Publications

Bringing Your Pharmaceutical Drug to MarketApril 1st, 2015
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 …
A Warning Letter on FDA’s Expansive Interpretation of Its Facilities – Inspection AuthorityMarch 13th, 2015
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 …
Prior Restraint and the Union Political Spech Opt-Out RequirementsMarch 1st, 2015
Additional information available here.
Drug Diversion Administrative Revocation and Application Hearings for Medical and Pharmacy PractitionersFebruary 28th, 2015
Additional information available here.
Exploring the FDA’s Flexibility With Novel Orphan Therapies, Neurological Rare Disease Special Report, Supplement to Neurology ReviewsFebruary 1st, 2015
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 …
Book Chapter, Co-Author, “Ch. 25: DEA Regulation of Controlled Substances, ” Food and Drug Law and Regulation (FDLI)January 1st, 2015
The Regulatory Landscape for Hospice and Home Health Providers Continues to ChangeJanuary 1st, 2015
510(k) Statistical PatternsDecember 2nd, 2014
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 …
Unearthing Mansfield’s Rule: Analysing the Appropriateness of Federal Rule of Evidence 606(B) in Light of the Common Law TradtitionDecember 1st, 2014
Additional information available here.
GEN LDT Article-New LDT Guidance Documents Face ScrutinyNovember 7th, 2014
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 …
Representativeness of the UN post-2015 National ConsultationsNovember 1st, 2014
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 …
FDA’s Move to Regulate LDTs Could Reshape the IndustrySeptember 19th, 2014
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 …
Substantial Equivalence Premarket Review: the Right Approach for Most Medical DevicesSeptember 12th, 2014
FDA Announces Intention to Regulate LDTs as DevicesAugust 7th, 2014
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 …
Significant Settlements, Top 20 Food and Drug Cases, 2013 & Cases to Watch, 2014May 30th, 2014
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 …
4 Regulatory Challenges Facing IVD Companies TodayMay 12th, 2014
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 …
How to Effectively Use FDA’s Presubmission ProcessMay 12th, 2014
Earlier this year, FDA issued the final guidance, “
Hospitals’ Heavy Lifting: Understanding OSHA’s New Hospital Worker and Patient Safety GuidanceMay 1st, 2014
FDA and LDTsApril 9th, 2014
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.
Complete or Partial Accommodation: An Analysis of the Federal Circuit Split Over the Duty of the Employer to Reasonably Accommodate the ReligiousApril 1st, 2014
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Article, The Need for Clarity: Where Should FDA Focus Its Resources When Implementing the Compounding Provisions of the Drug Quality and Security Act?February 4th, 2014
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 …
Annotated bibliography on participatory consultations to help aid the inclusion of marginalized perspectives in setting policy agendasJanuary 17th, 2014
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 …
Application of Health Care Fraud and Abuse Laws to the Marketing of Pharmaceuticals and Medical DevicesJanuary 5th, 2014
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 …
Thomson Reuters Book: Commercialisation of Health CareNovember 4th, 2013
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. …
Trends in Personalized MedicineOctober 31st, 2013
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 …
The Long and Winding Road to FDA Regulation of LDTsOctober 1st, 2013
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 …
What Can You Say?: Uncovering Trends in Recent Medical Device Enforcement ActionsSeptember 2nd, 2013
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, …
Draft Guidance on Medical Device Recalls: Improvements Are NeededAugust 1st, 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 …
How, and When, Will FDA Regulate LDTs?July 15th, 2013
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. …
Cell cycle activation contributes to increased neuronal activity in the posterior thalamic nucleus and associated chronic hyperesthesia after rat spinal cord contusionJuly 10th, 2013
Dissecting The Rules Of Generic Drug User Fee AmendmentsMay 9th, 2013
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 …
New Paper Argues 510(k) Program Has Strengths That Critics Have OverlookedApril 22nd, 2013
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 …
The US FDA and its Draft Guidance on Medical Device AppealsApril 4th, 2013
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 …
Federal Taint Teams And Attorney-Client Privilege In Corporate Criminal InvestigationsFebruary 27th, 2013
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.
Summary of CMS Final Rule on Transparency ReportingFebruary 12th, 2013
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.
Should DEA Provide Guidance & Conduct Rulemaking on Suspicious Orders to Ensure Balanced Approach to Reduce Abuse & Ensure Avail. of Needed Medicine?January 1st, 2013
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 …
FDASIA’s Impact on Novel IVDsOctober 1st, 2012
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, …
Ten Short Tips For The Medical Device IndustrySeptember 30th, 2012
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 …
USP Recognizes Work of Food Ingredients Expert CommitteeSeptember 20th, 2012
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 …
US FDA should be required to provide 510(k) decision summaries for devices – a missed opportunity by lawmakersJuly 2nd, 2012
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.
Garbage Runs, Fake Identities, and Surprise Home Visits – Strategies to Deal With FDA’s Nontraditional Investigative ToolsJune 20th, 2012
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. …
A Year in Review: CDRH Draft Guidance Documents of 2011May 15th, 2012
In recent years, both industry and consumer groups have grown frustrated with the 510(k) notification process, the most common premarket review process for medical devices. In 2009, in response to these concerns, the Center for Devices and Radiological Health (CDRH) began an internal review of …
CMS proposed ACA rule – 2-4-2012April 2nd, 2012
Foreign Territory: Dietary Supplement Clinical Trials Conducted AbroadApril 1st, 2012
Nutritional Outlook – The manufacturer’s resource for dietary supplements & healthy foods and beverages. Additional information available here.
FDA Appeals – Improving Your Odds of Success: Trends, Expectations, StrategiesMarch 21st, 2012
Pharmaceutical and medical device applicants faced with an adverse decision from FDA (e.g., regarding data requirements, study design, or regulatory pathway) may dispute that decision through multiple routes. The appeal processes in both CDER and CDRH offer numerous strategic and procedural advantages that, when used …
Quantum of Effectiveness Evidence in FDA’s Approval of Orphan DrugsMarch 16th, 2012
One of the key underlying issues facing the development of all drugs, and particularly orphan drugs, is what kind of evidence the Food and Drug Administration (FDA) requires for approval. The Federal Food, Drug, and Cosmetic [FD&C] Act provides that for FDA to grant approval …
Putting Together the Pieces: Recent Proposals to Fill in the Genetic Testing Regulatory PuzzleMarch 1st, 2012
Proper Reform Is Needed of the Appeals Process at the US Food and Drug Administration’s Device CenterJanuary 10th, 2012
On December 27, 2011, the Center for Devices and Radiological Health (CDRH) issued a draft guidance document on its appeals processes. While the guidance document is helpful in explaining the appeals processes, it does not go far enough. Even if the draft guidance is finalized, …
CMS Proposed Rule on Reporting of Payments or Transfers of Value and Physician Ownership or Investment InterestsDecember 22nd, 2011
In the December 19, 2011 Federal Register, CMS published a long-awaited proposed regulation to implement the transparency report requirements of the Patient Protection and Affordable Care Act. Hyman, Phelps & McNamara, P.C. has prepared a summary of the proposed rule. The CMS proposal is unusual …
Article, Court Ruling Casts Doubt On FDA’s Use Of Guidance DocumentsDecember 16th, 2011
In a new Legal Backgrounder published by the Washington Legal Foundation, Jeffrey N. Gibbs and Karla L. Palmer write that a recent Florida federal district court ruling in United States v. Franck’s Lab, Inc., if upheld on appeal, will have implications that extend broadly to …