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.

A plan to give people in the United States easier access to unproven peptide drugs favored by Health Secretary Robert F. Kennedy Jr. was opposed by most Food and Drug Administration scientific staff members, who had limited input in drafting the policy, according to six people familiar with its development.

Like most of American healthcare, kidney care has for decades been plagued by red tape. The Trump administration says it wants to change that. On Tuesday, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced his department's Kidney Care National Plan, which promises to introduce more competition, reduce regulatory barriers, expand patient choice, and overhaul America's kidney transplant system.

Much of the plan focuses on barriers to entry in dialysis care, which treats nearly 558,000 Americans. While dialysis can be performed at home, most patients receive treatment at specialized facilities, which must comply with federal certification requirements governing equipment, staffing, water quality, and patient safety in order to participate in Medicare.

Kennedy argues that regulatory barriers have discouraged competition and innovation, leaving patients with fewer dialysis treatment options. "Dialysis technology is an extraordinary technology," said Kennedy at the press conference, but "because of monopolies in the system and the barriers to new entrants, we have not seen any real improvements in that technology."

Of course, the existence of large or even monopolistic companies is not in itself evidence of a problem, but government regulation can often entrench those companies' positions in the market. "I like the fact that they're recognizing that a lot of regulatory…barriers are contributing to the problem, and that's refreshing to hear," says Jeffrey Singer, a practicing general surgeon and senior fellow at Reason Foundation, the nonprofit that publishes Reason. Singer says that removing barriers that prevent new companies from competing with established providers could not only increase choice but also drive down prices.

HHS says that two companies, DaVita and Fresenius Medical Care, control approximately 74 percent of the American dialysis market. As of 2019, roughly a third of Americans lived in areas where the only available dialysis provider was one of those two companies, according to the agency. The administration argues that government regulation has helped entrench this dominance by making it difficult for new providers to enter the market.

To address this, the Kidney Care National Plan suggests a number of reforms, including simplifying certification requirements. HHS also plans to investigate whether dominant dialysis providers have used payment arrangements and legal strategies to secure higher reimbursements without delivering better care.

The 17-page report calls for a review of existing requirements, but it does not specify which regulations will be repealed, nor does it establish a timeline for doing so. It also does not propose any significant reduction in the government's role in financing the distorted market. Instead, the plan largely seeks to make existing government-financed systems such as Medicare more competitive and efficient.

Kennedy has also correctly identified the need for reform regarding kidney donations. Nearly 90,000 people are waiting for a kidney transplant at any given time in America, and 11 people die every day waiting for a kidney. The transplant process is currently managed by Organ Procurement Organizations (OPOs), which are federally certified nonprofits responsible for recovering organs from donors and coordinating their transfer. There are currently just 55 federally designated OPOs operating in the United States, and HHS argues that they behave as "regional monopolies." Since no new OPOs have been approved in the last year, the Kidney Care National Plan suggests fast-tracking certification.

The plan also seeks to make living kidney donation easier by reducing financial barriers. Following the passage of the Honor Our Living Donors Act in February, HHS revised federal reimbursement rules so that a donor's eligibility for financial assistance is no longer determined by the transplant recipient's income. Eligible donors can receive up to $6,000 to cover expenses, including travel, lost wages, and childcare.

However, the reforms proposed stop short of allowing kidney donors to receive direct compensation for the organs themselves, which remains prohibited under federal law. "I can sell my blood. Why can't I sell my kidney?" Singer asks.

Peter Jaworski, director of the Georgetown Blood and Plasma Research Group, feels similarly, arguing that financial incentives are available to nearly everyone involved in kidney transplantation except the donors themselves. "According to this plan, it's OK to use incentives to encourage them to be more productive, to actually do a better job," Jaworski tells Reason, referring to transplant surgeons, hospitals, and organ procurement organizations. "The only exception, once again, is the donor who is offering a kidney."

Better solutions exist, according to Jaworski, who points to the proposed End Kidney Deaths Act. The bill, which was introduced by Rep. Nicole Malliotakis (R–N.Y.) last year, would offer living kidney donors a $50,000 refundable tax credit, distributed over five years. "We have those systems in order to make sure that we can treat patients. That's the point of blood donation. That's the point of plasma donation. That's the point of kidney donation too."

America's plasma market is an excellent example of financial incentives encouraging donation. Unlike many other countries, the U.S. allows plasma donors to be compensated, and despite accounting for just over 4 percent of the world's population, it supplies approximately 68 percent of the plasma collected globally for manufacturing medicines.

"Why do you think America does it? Is it because in America there's way more altruism than in France or Italy or Belgium? No, it's because in the United States you can be paid to donate plasma," argues Jaworski.

The Trump administration appears to recognize that government overreach has stifled competition and restricted patient choice. It also recognizes that living adults donating kidneys will be part of the solution to the long, deadly waiting lists. But its plan leaves the government's outsize role in kidney care largely untouched. For patients facing years on dialysis or waiting for a lifesaving transplant, recognizing the problem is not enough.

The post RFK Jr. Wants To Cut Red Tape in Kidney Care. He Should Go Further. appeared first on Reason Magazine.