June 13, 2018

Pharmaceutical Access

Pharmaceutical access is an important component to assessing healthcare autonomy. The policy choice to regulate or prohibit a drug is often based on policymakers’ perception of the drug’s risk, social vice, and cost to public health, as well as their belief that there is a gap in knowledge between the consumer and the manufacturer. Caffeine is available without restriction, alcohol and tobacco are heavily regulated, and drugs such as cocaine and opium are subject to criminal prohibitions. Oral contraceptives, safe and effective medications for preventing pregnancy and treating some medical conditions, still require a healthcare provider’s prescription.

Technological innovation in drug manufacturing has increased production and product complexity, increasing the risk of therapeutic failure or death linked to consumer ignorance. This is the justification for drug regulation. Over time, a regulatory hierarchy has evolved, affecting access to certain drugs. Until the late 19th century, most drug regulations in the United States were enacted at the state and local levels. In the early 20th century federal legislation greatly expanded, initially with the Pure Food and Drug Act of 1906, which prohibited misbranded drugs, food, and drinks in interstate commerce and led to the establishment of the Food and Drug Administration (FDA). Over the years, the FDA’s ability to regulate, prohibit, and criminalize drugs has exponentially expanded.

The United States has never had a completely unregulated drug market. In 1632, the Massachusetts General Court banned smoking in public. The temperance movement has been a strong force in America since the 1830s. The enactment of Prohibition and the criminalization of certain drugs have been directly linked to public support. The zeal to control and limit drug use has resulted in a significant and unfortunate disjunction between regulation or prohibition and actual dangers. For example, access to pseudoephedrine, a cold medication that is also a precursor drug to methamphetamine, has been significantly restricted in recent decades with unclear benefit. The policy and legal failure of the War on Drugs is well recognized and has been linked to wasted public funds, erosion of civil liberties, and the incarceration of a large number of US citizens. One in five people jailed in the United States is incarcerated for a drug offense, which amounts to almost half a million people. The daily toll of drug overdoses fuels lawmakers’ urge to act, but policy outcomes correlate poorly with social benefits.

The Goldwater Institute initiated a campaign to give terminally ill patients access to investigational treatments, supported by public concern regarding delays inherent in the three-phase process of clinical trials. Right-to-try laws sponsored at the state level seek to bypass the FDA application process and expand access programs for patients who meet certain eligibility criteria. The Institute of Medicine (now the National Academy of Medicine) has endorsed therapeutic use of marijuana, and polling shows that more than 70 percent of Americans support medical marijuana use with a doctor’s prescription. Multiple states have enacted legislation granting access to marijuana, but possession remains a federal crime.

The HOAP index’s Pharmaceutical Access Subindex analyzes state-level freedom of access to (1) investigational treatments, (2) medical marijuana, (3) pseudoephedrine, and (4) over-the-counter oral contraceptives