detection of device-related safety concerns.

Under the Federal Food, Drug, and Cosmetic Act, devices fall into three classes. The premarket approval (PMA) is the route to market for Class III devices, the highest risk medical devices. A Class III device is a device that cannot be classified as a Class I or II device …

Mark Schwartz is quoted in this article

An Implanted Brain Computer Interface (BCI) device may sound like something out of science fiction, but FDA apparently believes these devices are on their way to becoming a reality. FDA recently released a draft guidance document that provides recommendations on how to gain approval to …

On January 10, 2018, the Department of Justice (“DOJ”) issued a memo to all attorneys in the Commercial Litigation Branch, Fraud Section, and all Assistant U.S. Attorneys handling False Claims Act (“FCA”) cases, directing those attorneys to seek dismissal of FCA qui tam actions under certain circumstances.  When the so-called “Granston …

Hyman, Phelps & McNamara, P.C. is pleased to present the inaugural issue of its FDA Law Alert, a quarterly newsletter intended to highlight posts from our popular FDA Law Blog.  Please do not hesitate to call any of the authors identified below to discuss these …

The pending decision on the constitutionality of the Bipartisan Campaign Finance Reform Act (BCRA) prompts the question of whether the Supreme Court should allow BCRA’s increases in hard-money spending limits to stand if BCRA’s ban on soft-money is declared unconstitutional-that is, whether the Court should “sever” the soft-money ban …

Mark Schwartz is quoted in this article

Mark Schwartz is quoted in the attached article.

On 19 July 2018, the U.S. Food and Drug Administration (‘FDA’) announced their latest guidance, Use of Electronic Health Record Data in Clinical Investigations (‘EHR Guidance’). Providing recommendations for clinical trial sponsors on the permissible use of electronic health records (‘EHRs’) in FDA-regulated clinical investigations, a major challenge …

This article discusses a Congressional draft proposal, The Verifying Accurate Leading-Edge IVCT Development (VALID) Act of 2018, aimed at making regulatory changes for Laboratory Developed Tests (LDTs). The authors identify a number of important points about the draft and offer analysis and commentary on proposed changes to classification and …

The traditional model of evaluating treatments based primarily on primary outcome measures has stumbled in its application to rare disease. Rare disease clinical trials face the methodological challenges of small, heterogeneous patient populations and relatively few validated, disease-specific outcome measures. Incorporating qualitative research into rare …

This article describes the evolution of Risk Evaluation and Mitigation Strategy (REMS) from a safety program to an enforcement tool. The potential pitfalls related to promotional activities are exacerbated by the statutory tools and public health implications associated with REMS. Companies should take heed of two cases that …

On October 18, FDA issued a new draft guidance document, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (“Draft Guidance”). When final,it will supersede the 2014 guidance document of the same name (“Current Guidance”). The Draft Guidance expands significantly the recommendations for …

The 21st Century Cures Act (Cures Act), signed into law in December 2016, was designed to reduce regulatory obstacles for FDA approval of innovative medical therapies and accelerate the process of bringing innovative products to patients in need. Included in the Cures Act was a …

This article summarizes the regulatory history of Laboratory Developed Tests (LDTs) and describes where we are now and where we may be heading.

With one paragraph in a Summary Judgment Order issued July 24, the Northern District of California further expanded the patent safe harbor under 37 U.S.C. § 271(e)(1). Though not a huge leap from previous safe harbor decisions, the Order in Nevro Corp. v. Boston Scientific Corp. held …

This article provides a statistical analysis of Premarket Approval Application (PMA) data illustrating some new and interesting insights into the advisory panel process.

On April 27, 2018 FDA released a draft guidance describing the regulatory approach and policy for multiple function device products. The draft guidance, Multiple Function Device Products: Policy and Considerations, has been issued in response to the 21st Century Cures Act Sec. 3060(a) “Clarifying Medical …

Pharma experts warn the proposed tariffs on Chinese imports could spike prices or cause supply disruptions, but some trade observers argue the immediate effects would be minimal. Mark Schwartz is quoted in this article  

In January, FDA announced the release of its 2018 “Compounding Priorities Plan.”1 FDA also released several guidance documents in the wake of its announcement, such as its final guidance on essentially copies of commercially available drug products for Section 503A and 503B facilities, and guidance …

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 …