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A Heavy Homework Assignment for Food Importers and Producers
…or equivalent food safety system Consequences of failure to comply (e.g., issuance of 483s and warning letters; refusal of admission; import alert; civil and criminal actions; and debarment) Guidance for…
More Diversion Cases and WCF’s Opioid & Fentanyl Abuse Management Summit
…DEA, Palomar Hospital Pays $250,000 for Diverting Fentanyl (June 3, 2024). We also became aware that First Choice Surgical, an ambulatory surgical center in Cedar Rapids, Iowa, agreed to pay…
Continued Interest in Drug Categorization – OIG Finds Ten Potentially Misclassified Drugs May Have Led to $1.3 Billion in Lost Medicaid Rebates
…data.” The report does not mention that the Federal False Claims Act (FCA) has been used in several instances to target the knowing submission of false drug category data. OIG…
Latest FDLI Update Magazine Article Explains DEA Preregistration and Cyclic Inspections
…These were registrants that historically had not been subject to scheduled inspections. Registrant noncompliance disclosed during a DEA inspection can lead to significant administrative, civil and even criminal consequences. Hyman,…
Mylan Loses Again on Generic NORVASC
…ruling that it does not have jurisdiction now that the Court’s denial of Mylan’s earlier motion for a preliminary injunction is on appeal. But both the Federal Rules of Civil…
FDA Found Lead in Vitamins; California Files Suit
…California’s Attorney General, joined by a number of county district attorneys, has filed suit against dozens of dietary supplement manufacturers alleging that they marketed vitamin supplements containing lead “without first giving…
House and Senate Bills Would Require Reporting of Biosimilar Agreements to the DoJ and FTC
…Sarbanes, the bill is intended to address so-called “pay-for-delay” agreements. Specifically, H.R. 6478 would amend PHS Act § 351(l) to add item “(10)” to require the reporting of any agreement…
Stimulating Privacy: Changes to HIPAA in the Stimulus Bill
…and thus would apply to pharmacies, physicians, health plans, as well as pharmacy benefit managers. The Act also will also change liability for business associates. Business associates contract with entities…
Senate Judiciary Committee Adopts Amendment to Reverse Payment Bill
…S. 369 would amend the Federal Trade Commission Act to permit the FTC to “initiate a proceeding to enforce the provisions of [new Sec. 28] against the parties to any…
WLF Urges Supreme Court Review of Ortho Biotech Decision; Argues that the False Claims Act is Intended to Combat Fraud, not Legitimate Product Promotion
…allegation of an actual false claim is a “threshold issue” without which Federal Rule of Civil Procedure 9(b) is dispositive, and requires dismissal of Respondent’s claims. This argument is buttressed…
Rep. Hinchey Introduces the FDA Improvement Act of 2010; the Bill Would Unravel User Fee Legislation, Among Other Changes
…2010 (“FDAIA”). FDAIA is a sweeping reform bill that would unravel the Prescription Drug User Fee Act and other similar legislation establishing user fee systems for medical devices and animal…
The FTC’s Latest Patent Settlement Report Will Serve as Fodder for the Commission’s Crusade Against Patent Settlement Agreements
…almost double the amount received in any previous fiscal year. Of these 113 final resolutions, the number of potential pay-for-delay settlements (31 in FY 2010) and the number of potential…
The Opioid Abuse Deterrence Act and DOJ Initiatives: Just What the Doctor Ordered?
…force of federal, state, local, and tribal law agencies to identify opioid cases for federal prosecution, facilitate interdiction efforts, and tailor their district’s response to the needs of their communities;…
Senators Kohl and Grassley Introduce Bill Targeting Industry Gifts to Physicians
Many pharmaceutical manufacturers are already struggling under the regulatory burden associated with the various requirements of state gift reporting statutes. That burden may soon be made heavier. Earlier this month,…
Proposed Rule Requires Sponsors to Report Suspected Falsification of Data to FDA
…additional information should be included in the report, such as the National Clinical Trial (“NCT”) number assigned to a study when the study is registered with ClinicalTrials.gov. FDA intends to…