Rx Drugs

Hospitals are requesting CMS withdraw its proposal to survey 340B hospitals about their drug costs, saying the survey instructions aren’t clear and the agency lacks authority to gather information from a subset of hospitals and on a subset of drugs.

Global Blood Therapeutics said it is working with public and commercial payers to get broad coverage for its newly approved sickle cell drug Oxbryta (voxelotor) by the end of 2020.

The House Judiciary Committee unanimously approved two bills aimed at fighting drug companies’ misuse of patents.

FDA has reversed its stance that certain comparative clinical studies, including switching studies, are needed to prove interchangeability for insulin products, in a move that could speed access to less expensive insulin products.

When President Donald Trump took to Twitter Friday (Nov. 22) to weigh in on drug pricing reforms, he gave House Republicans cover to vote against House Democrats’ bill to let Medicare negotiate drug prices, instead of leaning on Senate Republicans to support the less-aggressive bipartisan drug pricing legislation in that chamber, even though White House adviser Joe Grogan said recently that the administration backs the Senate bill.

Lawmakers on both sides of the aisle lobbed questions and expressed concerns about issues related to drug pricing, such as drug importation, biologic patent gaming, generic drug exclusivity and insulin access, to FDA commissioner-nominee Stephen Hahn during his Senate confirmation hearing Wednesday (Nov. 20).

Democratic presidential primary candidate Elizabeth Warren says that during the first 100 days of her presidency she would lower brand drug prices and tackle drug shortages with strict antitrust enforcement, and compulsory licensing and march-in authorities.

HHS plans to propose this month the controversial International Pricing Index demonstration that the president announced in October of 2018, according to the fall regulatory agenda that the administration published Wednesday (Nov. 20).

The Center for Science in the Public Interest (CSPI) is asking FDA and the Federal Trade Commission to take enforcement action against more than 25 companies that market dietary supplements with the claim that they will treat female infertility.