The New York Times reports today that two small oral contraceptive makers, Cadence and HRA Pharma, have been seeking to make their birth control pills over-the-counter since 2016. The Food and Drug Administration has taken five years “dialoguing” with the pharmaceutical firms but has yet to give them “clearance” to formally apply for the switch. The Times article cites an FDA spokesperson as saying the agency hopes to reach a decision within 10 months of the companies submitting a formal application.

As I have written here, birth control pills are available over-the-counter in over 102 countries. That includes countries like communist China and Cuba. The U.S. joins Saudi Arabia and most Western European countries in denying women access to birth control pills without a permission slip from another autonomous adult, i.e., a licensed health care practitioner.

This is not the first time the FDA has blocked or delayed access to safe and necessary drugs. These drugs range from non-steroidal anti-inflammatory agents like ibuprofen to non-sedating antihistamines like Claritin (safer than over-the-counter alternatives like Benadryl).

The FDA has been infringing on the fundamental and sacred right to self-medicate since at least 1951, when the Durham-Humphrey Amendment to the Food, Drug, and Cosmetic Act of 1938 was enacted. Prior to that time, the manufacturers could decide whether their drug should be sold over-the-counter or prescription-only. They would base their decisions on the complexity of the drug, the likelihood of adverse reactions, and the risk of liability. Sadly, that decision became centered in a government monopoly agency which unavoidably adds the precautionary principle, politics, and special interest pleading into the mix. Michael Cannon and I dive into this in great detail in our October 2020 white paper, “Drug Reformation: End Government’s Power to Require Prescriptions.”

In our white paper we offer several reform proposals, including intermediate ones. One intermediate proposal is for Congress to adopt a rule that would automatically assign over-the-counter status to drugs that are OTC in a group of designated countries. Returning to the antihistamine example, Claritin was available over the counter in Western Europe several years ahead of the U.S. Statin drugs and asthma inhalers are OTC in the UK today, as is insulin in Canada. The opioid overdose antidote naloxone is OTC in Australia, Italy, and France, but is still prescription-only in the U.S. (Many states have come up with workarounds to this by having their state health directors, if they are licensed physicians, issue “standing orders” for naloxone.)

For more than a decade the American College of Obstetrics and Gynecology and the American Academy of Family Physicians has called on the FDA to make birth control pills available over-the-counter. Research shows making contraceptives over-the-counter leads to improved continuation. Research also shows women are quite diligent when they self-screen for oral contraceptives. Physicians concur with 90 percent of their assessments, while the women are more conservative than the doctors for the remaining 10 percent.

Michael Cannon and I have pointed out that switching from prescription to over-the-counter usually causes the price of the drug to fall. Thus a switch would make oral contraceptives more affordable and accessible to women of all income strata. But more importantly, it would respect women’s autonomy and their right to self-medicate.

The House-passed Build Back Better Act (BBBA) purports to make insulin more affordable. As Cato adjunct scholars Charlie Silver and David Hyman write in Overcharged: Why Americans Pay Too Much for Health Care:

Insulin is a drug used by millions of Americans afflicted with diabetes. It is off-patent and made by three companies, so it should be reasonably priced. It is not. The past two decades have seen stunning price increases. Short-acting insulin, which cost about $21 in 1996, went for about $275 in 2017. And…the prices went up in lockstep, even though there were two companies making short-acting insulin. Prices for long-acting insulins, which also had two makers, rose in tandem too.

Insulin prices are high not because the government has not intervened in health care but because government has intervened. Government has created an oligopolistic market for insulin where manufacturers raise prices far higher than they could in a free market.

• Congress, through the U.S. Food and Drug Administration (FDA), creates barriers to entry into the market for new and generic insulins, which reduces the number of manufacturers and facilitates tacit price collusion.
• Medicare, Medicaid, and the tax preference for employer-sponsored health insurance encourage excessive insurance. Since those policies heavily insulate diabetics from the price of insulin, they make diabetics less willing to switch to lower-priced insulins when insurers use that strategy to keep insulin spending down.
• Congress, through the FDA, requires diabetics to get prescriptions for most insulins, which adds the cost of a doctors’ visit and inhibits bulk purchases and discounts.
• Congress, through the FDA, restricts the right to purchase lower-priced insulin from other countries, including Canada where prices are lower and insulin is available without a prescription.

Unfortunately, the BBBA would not fix any of these policy errors. Instead, it takes the exact wrong approach to rising insulin prices by further encouraging excessive insurance.

Yes, the BBBA would would allow Medicare to “negotiate” the price of insulin with manufacturers. This would be great, if it resulted in Medicare paying lower prices for insulin, and thus lower Medicare spending and lower taxes. But it likely won’t. Why?

The next thing the BBBA would do is require private insurers to cover a range of insulin products, and require Medicare Part D plans to cover all insulin products, with just a $35 monthly copay. It is precisely because this measure would limit diabetics’ price-sensitivity that it would put upward pressure on insulin prices and prevent Medicare from negotiating lower prices.

When Medicare demands price concessions that insulin manufacturers consider unacceptable, or threaten to de-list uncooperative manufacturers’ insulin products, those manufacturers will complain to members of Congress. They will launch lobbying campaigns. And they will win. Because the voters who care about this issue – diabetics – will not care about prices. Congress will have capped their contribution to the price of their insulin at $35 per month. They will care only about maintaining their access to the (overpriced) insulin that they prefer. So diabetics will side with Big Pharma against the interest of taxpayers and they will succeed. This patient-pharma pincer movement is why Medicare has always overpaid for drugs. It is why Medicare will continue to overpay even under the BBBA. And woe unto any Medicare bureaucrat or member of Congress who gets in the way.

If Congress wants to lower the price of insulin, it should remove barriers to entry into the U.S. market by reducing regulatory burdens on generics and allowing purchases of insulin from other countries without limit. It should eliminate prescription requirements for all insulins. It should allow enrollees with Medicare and private insurance to keep the savings from switching to lower-price insulins, which would finally spark price competition in this market.

Just when we see encouraging signs that prohibitionists are beginning to learn that drug prohibition is the main cause of harm production from nonmedical drug use–with new initiatives at home and abroad to decriminalize illicit drug use–policymakers in New Zealand are about to add a widely used drug to the list of the prohibited: tobacco.

Reuters reports that New Zealand’s government intends to introduce legislation next year that would completely ban the sale of tobacco products to all people in the age 14 and under cohort beginning in 2027 and continuing indefinitely. At the same time, it will cut back on the number of licensed tobacco retailers and order the gradual reduction in nicotine concentration in all tobacco products sold to existing legal customers. The goal is to create an entirely “smoke-free” generation beginning in 2027. This will make New Zealand one of the most restrictive countries in the world with respect to tobacco use. Only Bhutan, which banned tobacco entirely in 2010, is more restrictive.

When will they learn? Prohibition only serves to open up new markets for the underground trade. Bhutan’s prohibition opened a new market for tobacco products smuggled primarily from India. The Bhutan government’s news service Kuensel reported in 2017 that this healthy black market made Bhutan’s rate of per capita tobacco users the highest in South East Asia at 24.6 percent:

Despite complete ban on tobacco sales, tobacco use remains high among 13- to 17-year-old which constitutes 9.4 percent of the total population

Bhutan also has the highest number of adolescents using other tobacco products at 29.3 percent followed by Timor-Leste (27.1 percent) and Thailand (14 percent).

The data used in the report are from the latest round of the global school-based student health surveys implemented by the member states of the WHO SEA region.

According to the report, while almost all countries in the region with a few exceptions legally restrict supply including sale of tobacco and alcohol to people under a certain age ranging from 18 to 21 years and completely ban the supply and sale of drugs, the results show their use remains high among 13–17-year-olds.

The Bhutanese seem to be learning from their disastrous mistake. Recognizing that increased tobacco smuggling is a main cause of COVID-19 transmission in its southern provinces, this past summer Bhutan’s National Assembly lifted the ban on the sale, importation, and distribution of tobacco products to persons over age 18. Growing tobacco or manufacturing tobacco products within the country’s borders remains prohibited. Bhutanese legislators are also considering repeal of its 100 percent sales tax on tobacco products. The national news service reported the proposal to repeal the sales tax was “made so that tobacco is available at the cheapest rates possible and shopkeepers and consumers do not resort to smuggled products.”

One would expect sophisticated leaders in New Zealand to be acutely aware of the harmful unintended consequences—and utter futility—of prohibition. If prohibition hasn’t worked for drugs that are much less popular, why would anyone they think it will work for tobacco?

I wrote earlier this year that a proposal to ban menthol cigarettes in the U.S. is likely to worsen racial inequities in the criminal justice system. Menthol cigarettes are particularly popular among young adults and in Black and Brown communities. With law enforcement already attracted to the “low-hanging fruit” of people like Eric Garner selling loose cigarettes on the street, adding menthol cigarettes to the menu of black market products can only make matters worse.

New Zealand is not immune to such an outcome. At present, roughly 12 percent of New Zealanders smoke, but 29 percent of indigenous Maori adults smoke. Expect this minority group to be a marketing target for black market tobacco dealers.

The New Zealand Department of Corrections reports that Maori are disproportionately represented in criminal justice statistics “to an alarming degree.” In 2016 the New Zealand Herald told readers Maori are imprisoned at twice the rate of New Zealanders of European descent. A phased in ban on tobacco products, as New Zealand policymakers envision, can only make matters worse.

If New Zealand is interested in reducing the harmful effects of tobacco smoking, it should liberalize its vaping regulations, which recently placed most flavored e‑cigarettes off limits. Nicotine-containing e‑cigarettes are a proven means of helping tobacco smokers quit. There is no evidence they are a gateway to tobacco smoking among youth.

It’s not too late for New Zealand lawmakers to change their minds about this.

With drug overdose deaths surging, policymakers and lawmakers increasingly recognize the value of harm reduction strategies in saving lives. Syringe services programs (SSPs), formerly called needle exchange programs, are a time-tested strategy and, in May of this year, Arizona became the latest state to enact legislation that legalizes them.

Federal law permits states to have SSPs, yet many states still prohibit them. States that permit SSPs vary greatly in the regulation and restriction as well as the number of SSPs they allow to operate. Every state except Alaska has drug paraphernalia laws that criminalize the possession, sale, or distribution of supplies used to make, test, or ingest illegal drugs. These laws define in detail the items that constitute “paraphernalia.” State laws ranging from those that permit patients to purchase syringes for medical use to those that permit harm reduction organizations to operate SSPs are all exceptions to their paraphernalia laws. Corey Davis, et al argue that paraphernalia laws are major obstructions to harm reduction efforts and should be abolished.

On December 7 the Substance Abuse and Mental Health Services Administration announced the start of a $30 million grant program to aid state and community-based harm reduction programs, including syringe services programs. At the same time, the White House Office of Drug Control Policy released model legislation to assist state lawmakers seeking to permit and promote SSPs in ways that don’t restrict their efficacy.

These developments occurred within days of New York City announcing it was opening two Safe Consumption Sites in defiance of the federal law prohibiting them. The federal government is currently in litigation that seeks to block a similar effort in Philadelphia.

These are encouraging signs that policymakers may be finally realizing we will never have a drug-free society, and that much of the harm resulting from drug use is a direct result of drug prohibition.

The main weapons against COVID-19 are the vaccines developed by Moderna and BioNTech after a decade of their research into mRNA technologies. That research was supported by more than $3 billion of private angel investment and venture capital.

Democrats and Republicans both support medical research funding, and Republicans tout the Trump administration’s Operation Warp Speed. But governments were not the key to mRNA development. Instead, we can thank the leaders and scientists at Moderna and BioNTech and the suppliers of private capital to them, as I discuss here and here.

The Wall Street Journal’s Allysia Finley discusses mRNA, Moderna, and BioNtech in a new piece. She focuses on the “vast promise of mRNA technology” beyond COVID-19. Numerous companies are developing mRNA vaccines for influenza, which are expected to be more effective than current vaccines. And Finley reports, “Moderna is also advancing vaccines for other infectious diseases, including Zika, HIV, Epstein-Barr, CMV, human metapneumovirus, parainfluenza virus and respiratory synclinal virus.”

There are many applications of mRNA technologies beyond infectious diseases. Finley says these may include regenerating heart tissue for patients with heart failure, addressing aging-related diseases, and stimulating the production of cartilage to ease arthritis. And she notes, “Autoimmune diseases … are another promising area of research. BioNTech this year published a study that showed an mRNA vaccine has potential to treat multiple sclerosis without suppressing the immune system like existing therapies do.” And there is cancer, which is BioNTech’s main focus. The company “has 21 mRNA products in its clinical pipeline that use 11 different approaches to killing cancer cells.”

These revolutionary developments are not being led by governments, but by biotech and pharmaceutical companies. The government can help by minimizing taxes and regulatory burdens. Capital gains taxes are crucial, as I discuss here. If investors in biotech are not allowed to keep a substantial return on their rare big wins, they will move their money to safer and lower-tax investments.

The largest factor producing rising living standards over the long run is technological progress and innovation. Startups and young growth companies funded by private capital make a huge contribution to innovation, which policymakers should keep in mind when considering all changes to tax and regulatory policies.

We can see with mRNA that a small number of determined investors, scientists, and entrepreneurs can make a major advance that may generate massive benefits to society years down the road. That is why it would be very short-sighted to raise taxes on capital gains. The same is true of raising taxes on business capital investment, which embodies much of our innovation and technological progress.

As policymakers consider the various tax increases in the Democratic reconciliation bill, they should know that the large and long-term benefits of mRNA-type advances are generally not captured in economic models used to judge tax-policy effects. Let’s not undermine medical advances that will benefit all of us—let’s keep taxes low and the breakthroughs coming.

Political polarization hinders progress against the COVID-19 pandemic.

Political polarization may explain why, after former President Trump called the off-label use of the anti-malarial drug hydroxychloroquine a “game-changer” in the battle against COVID-19 (randomized controlled trials found that is not the case), public health officials and the mainstream press appear uninterested in the off-label use of any other drugs as therapeutics against a COVID infection.

For example, impressive data from randomized controlled trials show the off-label use of the off-patent (therefore cheap) antidepressant fluvoxamine (brand name “Luvox’) appears highly effective in preventing COVID infections from progressing to hospitalization or death. Yet it has garnered little attention from public health officials or the press

A tweet by Andy Swan went viral yesterday informing people that the Merriam-Webster online dictionary defines “anti-vaxxer” as:

: a person who opposes the use of vaccines or regulations mandating vaccination especially : a parent who opposes having his or her child vaccinated

It was later pointed out by Rob Gavagan on the same Twitter thread that Merriam-Webster has been using this definition since 2018. Therefore, the definition was not the result of COVID politicization. Nevertheless, it is clearly inaccurate and can only pour more fuel on the political fire.

It is wrong to imply that anyone opposed to the state forcibly vaccinating individuals, or anyone disagreeing with any of the official public health recommendations regarding vaccination is an “anti-vaxxer.”

What about the members of the Food and Drug Administration’s Vaccine Advisory Committee who were not in favor of vaccine boosters for everyone over 18 in the general population? Were they “anti-vaxxers?” Or what about the many renowned experts—many of whom advise federal and state public health officials—who support vaccination but believe people with infection-acquired (“natural”) immunity may not need boosters or may need only one dose of the two-dose vaccine regimen? Do they meet Merriam-Webster’s definition of “anti-vaxxers?”

The New York Times reported there was a debate among members of the FDA’s Vaccine Advisory Committee over recommending vaccinating children aged 5–11 against COVID:

During a long debate before the vote, some committee members questioned whether every child in the age group really needed the vaccine or whether it should be limited to those at high risk of severe Covid-19 — an easily identifiable group, with underlying conditions such as obesity or other risk factors.

Dr. James E.K. Hildreth, the president and chief executive of Meharry Medical College, said that since many children between 5 and 11 may already have some immunity after contracting the virus, the need to vaccinate broadly in the age group might be less urgent.

“It just seems to me that in some ways we’re vaccinating children to protect the adults, and it should be the other way around,” he said. “I do believe that children at highest risk do need to be vaccinated. But vaccinating all of the children to achieve that just seems a bit much for me.”

And I recently wrote that vaccinations are the most effective harm reduction tool in the COVID pandemic toolbox. I have also written why I believe it is both morally and practically wrong for the state to mandate vaccinations. I am not an “anti-vaxxer.”

One can be pro-vaccine yet against mandatory vaccination. And one can be pro-vaccine and hold more nuanced views than the regulators do regarding who should get vaccinated.

Science is a process, not a religion. It requires constantly challenging long-held beliefs and assumptions. Injecting politics and dogmatism threatens scientific integrity. Merriam-Webster can undo an unintentional disservice to the scientific community by correcting its definition of “anti-vaxxer.” 

The City of New York announced today that it has authorized two safe consumption sites (sometimes called “overdose prevention sites”), both of which will be operated by a pair of non-profits. One will be in East Harlem and the other will operate in Washington Heights.

This comes about 6 months after Rhode Island’s governor signed legislation authorizing a safe consumption site pilot program that becomes effective in early 2022. The City of Philadelphia has been trying without success to establish Safehouse, after the project was challenged by federal prosecutors. This past October the U.S. Supreme Court refused grant certiorari after the 3^rd Circuit Court of Appeals ruled 2–1 that safe consumption sites violate federal law.

In March 2019 the Cato Institute held a policy forum evaluating harm reduction strategies for the overdose crisis, and a very interesting panel was held on safe consumption sites that included former Pennsylvania Governor Ed Rendell, a principal in the Safehouse endeavor.

As I’ve mentioned previously, safe consumption sites have existed since the mid‐​1980s, and now operate in more than 120 locations in 66 major cities throughout Europe, Canada, and Australia. The Government of Canada has authorized 38 safe consumption sites since 2016, after studying the success of its first site, Insite, which was founded in Vancouver, BC in 2003.

An unsanctioned safe consumption site has been operating in this country clandestinely since 2014, and researchers have been tracking and reporting on its success reducing overdoses (without revealing its name or location) in the peer-reviewed medical literature. Others operate underground in cities like Seattle, sometimes using apartments and operating like “speakeasies.”

Unfortunately, federal law, specifically the “Crack House Statute,” makes safe consumption sites illegal in the U.S. But a growing number of jurisdictions, aware that safe consumption sites are saving lives throughout much of the developed world, appear willing to test the resolve of federal prosecutors as overdose deaths continue to mount. Congress should repeal the Crack House Statute and get the federal government out of the way of cities and states trying to prevent overdose deaths.