FDA Regulations Limit Over-the-Counter Drug Access

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The article argues that the FDA should make more safe drugs available for over-the-counter purchase, starting with albuterol, in order to reduce costs and increase access to medicine. It cites examples of drugs like antihistamines and birth control pills that are available over-the-counter in many other countries but require a prescription in the U.S. due to outdated FDA regulations. The author suggests reversing the burden of proof so that drugs with a strong safety record are automatically considered eligible for over-the-counter sale unless the FDA can justify why they should remain prescription-only.

Why it matters

Allowing more safe drugs to be sold over-the-counter could significantly reduce healthcare costs for consumers by eliminating the need for doctor visits and prescription fees. It would also increase access to important medications, especially for those without insurance or the ability to regularly see a doctor. Modernizing FDA regulations in this area aligns with the Trump administration's promise to make more 'verified safe pharmaceutical drugs available for over-the-counter purchase' as part of its 'Great Healthcare Plan'.

The details

The article cites several examples of drugs that are available over-the-counter in much of the world but require a prescription in the U.S. due to FDA regulations. These include the asthma inhaler Primatene Mist, which uses the cruder drug epinephrine, while the more targeted and safer albuterol remains prescription-only. The article also points to antihistamines like Benadryl, which are available over-the-counter despite being more dangerous than the newer, safer alternatives like Claritin, Zyrtec, and Allegra. Similarly, birth control pills are available over-the-counter in over 100 countries but the FDA only recently approved a single brand of 'mini-pill' with strict restrictions.

• In 2001, an FDA advisory panel voted to allow over-the-counter access to newer, safer antihistamines like Claritin, but the agency delayed for years before approving them.
• The FDA approved over-the-counter access to Claritin in 2002, Zyrtec in 2007, and Allegra in 2011.

What’s next

Congress could adopt international drug reciprocity, allowing Americans to buy drugs over-the-counter that are already available on those terms in trusted countries like Australia, Canada, and the UK. This would spur the FDA to modernize its regulations and make more safe drugs available without a prescription.