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Hyman, Phelps & McNamara, P.C. Updates Fraud and Abuse Outline
February 2, 2009Hyman, Phelps & McNamara, P.C. today posted on its website an updated version of its outline entitled “Application of Health Care Fraud and Abuse Laws to Pharmaceutical Marketing." This 89-page outline, authored by Alan Kirschenbaum and Jeff Wasserstein, provides a comprehensive overview of how the federal health care program antikickback law, the Federal False Claims Act, and other federal and state laws affect pharmaceutical marketing activities. The outline focuses on the major problem areas for drug marketing under these laws, and, for each area, describes the pertinent safe harbors, OIG advisory opinions, and major enforcement actions. The outline also provides general guidelines for evaluating marketing proposals.
This outline was first published by Hyman, Phelps & McNamara, P.C. in 1996, and has been updated periodically. The new version is current as of January 31, 2009. Although the primary focus is on marketing of pharmaceuticals, much of the outline is equally applicable to the marketing of medical devices, and the major government actions against device companies are discussed.
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- Gun Violence Reduction Law Further Extends Moratorium on Trump-Era Rebate Rule June 27, 2022
- 10th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements is Just Days Away June 24, 2022
- Corporate Liability from Employee Diversion: Costly on Many Fronts June 22, 2022
- ‘Til I Hear It From Congress: FDASLA to Direct Publication of Final OTC Hearing Aid Rules June 22, 2022
- In Bid to Curtail 180-day Exclusivity, FDA Alters Longstanding Practice and Newly Declares that Converted OTC Products Are Not “Listed Drugs” June 21, 2022
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized