Chapter 38 — Further Reading

A note peculiar to this chapter: regulatory sources go stale faster than scientific ones. A 2015 paper on peptide chemistry is probably still accurate. A 2015 description of a compounding rule may not be. Where a source below is a living document — an agency page, a prohibited list, a database — the point of reading it is to see the current version, not the version described here. And nothing in this list, or in this chapter, is legal advice for anyone's particular situation.

Tier 1 — Start here

The current WADA Prohibited List (wada-ama.org). Free, short, updated annually, and the single most useful document in this chapter's subject area for anyone in tested sport. Read the S0 and S2 sections in full. Note how S0 is written — as a description of a property rather than an enumeration of names — because that construction is what §38.8 is about. Read this year's version, not a summary of a previous one.

FDA, "Frequently Asked Questions About Therapeutic Biological Products" and the agency's biosimilar education materials (fda.gov). Plain-language explanations of the drug/biologic distinction and of what a biosimilar is and is not. The interchangeability discussion is the part most worth your time, because interchangeability is the mechanism by which follow-on competition actually reaches a patient.

FDA's compounding pages, including the material distinguishing 503A from 503B (fda.gov). The agency's own framing of the two categories, the shortage-related provisions, and the lists of bulk substances identified as presenting significant safety risks. If you read only one thing here, read whichever page states plainly that compounded drugs are not FDA-approved.

Approved drug labels — any peptide drug, "Indications and Usage" section. Free, authoritative, and short. Reading three of them side by side does more to teach what "indication-specific" means than any explanation, including this book's. Note how narrow the wording is compared with how the drug is discussed in public.

O'Connor CM et al., "Effect of Nesiritide in Patients with Acute Decompensated Heart Failure," New England Journal of Medicine, 2011. The ASCEND-HF trial. Roughly 7,000 patients, and the reason §38.10 has a concrete example rather than a hypothetical. Read the primary endpoints and the discussion; the interesting part is how the trial simultaneously exonerated the drug on the safety worry and deflated it on efficacy.

Tier 2 — Go deeper

Jeremy A. Greene, Generic: The Unbranding of Modern Medicine (Johns Hopkins University Press, 2014). A history of how generic substitution came to exist and what had to be true — legally, politically, and analytically — for "the same drug" to become a defensible claim. The best available background for why the biosimilar pathway could not simply reuse the generic machinery, and therefore for §38.2.

Daniel Carpenter, Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton University Press, 2010). Long, scholarly, and unmatched on the question of why a regulator behaves as it does. Carpenter's central argument — that the agency's power is built on reputation, and that this shapes what it approves and how — is the best correction available to both the "captured regulator" and the "gold standard" caricatures.

Jerry Avorn, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs (Knopf, 2004). Still the clearest general-audience account of how approval decisions get made and how post-marketing evidence changes them. The material on drugs that looked good at approval and less good afterward is directly relevant to §38.10's first error.

Ben Goldacre, Bad Pharma (Fourth Estate, 2012). Read it for the argument about what regulators see versus what the published literature contains — a point this chapter leans on when it says a regulator reads data that never reaches a journal. Goldacre is polemical and occasionally overstates; read it alongside Carpenter rather than instead of him.

Peer-reviewed literature on the insulin biologic transition. Search terms: "insulin transition biological product," "deemed to be a license," "insulin biosimilar." A substantial health-policy literature examines what the March 2020 transition was expected to do and what it has done. The gap between the two is the interesting part, and it is a live argument rather than a settled one.

Anti-doping case law and published decisions. Decisions of the Court of Arbitration for Sport and national anti-doping tribunals are frequently public. Reading two or three S0 cases is the fastest way to understand how the "not approved by any governmental regulatory health authority" test is actually applied — and how rarely the argument "but it doesn't even work" gets anywhere.

Tier 3 — Specialist and reference

Peter Barton Hutt, Richard A. Merrill, and Lewis A. Grossman, Food and Drug Law: Cases and Materials (Foundation Press, multiple editions). The standard American casebook. Not light reading and not written for you, but if you want to see how the categories in this chapter are actually argued about, this is where the arguments live. Use the most recent edition; earlier ones predate much of the framework described here.

The regulatory text defining "protein" for purposes of the biological product definition (United States, Code of Federal Regulations). Worth reading once, in the original, precisely because it is two sentences long and decides so much. Note the qualifiers — alpha amino acid, specific, defined sequence — and consider which molecules sit awkwardly against them.

The Dietary Supplement Health and Education Act of 1994 and the FDA guidance on new dietary ingredient notifications. The statutory basis for §38.7. The guidance documents on what qualifies as a dietary ingredient are where the peptide question actually gets decided, and they are more readable than you would expect.

International Council for Harmonisation (ICH) guidelines (ich.org). The technical standards that make it possible for agencies in different countries to review broadly comparable dossiers. Reading a single ICH efficacy guideline explains a great deal about why international agreement is more common than §38.9's emphasis on divergence might suggest.

National regulator databases: EMA's medicine pages, MHRA, PMDA, TGA. Free, searchable, and the correct way to check a "it's approved in [country]" claim rather than accepting it. Many publish public assessment reports — which is the thing you actually want, because the assessment report tells you what the approval rested on.

If you only do one thing

Open the current WADA Prohibited List and read section S0 — the whole thing, in the original wording. It is a few lines long.

Then sit with what it says: that any pharmacological substance not currently approved by a governmental regulatory health authority for human therapeutic use is prohibited at all times.

Notice that it is a rule about a property, not a list of names. Notice that it contains no clause about whether a substance works. Notice that under its logic, the newer and more experimental a compound is, the more certainly it is prohibited — which is the exact inverse of how gray-market marketing presents novelty.

Five minutes, one document, and the most common argument in the performance-peptide world stops working. If you are subject to an anti-doping code, read it every January, because it changes.