Impact of COVID-19 on HIV testing

FDA proposes allowing certain prescription drugs to be sold over the counter

With everything going on, you might have missed a new announcement from the Food and Drug Administration (FDA). The agency released a proposed regulatory notice, titled “Over-the-counter drug product with an additional condition for use without a prescription (ACNU),” that would allow certain prescription drugs to be purchased without a prescription, provided that the manufacturer provides additional labeling and ‘other instructions for use, and applies certain conditions that the patient must meet before purchasing the drug.

Currently, over-the-counter medications, also known as over-the-counter (OTC) medications, can be purchased without consulting a doctor first. OTCs cover everything from cold medicine to aspirin to supplements and can treat a wide variety of conditions, from athlete’s foot to headaches. Over-the-counter medications should be labeled in such a way that the consumer has enough information to choose and administer the medications on their own without the help of a health care provider. For the most part, over-the-counter drugs don’t treat chronic health conditions, and that’s where the FDA sees an opportunity to expand the category of over-the-counter drugs.

Drugs that treat chronic conditions generally cannot achieve non-prescription drug status because their labels do not contain enough information for the consumer to select and administer them themselves – either because the drug’s effects are more complex than what may be indicated on a label, or because they require follow-up by a doctor. The proposed rule would require potential over-the-counter drugs that don’t need to be monitored by a doctor to have a UNAC as part of their new drug application. These ACNUs would provide an additional layer of information to help consumers determine if the drug is right for them. This information may be provided via an app or phone call, or other similar communication methods. The FDA estimates that the proposed rule would save the consumer an average of $26.70 per drug purchase by reducing the interaction between the consumer and the healthcare system, and would save new drug applicants $55,469. per request by reducing the number of meetings between the FDA and the industry. The FDA also projects savings for government and private payers, although it was unable to provide an estimate of those savings.

Overall, this rule is a common sense win-win. Consumers, manufacturers, and government and private payers would all save time and money. Consumers would no longer need to consult a doctor before purchasing a drug that is easy to self-administer and does not require monitoring. There’s an added bonus: it’s entirely possible that this rule will make consumers a little healthier overall. After all, studies show that even small barriers to getting medicine make people less likely to take the medicine they need. Manufacturers would spend less time haggling with others players in the prescription drug market, thereby reducing red tape and therefore the cost of drugs. Government and private payers would save money by not having to haggle with manufacturers and by reducing unnecessary interactions between doctors and patients needing prescriptions. There are also the potential downstream effects of patients being healthier and using services less if they adhere better to their medications. In short, the FDA’s proposed rule has real potential to improve patient outcomes and reduce costs.

Chart review: Impact of COVID-19 on HIV testing

Evan Turkowsky, Health Care Policy Intern

On June 24, the Centers for Disease Control and Prevention (CDC) released its report on how the COVID-19 pandemic has disrupted HIV testing, which is critical to combating the HIV epidemic in the United States. . From 2019 to the end of 2020, the number of CDC-funded HIV tests performed decreased by more than 43%. As shown in the table below, the most common sites for HIV testing are health care facilities, particularly sexually transmitted disease (STD) clinics and community health centers, which respectively conducted 24 .5% and 20.6% of all tests in 2020. These healthcare centers both facilities saw an almost 40% decrease in the number of tests performed from 2019 to 2020, while other sites in testing, including correctional facilities and non-healthcare community settings, saw the largest percentage drops in the number of tests distributed, at 73.7% and 59.8%, respectively. Notably, while overall testing has declined, the proportion of people newly diagnosed with HIV has still increased, from a positivity rate of 0.4% in 2019 to 0.5% in 2020.

Impact of COVID-19 on HIV testing

Data source: CDC 2019 and 2020 Annual HIV testing reports

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