This section is tricky. I recommend knowing a few laws and what they do.
- Food, Drug and Cosmetic Act (1938) – Give authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. Covers orphan drugs. The introduction of this act was influenced by the death of more than 100 patients due to a sulfanilamide medication.
- FYI: Medical devices are classed as I-III – I – least risk, II – moderate risk, III – highest risk. III requires FDA approval.
- Health Insurance Portability and Accountability Act (1996) – Created primarily to modernize the flow of healthcare information, stipulate how Personally Identifiable Information maintained by the healthcare and healthcare insurance industries should be protected from fraud and theft, and address limitations on healthcare insurance coverage.
- FDA Modernization Act (1997) – This act amended the Federal Food, Drug, and Cosmetic Act. This streamlined research on drugs and devices and established clincaltrials.gov. The act reauthorized, for five more years, the Prescription Drug User Fee Act of 1992 (PDUFA). The purpose of this was to enable the FDA to reduce the average time required for a drug review from 30 months to 15 months. The law abolishes the long-standing prohibition of broadcasting by manufacturers of information about unapproved uses of drugs and medical devices.
- FDA Safety and Innovation Act (2012) – This act gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority review voucher program to make eligible rare pediatric diseases.
- Best Pharmaceuticals for Children Act and Pediatric Research Equity Act (2002) – Companion legislation acts that together have resulted in a significant increase in new knowledge about the safe and effective use of medicines leading to a significant increase in the number of drugs that have pediatric labeling.
- Affordable Care Act (2010) – One thing it did that is applicable to clinical pharmacists was to establish biosimilar guidelines.
- FDA Amendments Act (2007) – This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. The FDAAA extended the authority to levy fees to companies applying for approval of drugs, expanded clinical trial guidelines for pediatric drugs, and created the priority review voucher program. An important thing it did was to establish REMS programs.
- REMs programs involve training for the prescriber, lab tests and a registry.
- You might check out the drugs with REMs programs on the FDA website.
- Institute For Safe Medication Practices (ISMP) – This isn’t a regulation, but there isn’t a good place to add it. The ISMP is a non-profit organization educating the healthcare community and consumers about safe medication practices. They publish safety alerts on emerging drug risks including QuarterWatch and unsafe abbreviation lists.