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Policymakers are now discovering that tobacco and e‑cigarette bans are not exempt from the iron law of prohibition.

Californians must still travel to Oregon or Colorado to exercise their fundamental right to self‐​medicate.

Oregonians will likely be asked to "fix" Measure 110 with "remedies" that have failed for more than 50 years and will only worsen the harms caused by drug prohibition.

Denying patients relief while enriching drug dealers: pseudoephedrine edition.

The DC Department of Health campaigns against an important tobacco harm reduction tool.

Expanding access to OUD treatment would reduce the number of people who seek drugs in the dangerous black market and, in turn, reduce the risk and incidence of overdose deaths.

Rescheduling marijuana still means that the millions of people who use marijuana recreationally are committing a federal crime. It also ensures that a black market in the prohibited plant will continue to thrive.

The senators tacitly admit that prohibition is the problem.

It is easier to embrace a false narrative than to face the inconvenient truth.

Jeffrey A. Singer


OnPoint NYC, the harm reduction organization tasked with opening and operating New York City's two overdose prevention centers (OPCs), announced that since the two centers (one in East Harlem and one in Washington Heights) launched on November 30, 2021, they had averted 1,008 overdoses. As of July 2023, more than 3,700 registered participants have used the centers nearly 84,000 times.
Unfortunately, the New York Times reports that Damian Williams, U.S. Attorney for Manhattan, responded to the news by implying he will take steps to close down the OPCs:
"I have repeatedly said that the opioid epidemic is a law enforcement crisis and a public health crisis," Damian Williams, the U.S. attorney for the Southern District of New York, said in a statement to The New York Times. "But I am an enforcer, not a policymaker." Until New York policymakers take action to authorize the supervised consumption sites, he said, they are operating in violation of federal, state and local law.
"That is unacceptable," he added. "My office is prepared to exercise all options — including enforcement — if this situation does not change in short order."

This is an ominous development. At a Cato online policy forum last March, Kailin See, the Senior Director of Programs for OnPoint NYC, told participants that the U.S. Department of Justice had sent inspectors to the two OPCs, who seemed pleasantly surprised at how they worked in the community. The Department of Justice has yet to act against the OPCs.
As I wrote in this Cato policy brief, OPCs have been around since the mid‐​1980s. There are now 147 government‐​sanctioned OPCs in 91 locations and 16 countries—including 38 in Canada, 14 in Switzerland (where the first OPC was opened in Bern in 1986), and 25 in Germany—preventing overdose deaths and the spread of HIV, hepatitis, and other diseases. But in this country, 21 U.S.C. Section 856, also known as the "crack house" statute, passed in the mid‐​80s, makes it illegal for entities to permit people to use prohibited drugs on their premises.
New York City's mayor defied federal law by authorizing OnPoint NYC to open the OPCs amid soaring overdose deaths during the winter of 2021. The National Institutes of Health announced in May that it will fund a study to assess the effect the OPCs have had on drug use, overdoses, and diseases.
And Rhode Island and Minnesota lawmakers have recently authorized OPCs in their states.
But as the saying goes, "No good deed goes unpunished." All this harm reduction progress can grind to a halt if the Justice Department decides to snuff out the OPCs.
In my policy brief, I called on Congress to repeal the "crack house" statute or "at an absolute minimum amend existing federal law so harm‐​reduction organizations can establish and run OPCs." Until Congress acts, no harm reduction organization seeking to save lives in its community can ever feel safe from law enforcement's wrath.

Jeffrey A. Singer


This June, Rep. Sheila Jackson‐​Lee (D‑TX) and more than 40 co‐​sponsors introduced H.R.4272, the "Stop Fentanyl Now Act." The bill essentially directs funding for the Secretary of Health and Human Services to develop programs to "provide outreach and awareness to the dangers of fentanyl" and enhances grants for "treatment and recovery services." It also increases penalties and fines for certain drug‐​related crimes.
While most of the proposal offers nothing new, Section 8 represents a welcome attempt to chip away at federal drug paraphernalia laws that undermine harm reduction.
The title of Section 8 is "Exclusion Of Fentanyl Drug Testing Equipment From Treatment As 'Drug Paraphernalia.'" The bill would amend Section 422 of the Controlled Substances Act (21 U.S.C. Section 863) that prohibits the interstate sale or transport of "drug paraphernalia." Section 422(d) defines "drug paraphernalia" and provides a list of examples. Section 422(f) lists exemptions.
This is the current language of Section 422(f):
(f) Exemptions
This section shall not apply to—
(1) any person authorized by local, State, or Federal law to manufacture, possess, or distribute such items; or
(2) any item that, in the normal lawful course of business, is imported, exported, transported, or sold through the mail or by any other means, and traditionally intended for use with tobacco products, including any pipe, paper, or accessory.

H.R. 4272 would add to Section 422(f):
(3) the possession, sale, or purchase of fentanyl drug testing equipment, including fentanyl test strips.

A week before Rep. Jackson‐​Lee introduced this bill, Rep. Jasmine Crockett (D‑TX) introduced H.R. 3563, called the STRIP Act. The STRIP Act clarifies in statute that "fentanyl drug testing equipment including fentanyl test strips" shall be excluded from the list of federally prohibited drug paraphernalia.
While both bills provide a welcome change to federal drug paraphernalia law, their wording is too narrow. As I explained to Rep. Jackson‐​Lee and her colleagues on the House Judiciary Committee Subcommittee on Crime and Government Surveillance last March:
[F]entanyl is just the latest manifestation of what drug policy analysts call "the iron law of prohibition."1A variant of what economists call the Alchian‐​Allen Effect, the shorthand version of the iron law states, "The harder the law enforcement, the harder the drug." Enforcing prohibition incentivizes those who market prohibited substances to develop more potent forms that are easier to smuggle in smaller sizes and can be subdivided into more units to sell.…The iron law of prohibition is why cannabis THC concentration has grown over the years. It is what brought crack cocaine into the cocaine market. And it made fentanyl replace heroin as the primary cause of overdose deaths in the United States.…The iron law of prohibition cannot be repealed. Already we have been getting troubling reports of the veterinary tranquilizer xylazine—drug users call it "tranq"—becoming an additive to fentanyl and other illicit narcotics. This tranquilizer greatly potentiates opioids' effects, producing more powerful "highs." Adding this potentiator again enables illicit opioids to be smuggled in smaller sizes and subdivided into more units to sell.…What makes xylazine more deadly is that it is not an opioid, and overdoses from it that cause people to stop breathing cannot be reversed with naloxone.

Fortunately, the company that manufactures fentanyl test strips now makes xylazine test strips. But neither the STRIP Act nor the Stop Fentanyl Now Act excludes xylazine test strips from Section 422.
I also warned Subcommittee members that the iron law of prohibition is responsible for the recent appearance of a new, more potent category of synthetic opioids called nitazenes. There are not yet any test kits for nitazene. Let's hope medical device manufacturers come up with them soon.
In a blog post about the STRIP Act, I wrote, "As long as policymakers persist in prosecuting America's longest war, the war on drugs, the iron law of prohibition guarantees there will always be a new and more potent drug to wage war against."
Here's a suggestion for lawmakers: exempt any drug testing equipment from drug paraphernalia laws. Better yet, repeal drug paraphernalia laws altogether.

Jeffrey A. Singer


On the same day that the Food and Drug Administration allowed women over‐​the‐​counter access to one progestin‐​only birth control pill, Rep. Mariannette Miller‐​Meeks (R‑Iowa) introduced the OTC (Orally‐​Taken Contraceptive) Act in the U.S. House of Representatives. The bill has seven Republican women co‐​sponsors. Notably, Rep. Miller‐​Meeks is also a medical doctor. As I have, the American College of Obstetrics and Gynecology, the American Academy of Family Physicians, and the American Medical Association have long supported making all hormonal contraceptives over‐​the‐​counter available.
Last session, Miller‐​Meeks co‐​sponsored the "Allowing Greater Access to Safe and Effective Contraception Act," which instructed the FDA to prioritize contraceptive makers' applications for over‐​the‐​counter status. But the OTC Act goes much further. The bill directs the FDA to provide guidelines to makers of hormonal contraceptives intended to facilitate their application for over‐​the‐​counter approval.
The bill's language appears inspired by how the FDA gradually nudged Emergent BioSolutions, the makers of Narcan naloxone nasal spray, to seek the agency's approval for over‐​the‐​counter sales. In that case, the FDA told makers of Narcan, who could charge high prices to third‐​party payers for the prescription drug, that the agency was likely to approve a generic competitor for over‐​the‐​counter access. The company then sought approval for over‐​the‐​counter status. Providing guidelines to hormonal contraceptive manufacturers on how to expedite over‐​the‐​counter approval might have a similar effect.
Congress has the authority to order the FDA to reclassify all hormonal contraceptives as over‐​the‐​counter by a specific date. But this bill certainly helps move the ball in the right direction.

Jeffrey A. Singer


Last November, I wrote about Senator Mike Lee's (R‑UT) effort to reduce pharmaceutical expenditures by introducing the Biosimilar Red Tape Elimination Act. This was an attempt to streamline the Food and Drug Administration's process to approve so‐​called biosimilar drugs. The bill didn't pass in the last Congress, but yesterday Senator Lee introduced a new and improved version. Biological drugs were only 0.4 percent of U.S. prescriptions, yet they accounted for 46 percent of U.S. drug spending in 2018.
Unlike conventional medicines, which drug companies chemically synthesize to a specific molecular structure, biological medicines have natural sources. Vaccines and blood products are examples of biologicals. When conventional drug patents expire, pharmaceutical makers produce generic versions to compete with the original drugs. The competition usually causes prices to come down. When biological drug patents expire, drug makers make biosimilar versions to compete with the original, thus driving down prices.
When the FDA approves a biosimilar, it defines it as having "no clinically meaningful difference" from the original (reference) biologic. FDA regulations can make it cost up to $250 million and take up to eight years for a drug maker to bring a biosimilar to market. The barriers to entry for biosimilars are much more challenging to overcome than those typically seen for generics.
But it gets even more complicated. In addition to the FDA determining that a biosimilar has no clinically meaningful difference from the reference drug, Congress created a category called interchangeability. For the FDA to classify biosimilars as interchangeable with the reference drug, manufacturers must put them through switching studies, delaying and increasing the cost of bringing biosimilars to market. These are trials where participants alternate back and forth between the reference drug and biosimilars to prove safety and efficacy. Unless they pass switching studies, the FDA will not approve biosimilars as substitutes for the reference drug.
This is important because some states have passed laws prohibiting pharmacists from substituting biosimilars for more expensive reference drugs if the FDA has not classified them as interchangeable.
Years of research suggest that "interchangeability" is unnecessary. Writing in the Journal of Clinical Pharmacy and Therapeutics, Dr. Sarfaraz Niazi stated:
FDA proposition that retesting an approved biosimilar is needed to allow it to interchange is faulty and irrational. Clinical efficacy testing is not needed for products that are supposed to be the same or highly similar because of the lack of sensitivity to show any difference. Once declared to have "no clinically meaningful difference," biosimilars should be interchangeable at the discretion of the prescriber. Two classes of biosimilars in the US will only help larger companies to prevent the entry of cost‐​effective biosimilars.

Furthermore, last year the European Medicines Agency (EMA)—the European Union's equivalent of the FDA—announced that it would not require switching studies to approve biosimilars and that all approved biosimilars "can be interchanged."
In April 2023, the American Society of Clinical Oncology called for ending the interchangeability requirement. One month later, the American Medical Association House of Delegates approved a resolution that stated:
RESOLVED, That our AMA advocate for state and federal laws and regulations that support patient and physician choice of biosimilars and remove the "interchangeable" designation from the FDA's regulatory framework.

The bill Senator Lee introduced last year prohibited the FDA from requiring biosimilar drugs to undergo switching studies before the agency approves them as interchangeable with the original biological medicine. The new, improved version he introduced yesterday is more straightforward and definitive. It would amend the federal code to state that all biosimilars that receive FDA approval are, by definition, interchangeable. This wording addresses state laws blocking pharmacists from dispensing biosimilars that the FDA had not explicitly designated as interchangeable.
The new version of the bill improves on the previous version. It should help to lower health care costs and improve patient access to the rapidly growing biological medicines market. It will bring FDA regulations into better harmony with EMA regulations. Unfortunately, the Biosimilar Red Tape Elimination Act leaves the rest of the cumbersome pharmaceutical regulatory regime intact.
As Michael F. Cannon and I pointed out in our white paper, the pharmaceutical regulatory system badly needs a complete reformation.

The FDA decision is only a mini step toward freeing the pill.

Jeffrey A. Singer


The Food and Drug Administration announced this morning that it has granted marketing approval for the over‐​the‐​counter sale of one type of birth control pill, a progestin‐​only pill (also called the "minipill"). As explained here, the minipill is not as easy to use as combination oral contraceptives. Dublin‐​based Perrigo, the maker of the pill that will have the brand name Opill, states it hopes to have the pill on the market by 2024.
As Josh Bloom and I wrote in May, enabling women to access this one brand of minipill is a ministep in the right direction. But the FDA should allow all women to access all forms of hormonal contraception over‐​the‐​counter.
Below are other articles I have written on the topic:
FDA Might Approve Over‐​the‐​Counter Sales of One Birth Control Pill. Now It's Time To Approve All the Rest
Hey FDA, Free the Birth Control Pill!
OTC Birth Control Pills–Just What The Doctor Ordered
LA Times: Birth control should be available over the counter. How Congress can make that happen
NY Daily News: Over‐​the‐​counter birth control? Bring it on
Time: Women Should Not Have to Visit a Doctor for Birth Control