Drug Reformation: End Government’s Power to Require Prescriptions

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https://www.cato.org/publications/white-paper/drug-reformation-end-governments-power-require-prescriptions

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U.S. law grants the Food and Drug Administration the power to make consumers get a prescription before purchasing certain drugs. The rationale behind government‐imposed prescription requirements is consumer safety—that is, the idea that some drugs are too dangerous for consumers to use without physician supervision.

 

Research shows, however, that government routinely requires prescriptions for drugs that are safe for consumers to use on their own. For years, Food and Drug Administration (FDA) prescription requirements steered consumers away from safer nonsedating antihistamines toward more dangerous sedating antihistamines. More recently and for political reasons, Presidents George W. Bush and Barack Obama collectively blocked access to “Plan B” emergency contraception for more than 12 years. The FDA continues to force consumers to endure unnecessary and costly visits to their doctors before obtaining routine‐use oral contraceptives and life‐saving drugs such as naloxone.

Government‐imposed prescription requirements violate the rights of individuals to access the medicines they want. Vesting this power in government has left Americans with less access to medicines overall—even relative to consumers in other nations where governments also impose prescription requirements. It imposes unnecessary costs that rise during public health crises such as the COVID-19 pandemic. Evidence also suggests that government‐imposed prescription requirements make patients less safe, not more.

Congress should deny the FDA any power to impose prescription requirements. Doing so would not end prescription requirements. The threat of tort liability would push pharmaceutical manufacturers to require authorization from a physician or other competent medical professional before consumers could purchase unusually dangerous drugs. Even without a statutory requirement, consumers would continue to consult health care professionals before accessing certain drugs when they see the need for expert advice. Drug manufacturers, pharmacies, and their liability insurers could develop innovative means of tailoring drug access to the risks that individual drugs pose.

Denying government the power to require prescriptions would expand drug access by reducing both drug prices and the associated nonprice costs of obtaining needed drugs. The evidence suggests that eliminating government‐imposed prescription requirements would lead to more‐judicious use of pharmaceuticals because consumers make more‐cautious drug decisions when the choice is theirs rather than when government forces them to consult physicians. Denying the FDA this power would help ensure access to beneficial medicines during the COVID-19 pandemic and subsequent public health crises.

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The current U.S. pharmaceutical regulatory regime is paternalistic. It restricts autonomy by denying consumers the right to self‐medicate and sometimes denies desperate patients an opportunity to save their own lives. It places the judgment of perceived experts above the autonomy of the individual. It fails to appreciate, much less replicate, the dynamism and responsiveness of a free market. It inhibits new drug development and contributes to excessive drug prices.

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Eliminating the FDA’s authority to impose prescription requirements on drug manufacturers and consumers would provide a safe and effective way to bring beneficial medications to patients who need them. Peltzman writes:

With the pressure mounting for action to restrain drug prices, you might think that speeding up and broadening the OTC transition would be on the FDA’s priority list or the priority list of its critics. But the topic is little discussed by anyone. This neglected area deserves more scrutiny.… Moving more drugs to OTC status is no free lunch, but it is as close to one as consumers are likely to get in the health care sector.²⁶³

The knowledge that some individuals would inevitably self‐medicate in ways that harm their health should not delay reform. Americans do the equivalent every day when they exercise their right to refuse potentially beneficial medical treatments.

The utilitarian argument for eliminating government‐imposed prescription requirements, moreover, is not that manufacturers and consumers of pharmaceuticals will never make harmful mistakes. It is that government is right now making far more harmful mistakes than would a free consumer populace aided by price competition, quality competition, third‐party certification, innovation, greater health literacy, and the threat of tort liability.

In any event, the burden of proof lies not with those who seek to restore the right of individuals to make their own medical decisions. It lies with those who would preserve laws that allow government to interfere in personal medical decisions. The individual‐rights argument for eliminating government‐imposed prescription requirements is that government has no legitimate authority to interfere in the first place.

Agreed.  State imposed prescription requirements needs to go away.    A fascinating white paper.