Publications

AbstractDuchenne muscular dystrophy (DMD) is a serious, rare genetic disease, affecting primarily boys. It is caused by mutations in the DMD gene and is characterized by progressive muscle degeneration that results in loss of function and early death due to respiratory and/or cardiac failure. Although …

After 5 long years, FDA has finally adopted the long-awaitedOTC hearing aid rules. While the Proposed Rule was a year anda half overdue, FDA impressively turned out the Final Rule about7 months after the close of comments on the Proposed Rule, whichis only one month …

Abstract:There are approximately 8,000 recognized rare diseases affecting close to 30 million people in the United States. Sponsors choosing to engage in research and development of drugs for rare diseases, known as orphan drugs, face challenges and opportunities that are unique to orphan drug development. …

The U.S. Food and Drug Administration (FDA) had only exercised its authority to ban medical devices twice by the time it finalized its ban on electrical stimulation devices (ESDs) for patients with self-injurious behavior (SIB) and aggressive behavior (AB). Jeff Gibbs, Faraz Siddiqui and Veronique …

The Food and Drug Administration (FDA) has been privately lobbying Congress to overturn recent judicial decisions that curb the agency’s discretion. While Congress can override federal court decisions, use of that authority to concentrate further power in a single executive-branch agency—and doing so without notice …

On November 15, 2021, the U.S. Department of Health and Human Services (“HHS”) and the Food and DrugAdministration (“FDA”) issued several policy changes governing the regulation of Laboratory Developed Tests(“LDTs”). These changes resume FDA premarket review of COVID-19 LDTs that HHS halted in August 2020 …

Addressing the COVID-19 pandemic has created many challenges for the Food andDrug Administration (FDA). One of the largest challenges in coping with COVID-19has stemmed from the ongoing need for access to accurate diagnostic tests for thevirus. FDA has well-established programs for reviewing in vitro diagnostic …

James Valentine, co-authored this chapter in the book, “Rare Disease Drug Development: Clinical, Scientific, Patient, and Caregiver Perspectives by Raymond Huml (Editor)

Mark is quoted extensively in this article

This study describes the person-centered experience and impact of symptoms and thetreatment needs of dementia-related psychosis (DRP) from a patient and care partner perspective.

Citing agency experience and expertise, courts have long afforded federal agencies discretion in administering their respective statutes.  But, in Genus Med. Techs., LLC v. United States FDA, 2021 U.S. App. LEXIS 10928, 994 F.3d 631 (D.C. Cir. 2021), the U.S. Court of Appeals for the District …

Every year, the Food and Drug Law Institute (FDLI) publishes a compendium of the Top Food and Drug Cases from the previous year, as well as Cases to Watch, in conjunction with its popular Annual Conference.

Every year, the Food and Drug Law Institute (FDLI) publishes a compendium of the Top Food and Drug Cases from the previous year, as well as Cases to Watch, in conjunction with its popular Annual Conference.  In this year’s publication, Sara Koblitz explains an …

Mark Schwartz is quoted in this article

Mark is quoted in this article

More information about book can be found here

The FDA under President Joe Biden has the opportunity to improve the availability of Covid-19 testing. Hyman, Phelps & McNamara P.C. attorneys say the FDA can start by eliminating needless hurdles in the regulatory approval process, providing greater clarity, and applying criteria consistently.

FDA is relying on other global inspection reports and remote document review, yet does not consider them equivalent to on-site inspections. Manufacturers await more clarity. Mark Schwartz is quoted in this article.

Nearly a year into the pandemic, the Food and Drug Administration, unlike its foreign counterparts, has yet to advance alternatives to on-site facility inspections. Mark I. Schwartz, a director at Hyman, Phelps & McNamara P.C. and former deputy director for the FDA’s Office of Compliance and Biologics Quality, says …

For more than twenty years, the U.S. Food and Drug Administration’s (“FDA’s” or “the Agency’s”) position has been that it could regulate a product as either a drug or a medical device as long as the product meets both statutory definitions. The implications of this approach, however, lead …

As the FDA considers regulations for OTC hearing aids, one of the thorniest issues it faces is federal preemption of all the various state laws that help protect consumers – many of which focus on the dispensing professional and not on the actual hearing device.

On Aug. 19, the U.S. Department of Health and Human Services published a brief announcement on its website that the U.S. Food and Drug Administration, an agency within HHS, will not require premarket review of laboratory-developed tests, absent notice-and-comment rulemaking. The announcement — published without fanfare on a …

On March 27, President Donald Trump signed into law the Coronavirus Aid, Relief and Economic Security Act, also known as Phase 3 of the coronavirus stimulus legislation. Title III, Subtitle F of the CARES Act, a provision unrelated to the current coronavirus pandemic, is an …

The First International Conference in Systems and Network Medicine gathered together 200 global thought leaders, scientists, clinicians, academicians, industry and government experts, medical and graduate students, postdoctoral scholars and policymakers. Held at Georgetown University Conference Center in Washington D.C. on September 11–13, 2019, the event …

The Q&A gives a high level overview of distribution and marketing of drugs law, including pre-conditions for distribution; licensing; wholesale distribution; marketing to consumers; marketing to professionals and engagement with patient organisations. To compare answers across multiple jurisdictions, visit the Distribution and Marketing of Drugs Country Q&A …

Mark Schwartz is quoted in this article

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 …