Morning Briefing
Summaries of health policy coverage from major news organizations
A Twist In The Pharmaceutical Price Wars: Drugs That Are Too Cheap
Reuters: Drug Shortages Prompt Question: Are Some Medicines Too Cheap?
Philip Aubrey buys medicines for British government-funded hospitals across London, capital of the world's fifth-largest economy, but last year he struggled to secure supplies of a basic AIDS drug. He is not alone. Shortages of essential drugs, mostly generic medicines whose patents have long expired, are becoming increasingly frequent globally, prompting the World Health Organization (WHO) to suggest minimum prices may be needed to keep some products on the market. (4/1)
Modern Healthcare: FDA Says Biosimilar Labels Should Rely On Reference Drug Data
Biologic manufacturers may not be pleased with the long-awaited biosimilar labeling guidelines released Thursday by the Food and Drug Administration. The agency is recommending that labeling for biosimilars use the clinical data gathered by the product the biosimilar is intended to emulate. Regulators would also allow biosimilar labels to state that the product is biosimilar to the reference product but has product-specific modifications. Biosimilars are derived from living organisms and therefore may not be identical to brand-name drugs. (Rubenfire, 3/31)
CQ Healthbeat: FDA Seeks To Add Identification Of Copycat Biotech Drugs To Labels
The Food and Drug Administration proposed that makers of copycat biotech medicines distinguish between their products and the original versions in new statements at the top of the prescribing information for the treatments, which is intended to be read by doctors. (Young, 3/31)
In other pharmaceutical news —
The Wall Street Journal: FTC Sues Endo, Alleges Company Paid Off Generic Drugmakers
The Federal Trade Commission said Thursday it sued drugmaker Endo International PLC, alleging the company violated federal antitrust laws by paying hundreds of millions of dollars to delay generic competition against two of its biggest drugs. The suit, filed under seal on Wednesday in U.S. District Court for the Eastern District of Pennsylvania, is the latest by the FTC to target alleged “pay-for-delay” agreements. (Walker and Hufford, 3/31)
The Wall Street Journal: Glaxo To Stop Seeking Drug Patents In Low-Income Countries
GlaxoSmithKline PLC said it would stop seeking patents for its drugs in low-income countries, a move the drugmaker said could help the world’s poorest people access copycat versions of its medicines at affordable prices. The U.K.-based company said it would take this approach in low-income and least-developed countries, a group totaling around 85 nations. In so-called lower-middle-income countries, a group of 51 nations that includes Vietnam, Cameroon and Sri Lanka, it said it would file patents but aim to grant licenses to generic manufacturers to supply low-cost versions of its drugs in those markets in return for a small royalty. (Roland, 3/31)
The Wall Street Journal: Regeneron, Sanofi Say New Eczema Drug Met Targets In Late-Stage Studies
Regeneron Pharmaceuticals Inc. and Sanofi SA said their experimental drug for a debilitating skin condition called atopic dermatitis met all of its major treatment targets in two late-stage studies, a key step in advancing a potential blockbuster medicine toward the market. The drug, called dupilumab, substantially improved rash, itching and other symptoms of the condition, the companies said, which is a serious type of eczema that in its moderate to severe form affects about 1.6 million American adults and a significant number of children. By some estimates, as many as 3% of adults world-wide suffer from some form of the disease. (Winslow, 4/1)
