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A 2016 US law that funded the Cancer Moonshot, created the RMAT designation for cell and gene therapies, told the FDA to work out how real-world data could support approvals, and made companies publish how patients can request unapproved drugs.

A 2007 US appeals court ruling that terminally ill patients have no constitutional right to buy unapproved drugs after phase 1, which pushed the access movement toward legislation and eventually the Right to Try Act.

The 2013 US Supreme Court ruling that human genes as they occur in nature cannot be patented, which ended one company's monopoly on BRCA testing and let hereditary cancer testing become cheap and widely available.

The 2010 US law that created a route for copies of biologic drugs such as trastuzumab and rituximab, while giving the original twelve years of protection from those copies.

The regulated way a seriously ill patient who cannot join a trial can get an unapproved drug: the doctor asks the company, the company agrees, and the regulator reviews the request, usually within days for a single patient.

The 2009 US law that finally gave the FDA power over tobacco products, the cause of roughly a third of cancer deaths, including authority to ban flavours, restrict marketing and set nicotine levels, though it may not ban cigarettes or nicotine outright.

The 2012 US law that created Breakthrough Therapy designation and made the paediatric study laws permanent, sitting on top of the 1992 user-fee law that gave the FDA review deadlines and the 1997 law that created Fast Track.

A December 2022 US law that lets the FDA insist the confirmatory trial for an accelerated approval is already running before the drug is approved, and gives it a quicker way to withdraw a drug when confirmation fails.

The 1938 US law that makes a company prove a medicine is safe before selling it, and the 1962 amendments that added the requirement to prove it works, which is why every cancer drug approval rests on controlled trials.

A 2008 US law that stops health insurers and employers using your genetic test results against you, so a BRCA or Lynch syndrome result cannot raise your premiums or cost you a job; it does not cover life, disability or long-term care insurance.

The 1984 US law that created the modern generic drug: copies are approved on bioequivalence alone, brands get patent time restored for years lost in review, and the two sides fight it out through patent challenges with a 30-month pause.

The 1996 US law whose privacy rules govern how hospitals, insurers and their contractors may use and share a patient's health records, including tumour genomics, and what must be stripped out before data can be used for research without consent.

The 2022 US law that for the first time lets Medicare negotiate prices for top-selling drugs, capped what older patients pay for prescriptions at 2,000 dollars a year, and exempted drugs approved only for rare diseases, an exemption widened in 2025.

Medicare's way of paying for a promising but uncertain test or treatment only for patients enrolled in a registry or study, used for PET scans in cancer from 2006 and now the frame for how Medicare covers gene panels and cell therapies.

The 1983 US law that pays companies to develop drugs for rare diseases with seven years of market exclusivity, tax credits and fee waivers, which is why so many cancer drugs are first approved for a rare subtype.

Two US laws, one a carrot and one a stick, that get new drugs studied in children: BPCA gives six extra months of exclusivity for doing requested paediatric studies, and PREA requires paediatric assessments, though until 2020 cancer drugs mostly escaped it.

A 2018 US law letting patients with life-threatening illnesses ask a company directly for a drug that has passed phase 1 without going through the FDA; companies still decide, and in practice most access happens through the older expanded access route.

A wave of US state laws, starting in 2021, that require insurers regulated by the state and often Medicaid to pay for the tumour and inherited gene tests that decide which targeted drug a patient should get.

The US rules that require an ethics committee to approve research on people and require informed consent, written in 1991 and rewritten in 2018 so that a single committee can oversee a multi-site cancer trial and patients can give broad consent for future use of their samples.

Since December 2019 it has been illegal across the United States to sell tobacco or vaping products to anyone under 21, a rule that started in one Massachusetts town and spread state by state, aimed at the years when most smokers start.

Separate from patents, US law gives an approved drug fixed periods during which the FDA will not approve a copy: five years for a new chemical, three for new clinical studies, seven for an orphan indication, twelve for a biologic, plus six months for paediatric studies.