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Context: With the development of transformative drugs at a low point, numerous commentators have recommended new legislation that uses supplementary market exclusivity as an incentive to promote innovation in the pharmaceutical market.

Though patents are effective tools for promoting innovation and protecting intellectual property in the pharmaceutical sciences, there has been growing concern about 2 important ways that patents in this field can have a negative effect on patient care and the practice of medicine. First, inventors can seek and receive patents on pharmaceutical products or research tools that stretch the statutory requirements for patenting. Second, patent holders in the pharmaceutical market can used legal loopholes or aspects of the patent registration system to extend exclusivity for inventions beyond what was anticipated by the Patent Act or subsequent legislation. The monopoly control bestowed by such inappropriate patents or manipulation of the patent system can limit options available to patients, increase the cost of health care delivery, and make cooperative research more difficult. In response, several different government and market-based efforts have emerged to promote more equitable patent policy in health care that encourages dissemination of ideas while still supporting the development of innovative products.

There is popular and bipartisan support for legalizing the importation of lower-cost medicines from Canada to help reduce the high prescription drug costs that Americans pay. Despite the wide interest in this policy, attempts over the last sixteen years to create a formal system for large-scale prescription drug importation in the United States have failed. The Trump Administration recently issued a final rule to enable the legal importation of prescription drugs from Canada, but the rule has important design flaws and seems destined to suffer a similar fate as previous efforts. In this Article, we argue that prescription drug importation is a form of international regulatory engagement that can work, but not in the manner that recent congressional legislation or the Trump Administration has proposed. Importation of prescription drugs, even foreign versions of already-approved drugs, requires the importing nation to accept the marketing approval standards, processes, and product-specific decisions of the exporting nation as equivalent to domestic regulation. The FDA, however, has made far fewer determinations of foreign regulatory equivalence than its counterpart regulators. As a result, the statutory requirements for the FDA maintaining direct oversight over prescription drug imports from Canada are onerous and unlikely ever to be fulfilled. Examining U.S. prescription drug importation as a form of reliance on the equivalence of foreign regulation is, as far as we can determine, a novel inquiry, and it offers useful insights. Foreign equivalence determinations have been successfully used in pharmaceutical regulation in two contexts: (1) trade initiatives and (2) circumstances in which regulatory agencies were unable to fulfill their core institutional mandates without relying on the decisionmaking of their foreign counterparts. The FDA has not fit neatly into either of these contexts. In contrast to many of its foreign counterparts, the FDA has consolidated authority over pharmaceutical regulation, which it ...

OBJECTIVE: To determine differences in the characteristics of cancer drugs designated as orphan drugs by the Food and Drug Administration (FDA) and European Medicines Agency (EMA). DESIGN AND SETTING: Identification of all cancer drugs (initial or supplementary indication) with orphan status approved by the FDA between 2008–2017 based on publicly accessible reports. The European public assessment reports (EPAR) was searched to determine whether these FDA-approved drugs were also approved by the EMA. MAIN OUTCOME MEASURES: Extraction of active ingredient, trade name, approval date and approved indication from two FDA data sources (Orphan Drug Product Designation Database, Drugs@FDA) and comparison with the same data from EPAR. RESULTS: The FDA approved 135 cancer drugs with orphan indications that met our inclusion criteria, of which 101 (75%) were also approved by the EMA. 80/101 (79%) were first approved in the USA. Only 41/101 (41%) also received orphan designation by the EMA. 33/101 (33%) were approved for biomarker-based indications in the USA, however, only nine approved cancer drug indications by the EMA were biomarker-derived drugs. 78% (47/60) of approved cancer drugs that were only approved in the USA with orphan status were indicated for solid tumours, 22% (13/60) had indications for non-solid tumours. By contrast, out of those approved cancer drugs that received orphan designation by both agencies, 20% (8/41) were indicated for solid, and 80% (33/41) for non-solid tumours. CONCLUSIONS: Orphan designation was intended to encourage drug development for rare conditions. This study shows that the FDA approves more cancer drugs with such designations compared with the EMA, especially for subgroups of more prevalent cancers. One reason for the difference could be that the European Union requires demonstration of significant benefit for drugs that target the same indication as a drug already on the market to earn the orphan designation.