title: Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe.
abstract: The US Food and Drug Administration is often criticized as inefficient compared to its European counterpart, the European Medicines Agency. This criticism is especially common in the field of oncology, where severely ill patients have few therapeutic options. We conducted a direct drug-to-drug comparison of the two regulatory agencies' approvals of new oncology drugs. We found that contrary to public assertions, the median time for approval for new cancer medicines in the United States was just six months--and that these new anticancer medicines are typically available in the United States before they are in Europe. Our findings reinforce the need for strong financial and public support of the Food and Drug Administration, so that such medicines can continue to be made available speedily to patients in need.
authors.affiliation: Friends of Cancer Research, Washington, DC, USA. sroberts@focr.org
authors.forename: Samantha A
authors.initials: SA
authors.lastname: Roberts
authors.forename: Jeff D
authors.initials: JD
authors.lastname: Allen
authors.forename: Ellen V
authors.initials: EV
authors.lastname: Sigal
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000494:pharmacology*; D002986:Clinical Trials as Topic; D003430:Cross-Sectional Studies; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data*; D015507:Drugs, Investigational / Q000494:pharmacology / Q000627:therapeutic use*; D005060:Europe; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy; D011786:Quality Control; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000970:Antineoplastic Agents; D015507:Drugs, Investigational