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In an unusual move... officials with the National Institute of Allergy and Infectious Diseases urged AstraZeneca to ensure it is providing the most recent efficacy data on its coronavirus vaccine. The statement came 1 day after the manufacturer released interim data from its U.S. trials...NIAID...said an independent monitoring board informed it that AstraZeneca's disclosures of the study results may have been based on outdated evidence. The agency's response to the company...READ MORE

The United States plans to send roughly 4 million doses of AstraZeneca's COVID-19 vaccine that it is not using to Mexico and Canada in loan deals with the two countries, yielding to requests to share vaccines with allies...Mexico will receive 2.5 million doses of the vaccine and Canada is to receive 1.5 million doses...The Biden administration has come under pressure from countries around the world to share vaccines, particularly its stock of AstraZeneca’s vaccine, which is authorized for use elsewhere but not yet in the United States...READ MORE

Here's a hypothetical: What happens when the FDA grants exclusivity to a new drug ingredient that isn't exactly new?...Novartis' generics unit claims the agency did just that with Sanofi's multiple sclerosis med Aubagio—but the dispute isn't necessarily just about the New Chemical Entity exclusivity itself. That's no longer in force according to the FDA Orange Book. It's also about the 180-day exclusivity drugmakers win when they're first to file for copycat approval—and right now, 20 generics are poised to hit the scene simultaneously in 2023...READ MORE

The Government Accountability Office has concerns about the FDA's widening inspection backlog. COVID-19 certainly amplified the problem, but the issues had been mounting long before last March...As the FDA looks to honor lockdown rules and protect its staffers, the agency has largely paused inspections since the pandemic started last spring, conducting only those deemed “mission-critical.” In fact, the FDA was unable to complete more than 1,000 planned inspections in 2020—and that backlog will likely grow with time, the U.S. Government Accountability Office (GAO) said in a release...READ MORE

Nevada has struck a $45 million settlement deal with McKinsey & Company for the global consulting firm’s role in advising opioid makers how to sell more prescription painkillers amid a national overdose crisis...The western state reached the deal after sitting out a multi-state settlement with McKinsey announced in February. The hard bargaining has allowed Nevada to win a settlement that’s three and a half times larger than the average settlement with other states...READ MORE

Drug names often draw curiosity and confusion—and they always get a once-over by the FDA. The agency is more than usually interested these days, though...After a round of new guidance issued in December, the FDA is dipping back into the issue by reopening a proposed study to determine how drug names influence consumers and healthcare providers...Its December report “Best Practices in Developing Proprietary Names for Human Prescription Drug Products” includes suggestions for drugmakers and their naming agency partners to avoid misbranding violations...READ MORE

A December 2020 opinion issued by Washington Attorney General...affirmed pharmacists’ standard of practice under collaborative drug therapy agreements (CDTAs)...“[The opinion] clearly states that pharmacists working under CDTAs can identify and treat illness. This is reassuring news to practitioners who have developed practices that care for patients with these agreements,”...The opinion was a response to questions from the Washington State Medical Commission about whether pharmacists can diagnose patients pursuant to CDTAs—and if that constitutes unauthorized practice of medicine—and whether prescribers can enter CDTAs permitting pharmacists to diagnose patients...READ MORE

Shoddy manufacturing practices triggered FDA warning letters for a pair of foreign producers of over-the-counter drugs...Dibar of Mexico, a CDMO for nutritional and self-care products, and Foshan Biours Biosciences of China, which specializes in gel patches, were cited for failure to fix problems the FDA raised in April of last year...The companies have been barred from importing their products to the U.S. since last fall...READ MORE

The U.S. Federal Trade Commission will join European, British and Canadian regulators, as well as with counterparts at the U.S. Justice Department and states attorneys general, to update their approach to reviewing pharmaceutical acquisitions, a move the commission's acting chair said was prompted by the "high volume of these mergers," increasing drug prices and other anti-competitive issues...Antitrust regulators watch drugmaker mergers closely to determine whether tie-ups could impede development of newer and potentially better medicines...READ MORE

Manufacturing capacity and ingredients shortages are the main bottlenecks to expanding COVID-19 vaccine production, several global drug groups said...not patents that some critics are demanding be removed...“IP (intellectual property) rights is not the issue,” said Thomas Cueni, who heads the International Federation of Pharmaceutical Manufacturers and Associations...“The bottlenecks are the capacity, the scarcity of raw materials, scarcity of ingredients, and it is about the know-how.”...READ MORE