Publications

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, …
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
Draft Guidance on Medical Device Recalls: Improvements are NeededJuly 1st, 2013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The US FDA and its Draft Guidance on Medical Device AppealsApril 4th, 2013
On December 27, 2011, the Center for Devices and Radiological Health (CDRH) issued a draft guidance document on its appeals processes.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 …
Keeping Up with Events: The US FDA and it’s Draft Guidance on Medical Device AppealsApril 1st, 2013
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 …
FDASIA: New Opportunities, New Complexities for Pharma and MedtechSeptember 1st, 2012
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 …
HP&M Files Comments on Draft NDI Guidance; Request Withdrawal and Reissuance Reflecting DSHEA IntentDecember 2nd, 2011
On December 2, 2011, Hyman, Phelps, & McNamara filed comments (here and here) to the controversial draft guidance on New Dietary Ingredient (“NDI”) notifications that FDA issued in July 2011. The current draft guidance ignores the balance struck by the Dietary Supplement Health and Education Act …
Death, Taxes and DEA Inspections: Dealing with the InevitableDecember 1st, 2011
In his recent article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Of Counsel, and former diversion investigator for the Drug Enforcement Administration (“DEA”), Larry K. Houck, explains the scope of DEA pre-registration and cyclic inspections as a step-by-step guide to actions and procedures …
Knocking On Your Front Door: Government Visits To Employees’ HomesAugust 19th, 2011
Many federal prosecutors and investigators believe that private counsel hinder the government’s ability to gather evidence in civil and criminal matters. To circumvent the involvement of company counsel in such investigations, government officials have increasingly turned to catching potential witnesses and defendants off-guard. Investigators frequently …
FDA’s Pursuit of Punishing PeopleAugust 1st, 2011
This FDLI Update article discusses the recent and highly publicized directed verdict for Lauren Stevens, the former in-house lawyer at GlaxoSmithKline, who was on trial for charges that she, basically, lied to the federal government in response to a subpoena demanding documents. United States District …
New Guidance from US FDA May Mean Just One Thing for Medical Device Manufacturers –
More 510(k)sAugust 1st, 2011
At first glance, the draft guidance that the US Food and Drug Administration has issued on when to submit a new 510(k) pre-market notification for a change to an existing device does not appear to be too different from its 1997 predecessor. Both the …
Draft Guidance for RUO Products IssuedAugust 1st, 2011
For decades, products labeled for research use only (RUO) have been widely sold and used in the United States, playing a pivotal role in the development of new diagnostic tests. During this period, neither the definition of this class of products nor the marketing restrictions …
Regulating Molecular Diagnostic Assays: Developing a New Regulatory Structure for a New TechnologyMay 15th, 2011
Molecular diagnostics are playing an increasingly important part in the practice of medicine. However, molecular diagnostics have not yet made the clinical impact that many had predicted. Multiple factors affect the uptake and utilization of molecular diagnostics, including government regulation. Current regulatory …
Personalized Medicine: Improving the Regulatory PathwayMay 1st, 2011
Personalized medicine has provided both great hope and great hype. Even partial realization of the potential of personalized medicine could significantly change medicine by enabling the right patients to get the right medicine at the right time in the right dose. Yet while new diagnostic …
Just What the Doctor Ordered? Legal Implications of Scheduling and Prescription-Only Approach to Methamphetamine Precursor RegulationMay 1st, 2011
This FDLI Update article examines the increasing legislative efforts by states to require prescriptions for products containing methamphetamine precursors (such as pseudoephedrine and ephedrine), and to list them as Controlled Substances. It suggests that such laws would tend to encroach upon the practice of …
Guidance for Industry Helps FDA (Mostly) Win First Amendment Case on Health ClaimsMay 1st, 2011
After more than 15 years of related cases in the larger matter of The First Amendment v. Dietary Supplement Health Claims, FDA mostly won one. And its winning card? Knowing that the courts will not, and cannot, independently assess whether the scientific evidence provided to …
Uncertainty Persists with RUO Products – FDA May Be Considering More Restrictive Approach with Research Use Only AssaysApril 1st, 2011
Research use only (RUO) products are ubiquitous in the life science industry. They are widely sold, prominently displayed at major conferences and routinely used by laboratories. Yet, as common as RUOs are, their regulatory status is not well understood or defined. That is not surprising because …
D.I.Y. Enforcement: Relators, the False Claims Act and the FDCAFebruary 1st, 2011
It is an oft-cited feature of the food and drug enforcement landscape that the Federal Food, Drug and Cosmetic Act (FDCA) does not authorize a private cause of action. Increasingly, however, we see suits brought by private citizens under the Federal False Claims Act(FCA) to …
What Happens to Medical Device Reports Once They Reach FDA?January 3rd, 2011
Ever wonder what happens to the thousands of medical device reports that are filed every month with FDA? Are they being put to good use? In October 2009, the HHS Office of Inspector General(OIG) issued a report titled, “Adverse Event Reporting for Medical Devices. This report …
Can We Say That? A Practical Guide to Substantiating Claims for Food and Consumer Health ProductsJanuary 1st, 2011
Food and Drug Law Institute Monograph, Vol. 2., No. 3 Additional information available here.
Must FDA Treat Similarly-Situated Competitors the Same Way?December 28th, 2010
It is obviously unlawful to discriminate because of race, religion and numerous other criteria. However, one factor generally thought not to be in the “prohibited factors” category is the location of a place of business. Should one business be held to a high degree of scrutiny …
On FDA And Food Ingredient Safety: Is The “Gras” Henhouse At Risk?December 3rd, 2010
For over 50 years, U.S. food manufacturers and consumers have benefited from a provision of law that enables manufacturers to market a food ingredient without prior government approval – provided that the use of the ingredient is “generally recognized as safe” (GRAS). The right of …
The Cost of Inadequate SubstantiationNovember 5th, 2010
Although FDA appears reluctant to take an aggressive stance with respect to substantiation of health-related claims for foods, FTC has forged ahead with a number of investigations of allegedly false or misleading advertising that have resulted in restrictive settlements – and the plaintiffs’ bar has …
The Evolution and Resurgence of Strict Liability Criminal Prosecutions Under the Park DoctrineOctober 8th, 2010
In criminal prosecutions of corporate executives, ignorance of the law and the facts is often no defense. FDA’s application of the Park Doctrine has taken different forms in the decades since its inception. In the 1960’s through 1980’s, FDA frequently prosecuted company officials without any …
Publish and Perish: A Disturbing Trend in the European Union’s Regulation of Nutrition Health Claims Made on FoodsOctober 1st, 2010
Recent developments in the European Union’s regulation on health claims used in food labeling could have the effect of suppressing publication of scientific research on the health benefits of food substances. Given that scientific research and collaboration is an international phenomenon, the negative effect …
New Use of Old Tools: Career-Ending OIG Exclusion and FDA DebarmentOctober 1st, 2010
In a January 2010 report on off-label promotion and Medicare fraud, television reporter Dan Rather asked Lewis Morris, the Chief Counsel of the Department of Health and Human Service’s Office of Inspector General (OIG): “The executives of these big pharmaceutical companies are never putting on …
Regulating Laboratory-Developed TestsSeptember 15th, 2010
The U.S. diagnostic market has long been divided into two major regulatory branches. In vitro diagnostic (IVD) kits that are sold by manufacturers to laboratories are regulated by the FDA. Tests developed by a laboratory and offered as a diagnostic service by that laboratory are …
Using Social Media in FDA-Regulated Industries: The Essential GuideSeptember 13th, 2010
Jeff Wasserstein has written a chapter in this book. The Regulation of Social Media: Whither FDA? This chapter provides a foundational understanding of FDA’s regulation of social media and Web 2.0 and offers a practical approach to marketing in this environment. The first section briefly introduces …
15th Anniversary Essay: Regulation Then and NowAugust 30th, 2010
In the fifteen years since the founding of IVD Technology, the IVD industry-and its regulation by FDAhave both changed. The diagnostic capabilities of IVDs have improved dramatically during that period. Some of the advances, such as high-speed, lower-cost genomic sequencing, seemed like the stuff of …