What is a critical regulatory issue in health care?

An example of a critical regulatory issue in health care is the process of developing a new drug for sale according to the National Institutes of Health. Federal bureaucracy, private regulatory agencies that may have conflicts of interest and an unclear division of authority are factors that keep the process from being streamlined.

The drug approval process involves:

• Gaining U.S. Government approval through the Food and Drug Administration (FDA) and the Patent and Trade Office.
• Marketing the drug in accordance with New Drug Approval (NDA) regulations.
• Placing the drug with private companies that manage pharmacy reimbursement plans.
• Dispensing the drug through highly-regulated physicians and pharmacists.

Health care regulation — the governing of health care by federal, state and local laws as well as regulations from within health care institutions — is complex. If the process remains inefficient and flawed, unsafe drugs may potentially be approved, while useful drugs may be kept off the market.