- Assisting FDA-regulated entities on emergency use authorization in relation to coronavirus test kits, hand sanitizers, and surgical masks.
- Represented a major pharmaceutical manufacturer in amending an analgesic over-the-counter drug monograph to recognize preventive cardiovascular uses of aspirin.
- Assisted in the preparation and advocacy of an orphan drug designation request for a biologic leukemia drug.
- Obtained an FDA Division of Drug Marketing, Advertising, and Communications (DDMAC) warning letter against the illegal marketing practices of the competitor manufacturer of the COX-2 inhibitor.
- 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 acquisition by a major online medical information provider of an accredited continuing medical education sponsor.
Partner,
- Phone: 202.239.3465
- Email: marc.scheineson@alston.com
Marc is an FDA and congressional insider experienced in strategically resolving regulatory and legislative issues for product manufacturers using the legal levers available in Washington, D.C.