Publications

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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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 …

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On July 31, the Food and Drug Administration (FDA) notified Congress that it intended to issue two draft guidances regulating laboratory-developed tests (LDTs). While the Energy & Commerce Committee House Subcommittee on Health did hold a hearing on September 9, Congress took no steps to …

The Millennium Development Goals (MDGs) have been criticised for being created by developed countries for developing ones. For its post-2015 Sustainable Development Goals (SDGs), the UN Development Group (UNDG) undertook 88 national consultations to “widen the net of engagement” and include the views of vulnerable …

For decades, FDA has asserted that it has the authority to regulate laboratory-developed tests (LDTs). But on July 31, 2014, FDA took its biggest steps yet toward actively regulating such tests: FDA notified Congress of its intent to issue two draft guidance documents regarding oversight …

Jeff Gibbs authored and article “FDA Announces Intention to Regulate LDTs as Devices” for Genetic Engineering & Biotechnology News In 1992, the Food and Drug Administration (FDA) first stated that it had authority to regulate laboratory-developed tests. On July 31, FDA took its biggest step toward …

Anne Walsh and Jennifer Thomas co-authored Chapter 22, “, Significant Settlements”, of FDLI’s book “Top 20 Food and Drug Cases, 2013 & Cases to Watch, 2014” The chapter provides summary of the top settlements that have occurred in 2013 affecting drugs, biologics, devices, foods and dietary …

In vitro diagnostics (IVD) companies today are facing a number of challenges related to FDA regulation of their products and tests. And many of these challenges can be summed up with just one word: uncertainty. Many regulatory challenges for IVD companies relate to issues that …

Earlier this year, FDA issued the final guidance, “

FDA and LDTs – What’s Next? The Administration is claiming power over laboratory-developed tests. However, the lab industry disagrees. Jeffrey N. Gibbs Additional information available here.

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After months of Congressional consideration throughout the year, on November 27, 2013, President Obama signed into law the “Drug Quality and Security Act” (DQSA). Title I of the DQSA, titled the Compounding Quality Act, both removes the unconstitutional advertising and promotion provisions that for years plagued …

The purpose of this bibliography is to present studies from peer-reviewed and grey literature that used consultations and other participatory strategies to capture a community’s perspective of their health priorities, and of techniques used to elevate participation from the implementation phase to a more upstream …

Hyman, Phelps & McNamara, P.C. has updated the firm’s outline on the Application of the Health Care Fraud and Abuse Laws to the Marketing of Pharmaceuticals and Medical Devices. The outline, which was last updated in 2009, has been expanded to cover devices as …

This book published by Thomson Reuters, delves into how health care products, including drugs, medical devices, biologics, and dietary supplements, are regulated across 21 major jurisdictions throughout the world. Jeff Gibbs is one of the general editors. Jeff Gibbs, Jennifer D. Newberger, and Alexander J. …

This RAPS article discusses the recent trends and developments in personalized medicine, including FDA’s current thinking and new challenges facing industry. Despite the promising potential of personalized medicine, the field is still in its infancy and there is much uncertainty. The article surveys key issues …

Over the years, FDA’s regulation of in vitro diagnostics (lVDs) has raised many policy issues. Some are short-lived and quickly resolved, such as the creation of the Analyte Specific Reagent (ASR) regulation, and the subsequent guidance which curtailed the distribution of ASRs. Other policy issues …

Over the past year, the US Food and Drug Administration (FDA) has steadily acted against medical device manufacturers for off-label promotion. FDA’s enforcement against medical device manufacturers has typically taken the form of Warning Letters. Between 1 May 2012, and 30 April 2013, …

On February 22, 2013, FDA issued a draft guidance intended to help medical device manufacturers distinguish product enhancements from recalls. Unfortunately, the draft guidance created more questions than it answered. This article discusses, among other things, a new interpretation of the Part 806 …

Over the years, FDA’s regulation of IVDs has raised many policy issues. Some are short-lived and quickly resolved, such as the creation of the analyte-specific reagent (ASR) regulation, and the subsequent guidance that curtailed the distribution of ASRs. Other policy issues remain open for decades. …

The Generic Drug User Fee Amendments (GDUFA), which were enacted as part of the comprehensive U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) in July 2012, changed the practice of generic drug sponsors in a multitude of ways, most notably, the requirement of …

On May 4, 2013, Hyman, Phelps & McNamara, P.C. Director Jeffrey K. Shapiro presented a draft paper and slides on the 510(k) medical device substantial equivalence program during a conference on FDA in the 21st Century. The conference was held at the Harvard Law School’s …

On December 27, 2011, the Center for Devices and Radiological Health (CDRH) issued a draft guidance document on its appeals processes. On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) became law, and put in place processes for medical …

In a new Contemporary Legal Note published by the Washington Legal Foundation (“WLF”), Douglas Farquhar explores issues surrounding privileged material and so-called “taint teams” when government investigators seize company materials that may be used to build a criminal case. Additional information available here.

On February 8, 2013, CMS published its final regulation implementing the physician payment transparency provisions of the Patient Protection and Affordable Care Act. Hyman, Phelps & McNamara has prepared a memorandum summarizing the final rule.

The increase in prescription drug abuse in the United States is the result of multiple factors (e.g.,rogue Internet pharmacies, pain clinics, and doctor shopping) often requiring law enforcement and the regulated industry to play catch-up to address the ever-changing sources of diversion. However, the bulk …

On July 9, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA). FDASIA significantly affects both pharmaceutical and device manufacturers. It has a direct impact on all in vitro diagnostic (IVD) manufacturers, and for IVD companies developing companion diagnostics, …

Device companies do not lack advice or resources to help meet Food and Drug Administration (FDA) requirements. FDLI’s extensive publications present a wealth of information, and this is only one source of many. Sometimes, what companies need most is advice on how to take this …

The U.S. Pharmacopeial Convention (“USP”) recently announced at an Awards and Recognition Program for USP Expert Volunteers that the 2012 USP Award for an Innovative Response to Public Health Challenges went to the Food Ingredients Expert Committee. Hyman, Phelps & McNamara, P.C. Director Diane …

In this article, published in the July 2012 issue of Scrip Regulatory Affairs, Jeff Shapiro explains why medical device companies whould benefit from regular and detailed Food and Drug Administration 510(k) decision summaries.

This presentation features HPM attorneys Doug Farquhar, John Fleder, and Anne Walsh, who bring the full perspective of experience in government enforcement, including a former Assistant U.S. Attorney, the former Director of DOJ’s Office of Consumer Litigation, and a former Associate Chief Counsel at FDA. …