Morning Briefing
Summaries of health policy coverage from major news organizations
Pharma's Hiatus On Drug Price Hikes Goes Out The Door In January As Industry Returns To Status Quo
Reuters: Exclusive: Big Pharma Returning To U.S. Price Hikes In January After Pause
Novartis AG and Bayer AG are among nearly 30 drugmakers that have taken steps to raise the U.S. prices of their medicines in January, ending a self-declared halt to increases made by a pharma industry under pressure from the Trump administration, according to documents seen by Reuters. Other drugmakers set to raise prices at the start of 2019 include Allergan Plc, GlaxoSmithKline Plc, Amgen Inc, AstraZeneca Plc and Biogen Inc, the documents show. (12/19)
Stat: Trump Report Would Preclude Patent Seizures To Lower Drug Prices
In a rebuke to Democratic lawmakers and advocacy groups, the U.S. Department of Commerce released a report earlier this month saying the federal government should not use so-called march-in rights, which involve seizing patents, as a tool to address high prices for prescription medicines. Under federal law, a government agency that funds private research — such as the National Institute of Health — can require a drug maker to license its patent to another party in order to “alleviate health and safety needs which are not being reasonably satisfied.” An agency can also do so when the benefits of a product, such as a medicine, are not available on “reasonable terms.” (Silverman, 12/19)
Modern Healthcare: Providers, Insurers Call For Strong Enforcement Of Drug Price Transparency
Providers and insurers want the CMS to put some real teeth—including financial penalties—into any plan requiring greater price transparency from drugmakers. In comments on a proposed rule to require drugmakers to list a drug's wholesale price in TV ads, several provider and insurers groups told the agency that a stick is needed to ensure pharmaceutical companies follow through. (Meyer, 12/19)
Stat: DBV Technologies Pulls Peanut Allergy Treatment From FDA Review
DBV Technologies is withdrawing its marketing application for a peanut allergy therapy following discussions with the Food and Drug Administration, the company said Wednesday. Based on feedback from regulators, DBV concluded that its submission lacked “sufficient detail regarding data on manufacturing procedures and quality controls.” The company believes it can re-file with the FDA without having to conduct any additional clinical trials, although when that will happen was not made clear. (Feuerstein, 12/19)
Kaiser Health News: Why The U.S. Remains The World’s Most Expensive Market For ‘Biologic’ Drugs
Europeans have found the secret to making some of the world’s costliest medicines much more affordable, as much as 80 percent cheaper than in the U.S. Governments in Europe have compelled drugmakers to bend on prices and have thrown open the market for so-called biosimilars, which are cheaper copies of biologic drugs made from living organisms. The brand-name products — ranging from Humira for rheumatoid arthritis to Avastin for cancer — are high-priced drugs that account for 40 percent of U.S. pharmaceutical sales. (Tribble, 12/20)
