The FDA has issued the Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency. The Prescription Drug Marketing Act of 1987 (PDMA) describes manufacturers’ drug sample storage, handling, and recordkeeping obligations as well as the written request and receipt requirements for prescribers.
Many manufacturers utilize their field sales representatives to deliver drug samples directly to, and collect written receipts from, prescribers at prescriber offices during sales calls. The COVID-19 crisis has disrupted field sales representatives’ ability to have face to face visits with prescribers, preventing them from delivering samples and collecting required receipts. In addition, as a result of the crisis, many prescribers are providing telehealth services from their homes, impacting prescribers’ ability to receive, store and distribute samples at their offices.
Blog Editors
Recent Updates
- The AI Doctor Is Out? How California’s Ab 489 Could Limit AI Development in Healthcare
- Complex Billing and Reasonable Interpretations: Jury Was Entitled to Find Fraud in Doctor’s Upcoding of Speedy COVID-19 Tests, Fourth Circuit Says
- Governor Kotek Signs Oregon’s SB 537, Strengthening Workplace Violence Prevention in Health Care
- From Best Practices to Enforcement: Decoding DOJ’s July 29 Anti-Discrimination Guidance
- HRSA Seeks Applicants to Test 340B Rebate Model Pilot Program