The Department of Health and Human Services (HHS) will let pharmacies produce and sell treatments involving six peptides that aren't specifically approved by the Food and Drug Administration (FDA). The move is meant to provide a "controlled alternative" to buying peptides from possibly sketchy foreign pharmacies, HHS said.

Under the new HHS policy, the agency will not "take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product" using one of six named "peptide bulk drug substance[s]."

This is a major win for peptide proponents, compounding pharmacies, and health freedom—and hints that HHS Secretary Robert F. Kennedy Jr. may be feeling frustration with the slow pace of things at the FDA.

The six peptides in question—BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500—were the subject of a summer meeting of the FDA's Pharmacy Compounding Advisory Committee (PCAC).

Up for debate was whether these six "bulk drug substances" and another, Emideltide, should be put on the FDA's Section 503A Bulks List. That list governs which substances licensed physicians and specialty pharmacies can compound into drug products without them being a component of an already FDA-approved drug or having "an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph."

In July, the panel voted to put six of the seven peptide-related substances under consideration (all except Emideltide) on the bulks list. But the panel's vote is not binding.

It's ultimately up to FDA authorities to decide whether they accept the advisory committee's recommendations. So far, no decision has been released.

But yesterday, HHS unveiled an "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances." And it effectively puts the committee's recommendations into practice by proxy.

Kennedy can't ensure FDA approval, of course. But he can—and will—stop HHS from taking action against physicians or pharmacies that compound and distribute these substances under his prescribed rules.

In an explainer about the new policy, HHS notes that "compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed." Nonetheless, "compounded drugs can serve an important medical need for certain patients" and "there is significant interest in the use of these peptides in compounding," it says.

Opponents of allowing more peptide-based treatments to be compounded by licensed U.S. pharmacies often focus on the fact that these products don't have FDA approval and may not have the extensive experimental backing required of FDA-approved treatments.

But people are already taking BPC-157, MOTS-c, and other peptides anyway, buying them from companies selling them under "for research use only" labels or obtaining them from foreign distributors. Peptides can even be found on discount everything-marketplaces like the China-based AliExpress.

Allowing licensed physicians and pharmacies in the U.S. to compound these substances without fear of being punished gives people access to safer options than they might otherwise have.

Pharmacies compounding peptide-based products under the rules set forth by federal law still have to be licensed in the states where they operate and follow certain rules, including a requirement that active ingredients used for compounding must be "accompanied by valid certificates of analysis" and "be compounded based on the receipt of a valid patient-specific prescription." Per the new HHS policy, they must also follow several other rules regarding the packaging and labeling of these peptides.

"The Secretary of HHS has determined that this limited enforcement-discretion policy will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients," notes the HHS explainer. "By allowing limited compounding of the substances addressed in this guidance under appropriate safeguards, the policy provides patients with a more controlled alternative."

It's an astoundingly reality-based policy for government health officials, who often act as if matters like this come down to a binary between perfect health and safety on one hand and certain danger on the other.

Rather than relegating peptides to gray or black markets until they (may be) pronounced all clear by the FDA, RFK Jr.'s HHS has chosen to balance safety with "patient choice and freedom," as the HHS states.

The post RFK Jr. Institutes Backdoor Approval of 6 Peptides appeared first on Reason Magazine.

Eight years ago, Scott Hancock, then 28, helped a 19-year-old acquaintance, identified in court records as T.G., buy fentanyl. At her request, Hancock, who had been addicted to opioids for years, got in touch with his drug dealer, who gave him five capsules that he handed over to T.G. in exchange for $20. Then Hancock gave the money to his dealer. Because T.G. subsequently died from a fentanyl overdose, Hancock is serving a 20-year sentence at a federal prison in Illinois.

That was the mandatory minimum sentence under 21 USC 241, which prescribes penalties for drug distribution resulting in death. Although that law has been on the books since 1986, the dramatic increase in fentanyl-related deaths during the last decade prompted a surge in federal drug prosecutions involving overdoses, which rose by 44 percent between FY 2019 and FY 2023. Hancock's case was part of that trend, and it prompted his mother, G.D. Hancock, a retired finance professor, to delve into the subject, resulting in a database that sheds light on what happens when the government treats accidental deaths as homicides.

So far, Hancock has identified 2,930 sentences in such cases since 2010. That includes 1,399 federal cases and 1,531 state cases, which rely either on laws dealing specifically with drug-induced deaths or on more general statutes addressing felony murder, "depraved heart" homicide, or manslaughter.

Sentences of 20 years or more were pretty common at the federal level, accounting for 37 percent of the cases, compared to 13 percent at the state level. The vast majority of the cases (84 percent) were resolved by plea deals. That is not surprising, given the potential consequences of going to trial. While the median sentence for defendants who pleaded guilty was nine years, it was 20 years for defendants who insisted on making the government prove its case.

Hancock's tally is based on news reports, court records, announcements by state and federal prosecutors, her own "case files and research," and "cases sent in by families, lawyers and researchers." A separate database compiled by researchers at Northeastern University, drawn from news reports, includes 3,264 cases involving drug-induced homicide from 2011 to 2022.

These prosecutions are morally nonsensical. They treat people who voluntarily consume drugs as helpless victims of supposed predators who gave them the drugs they wanted. By similar logic, bartenders and liquor store owners should be held criminally liable whenever a customer succumbs to alcohol poisoning or the long-term effects of heavy drinking. The main difference is the legal status of the drug, which is arbitrary, politically determined, and historically contingent. And while illegal drugs pose special hazards, that is a result of prohibition, which creates a black market where product composition is highly variable and unpredictable.

Charging people with homicide based on accidental overdoses would be illogical and unjust even if the defendants were limited to actual drug dealers. But you can be charged with drug-induced homicide even if your "trafficking" consisted of nothing more than sharing drugs with a relative, romantic partner, friend, or acquaintance. Based on the information Hancock was able to glean, she counts 241 cases where the person who died from an overdose was the defendant's friend, partner, or family member, and other sources suggest such prosecutions are common.

The Northeastern University researchers analyzed a sample of 213 online news reports from 2000 to 2017. They found that 50 percent of defendants charged with drug-induced homicide were caretakers, family members, friends, or partners of the people who died.

In 2021, when the Pittsburgh Tribune-Review examined Pennsylvania prosecutions for "drug delivery resulting in death" (DDRD), it described a case involving "a Westmoreland County man" who "died from an overdose of drugs he'd gotten from a friend of a friend of a friend." Although "the drugs ultimately came from a man called 'Bee' in Penn Hills," the paper noted, "the three individuals between the victim and Bee were all charged" with DDRD, a first-degree felony punishable by up to 40 years in prison.

The Tribune-Review described several other DDRD defendants, including "a Delmont woman" who "called paramedics when she found her boyfriend unresponsive in their bathroom"; "two friends" who bought heroin for a man who overdosed at a Taco Bell; and "a Monessen woman" who "sent her cousin to buy a brick of heroin" and "sold five stamp bags to a friend, who then sold four bags to an Elizabeth Borough man who died from a fatal overdose."

The Tribune-Review also found that "many facing these charges are relatively low-level dealers." Jonathan Fodi, a defense attorney and former prosecutor, told the paper he and his colleagues had never seen a DDRD case involving a high-level dealer. Given the need to prove a link between the defendant and the person who died, that is not surprising. But that situation compounds the injustice of treating such deaths as homicides, since low-level dealers often do not know exactly what is in the drugs they are selling.

A 2002 analysis of 32 drug-induced homicide prosecutions, published in the New Jersey Law Journal, found that "25 involved prosecution of friends of the decedent who did not sell drugs in any significant manner." According to a 2017 report by a Wisconsin TV station that looked at the 100 most recent prosecutions for drug-induced homicide in that state, "nearly 90% of those charged were friends or relatives of the person who died, or the lowest people in the drug supply chain." When the Chicago Tribune examined drug-induced homicide cases filed between 2011 and 2014, it found "the defendant was typically the last person who was with the person who overdosed."

Even people who support the war on drugs should be able to recognize the injustice of sending people to prison for 10 or 20 years based on their tangential roles in deaths they neither caused nor intended. And far from making such deaths less likely, that policy impedes potentially lifesaving medical assistance because the risk of a homicide charge is apt to discourage bystanders from calling for help. That daunting deterrent undermines the goal of "Good Samaritan" laws that are supposed to shield 911 callers from criminal charges in such situations.

The official justification for these prosecutions is completely disconnected from the reality of the cases. "Deaths from illicit drugs, especially fentanyl, are at historic highs," the Drug Enforcement Administration (DEA) said in a 2023 press release. Because the DEA is "committed to protecting Americans and saving lives by pursuing those responsible," the agency explained, it aims to "make sure as many drug traffickers involved in those deaths as possible get an appearance in front of a judge."

As an example of that strategy, the DEA cited Scott Hancock's case, describing him as a "trafficker" who was "found guilty of providing the drugs that killed a 19-year-old woman in 2018." Given the details of that transaction, it is hard to see the logic here. Sending someone like Hancock to prison for 20 years has nothing to do with "saving lives."

The post How Helping Someone Buy Drugs Can Send You to Prison for 20 Years appeared first on Reason Magazine.

Last March on Instagram, Students for Life President Kristan Hawkins posted a photo showing her and two other members of the Virginia-based group standing outside Space Center Houston. According to the captions, Hawkins and her fellow activists, one of whom was holding a mobile phone, were "ordering abortion pills undercover."

A lawsuit filed last week in Harris County, which includes Houston, describes that Instagram post as "nothing more than a publicity stunt." The lawsuit, which aims to deploy a Texas abortion law championed by Students for Life against the organization, is also a publicity stunt. But while it may be effective by that measure, it faces legal challenges that will be hard to overcome.

The lawsuit, which a Texas woman who opposes her state's abortion ban filed under the pseudonym Maria Puerto with help from the reproductive rights group Amplify Legal, is supposed to highlight the vagueness and broad scope of House Bill 7, a 2025 law that authorizes private civil action to enforce state restrictions on "abortion-inducing" drugs. But Puerto's attempted act of legal jiu-jitsu seems too clever by half, relying on a dubious reading of the statute to seek "monetary compensation" it does not authorize and thereby punish anti-abortion activists for constitutionally protected advocacy.

H.B. 7, also known as the Woman and Child Protection Act, says "a person may not manufacture or distribute an abortion-inducing drug in this state" or "mail, transport, deliver, prescribe, or provide an abortion-inducing drug in any manner to or from any person or location in this state." Those prohibitions, it says, "may be enforced only through a qui tam action" against a "person" who "violates" or "intends to violate" them.

Any "person" other than a state or local official can qualify as a "relator" authorized to bring such an action. The relator can seek injunctive relief and "an amount of not less than $100,000 for each violation," plus "costs and reasonable attorney's fees." A successful relator generally receives $10,000 of that "amount," with the rest going to a "charitable organization" of his choice.

As a "person" who is not a government official, Puerto meets H.B. 7's minimal test for standing. And although H.B. 7 precludes lawsuits against pregnant women who obtain "an abortion-inducing drug," Puerto says Hawkins and the other activists "are not pregnant and were not pregnant" at the time of the Instagram post. So far, so good. But although the lawsuit asserts that Hawkins et al. "openly and flagrantly violated" the law's prohibitions, it does not explain how.

A photo accompanying a recent Mother Jones profile of Hawkins shows her and her social media coordinator, Lydia Taylor Davis, outside Space Center Houston during their "abortion-pill 'sting' stunt." Another Mother Jones photo shows Hawkins holding a mobile phone displaying what Puerto's lawsuit describes as "an order confirmation."

Judging from the Mother Jones account, it is not clear whether that description is accurate. "The scheme rapidly went off the rails," Amy Littlefield writes. "The plan was to purchase pills from a couple of services, with Hawkins posing as a male abuser while Davis pretended to be a 16-year-old—all to try to portray mail-order suppliers as reckless and dangerous. For reasons even she couldn't explain, Hawkins chose the fake name 'Wanda' as her male-abuser alter ego. But when Davis input her information, she hit a snag."

Davis was trying to order pills from the Massachusetts Medication Abortion Access Project. But according to Littlefield, that organization "had blocked Davis in its system after Students for Life teased the sting operation on social media." Hawkins "attempted to save the stunt by placing her own order, but 'Wanda' accidentally gave her age as 15," which was below the supplier's minimum age, Littlefield says. "Now a security guard was wandering over to tell them they couldn't film. Having set out to show that telemedicine services don't screen their clients, they inadvertently proved the opposite."

Puerto "will need proof that the Students for Life leaders actually obtained or intended to obtain the pills," abortion law scholar Mary Ziegler notes in Slate. "The activists may argue that the post was not in earnest, and that no one involved ever seriously intended to bring pills into Texas."

Even assuming that Hawkins et al. successfully ordered abortion pills, that conduct by itself does not fit the language of H.B. 7, which applies to people who "distribute" such drugs or who "mail, transport, deliver, prescribe, or provide" them "to or from any person or location in this state." That language encompasses out-of-state suppliers, which raises obvious concerns about extraterritorial application of Texas law. But on its face, the prohibition does not cover someone who simply orders abortion pills.

Puerto's lawyer, Amplify Legal attorney Molly Duane, argues that Hawkins et al. could be covered by the statute's reference to transportation. "What the statute says is that transporting abortion drugs from one location to another within the state is a violation of H.B. 7," Duane told The Texas Tribune. "By the plain language of the statute, this would seem to be a violation. This is the problem with writing such a confusing and vague law."

Under that theory, however, Hawkins, Davis, and the two other activists named in the lawsuit violated H.B. 7 only if they 1) successfully ordered abortion pills, 2) took delivery of them, and 3) subsequently moved them to another location within Texas. The lawsuit alleges only that they "ordered abortion pills, apparently multiple times." According to The Texas Tribune, Duane and Puerto "are hoping that the lawsuit will eventually surface more about what the defendants did with the abortion pills once they ordered them."

The lawsuit faces another obstacle. H.B. 7 does not apply to "speech or conduct protected by the First Amendment." Hawkins et al.'s efforts to show how easily state abortion bans can be circumvented certainly seem to fall into that category. "Students for Life may stress that the case targets their political speech about abortion," which is "protected under the First Amendment," Ziegler notes.

Those are not the only puzzling aspects of the lawsuit. Puerto, a 26-year-old single mother of two young children, emphasizes that she "had no choice but to continue" those pregnancies because she did not "have access to transportation or the economic resources to pay for travel out of state." The lawsuit devotes 11 paragraphs to describing the burdens imposed by her state's denial of "true reproductive rights," which she argues justifies some sort of compensation.

All of this seems legally irrelevant under H.B. 7, which does not require a relator to allege damages of any sort, let alone damages stemming from the abortion ban it aims to reinforce. "With nowhere else to turn for assistance," the lawsuit says, "Ms. Puerto is seeking financial compensation" from Hawkins et al. "in the amount of $459,782—the average cost of raising two children from birth to age 18 in the state of Texas."

Although H.B. 7 sets a minimum award of $100,000, the lawsuit notes, "there is no cap on the monetary compensation owed a relator." But the law does not describe H.B. 7 awards as "monetary compensation" for injuries allegedly suffered by the relator.

The statute's only reference to "compensatory damages" deals with lawsuits filed against H.B. 7 relators under "clawback provisions" of other states that have tried to thwart such litigation. In response to a "clawback" action, the law says, an H.B. 7 relator can seek "compensatory damages, including money damages in an amount equal to the judgment damages and costs, expenses, and reasonable attorney's fees spent in defending the action." By contrast, the bounty for proving a violation of the restrictions on abortion pills is simply "an amount."

The lawsuit itself, emphasizing the lax standards for filing a claim under H.B. 7, notes that Puerto "did not suffer an injury traceable to [the defendants'] ordering of abortion pills that can be remedied by a court." But it suggests that an award to Puerto would be appropriate given the defendants' anti-abortion activism.

The lawsuit notes that Students for Life "proudly advertised" its support for H.B. 7. Puerto complains that Hawkins et al. "ignore the immense harms and multiple deaths already attributed to Texas's cruel abortion bans" and "demean the six million Texans of reproductive age who have had their ability to decide whether and when to begin or expand a family stripped away by these bans." Whatever you make of that charge, the defendants' activism is constitutionally protected and therefore cannot support a cause of action in civil court.

"Texas is a strange place filled with vigilante statutes" that "seek to turn Texans against each other," Duane told The Texas Tribune. "But if anyone should be benefiting from these legal regimes, it's people like our client." While "putting those two things together…might be unusual," she said, "this is the situation that Texas has put its citizens in."

Depending on your perspective, you may or may not sympathize with Duane's reasoning. But it seems unlikely to pass muster as a matter of law.

The post A Texas Lawsuit Dubiously Accuses Students for Life of Violating the State's Abortion Pill Restrictions appeared first on Reason Magazine.