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K Schulman, AL Kellermann. NEJM 2026;394:1669-1672. Substandard Generic Drugs — Threats to Patient Safety and National Security

An excerpt:

Generic drugs account for more than 90% of prescriptions filled in the United States. The first paragraph on the home page of the Office of Generic Drugs at the Food and Drug Administration (FDA) asserts that “FDA-approved generic drugs have the same high quality, strength, purity and stability as brand-name drugs.” On the strength of this assurance, America’s doctors, pharmacists, and patients assume that every version of a generic drug is equally safe. But this proposition is now being seriously challenged...

Between 2009 and 2019, the availability of generic medicines saved U.S. patients $2.2 trillion, according to the FDA.

Over time, intense price competition drove most production of generic drugs and ingredients offshore to countries with low labor costs and lax regulatory controls. Once that shift occurred, relentless pressure to minimize costs led some manufacturers to compromise on quality. Rapid globalization also outstripped the FDA’s capacity to monitor manufacturers. In 2022, the Government Accountability Office reported that 61% of foreign plants had not been inspected by the FDA in the preceding 5 years.¹

When FDA inspectors finally reach these plants, some find glaring problems…More than 60% of generic-drug shortages are attributable to quality concerns, according to the FDA…

A private-sector laboratory detected high levels of nitrosamines (known carcinogens) in drugs made by several FDA-approved manufacturers, prompting recalls of metformin, angiotensin-receptor blockers, angiotensin-converting–enzyme inhibitors, prazosin, and ranitidine. More recently, independent tests of generic methylphenidate found nitrosamine levels above the FDA’s safety threshold in 7 of 15 immediate-release products…²

Recently, a team of U.S. and South Korean researchers with access to FDA data determined that significantly more serious adverse event reports were linked to generic drugs manufactured in India than to equivalent drugs manufactured in the United States…⁴

In 2008, a total of 238 deaths in the United States were linked to adulterated Chinese heparin. When the FDA toughened its approach to quality assessment of foreign manufacturers, shortages of more than 200 medications followed. This crisis prompted the FDA to prioritize minimizing drug shortages over ensuring safety… 

There is a better way to assure the safety of generic drugs. In 1994, the European Medicines Agency (EMA), for example, established a proactive approach involving risk-based surveillance in addition to systematic planned and ad hoc testing of generic drugs both on the market and during routine inspections of manufacturers (in contrast, the FDA does not routinely test generic-drug products themselves, either on the market or during quality inspections of manufacturing plants). EMA testing relies on a network of official medicines control laboratories (OMCLs) that operate in accordance with International Organization for Standardization (ISO) accreditation standards for testing and calibration laboratories. At any point in a drug’s life cycle, an OMCL can pull samples for product testing...

The U.S. government should oversee an effort to rebuild America’s capacity to manufacture generic drugs, combining investment in private manufacturing with incentives for purchasing U.S.-made products under the Medicare and Medicaid programs. Currently, the United States is vulnerable to an embargo of essential drugs or the materials required to make them. A recent evaluation for the Department of Health and Human Services found that 87% of sites that make active pharmaceutical ingredients (APIs) and 63% of sites that produce finished dosage forms were located overseas…

My take (borrowed from the authors): Most generic drugs are safe, but a troubling minority are not…The United States already tests a wide range of consumer products. We should also test our generic drugs.

Related blog posts:

• Lower Generic Drug Costs
• Annual Costs: Generics vs. Brand-Name Medications
• Cornering the Generic Markup