How has the regulation of pharmaceuticals changed over time?

Pharmaceutical law in Washington has evolved over time to keep up with advances in drug development and technology. Historically, laws focused on ensuring that drugs were safe and effective before they could be approved for sale. The Food and Drug Administration (FDA) was originally established in 1906 to oversee the safety of foods, but it has since expanded to regulate the production and distribution of medications as well. More recently, the focus of regulation has shifted to include efforts to ensure the affordability of medications, prevent drug manufacturers from engaging in unethical practices, and guard against drug abuse. In 2003, the Medicare Part D program was enacted to help seniors afford the cost of prescription drugs. The Prescription Drug Marketing Act of 1987 protects consumers from counterfeit or misbranded drugs. In 2015, the Drug Supply Chain Security Act was passed to ensure the integrity of drug products throughout the supply chain. In addition to legislation, other agencies, such as the Office of National Drug Control Policy and the Drug Enforcement Administration, have been tasked with regulating drug use and preventing drug abuse. These efforts include tracking the distribution of certain drugs, such as opioids, to prevent diversion and reduce overdose deaths. Over time, the regulations governing pharmaceuticals have grown more complex, but they are necessary to protect patients and ensure they get the highest quality care.

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