It can be overwhelming to understand and keep current with the regulatory compliance requirements of the Prescription Drug Marketing Act (PDMA), anti-kickback statutes, false claims act, FDA regulations and OIG guidances.
Porzio Pharmaceutical Services (PPS) is dedicated to helping pharmaceutical and medical device manufacturers, wholesale distributors, labelers, sales and sales support companies master the continually changing regulatory environment that impacts their business. PPS provides the life sciences industry with informational resources such as Porzio Compliance Digest (PCD), Porzio Compliance Modules (PCMs) and our aggregate spend tool, Porzio EXP. These tools enable companies to stay compliant with the growing body of federal and state regulations affecting the life sciences industry.
Porzio Pharmaceutical Services, LLC (PPS), is a wholly owned subsidiary of Porzio, Bromberg & Newman P.C. (Porzio), a law firm nationally recognized for its litigation and regulatory compliance work for the life sciences industry.
PPS, together with Porzio, provides a full array of consultative and legal services to help companies comply with state and federal laws that target the marketing and sales practices of the pharmaceutical, biotechnology and medical device industries. Porzio and PPS provide services that include:
Audits of Sales and Marketing Practices
An Audit and Risk Evaluation Assessment, conducted under the protection of the attorney-client privilege, assesses compliance on federal and state levels, provides a gap analysis of sales and marketing practices, and recommends any necessary corrective action plans.
Reviewing Promotional Materials
We review all types of promotional materials, from advertisements to slim-jims, for compliance with PDMA, FDA and OIG regulations.
Negotiating Contracts
We review, negotiate and draft many types of contracts concerning the marketing of pharmaceutical products, including contracts for physician consultants, speakers, vendors, licensing arrangements and events.
Preparing Standard Operating Procedures
We assist companies in preparing and implementing SOPs, policies and guidelines in such areas as:
- Corporate Compliance Programs
- Interdepartmental Reviews of Promotions
- Evaluation of Adverse Event Reports
- Sampling (Prescription Drug Marketing Act—PDMA)
Conducting Training Sessions
We conduct training sessions to educate company employees on legal requirements in areas such as:
- FDA-regulated promotion and permissible conduct of sales representatives
- Gifts, grants and CME, including individual state reporting requirements and discussion of PhRMA Code, AMA Guidelines, ACCME standards and OIG Guidance
- Use of discretion in e-mail and other corporate communications