Kleinfeld, Kaplan & Becker

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The reporting requirements are relatively detailed, and data collection efforts may be quite extensive for some applicable manufacturers. It is likely that some companies may strive to limit reportable payments or other transfers of value to decrease the burden of collecting and reporting such information, potentially resulting in less collaboration with physicians and teaching hospitals.

Scott Lassman brings nearly twenty years of experience in food and drug law to the representation of his clients. His practice focuses on providing strategic advice, counseling, and advocacy on complex legal, regulatory and legislative matters affecting pharmaceutical, biotech, medical device, cosmetic and dietary supplement manufacturers.

Our clients consist principally of manufacturers, importers, and distributors of FDA-regulated products and other providers of consumer products and services.We also handle private actions relating to FDA-regulated products and consumer products and services, such as claims for false and misleading advertising under the Lanham Act, and contractual disputes. We provide defensive counseling to our clients with respect to products liability.

Generally, applicable manufacturers must report all payments or other transfers of value to physicians or teaching hospitals, regardless of whether the payment or transfer of value is related to a covered product, and must categorize the reportable payments by the nature of the payment. Some reportable payments include payments to physicians for consulting, speaking at events, travel and lodging, research, grants, and gifts.

However, in its analysis, the Court found that GOL’s actions did not violate the terms of the consent decree. First, the Court found that allergen statements prepared by manufacturers qualify as competent and reliable scientific evidence, and so GOL’s reliance on allergen statements in making the “no soy allergens” claim was substantiated.

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