Hyman Phelps and McNamara
Search Firm Publications
  50 Ways to Leave Your Lover and 56 Ways to Go to Jail,  October 17, 2017
  Judicial Efficiency: DEA’s Expanding Use of Summary Dispositions to Narrow the Opportunity for an Administrative Hearing,  October 15, 2017
  Fifth Circuit Upholds Summary Judgment for Solvay Pharmaceuticals in Off-Label and Anti-Kickback FCA Case,  September 20, 2017
  CDRH Issues Final Guidances Regarding Use of Real-World Evidence and Procedures for Advisory Committee Meetings,  September 13, 2017
  REMS Program Violations Result in Disgorgement and False Claims Act Liability,  September 6, 2017
  Medical Device “Fraud on the FDA” Theory Might Be Viable in Minnesota, if Properly Pled,  September 6, 2017
  OIG Issues an Advisory Opinion on Providing Replacement Product,  August 28, 2017
  Another Brick in the Wall: A New Commitment Implementing the Mutual Recognition of Inspections,  August 24, 2017
  FDA Action Against Outsourcing Facility, the Sequel,  August 14, 2017
  First Circuit Holds that Identifying One Fraudulent Medicaid claim, with Projections, is Sufficient to Survive Motion to Dismiss in FCA Case,  August 3, 2017
  Celgene Pays $280m in False Claims Act Case in Which U.S. Did Not Intervene,  August 1, 2017
  United States v. Medistat RX LLC Consent Decree: FDA’s Latest Enforcement Effort Related to Compounders and Title I of the Compounding Quality Act,  July 24, 2017
  DEA Announces “Groundbreaking” Guidance that is Inconsistent with the Settlement they are Announcing – Time at Last for Rulemaking?,  July 20, 2017
  Ninth Circuit Revives False Claims Act Case Applying Escobar Materiality Standard,  July 17, 2017
  A Call to Duty: DEA Practitioner Registrants Beware—DEA Wants You!,  July 10, 2017
  FDA: Protecting the Integrity of Horse Racing Since 1906,  June 19, 2017
  Supreme Court Ruling on SEC Statute of Limitations May Affect Other Agencies’ Pursuit of Disgorgement,  June 15, 2017
  DEA Administrative Decisions Update: Has DEA Established New Grounds for Summary Disposition?,  May 24, 2017
  DEA Administrative Decisions Update: What’s Prescribed in Vegas . . . Has Got to Stay in Vegas,  May 15, 2017
  Texas Department of Criminal Justice Challenges FDA Thiopental Sodium Import Prohibition,  May 1, 2017
  New Legislation Seeks Limits on Opioid Prescriptions for Acute Pain, But Will it Reduce Opioid Abuse?,  April 20, 2017
  So . . . About That Guilty Plea: The Government Responds to the Decosters’ Petition for Cert,  April 19, 2017
  Another False Claims Act Case Dismissed in the Post-Escobar Landscape,  April 12, 2017
  Jury Rules on Charges against Owner and Head Pharmacist of NECC,  April 4, 2017
  “Eggshell Plaintiffs” Meet Administrative Deference: Ninth Circuit Affirms Dismissal of Proposed Chicken Shed Rule,  March 6, 2017
  Maybe It Was Worth a Try . . . . Kentucky Defendant, Charged with Illegally Selling “Herbal Supplements,” Loses Motion to Dismiss,  March 1, 2017
  Drug Debarment Actions: Beware,  February 26, 2017
  Hemp Industries Association Seeks Contempt against DEA; Alleges Violation of 2004 Hemp Order,  February 23,2017
  DEA Administrative Decisions Update: (Un)official Notice Revisited,  February 22, 2017
  DEA Administrative Hearings Update: Rethinking DEA’s Summary Disposition Power in “Loss of State Authority” Cases,  February 15, 2017
  Rare Basis for False Claims Act Settlement,  February 12, 2017
  The FTC Takes Action for Alleged Anticompetitive Citizen Petitioning Activities Surrounding Generic VANCOCIN,  February 7, 2017
  Update on the DeCosters’ Case: Here Comes the U.S. Supreme Court (Maybe),  January 22, 2017
  OPDP Doubles Enforcement Letters, But is Carefully Picking Its Battles,  January 19, 2017
  First Circuit Rejects Fraud-on-FDA Allegations Under False Claims Act,  January 16, 2017
  DEA Finalizes Amendments on Imports and Exports, But Misses Opportunity to Improve Re-Export Requirements,  January 8, 2017
  Not Dead Yet – OPDP Issues Two Untitled Letters Late in the Year (Our 3,000th Post!),  December 18, 2016
  FDA’s Draft Quality Metrics Guidance, Version 2.0,  December 5, 2016
  There’s a New Reporting Tool in Town,  November 3, 2016
  DEA Withdraws Notice of Intent to Place Opioids Mitragynine and 7-Hydroxymitragynine, in CSA’s Schedule I,  October 16, 2016
  Update on the DeCoster Criminal Case,  October 7, 2016
  Say Cheese! FDA Issues Warning Letter Based Solely on Company’s “Refusal”,  October 6, 2016
  Court Rules that FDA's FOIA Expedited Processing Procedures Are Legal but Requires FDA to Immediately Produce Certain Records,  October 2, 2016
  The DeCosters Battle On,  September 20, 2016
  FDA Rolls Out a New Form—You May Want to Pay Attention to This One,  September 15, 2016j
  How Many Federal Agencies Does it Take to Interpret the Industrial Hemp Law? USDA/DEA/FDA Weigh in on Industrial Hemp Research Requirements,  September 8, 2016
  Still Not Ready for Prime Time: DEA Denies Joint Petitions to Reschedule Marijuana,  August 24, 2016
  Assessing the FDA's Safety Drive  August 1, 2016
  Striking the Right Balance – Comprehensive Addiction and Recovery Act of 2016,  July 26, 2016
  FDA Releases “Notice” Advising of Change in Inspections of Pharmacies Compounding Drug Products within FDCA Section503A: Let’s Watch What Happens Next,  July 20, 2016
  Federal Circuit Says BPCIA’s 180-Day Post-Licensure Notice Is Mandatory and Enforceable by Preliminary Injunction,  July 7, 2016
  The Biggest Park Doctrine Ruling in Over 40 Years?,  July 6, 2016
  PTO Prevails in Challenge to Drug Eluting Stent PTE Denial, and Encounters Some Interesting Characters Along the Way . . . Including a Unicorn!,  June 27, 2016
  A New and Improved (Updated) List of Pending DESI Program Proceedings,  June 21,2016
  Health Science Funding Case – A Lesson in How Not to Address Marketing Uncertainty Surrounding Medical Foods,  June 12, 2016
  International Pharmaceutical Supply Chain Imperiled Like Never Before: A Webinar Presented by Dechert LLP and Hyman, Phelps & McNamara PC ,  June 2, 2016
  Yates' Update on Yates Memo,  May 16, 2016
  Does FDA’s Per Se Prohibition Against Off-Label Promotion Have a Future?,  April 26, 2016
  Another Data Integrity Warning Letter for an Indian Facility, This One with Explicit FDA Requests for Corrective Actions,  April 24, 2016
  FDA’s Permanent Injunction Authority: Is There a Crack in FDA’s Resolve to Shut Down a Facility’s Operations?,  April 6, 2016
  QSR/cGMP Compliance the Failure to Document and A Few Good Men,  March 21, 2016
  Research Institution Pays $3.9 million HIPAA Settlement for Breach,  March 20, 2016
  Attorney General Lynch Delivers a Public Service Announcement About DOJ’s Enforcement Actions for Unsafe Dietary Supplements,  March 10, 2016
  Amarin Announces a Proposed Settlement of its First Amendment Lawsuit Against FDA: Coming Full Circle in a New Era of the Regulation of Off-label Prom,  March 8, 2016
  International Pharmaceutical Supply Chain Imperiled Like Never Before,  February 29, 2016
  Another Court Weighs In on Whether Off-Label Promotion is Per Se Illegal; Jury Finds Both Defendants Not Guilty on All Counts,  February 26, 2016
  The Perennial Perils of Aseptic Manufacturing,  February 22, 2016
  The Perils of Being a Store Clerk in an FDA-Regulated World,  January 28, 2016
  DOJ Makes History: On a Single Day It Files a Criminal Prosecution, a Consent Decree and a Criminal Forfeiture of Foods Involved in the Same Incident,  January 26, 2016
  FDA Broadens Arsenal in Fight Against Kratom,  January 6, 2016
  WARNING: GMP Problems No Excuse for Caraco’s Lack of WARN Act Layoff Notifications,  January 4, 2016
  The Government Really Means It This Time (Part II),  November 22, 2015
  Cannabis(ness), Patient, or Recreational User be Assured They Will Not be Subject to DOJ Enforcement for Activities in States that have Legalized Mari,  November 11, 2015
  Is This the New Beginning of Individual Prosecutions? Probably Not,  November 11, 2015
  Warner-Chilcott Resolution Includes Indictment of President,  November 11, 2015
  FDA Spotlights Products “Fraudulently Marketed for Serious Diseases”,  November 5, 2015
  A Matter of Substantial Discretion: A Recent Rift between DEA and Its ALJs Could Significantly Impact Registrants  November/December 2015
  Do You Really Want to Be An Executive In An FDA-Regulated Company?,  October 26, 2015
  Sovereign Immunity in Texas for Warning Letters Sent by the Attorney General? The U.S. Court of Appeals for the 5th Circuit says, “Not so fast cowboy”,  October 13, 2015
  Bayer Scores a Big Win in Action Involving Dietary Supplement Claim Substantiation,  October 1, 2015
  Be Careful What You Wish For: Specialized FDA Inspectors Don’t Necessarily Mean Happier Inspections,  September 29, 2015
  The Government Really Means It This Time,  September 21, 2015
  Senate Bill Would Protect Banks Serving Marijuana Businesses,  July 30, 2015
  Must FDA-Regulated Companies “Allow” FDA To Conduct Warrantless Inspections?,  June 30, 2015
  Intra-Department Grudge Match – FDA vs. NIH?,  June 18, 2015
  The Government Taketh and then Giveth Back,  June 16, 2015
  Congress is Taking FDA to Task on its Use and Posting of Untitled Letters,  June 1, 2015
  Supreme Court Rejects Plaintiff’s Timeliness Argument in False Claims Acts Case,  May 28, 2015
  Strike Two: GAO Releases Statement About DEA’s Administration of the Quota Process and Lack of Coordination with FDA in Setting Quotas for Schedule II,  May 7, 2015
  Quality Egg and Jail Time for a Park Doctrine Prosecution,  May 5, 2015
  Quality Egg and Jail Time for a Park Doctrine Prosecution  May 6, 2015
  HP&M-Authored WLF Legal Backgrounder Provides “Warning Letter” to Industry Regarding FDA’s Inspection Practices,  March 16, 2015
  A Warning Letter on FDA's Expansive Interpretation of Its Facilities - Inspection Authority  March 13, 2015
  A Bitter Pill for DEA: GAO Releases its Report on Drug Shortages and DEA’s Management of the Quota System,  March 9, 2015
  FTC Settlement Silences Advertisers of Supplements Advertised as Effective for Children’s Speech Disorders; Settlement Silent on the Number of RCTs Re,  January 13, 2015
  Unearthing Mansfield's Rule: Analysing the Appropriateness of Federal Rule of Evidence 606(B) in Light of the Common Law Tradtition  December 1, 2014
  DOJ Announces Another GMP Consent Decree for a Dietary Supplement Manufacturer,  November 19, 2014
  DOJ Files Criminal Case Against Vascular Solutions, Inc. for Off-Label Device Promotion,  November 18, 2014
  How Far Does FDA's Say-So Travel?,  November 16, 2014
  CPSC Imposes Largest-Ever Failure to Report Civil Penalty against Baja Inc.,  November 3, 2014
  What Can FDA Do During Drug Inspections: Will FDA Apply Its New Guidance to Other Products?,  October 22, 2014
  Supreme Court Declines to Hear Omnicare False Claims Act Case,  October 6, 2014
  Bayer Case Highlights the Importance of Involving an Expert in Substantiation,  September 28, 2014
  Legislation Would End Constructive Transfer and Change CSA Definition of Dispense,  September 26, 2014
  Former Officials of Peanut Corp of America Found Guilty; FDA Proposes to Require Supplier Verification Under the FSMA Preventive Controls Rule,  September 22, 2014
  Latest CSA Legislation Would Streamline Drug Scheduling, Clarify Imminent Danger, & Permit Registrants to Submit Corrective Action Prior to Revocation,  September 22, 2014
  DEA Issues Final Rule on Controlled Substance Disposal,  September 14, 2014
  A Primer for Navigating the Murky, Drug-Infested Waters of Drug Diversion Administrative Revocation and Application Hearings,  September 3, 2014
  Eisai Sues FDA Over NCE Exclusivity False Starts for BELVIQ and FYCOMPA,  August 10, 2014
  Zarbee's Honey-Based Cough Claims Choked by FDA,  July 8, 2014
  KV Lawsuit Involving MAKENA and Compounded 17p Concludes . . . . In Sopranos Style,  July 7, 2014
  DEA Controls Tramadol as a Schedule IV Controlled Substance, Effective August 18, 2014,  July 2, 2014
  I Didn't Inhale - But FDA's Position on Medical Marijuana is Still Cloudy,  June 25, 2014
  The Nuts and Bolts of Preparing For and Managing DEA Cyclic Inspections: What Every Registrant Should Know,  June 19, 2014
  The Nuts and Bolts of Preparing For and Managing DEA Cyclic Inspections: What Every Registrant Should Know,  June 19, 2014
  The Ascension of FDA's September 19, 2011 Marketed Unapproved Drugs Compliance Policy Guide,  June 2, 2014
  Significant Settlements, Top 20 Food and Drug Cases, 2013 & Cases to Watch, 2014  January 2014
  DOJ Announces Significant Policy Shift on Electronic Recordings of Statements; Will Other Agencies Follow?,  May 29, 2014
  As Senate and House Lawmakers Slog Through FDA Appropriations Bills, FDA's To-Do List Grows,  May 29, 2014
  Race to Market: Drugs vs. Dietary Supplements; FDA Plants a Landmine,  May 11, 2014
  Zogenix Sues Massachusetts Over Order Banning ZOHYDRO ER; Alleges Ban is Unconstitutional,  April 8, 2014
  ACI's Annual Paragraph IV Disputes Conference,  April 7, 2014
  Congressional Hearing on Improving Predictability & Transparency in DEA & FDA Regulation Monday, April 7th at 3PM; Three Bills Appear on the Agenda,  April 7, 2014
  Proposed Federal Legislation Aims to Speed Up DEA,  April 7, 2014
  Limitations Imposed on Use of FDA Warning Letters,  March 25, 2014
  FDA Sued Over Failure to Issue Export Certificate,  March 13, 2014
  Court Rules that FTCs Substantiation Requirements Are Applicable to Claims for Medical Foods,  March 11, 2014
  Maryland Bill Would Place Wholesale Distributors in Catch-22 with DEA Suspicious Order Requirements,  March 9, 2014
  Endo Pharmaceuticals  Not Your Typical Off-Label Settlement,  March 8, 2014
  Every Breath You Take . . . FDA is Watching You!,  March 5, 2014
  DEA Issues A Notice of Proposed Rulemaking to Reschedule Hydrocodone Combination Products,  March 3, 2014
  Government Says Supreme Court Should Not Take Up False Claims Act Case Alleging Off-Label Promotion,  February 27, 2014
  Is the Government Entitled to Deference in FDA Criminal Cases?,  February 27, 2014
  We'll Say It Again: Regulatory Noncompliance Does Not an FCA Case Make,  February 24, 2014
  ACLU Intervenor Patients and Prescriber Win a Fourth Amendment Challenge Concerning DEAs Attempt to Subpoena PDMP Records,  February 18, 2014
  Examining Hot Button Areas for FDA & Related Government Enforcement  February 12, 2014
  DEA Representative States it has Received the HHS Recommendation on Rescheduling of Hydrocodone,  February 9, 2014
  NABP and Healthcare Stakeholders Announce Collaborative Efforts Addressing Prescription Drug Abuse and Practitioner Responsibilities,  February 6, 2014
  Second Bill to Curb Underage Dextromethorphan Abuse Introduced in House,  February 5, 2014
  Speech by High-Level DOJ Official Claims Shared Interests of Prosecutors and Regulated Industry,  January 30, 2014
  An Old Fashioned Park Criminal Prosecution With Some Twists - Part II,  January 30, 2014
  Industry Challenges Hydrocodone Combination Reclassification in Citizen Petition,  January 29, 2014
  Increase in Enforcement Actions against Medical Foods; FDA Sends Two Warning Letters,  January 28, 2014
  Tenth Circuit Affirms False Statement Conviction: Lesson Learned,  January 23, 2014
  DC Circuit Reinstates KV Lawsuit Over MAKENA and Compounded 17p in Light of Cook Decision and DQSA,  January 9, 2014
  Application of Health Care Fraud and Abuse Laws to the Marketing of Pharmaceuticals and Medical Devices  January 5, 2014
  The Federal Circuit Wades into FDC Act Preemption and Intended Use in RevitaLash Decision,  January 2, 2014
  Harkonen's Supreme Court Petition Denied,  December 20, 2013
  First Circuit Skirts the Issue of the Scope of the False Claims Act Regarding FDC Act Violations,  December 9, 2013
  DEA Moves Swiftly in Issuing Final Rule Placing FYCOMPA In Schedule III,  December 5, 2013
  FDA Sued After Refusing Shipment of Bulk Drug Product,  December 4, 2013
  Coming Clean with DEA: No Good Deed Goes Unpunished ,  November 21, 2013
  DEA Releases 2013 Drug Threat Assessment Summary,  November 20, 2013
  FDA Takes Aim at a Financial Community Broadcast in New Warning Letter,  November 13, 2013
  Did FDA Shed Light on the Meaning of "Market Withdrawal" in the Updated RPM? Unfortunately, No.,  October 31, 2013
  FDA Flexes GDUFA Enforcement Muscle; Issues First Warning Letter to Non-Compliant Manufacturing Facility,  October 2, 2013
  An Old Fashioned Park Criminal Prosecution With Some Twists,  October 2, 2013
  What Can You Say?: Uncovering Trends in Recent Medical Device Enforcement Actions  September 2, 2013
  An FDA Warning Letter that Does Not Add Up: OTC Drug Monograph Combination Products With Conflicting Dosing Directions,  August 26, 2013
  Harkonen Again Raises First Amendment Issues,  August 12, 2013
  The Worm Turns: the Government Stakes Out a Standard that May Foreclose Many Federal False Claims Act Cases Based on Certain Alleged FDCA Violations,  August 8, 2013
  Draft Guidance on Medical Device Recalls: Improvements Are Needed  July / August 2013
  Getting to the Bottom of the Bottomley Case?,  July 24, 2013
  FDA Racks Up a Circuit Court Loss in Imported and Unapproved Thiopental Sodium Case; Will It Jeopardize FDA's Drug Shortage Program?,  July 23, 2013
  "Put Down that Camera," No More,  July 18, 2013
  FDA Cites Park Doctrine in a Different Context,  May 28, 2013
  Using Scientific Literature in Food or Dietary Supplement Marketing? Proceed with Caution,  May 1, 2013
  The HHS Office of Inspector General Reports on Acute-Care Hospitals' Ubiquitous Practice of Outsourcing High-Risk Compounded Sterile Products,  April 16, 2013
  When is a Website Considered Labeling?,  April 16, 2013
  FDA's High Risk Pharmacy Inspections and Enforcement Actions: Coming to a Sterile Compounding Pharmacy Near You?,  April 14, 2013
  New Legislation Schedules Any Substance Containing Hydrocodone in Schedule II,  March 21, 2013
  KV Says "Heckler/Chaney Defense" is Inapplicable in Appeal Concerning Compounded 17P and Orphan Drug MAKENA,  March 13, 2013
  CDRH Issues Joint FDA/FTC Promotion/Advertising Untitled "Email" to On-line Distributors; Unprecedented Approach Warning Possible Criminal Prosecution,  March 7, 2013
  First Amendment Argument Fails in Appeal of Wire Fraud Conviction,  March 5, 2013
  Federal Taint Teams And Attorney-Client Privilege In Corporate Criminal Investigations  February 2013
  GAO Report Assesses State Approaches to Control Pseudoephedrine,  February 26, 2013
  New FDC Act Criminal Penalty for Intentional Drug Adulteration Receives Sentencing Commission Consideration,  January 31, 2013
  FDA Advisory Committee Votes 19 to 10 In Favor of Rescheduling Combination Hydrocodone,  January 30, 2013
  Blunt Talk from DC Circuit: No "Adequate & Well-Controlled Studies Exist" on Marijuana's Medical Efficacy,  January 27, 2013
  FTC Hammers POM Wonderful: Now On to the World Series,  January 17, 2013
  FDA Ramps Up Focus on Advertising of Restricted Devices to Consumers,  January 7, 2013
  The Prosecution of Gary D. Osborn - An Old School "Park" Prosecution?,  January 1, 2013
  Trade Groups Sue Alameda County Over Drug Take-Back and Disposal Ordinance,  December 19, 2012
  A Deep Dive Into the Second Circuit's Caronia Decision, Potential Next Steps, and Potential Enforcement Fallout,  December 12, 2012
  Proposed Legislation Seeks to Amend Controlled Substances Acts Preemption Provision: A Reminder Of States' Role in Regulating Drugs of Abuse,  December 6, 2012
  Red Flags Rule Comes Back,  December 5, 2012
  In a FSMA First, FDA Suspends a Food Facility's Registration,  November 29, 2012
  A Congressional Hearing: "The Fungal Meningitis Outbreak: Could It Have Been Prevented?" Is Scheduled for Wednesday, November 14, 2012,  November 12, 2012
  FDA Presses "Heckler Defense" in Appeal of Unapproved Thiopental Sodium Death Row Inmate Case,  November 12, 2012
  The End of the Road: Franck's Compounding Case is Moot,  October 16, 2012
  Lawmakers' Concerns Highlight DEA Deficiencies in Establishing Clear Requirements for Identifying and Reporting Suspicious Order ,  October 14, 2012
  Fungal Meningitis Outbreak Prompts Calls for Greater Regulation of Compounders,  October 10, 2012
  The Whole Ball of Wax: FDA Says Supreme Court Review of Holistic Candlers Case is Not Warranted,  September 18, 2012
  KV Takes a Hit With the Dismissal of Its Case Against FDA Over Compounded 17P,  September 6, 2012
  DEA Announces Approved Certification Processes for Electronic Prescriptions,  August 9, 2012
  DEA Controls Prostanozol and Methasterone As Schedule III Anabolic Steroids,  July 30, 2012
  DEA Leads First Nationwide Synthetic Drug Takedown in "Operation Log Jam",  July 29, 2012
  D.C. Circuit Decides Case Involving Exclusion of Former Purdue Executives,  July 27, 2012
  Designer Anabolic Steroid Control Act of 2012 Introduced; Would Bulk Up Federal Anabolic Steroid Controls,  July 26, 2012
  Lack of Regulatory Guidance Fatal to Some, But Not All Claims in AMP False Claims Act Case,  July 18, 2012
  Debarred By FDA! For What? For How Long? Really?,  July 17, 2012
  FDASIA Enacted; HP&M Issues Detailed Summary and Analysis,  July 11, 2012
  FDA Sued for Abrogating MAKENA Orphan Drug Exclusivity; Suit Alleges FDA is Turning a Blind Eye to Compounded 17P and Bowing to Political Pressure,  July 8, 2012
  Supreme Court to Regulatory Agencies: Due Process Requires "Fair Notice" of Agency Interpretations,  July 1, 2012
  Garbage Runs, Fake Identities, and Surprise Home Visits - Strategies to Deal With FDA's Nontraditional Investigative Tools  June 20, 2012
  Court Rejects FTC's Effort to Require Two Studies,  June 13, 2012
  FDA Misdemeanor Cases-Not Always A Sure Win for the Government,  June 4, 2012
  House Passes FDA Reform Act of 2012; Next Up - Conference Committee,  May 31, 2012
  U.S. Senate Slogs Through Amendments and Passes FDA Safety and Innovation Act; Onward to the House Bill,  May 25, 2012
  Abbott's Resolution of Off-Label Allegations Has Familiar and New Elements to It,  May 22, 2012
  Initial Decision in POM Wonderful Case - Each Side Can Claim Victory,  May 21, 2012
  Court Denies ViroPharma's Motion for TRO/PI in Vancomycin Case-Leaves Generics on the Market,  April 25, 2012
  Warning Letters Begin Addressing FSMA Reinspection Fees,  April 9, 2012
  Another Loss in Court for FDA; Judge Leon Rules for Death Row Inmates in Unapproved Thiopental Sodium Case,  March 27, 2012
  Supreme Court Decision Raises Interesting Questions Regarding Judicial Review of Agency Action, Provides Few Answers,  March 23, 2012
  Breathable Food Draws FDA Warning Letter,  March 7, 2012
  FTC v. POM WONDERFUL: An Update,  March 5, 2012
  FDA Flexes New Enforcement Muscle; Issues Warning Letter for Failure to Meet Required Postmarketing Study Milestone Dates,  February 28, 2012
  Seeking a Second Bite at the Apple? Lannett Petitions FDA on the "Grandfather" Status of Morphine Sulfate,  February 20, 2012
  GAO Recommends Coordination and Assessment of Federal Efforts to Educate About Prescription Pain Reliever Abuse and Misuse,  January 25, 2012
  Supreme Court To Decide When EPA and Perhaps Other Federal Agencies Can be Sued in Federal Court,  January 17, 2012
  D.C. Circuit Affirms Dismissal of Holistic Candler's Lawsuit and Tosses Out the Whole Ball of Wax,  January 5, 2012
  Sentencing Hearings for Synthes Executives Suggest that Government May Try to Prove Fraud In Connection with Park Cases,  December 22, 2011
  Court Ruling Casts Doubt On FDA's Use Of Guidance Documents  December 16, 2011
  Revelations: FDA's Perspective on Drugs Marketed Pursuant to a Pending DESI Proceeding and the Unapproved Drugs CPG,  December 14, 2011
  Court Finds That Lane Labs' Advertising Claim Lacks Substantiation,  December 14, 2011
  Pending DESI Program Proceedings - The List,  December 11, 2011
  Dietary Supplement GMPs: Repeat Offenders Beware,  December 5, 2011
  GAO Says FDA Needs to do More to Address "Economic Adulteration",  November 27, 2011
  DOJ's West Outlines Enforcement Considerations,  November 8, 2011
  FDA Prevails in 10th Circuit Unapproved Morphine Sulfate Case; Court Does Not Reach Merits of Grandfather Claim,  November 6, 2011
  FDA Continues Efforts to Expand Power Over Intrastate Commerce,  October 26, 2011
  In a First, FDA Seizes Administratively Detained Food,  October 13, 2011
  DEA Issues Final Rule Clarifying When a Voluntary Surrender of a DEA Registration is Effective,  October 10, 2011
  GAO Report Criticizes DEA Diversion Control Performance Measures But Fails to Address Several Issues of Concern,  October 6, 2011
  Are Prenatals Marketed as Unapproved Drugs Exempt from FDA's September 19 Guidance? No,  October 5, 2011
  New Twists and Turns in Off-Label Marketing,  September 21, 2011
  Pain Relief on the Way? Senator Kohl's Proposed Bill to Provide Easier Access to Controlled Substances to Patients in Long-Term Care Facilities,  September 20, 2011
  Government Files Appellate Brief in Purdue Executives' Exclusion Litigation,  September 20, 2011
  FDA Ramps Up Enforcement on Marketed Unapproved Human Drugs - Revised CPG Says New Products Will be Subject to Immediate Enforcement Action,  September 19, 2011
  Court Sides With Government in Case Alleging Adulteration, But Deems Injunction Request Overbroad,  September 15, 2011
  The Feds Challenge Mobile Medical Apps,  September 12, 2011
  Citing Imminent Hazard to Public Safety, DEA Publishes Notice of Intent to Temporarily Places Synthetic Cathinones Into Schedule I of the CSA,  September 9, 2011
  Google to pay $500 Million Regarding Pharmacy Advertising; What is Next?,  August 25, 2011
  Knocking On Your Front Door: Government Visits To Employees' Homes  August 19, 2011
  FDA Says Tenth Circuit Should Say Adieu to Grandfather Drug Case Without Much Ado; Not So Fast, Says Cody/Lannett,  August 15, 2011
  FDA's Pursuit of Punishing People  July / August 2011
  President Obama to Nominate Maureen K. Ohlhausen to the Federal Trade Commission,  July 20, 2011
  DEA Proposes Raising Registration Fees,  July 12, 2011
  No End to Aggressive Investigative Techniques,  July 7, 2011
  Washington Legal Foundation Files Amicus Brief Arguing that HHS Exclusion is Unconstititional When Founded on Park Doctrine Misdemeanor Conviction,  July 4, 2011
  Change Is In The Winds At DOJ,  June 19, 2011
  Not an Empty Threat; Recent FDA Seizure Actions Follow Warning Letters to a Dietary Supplement Distributor and a Winery,  June 12, 2011
  Kansas Federal Grand Jury Indicts Physician and Research Coordinator for Falsifying Clinical trial Study Data,  June 8, 2011
  Consolidation of Seizure and Forfeiture Regulations under CAFRA - DEA Proposed Rulemaking,  May 18, 2011
  FDA's Warning Letter "Close-Out" Process Is Not Working,  May 11, 2011
  Black Tuesday for the Government: The Lauren Stevens Case is Dismissed,  May 10, 2011
  Double Whammy for a Dietary Supplement Company Executive - First Come Civil Charges, Now Criminal Charges,  May 3, 2011
  D.C. Circuit is Asked to Review Two DESI "New Drug" Decisions,  May 2, 2011
  The Government Says That If At First It Does Not Succeed, Try, Try Again: Former GlaxoSmithKline Attorney Lauren Stevens Re-Indicted,  April 15, 2011
  DDMAC Announces Enforcement Webinar Series,  April 12, 2011
  Georgia Department of Community Health Requires Showing of "Medical Necessity" for FDA-Approved Drug Over Compounded Versions,  April 7, 2011
  Cost of Compliance - FDA's New Enforcement Discretion,  March 31, 2011
  Indictment of Former Glaxo In-House Attorney Dismissed,  March 24, 2011
  California Insurance Commissioner Intervenes in Qui Tam Lawsuit Alleging Pharma Company paid Physicians as "Runners and Cappers",  March 24, 2011
  Legislative Fixes Focus on Controlled Substance Issues,  March 22, 2011
  Judge Snuffs Out Holistic Candlers Lawsuit; Constitutional Challenge Falls on Deaf Ears,  March 20, 2011
  DEA Seizes Georgia's Sodium Thiopental,  March 17, 2011
  Will Proposed Amendments to the U.S. Sentencing Guidelines Have A Far-Reaching Impact for Persons Regulated By FDA?,  March 3, 2011
  Citing Imminent Hazard to Public Safety, DEA Temporarily Places Synthetic Cannabinoids Into Schedule I,  March 2, 2011
  Sen. Leahy Asks DOJ for Update on Investigation of Peanut Corporation of America,  February 23, 2011
  New Senate Legislation May Impede Voluntary Self-Enforcement by Companies Regulated by FDA,  February 22, 2011
  In Unusual Twist, FDA Warning Letter Cites Potential FTC Act Violations,  February 14, 2011
  FDA Finally Releases "Non-binding" Park Doctrine Criteria,  February 6, 2011
  D.I.Y. Enforcement: Relators, the False Claims Act and the FDCA  January/February 2011
  Enhanced Criminal Penalties for Food Safety Violators?,  February 1, 2011
  FDA Seeks to Clean Up Unapproved Cough/Cold/Allergy Drug Market,  January 6, 2011
  What Happens to Medical Device Reports Once They Reach FDA?  January 2011
  Must FDA Treat Similarly-Situated Competitors the Same Way?  December 2010
  Court Rules that a Dietary Supplement Company Needed Clinical Trials with Human Subjects to Support Advertising Claims,  December 22, 2010
  Sandoz Requests 180-Day Exclusivity Forfeiture Decision for Generic HECTOROL,  December 21, 2010
  Court Upholds Exclusion of Former Purdue Executives,  December 20, 2010
  Are Attorneys the FDA's New Enforcement Target?,  December 20, 2010
  FDA Steps Up Efforts Against "Tainted" Products Masquerading as Dietary Supplements,  December 19, 2010
  The DEA Opines on a Pharmacist's "Corresponding Responsibility",  December 1, 2010
  FDA and FTC Target Caffeinated Alcoholic Malt Beverages,  November 23, 2010
  Former Pharma Company Attorney Indicted for Her Role in FDA Investigation of Her Employer,  November 9, 2010
  WLF Cautions FDA Regarding Park Doctrine,  November 1, 2010
  GAO Report Blasts FDA for Failure to Implement 2008 Recommendations,  October 31, 2010
  REMS and 180-Day Exclusivity Forfeiture - Some Interesting Disclosures to the SEC,  October 28, 2010
  Another Capitol Hill Missive Objects to the Inclusion of Patent Settlement Provisions in FY 2011 Appropriations Bill,  October 27, 2010
  For Whistleblowers, Complaining to Government Pays: GlaxoSmithKline Pays $750 Million to Resolve Criminal & Civil Liability for Alleged cGMP Failures,  October 27, 2010
  Amphastar Challenges FDA Import Detention,  October 26, 2010
  FDA Grants Petition Requesting a "Superseding" 30-Month Stay for Generic HECTOROL,  October 25, 2010
  Watch Out! At FDLI Conference, Government Says More People Will Be Convicted of Crimes,  October 14, 2010
  The Evolution and Resurgence of Strict Liability Criminal Prosecutions Under the Park Doctrine  October 8, 2010
  New Use of Old Tools: Career-Ending OIG Exclusion and FDA Debarment  September / October 2010
  Cody/Lannett Unapproved Morphine Sulfate Litigation Gets New Legs; But FDA Motion to Dismiss Tries to Pull the Rug Out From Under Them,  September 6, 2010
  Veterinary Compounding Pharmacy Resumes Operations Despite FDA's Attempt to Obtain a Preliminary Injunction,  September 2, 2010
  Allergan Settles with DOJ Related to the Sales and Marketing of BOTOX,  September 1, 2010
  Responding To Recalls May Be a Walk in the Park for FDA,  August 29, 2010
  Advertising and Promotion: FDA Is Not the Only Cop on the Beat  August 2010
  Another Advocacy Group Asks FDA to Increase Marketed Unapproved Drugs Enforcement Crackdown,  August 12, 2010
  Regenerative Sciences Faced with FDA Injunction,  August 11, 2010
  DDMAC re Facebook Share - Be Careful of What You Are Sharing,  August 6, 2010
  District Court Denies Motion for Temporary Restraining Order and Preliminary Injunction in Marketed Unapproved Morphine Sulfate Oral Solution Case,  July 26, 2010
  FDA Sued Over Enforcement Action on Marketed Unapproved Morphine Sulfate Oral Solution,  July 22, 2010
  Whistleblowers: Treat Them With Kid Gloves  July 2010
  Nestle Unit's Settlement with FTC Contains New Provisions Regarding Substantiation,  July 15, 2010
  Compounding Pharmacies Strike back Against Government Actions,  July 11, 2010
  Regenerative Sciences, Inc. Attempts to Avoid FDA Action,  June 27, 2010
  High Court Declines to Hear Solvay and Duxbury FCA Cases,  June 21, 2010
  You Better Watch Out, and You Can Pout, but FDA User Fee Invoices Are Coming Out; FDA is Making a List and Checking it Twice - You Should Too!,  May 18, 2010
  Advocacy Groups Ask FDA to Further Crack Down on Marketed Unapproved Drugs,  April 20, 2010
  The Lanham Act: Another Vehicle to Enforce the Food, Drug, and Cosmetic Act?  April 2010
  Here We Go Again! MDCO Launches Another Lawsuit Against the PTO Over ANGIOMAX PTE,  March 26, 2010
  FDA Relies on Drug Listing Information in the Latest Round of Marketed Unapproved Drug Warning Letters,  March 19, 2010
  UN Addresses Worldwide Controlled Substance Issues,  March 18, 2010
  Will the Government Expect FDA-Regulated Companies to Make Restitution Self Report Each Time a Company Commits an FDC Act Violatition,  March 17, 2010
  FDA May Increase Misdemeanor Prosecutions Against Responsible Corporate Officials,  March 4, 2010
  Federal Court Recognizes Lack of Private Enforcement of FDC Act, But Permits Private Lawsuit Seeking to Block Unapproved Drugs to Proceed Anyway ,  February 15, 2010
  But My Lawyer Told Me It Was Okay  January/February 2010
  WHO Accepts New Guidelines on Psychoactive Substances for International Control,  January 26, 2010
  Sentencing Commission Proposes Changes to Guidelines That Could Affect Day-to-Day Business Decisions,  January 21, 2010
  Prominent Medical Researcher Charged with Health Care Fraud for Falsifying Research,  January 19, 2010
  Retailers on the Radar of FDA Under the Family Smoking Prevention and Tobacco Control Act  November/December 2009
  The Family Smoking Prevention and Tobacco Control Act: An Overview  December 2009
  Contracting with the Dietary Supplement cGMPs in Mind  September 2009
  The Park Criminal Liability Doctrine: Is it Dead or is it Awakening?  September/October 2009
  Vindicated on Appeal - It Does Happen  July/August 2009
  Search Warrants - What Happens When the FDA Storm Arrives  May/June 2009
  The Curious Case of the Prosecution of Lawyer Paul Kellogg  March/April 2009
  Imported Products - FDA Is Not Fooling Around  January 2009
  A Bad Fit: Qui Tam Actions and Off-Label Use Allegations  November 2008
  Cosmetics Product Enforcement - Not an Oxymoron  September 2008
  Lessons Learned from the AbTox Ruling  September 2008
  Checking the Box Can Get You in the Hot Seat  August 2008
  FDA Moves Against Marketed Unapproved Human Drugs  May/June 2008
  Playing "Hard Ball" With FDA Might Lead to Criminal Prosecution  April 2008
  FDAAA Enforcement Summary  February 2008
  The Pursuit of Civil Money Penalties - An Important Weapon in FDA's Enforcement Arsenal  December 2007
  FDA Amendments Act - HPM Issues Detailed Summary and Analysis  October 2007
  The OxyContin Case - Something for Everyone  September 2007
  Who Decides A Company's Fate in FDA Enforcement Matters?  May 2007
  Corporate Compliance Officer - Gatekeeper or Jailbird  January 2007
  Justice Department Alters Its Policies for Prosecuting Business Organizations  December 2006
  FDA's Final Compliance Policy Guide for Marketed Unapproved Drugs ─ Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle?  August 11, 2006
  Medtronic Reaches Settlement over Allegations of Illegal Physician Payments to Promote Spinal Products  July 18, 2006
  Product liability drug case not preempted by FDC Act  March 3, 2006
  It's The Law: Disgorgement and Restitution  February 2006
  Responding to FDA Form 483 and FDA Warning Letters  January 18, 2006
  What You Don't Know about AIP Can Hurt You  November 2005
  Government Investigations: Responding to Requests for Information Including E-Discovery  September 2005
  New Case Raises Doubts on FDA's Authority to Obtain Restitution and Disgorgement  May/June 2005
  Expanding FDA's Authority to Protect the Food Supply: Administrative Detention  January/February 2005
  FDA's Right to Get Disgorgement Is Threatened  2005
  Courts Scrutinize FDA  November 4, 2005
  Current Good Manufacturing Practices, and FDA Enforcement Actions and Inspections  July 2004
  Enforcement and Litigation Conference: Actions Against Competitors  September 23, 2003
  Can FDA Seek Restitution or Disgorgement?  2003
  What You Say May Be Used Against You  May/June 2002
  Criminal Prosecutions Initiated for the FDA  April 2001
  A Voluntary Disclosure Programs for FDA - The Time has Come  1999
  The Role of the Department of Justice in Enforcement Matters Relating to the Food and Drug Administration  1991
  Administrative Inspections by the Food and Drug Administration: the Role of the Department of Justice  July 1989