To his credit, Dr. Rahul Gupta, the Director of the Office of National Drug Control Policy (ONDCP), has expressed an appreciation for harm reduction strategies to address the overdose crisis, and appears committed to using them. The latest example is a plan to deploy drug paraphernalia “vending machines” in rural Kentucky.

As Sophia Heimowitz and I explained in a recent Cato policy analysis, state drug paraphernalia laws block harm reduction organizations from establishing syringe services programs (also called SSPs or “needle exchange programs”), a proven way of reducing the spread of HIV and other infectious diseases, distributing the opioid overdose antidote naloxone, and offering rehab services to people who use drugs. Kentucky law explicitly permits such programs. There are now 80 SSPs operating in Kentucky, more than any other state. Unfortunately, many people in the most rural regions of the state have not been using these services. Therefore, to improve outreach, the National Institutes on Drug Abuse (NIDA) is teaming up with the University of Kentucky School of Public Health to install kiosks containing clean syringes, fentanyl test strips, hygiene kits, condoms, naloxone, and other paraphernalia in rural parts of the state.

Such kiosks are nothing new. They have been used to reach isolated people in Canada, Australia, and Europe for decades. Several other states have recently deployed them. As the Washington Free Beacon reports, in some cases the kiosks contain smoking equipment. The ONDCP came under withering criticism when news leaked that it might endorse distributing “crack pipes,” and walked back the idea.

But as we learned at a Cato policy forum last June, there is a public health rationale for making smoking equipment available: an increasing number of IV drug users have switched to smoking opioids in addition to stimulants. Illicit fentanyl is being sold in the black market more and more often in pill form, and users find it easier to pulverize and smoke the pills than to liquify and inject them. (It is also safer, since smokers can adjust the dose they inhale to the desired result rather than risk overdosing on an unknown quantity of intravenous fentanyl.) Smokers of illicit drugs use makeshift tubes of glass or metal which often produce cuts and sores in the oral area. Sharing smoking paraphernalia is another way to spread disease. The reporter at the Washington Free Beacon was unable to ascertain if the kiosks in Kentucky will contain smoking equipment.

Kiosks are no substitute for the human contact and interaction of syringe services programs. SSPs are more likely to succeed in bringing users into rehab. But kiosks certainly help get safe drug paraphernalia to hard-to-reach individuals. Hopefully the strategy will catch on and spread to other jurisdictions.

Roughly three weeks ago I sounded a hopeful note that California would be the second state to defy federal law and authorize safe consumption sites. In early August the California legislature passed and sent to Governor Gavin Newsom’s desk SB 57. The bill, introduced by Senator Scott Weiner, would have authorized the County and City of San Francisco, the County and City of Los Angeles, and the City of Oakland to approve safe consumption sites, dubbed “Overdose Prevention Programs” (OPPs). The authorization would remain in effect until January 1, 2028. Any jurisdiction establishing an OPP must contract with an independent third party, using private funds, to conduct a peer‐​reviewed study on the impacts of the program and submit results to the Governor’s office no later than January 15, 2027.

August 22 was the deadline for Governor Newsom to decide if he will veto the bill, sign the bill, or let the bill become law without his signature. Alas, at the eleventh hour, the Governor vetoed the bill.

In a signed statement accompanying his veto, the governor said he was concerned the OPPs “could induce a world of unintended consequences.” The governor did not elaborate as to what any of those “unintended consequences” might be, other than to mention “worsening drug consumption challenges.”

But with overdose deaths surpassing 100,000 per year, it is hard to imagine how creating centers that are proven to prevent overdose deaths for more than three decades in more than 100 locations in Europe, Canada, and Australia can “worsen” drug consumption challenges, when the greatest challenge drug users face is death from overdose.

Governor McKee of Rhode Island signed similar legislation in the summer of 2021 authorizing safe consumption sites and began accepting applications from privately-funded organizations seeking to establish sites this past March. New York City opened two safe consumption sites in November 2021, and by April they had already averted 230 overdose deaths.

California’s political leaders, including Governor Newsom, often crow about California leading the rest of the nation in innovation. In this year’s State of the State Address, Newsom boldly claimed, “The California way means rejecting old binaries and finding new solutions to big problems.”

Safe consumption sites will continue to save lives in most of the rest of the developed world. They have been so successful in Canada since Insite, the first safe consumption site in North America, opened in Vancouver, BC in 2003, that Health Canada approved an additional 37 sites by 2020.

Sadly, perhaps because he is contemplating a presidential run in 2024, the governor quashed a chance, provided by the state legislature, for California to show the nation a new way to address the overdose crisis, and reverted to the safe political strategy of “old binaries”—in this case, the binaries being abstinence or death.

Today the Food and Drug Administration issued a final rule which will give millions of Americans over-the-counter access to hearing aids that heretofore required a prescription. The new rule, scheduled to take effect in mid-October, will benefit as many as 30 million people who suffer from hearing loss.

In 2017 Congress passed, and President Trump signed, the Over-the-Counter Hearing Aid Act as a rider on the FDA Reauthorization Act of 2017. The Act created a new category of OTC hearing aids as devices using air conduction to improve hearing among adults with mild to moderate hearing impairment. It differentiates these devices from devices that amplify sound for people with normal hearing, such as noise-cancelling headphones. The latter are not considered to be hearing aids. Regulations for the new class of OTC hearing aids were originally supposed to be released in 2020 but were delayed due to the COVID-19 pandemic. President Biden issued an executive order on July 9, 2021 that, among other things, prodded the FDA to speed up the rule-making process for OTC hearing aids.

The new rule applies only to persons over age 18 with mild-to-moderate hearing loss. Hearing aids intended for children and for people with severe hearing loss will still require a prescription.

This is welcome news. But it doesn’t go far enough. As Michael Cannon and I explain in Drug Reformation, the FDA has, since at least the 1950s, blocked access to countless life-saving and life-improving medicines and devices by requiring autonomous adults to get permission slips (i.e., prescriptions) from state-licensed gatekeepers, in order to acquire them. This violates their fundamental right to self-medicate. It also tends to inflate the prices of drugs and devices.

As we explain in Drug Reformation:

Evidence suggests that, in addition to the other access barriers they create, prescription requirements correlate with higher drug prices and that removing them correlates with reductions in drug prices…Numerous examples and studies show a correlation between removing prescription requirements and reductions in the price of a drug.

Consequently, the FDA estimates the new rule will save consumers roughly $2,800 for a pair of hearing aids.

Look for competition and consumer choice to further drive down the prices of OTC hearing aids, boosting access to these devices for millions who now go without them. The FDA should next liberate the children, as well as the adults with severe hearing loss.

The Washington Post recently reported on the logistic and technological failings of the United Network for Organ Sharing (UNOS), the private non-profit agency with a government-enforced monopoly on the United States’ system of procuring organ donations and matching donated organs to the over 100,000 people waiting for them. A report from the White House US Digital Service found that UNOS has been ineffective, lacks transparency, and relies on outdated software, with frequent system failures and cybersecurity concerns. While UNOS has resisted efforts to modernize and reform, these problems have necessitated billions of dollars every year for continuing medical treatments like dialysis and meant that the organ donation system has failed to prevent the deaths of thousands who could have been saved by getting a donated organ.

UNOS, and the entire organ donation system, is sorely in need of reform, but the ultimate issue with US organ donation is that there is a supply shortage caused by laws banning compensation for donors. The Summer 2022 issue of Regulation features ideas on how to overhaul the system from some of the experts involved in efforts to change US organ donation policy.

Most of the current problems stem from the National Organ Transplant Act (NOTA) of 1984, which established the system of monopoly contractors to supply donated organs (organ procurement organizations (OPOs)) overseen by an organ procurement and transplantation network (OPTN). UNOS has been the OPTN since a contract was finalized in 1986.

At the same time, the NOTA banned the purchase of organs, making it a federal crime for “any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce.” The justification for this ban was to prevent the exploitation of the poor by wealthy patients in need of organ transplants, but its effect has been to severely curtail the availability of donated organs.

The easiest way to address the shortage would be to provide some type of incentive for organ donors. As Van Doren has discussed previously, many people have animosity towards the sale of human organs. But if it is not immoral to do something for free, then it is not immoral to do it for money: “Adding money to a transaction never turns an otherwise moral exchange into an immoral one.”

The potential benefits of paying donors softens people’s animosity towards the idea, as long as the system is designed to limit the possibility of exploitation. Mario Macis, a Johns Hopkins University economist, describes his research on public attitudes towards compensation for kidney donation. In a survey of more than 2,500 people, Macis and his colleagues found that attitudes toward paying kidney donors depend both on ethical considerations and the potential for reducing the United States’ kidney shortage. Macis explains:

These results suggest that a majority of Americans would support compensating organ donors if the system were governed by a public agency ensuring transparency and fairness. The system with the highest support was one with non‐​cash compensation (such as contributions to a retirement account) provided by a public agency. Support for such a system ranged from 64% to 77%, depending on its hypothesized effect on lives saved.

Along these lines, Josh Morrison and Sammy Beyda of the advocacy group Waitlist Zero suggest emulating Israel’s donor support system. Israel provides living organ donors with temporary benefits such as an exemption from the national health insurance tax, reimbursement for health, life, and disability insurance expenses, paid time off from work, therapy, a recuperative vacation, and reimbursement for travel expenses. Since implementation in 2008, living donation rates in Israel have quadrupled. Morrison and Beyda estimate that a similar program in the United States with a similar increase in donations would save about 18,000 lives and billions of dollars per year.

Sally Satel and Alan D. Viard of the American Enterprise Institute propose more direct compensation through a $50,000 tax credit for living donors and a $5,000 tax credit for deceased donors. The physical and emotional health of prospective donors would be carefully screened, and there would be a six-month waiting period to deter people from donating organs impulsively or under duress. Satel and Viard note that opponents might view such compensation as “commodifying the body,” but argue that this concern is misplaced:

Recipients would not be allowed to buy organs; instead, donors would receive compensation from the government for contributing to the public good. When a transplant is performed, the surgeons and hospitals are paid, as are the agencies that obtain and transport the organs in the case of cadaveric organs. Currently, the only entity in the entire process that does not receive any compensation for its contribution is the donor, who bears a modicum of risk and myriad costs as well.

Even with some form of compensation for donors, as long as there is not a pure free market for organ donation, the system the government relies on for matching donated organs to potential recipients requires reform. Abe Sutton, former White House domestic policy advisor, proposes several reforms to the system of OPOs and OPTN to improve their performance. Most notably, Sutton argues that organ procurement policy has prioritized the incumbency and monopoly of the current system participants at the expense of patients. The system should be opened up to competition through standard government contracting procedures. Furthermore, Sutton proposes reforming governance of the OPTN, separating the policy-making and technological functions of the OPTN, opening the technology component to all bidders to better identify the best vendors, and making de-identified OPTN data publicly available to increase the transparency of the system.

The Post’s report on the current issues with UNOS, and its refusal to be transparent and to modernize, highlight the need for the reforms Sutton suggests. Even with a more effective procurement and matching system, however, the fundamental problem of the supply shortage would remain. The most direct way to address this shortage would be incentivizing donors, who currently endure the risks and costs of organ donation without any financial compensation.

Congressional Republicans have defeated a proposal by congressional Democrats to mandate that private insurance companies cap out-of-pocket spending on insulin by their enrollees at $35 per month. Republicans were right to do so. Government is already driving insulin prices sky-high. Further intervention would make matters worse.

Diabetics need insulin to live. Insulin prices should be falling over time, yet they have more than doubled over the last 10 years. Many diabetics struggle with those rising prices, sometimes with deadly consequences. A humane health system would make insulin increasingly accessible to diabetics.

Government has made the U.S. health sector inhumane toward diabetics.

• First, to bring a new insulin product or delivery system to market, manufacturers must go through the U.S. Food and Drug Administration‘s wildly expensive processes for approving new drugs and medical devices. Elsewhere, my colleague Dr. Jeffrey Singer and I report “in 2019 dollars, the average estimated cost of each new drug approval has risen from $523 million in 1987 to $1.2–1.8 billion in 2000 to $3.2 billion in 2013. The cost grew at an average annual real rate of 9.4 percent in the 1970s, 7.4 percent in the 1980s, and 8.5 percent from 1990 through the early 2010s.” The high cost of government regulation discourages the development of new insulin products, reduces the number of insulin manufacturers, and increases the prices of any products that do make it through that process, both by requiring manufacturers to recoup those regulatory-compliance costs and by enabling tacit price collusion (see below).
• Second, government increases the cost of insulin by requiring diabetics to get prescriptions before purchasing many insulin products. It makes little sense to require diabetics, who are highly knowledgeable repeat consumers of insulin, to obtain prescriptions each time they purchase it. Canada allows diabetics to purchase any insulin product without a prescription. If the FDA or Congress were to remove those requirements, both the price of insulin and the ancillary costs of obtaining it would fall.
• Third, even though U.S. diabetics have a fundamental human right to travel to Canada to purchase lower-cost insulin without a prescription, the FDA infringes that right by prohibiting U.S. residents from purchasing more than a 30-day supply. Removing that restriction would cause average insulin prices to fall and make insulin more accessible to U.S. diabetics.
• Fourth, government pushes insulin prices higher still by encouraging excessive levels of health insurance, both in “private“ and government-subsidized insurance. As Cato scholars explain here, here, and here, excessive health insurance encourages providers to increase prices because heavily insured patients care less about price increases. The fact that government insulates consumers from the price of their health insurance then guarantees that consumers will rebel against attempts by insurance companies to negotiate lower prices, such as by excluding high-price drugs or providers from coverage. When Congress capped cost-sharing for contraceptives at $0, prices for hormones and oral contraceptives skyrocketed.
• Cato adjunct scholars Charlie Silver and David Hyman write in Overcharged: Why Americans Pay Too Much for Health Care that government-encouraged excessive coverage enables tacit collusion among insulin manufacturers to raise prices. Insulin manufacturers have little incentive to cut prices—and every incentive to raise them—because government already so heavily insulates diabetics from the price of insulin that reducing prices does not gain manufacturers a larger market share.
• Fifth, government discourages private insurance companies from structuring insulin cost-sharing to maximize the long-term health of diabetics. If insurance companies had lifelong relationships with their enrollees, they would have incentives to structure cost-sharing for insulin and other preventive care in a way that keeps their enrollies alive and paying premiums while minimizing their enrollees’ long-term medical spending. Insurance companies do not have lifelong relationships with enrollees because Congress penalizes lifelong insurance. The U.S. tax code penalizes workers unless they obtain employer-sponsored health insurance, a type of health insurance that disappears when workers change jobs. Given that Americans change jobs on average a dozen times by age 52, insurance companies that invest in promoting cost-effective preventive care (e.g., insulin use) will not see the long-term benefits of that investment. Those benefits will likely go to one of their competitors, either another private insurance company or the government. Thanks to government, insurance companies at best only have an incentive to maximize the short-term health of diabetics.

Had government never intervened in the health sector, private insurance companies might already be offering more comprehensive cost-sharing for insulin than congressional Democrats propose, without driving insulin prices higher. Or perhaps insulin prices would be so low that no one would feel the need to purchase insurance that covers it. All we know for sure is that, like past government interventions, attempts by government to cap cost-sharing for insulin will have unintended consequences that make matters worse for diabetics and all consumers.

If Congress and/​or federal bureaucrats really wanted to expand access to insulin, they could do so tomorrow. But it would require them to give up some of their power. The fact that congressional Democrats and the rest of the federal government will not give up even a little bit of their power in order to help diabetics tells you where their hearts really lie.

This week the California State legislature passed and sent to the Governor’s desk SB57, introduced by Senator Scott Wiener, which authorizes the County and City of San Francisco, the County and City of Los Angeles, and the City of Oakland to approve safe consumption sites, dubbed “Overdose Prevention Programs” (OPPs). The authorization remains in effect until January 1, 2028. Any jurisdiction that establishes an OPP must contract with an independent third party, using private funds, to conduct a peer-reviewed study on the impacts of the program and submit results to the Governor’s office no later than January 15, 2027.

This bill was passed almost exactly one year after Rhode Island’s Governor signed similar legislation. Last November, the City of New York authorized two safe consumption sites. A privately-funded organization in Philadelphia, authorized by the City Council, has been attempting to establish a site called Safehouse since 2018, but the organization’s efforts have thus far been thwarted by the U.S. Department of Justice (DOJ).

California’s action is the latest attempt to apply a proven harm reduction tool used by much of the developed world (a total of 40 are now approved in Canada), though federally banned in the U.S. by a law called the “Crack House Statute” (21 U.S.C Sec. 856), which prohibits people from renting, leasing, using, or maintaining a place for the purpose of consuming controlled substances. Thus far the Biden DOJ has not acted against Rhode Island or New York City.

As drug overdose deaths multiply, more state and local governments are flouting federal law to save lives. Hopefully these efforts will culminate in Congress repealing the Crack House Statute and getting the federal government out of the way of people trying to save lives and prevent the spread of disease in their communities.

Sometimes it feels as if it’s March 2020 again. Back then I complained that bureaucratic red tape from the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) made Americans wait too long to access COVID-19 tests when they were already widely available in much of the developed world. That made it more difficult to slow the spread of the virus at a time when vaccines and therapeutics were not yet available. Now it appears the FDA and CDC are about to repeat the same mistakes with monkeypox testing and treatment.

In the past, monkeypox outbreaks were rather uncommon, small, and short-lived outside of the African continent where the virus originated. Because of this, commercial tests have not yet been developed in the U.S. or elsewhere. Increased global travel and trade means that monkeypox will likely become endemic worldwide, increasing the demand for rapid and accurate tests.

Testing for monkeypox requires sampling secretions from the monkeypox lesions. As in the early days of the COVID pandemic, tests were initially only done at the CDC and some of its 67 designated federal laboratories in 48 states. In late June the CDC authorized Labcorp, Quest, Mayo Clinic, and Aegis Science labs to perform the tests as well. Unfortunately, those labs can detect the presence of an orthopox virus (monkeypox, smallpox, and cowpox are members of that virus family), but positive samples must then be sent to the CDC for typing to confirm they are monkeypox. Several days can go by before confirming a patient has monkeypox. Last month Stanford University School of Medicine announced its Clinical Virology Laboratory developed an in-house PCR test that bypasses the cumbersome CDC confirmation system and yields a specific result in 24–48 hours. Hopefully the FDA will not repeat the mistakes of March 2020 by throwing regulatory sand in the gears of academic and commercial laboratories that are responding to the demand for rapid monkeypox tests.

Most monkeypox patients get better on their own without treatment in 2 to 4 weeks. This clade of monkeypox appears non-lethal. No deaths have occurred anywhere in the world since the outbreak began. But sometimes lesions can become secondarily infected by bacteria and lead to pneumonia, eye infections, and encephalitis. Therefore, it would be good to have a drug that can make monkeypox infections resolve more quickly, before complications develop. Such a drug exists. The antiviral drug tecovirimat or TPOXX, used to treat smallpox and cowpox, works on monkeypox as well. The European Medicines Agency authorized the drug to treat monkeypox in the spring.

Unsurprisingly, regulators in the U.S. are behind the curve. While approved to treat smallpox, the drug is not yet approved to treat monkeypox. But in mid-July, the CDC began an Expanded Access-Investigational New Drug (EA-IND) program, through which clinicians can use the drug to treat their monkeypox patients. Under its EA-IND umbrella, the CDC provides TPOXX from the national stockpile through state and local health departments. Initially clinicians had to submit cumbersome paperwork to prescribe the drug. Hoping to ease that burden, the CDC later began allowing clinicians to submit the paperwork after beginning treatment. However, the inconvenience—and disincentive to prescribing—remains. Furthermore, the CDC recommends against prescribing TPOXX until testing confirms a monkeypox infection. Because waiting for the CDC to confirm that a positive orthopox test from one of the commercial labs is indeed monkeypox delays treatment even longer, the CDC lets clinicians treat their patients as soon as they receive a positive test for orthopox—since it is highly likely viral typing will confirm it is monkeypox.

Like the antiviral Paxlovid used to treat COVID, TPOXX must be started soon after symptoms appear for it to work to resolve the infection and heal the lesions quickly. When the FDA issued Emergency Use Authorization (EUA) of Paxlovid on December 22, 2021, the agency included unworkable prescribing guidelines and required a positive test before Paxlovid could be prescribed to patients. At the time, rapid at-home self-administered test were not widely available, and in most cases, patients had to wait 2 to 3 days for a test result and then get in to a doctor’s office. By then the window for the drug to work might have already closed. Josh Bloom and I argued in the New York Daily News back then that these regulations were counterproductive and harmful to COVID patients. We concluded:

A better approach would be for the FDA to remove the testing requirement, stop micromanaging nuanced clinical decision-making, and let doctors use their knowledge and judgment in deciding to whom and when to recommend the drugs. Physicians, not government agencies, are best equipped to be making critical decisions concerning the health of their patients.

Eventually, as rapid COVID tests became widely available, the Biden Administration implemented the “Test to Treat Program,” a much more efficient strategy, which gives patients ready access to rapid tests in retail pharmacies and wisely permits pharmacists to prescribe Paxlovid to patients who test positive.

Alas the FDA and CDC seem poised to repeat with monkeypox many of the mistakes in testing and treating that they made with COVID. In contrast, the New York City Department of Health states in its Interim Guidance for Treatment of Monkeypox:

Tecovirimat should be considered broadly for treatment of monkeypox, and patient selection is at the discretion of the treating clinician under the EA-IND. Both oral and intravenous formulations are available. Empiric treatment can be considered if there is appropriate clinical indication prior to laboratory confirmation, especially in the context of limited or delayed testing. (emphasis added)

Unfortunately, New York’s Department of Health can’t unburden prescribers of the CDC’s required paperwork. But at least one public health agency is showing signs it is learning from the mistakes of the recent past.