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Add PreP and PEP to The List of Drugs the FDA Should Make OTC

Summary:
This week California Governor Gavin Newsom signed into law a bill that allows people at risk for contracting HIV to obtain both pre-exposure prophylaxis (PreP) and post-exposure prophylaxis (PEP) directly from a pharmacist, avoiding the inconvenience and expense of having to visit the doctor for a prescription. Drugs that provide HIV prophylaxis are classified as prescription-only by the Food and Drug Administration. States get to determine the scope of practice of their licensed health care practitioners. Expanding the scope of practice of pharmacists to allow them to prescribe a prescription-only drug has been increasingly used by state legislatures to work around the federal prescription requirements in order to improve access (and decrease cost) to medications their residents want and

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This week California Governor Gavin Newsom signed into law a bill that allows people at risk for contracting HIV to obtain both pre-exposure prophylaxis (PreP) and post-exposure prophylaxis (PEP) directly from a pharmacist, avoiding the inconvenience and expense of having to visit the doctor for a prescription. Drugs that provide HIV prophylaxis are classified as prescription-only by the Food and Drug Administration. States get to determine the scope of practice of their licensed health care practitioners. Expanding the scope of practice of pharmacists to allow them to prescribe a prescription-only drug has been increasingly used by state legislatures to work around the federal prescription requirements in order to improve access (and decrease cost) to medications their residents want and need.

The legislation improving the availability and access to HIV prophylaxis is an excellent public health measure that was endorsed by the California Medical Association and received bipartisan support.

California also has a well-developed syringe services program, operating in the state since the 1980s, aimed at getting clean needles to, and reducing needle sharing among, intravenous drug users.

Both needle exchange programs and expanding access to HIV prophylaxis are two excellent public health measures that, in combination, should go a long way towards the goal of eliminating new cases of HIV, and can be enacted on the state level without requiring federal consent.

California’s move represents the latest example of states using work-arounds to reduce the costs and obstacles of getting prescription-only drugs to consumers. Ten states have allowed pharmacists to prescribe oral contraceptives, which the American College of Obstetrics and Gynecology has urged be made over-the-counter for years. And all 50 states and the District of Columbia have used work-arounds so that opioid users can get the overdose antidote naloxone directly from the pharmacist.

While these efforts by states are laudable, a better approach would be for the FDA to reclassify these drugs as over-the-counter. Past experience tells us that prices drop when a drug moves to OTC. But, more important from a public health standpoint, when drugs become available OTC they can be sold at outlets other than pharmacies—in hundreds of thousands of retail outlets—even in vending machines. This will help get these drugs to the many consumers who may not have a pharmacy close by, or are deterred from asking for a prescription from a pharmacist due to stigmas attached to the drugs they are requesting.

For this to happen, the FDA needs to be more aggressive and proactive in reclassifying drugs as over-the-counter.

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