Mr. Scheineson is a partner in the Washington, D.C., office, where he heads the firm's Food and Drug Law Practice. He advises companies on a wide range of issues, including product approvals, marketing, clinical studies and enforcement. Previously, he served as the associate commissioner for legislative affairs of the Food and Drug Administration. He was involved there in many agency innovations, including prescription drug user fees, debarment, medical device amendments and nutritional labeling. He was also counsel to the ranking member of the Health Subcommittee of the House of Representatives Committee on Ways and Means, and a senior vice president of Ketchum Communications. Mr. Scheineson is also experienced with the application of the OIG anti-kickback statute, HIPAA privacy rules, patent term exclusivity, institutional review board regulation, human research protection, scientific misconduct, technology transfer and licensing, advertising and promotion law, ACCME accreditation, and advises on the FDA regulatory aspects of corporate acquisitions. Mr. Scheineson received an LL.M. degree from the Georgetown University Law Center, and his B.A. and J.D. degrees from the University of Cincinnati and its College of Law.
- Successfully represented a major pharmaceutical manufacturer in amending an analgesic over-the-counter drug monograph to recognize preventative cardiovascular uses of aspirin.
- Assisted in the preparation and advocacy of a successful orphan drug designation request for a biologic leukemia drug.
- Obtained an FDA Division of Drug, Marketing, and Advertising (DDMAC) warning letter against the illegal marketing practices of the competitor manufacturer of the Cox-2 inhibitor.
- Successfully defended against a DDMAC investigation of the marketing practices of an MRI-MRA imaging contrast agent maker.
- Participated on company review committees for the launch and dissemination of promotional materials for a biologic arthritis drug, and for collagen device dermal filler products.
- Performed regulatory due diligence for the acquisition of companies and products, including over-the-counter cough medicine, high dose expectorant, infant formulas, multiple prescriptions and over-the-counter drug products, and heart monitoring devices.
- Led a legal and regulatory team to obtain the first FDA clearance of private label infant formula.
- Negotiated an FDA Good Manufacturing Practice consent decree for a catheter maker that preserved existing inventory.
- Assisted with the New Drug Application approval of the first levothyroxine product, and removed unapproved guaifenesin products.
- Represented a major national clinical research organization in FDA self-disclosure, inspection and negotiations for remedial action.
- Led a litigation and regulatory team to preserve marketing rights for “grandfathered drug” products until FDA approvals could be obtained.
- Assisted in the review, revision and acquisitions by a major online medical information provider of an accredited continuing medical education sponsor.
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June 16, 2009
In The Press
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October 28, 2008
In The Press
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July 25, 2008
In The Press
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April 24, 2008
In The Press
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1 February 2008
In The Press
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6 November 2007
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21 August 2006
In The Press
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26 May 2006
In The Press
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"Democrats Focus on FDA to Improve Treatment Quality and Reduce Cost," FDLI Update, March/April 2009.
March/April 2009
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September 2007
Publications
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March/April 2007
Publications
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"Regulatory Pathway for 'Biosimilar' Products Debated," Legal Backgrounder, February 23, 2007.
February 23, 2007
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“50 Sets of Labeling Rules Creates Confusion,” The Hill, June 2006.
June 2006
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"Lessons From Expanded Government Enfocement Efforts Against Drug Companies," Food and Drug Law Journal, Vol. 60, No. 1, 2005.
2005
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3 December 2004
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"FDA Lacks Authority to Impose Civil Monetary Fines," Legal Backgrounder, Washington Legal Foundation, Vol. 18, No. 44, October 17, 2003.
October 17, 2003
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"FDA Limits on Dual Trademarks Tread on Patient Safety and Law," Legal Backgrounder, Washington Legal Foundation, Vol. 18, No. 14, April 25, 2003.
April 25, 2003
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"Gene Therapy Forces Public Health Community to 'Know Thyself'," Update Magazine, Food and Drug Law Institute, Jul/Aug 2002.
July/August 2002
Past Events
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April 25, 2012
Event
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December 7-8, 2009
Seminar
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October 14-16, 2009
Seminar
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September 21-22, 2009
Seminar
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February 24-25, 2009
Seminar
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February 4-5, 2009
Seminar
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November 10, 2008
Seminar
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October 27-28, 2008
Seminar
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October 21-23, 2008
Seminar
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October 16-17, 2008
Seminar
- Former Chair, American Bar Association (ABA) Committee on Food and Drug Law
- Former Chair, ABA Task Force on FDA Reform
- Former Chair, Editorial Board, Update Magazine (Food and Drug Law Institute)(FDLI)
- Member, Editorial Advisory Board, FDANews Washington Drug Letter
- Former Chair, Young Lawyers Section, Bar Association of the District of Columbia
- In-House Training Team to FDA sponsored by FDLI
- Executive Committee, Board Member, Anti-Defamation League, Washington, D.C., Chapter
- Former Board Member, American-Israel Public Affairs Committee, Washington, D.C., Chapter
- Board Member, University of Cincinnati Foundation
- Board Member, University of Cincinnati College of Law Alumni Association