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Practice/Industry Group Overview
Porzio, Bromberg & Newman has been providing regulatory counseling, risk management and litigation avoidance counseling to pharmaceutical and medical device manufacturers for over thirty years. We are recognized as the premier law firm in the areas of state sample distribution laws, PDMA Compliance and risk management with respect to state marketing disclosure and marketing prohibition laws. Additionally, Porzio, Bromberg & Newman is well-versed in the interrelationship between the federal and individual state anti-kickback laws that impact the marketing and sales practices of pharmaceutical and medical device manufacturers.
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Services Available
Our services include counseling and advising on:
- The propriety of promotional and advertising materials, including physician, managed care and direct-to-consumer pieces
- The structuring and implementation of fully compliant continuing medical education programs
- The procurement of insurance, product liability issues and general risk-management initiatives
- Internal corporate investigations lead by a recently retired New Jersey Supreme Court Justice and additional leading industry experts
- PDMA sampling regulations and the implementation of compliant product sampling programs
- Revisions to product labels, and involuntary recalls due to post-marketing adverse events
- Patient assistance programs to provide free or reduced price medications
- Standards governing industry-sponsored research and company-sponsored medical literature
- Negotiation of commercial, managed care, market research services, personal services and other contracts, particularly for Marketing & Sales and Managed Care Department clients
- Evaluating and structuring advisory boards
- Legal considerations associated with market research services
We train and assist company personnel on:
- Topics relating to promotion, continuing medical education and other educational grants, and the release of the Office of Inspector General's guidance document for pharmaceutical manufacturers
- Development of physician speaker programs and physician speaker training
- PDMA compliance, OIG compliance, sample accountability, anti-kickback statute, fraud and abuse, and false claim act liability
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