Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Drugs are approved by FDA based upon substantial evidence from clinical trials that the medicine will be both effective and safe for use if prescribed according to its labeling. However, there may be issues that need additional evaluation after approval.
FDA’s ability to require post-approval studies, referred to as post-marketing requirements (PMRs), has evolved over time. Prior to 2007, FDA could require post-approval studies for the few drugs approved under the accelerated approval pathway, for the rare drugs approved based solely on animal studies and, in certain cases, for drugs that may be used in pediatric populations. If FDA wanted other types of post-approval studies, it would seek an agreement with the manufacturer, called a post-marketing commitment or PMC. The FDA Amendments Act of 2007 (FDAAA) was a major step forward for drug safety in the United States. It gave FDA authority to require safety-related PMRs when the agency becomes aware of new safety information.
FDA is committed to making sure industry fulfills their PMRs and PMCs and that the post-market studies are transparent to the public. Certain information about PMRs and PMCs is made available to the public in a searchable database on the agency’s website. Additionally, the FDA monitors the progress of PMRs and PMCs to ensure they are conducted in a timely manner. Each year, FDA issues a report via a Federal Register (FR) Notice on the status of PMRs and PMCs. Our most recent FR report shows that, overall, the majority of PMRs and PMCs are progressing toward completion according to the original agreed-upon schedule (85 percent of PMRs and 77 percent of PMCs).