Porzio Compliance Digest (PCD) is the first interactive, Internet based compliance database on state and federal laws, regulations and pending legislation governing the distribution of trade and sample products, sampling to mid-level practitioners and marketing disclosures, restrictions and limitations.
Comprised of ten distinct web-based databases, Regulatory Compliance, Enforcement Action and International Life Sciences Transparency Databases, designed to enable manufacturers and distributors, to master state, federal and global laws and regulations.
Porzio Compliance Digest Customer
Contains in-depth information on current global laws, industry codes, and pending legislation, related to non-US sales and marketing practices and interactions with healthcare professionals.
The federal government’s intensified scrutiny of life sciences companies has increased the demands on today’s compliance professionals.
To aid our customers in recognizing and understanding the significance of trends in government enforcements and inspections, Porzio Life Sciences is pleased to expand our Porzio Compliance Digest with three new Enforcement Action Databases.
FDA PDMA Inspections
Information on Established Inspection Reports (EIRs) related to Prescription Drug Marketing Act (PDMA) inspections.
The database catalogues and synthesizes violations noted by FDA inspectors in a searchable format.
Overview of federal actions against life sciences companies that have allegedly violated Anti-Kickback laws, FDA regulations, PDMA or False Claims Act, among others.
The database summarizes compliance requirements of corporate integrity agreements and provides insight into violations most often pursued by the federal government.
OPDP Promotional Violations
Searchable summaries of Untitled and Warning letters issued by FDA’s Office of Prescription Drug Promotion (OPDP), categorized by date of issuance, type of promotional material, identified violation, and other factors.
The database contains copies of issued letters and associated materials, when available, allowing users to assess enforcement trends.
These databases assist pharmaceutical, medical device and biotechnology companies in complying with marketing and sales regulations, including PDMA, anti-kickback statutes, False Claims Act, FDA, OIG, Physician Payments Sunshine Act, Affordable Care Act and state aggregate spend compliance regulations.
Distribution: Trade and Sample - Controlled Substances Database
Nationwide statutes, regulations and pending legislation governing the distribution of controlled substances by companies and sales representatives.
The database contains all state requirements on controlled substances licensing, sampling, storage and handling, record keeping, policies and procedures, reporting requirements, agency information and theft/loss reporting.
Distribution: Trade and Sample - Legend Drug Database
Nationwide statutes, regulations and pending legislation governing distribution of legend drug trade products and drug samples by companies and sales representatives.
The database contains all federal and state requirements on licensing, sales representatives, company registration, and theft/loss reporting.
Distribution: Prescription Device Database
Statutes, regulations, and pending legislation governing distribution of prescription devices, such as trade products and samples.
The database includes licensing requirements, storage and handling requirements, record keeping requirements, and theft/loss reporting. It also includes certain aspects of federal device requirements, such as registration, reporting, and device classification.
Transparency and Limitations Database
Current laws and pending legislation on marketing and sales practices and interactions with healthcare professionals.
Topics include gifts to physicians, drug price reporting, clinical trials, pharmacy benefit managers, prescriber data, and direct-to-consumer advertising. The database also includes medical school and healthcare institution interaction policies, as well as, federal legislation, industry codes of conduct, and industry guidance documents.
HCP Authorities/Restrictions Legend Drug Database
Statutes, regulations, and pending legislation governing sampling legend drugs to mid-level practitioners for compliance with PDMA and requirements of all 50 states, plus the District of Columbia.
The database provides complete sampling and prescribing authority for 40 classes of mid-level practitioners, plus medical doctors, osteopathic doctors, dentists, podiatrists and veterinarians.
HCP Authorities/Restrictions Controlled Substance Database
Statutes, regulations, and pending legislation governing sampling controlled substances to mid-level practitioners for compliance with PDMA and requirements of all 50 states, and the District of Columbia.
The database provides complete sampling and prescribing authority for 40 classes of mid-level practitioners, plus medical doctors, osteopathic doctors, dentists, podiatrists, and veterinarians.