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Friday, Jun 5 2015

Full Issue

Drug Companies Trying To Press Monopoly Pricing Power Into Trade Deal

The drugs in question include costly and revolutionary drugs to treat cancer and other intractable diseases, Politico reports. In other pharmaceutical news, CMS allows drug and medical device companies access to Medicare data, and a new HPV-vaccine shows greater cancer protection.

A revolutionary class of drugs with the potential to treat intractable diseases like cancer and other killers 鈥 as well as to explode health spending globally 鈥 is at the center of the toughest negotiations of the biggest trade deal in history. The pharmaceutical industry has been pressing the Obama administration to insist that the Trans-Pacific Partnership include 12 years of monopoly pricing power for the makers of these complex and costly drugs. But critics and international relief organizations warn that the deal would lock in higher costs and mean that far fewer people in developing countries would be able to afford life-saving medication. (Norman and Behsudi, 6/5)

Drug and medical device companies can now access a wealth of raw Medicare claims data, thanks to a move this week by CMS that is expected to increase industry research on the 鈥渞eal world鈥 benefits, risks and economic value of medical treatments. (Karlin, 6/4)

The latest generation of human papillomavirus vaccines, 9-valent, offers "potential" 11.1 percent greater protection against HPV-related cancers than does its predecessor, according to a study funded the U.S. Centers for Disease Control and Prevention. The projection is based on the prevalence of HPVs in 2,670 patients with cancer of the oropharynx (tonsils, tongue, throat), cervix, vulva, vagina, penis or anus. The study analyzed the DNA of the cancers to see if the new vaccine could provide greater protection. The new vaccine is marketed by Merck & Co. as Gardasil 9. It replaces Gardasil. (Mann, 6/4)

The FDA recommends approval of a drug to boost female libido --

The first-ever "female Viagra" came one step closer to coming to market, as a key advisory committee to the Food and Drug Administration voted Thursday afternoon to recommend that the FDA approve the drug with conditions. The committee voted 18-6 to recommend that the FDA approve flibanserin, a drug designed to boost the low sexual desire of otherwise healthy women. (Schulte, 6/4)

The drug industry鈥檚 decade-spanning search for a female equivalent to Viagra took a major step forward Thursday, as government experts recommended approval for a pill to boost sexual desire in women. The first-of-a-kind endorsement came with safety reservations, however, due to drug side effects including fatigue, low blood pressure and fainting. The panel of Food and Drug Administration advisers voted 18-6 in favor of Sprout Pharmaceutical鈥檚 daily pill, flibanserin, on the condition that the company develops a plan to manage its risks. (Perrone, 6/4)

And a drug maker subpoenas a journalist in a lawsuit brought by shareholders --

As an outgrowth of ongoing litigation between Amgen and some of its shareholders, the biotech has subpoenaed a journalist whose stories eight years ago revealed negative clinical trial results for a best-selling product. And the journalist, Paul Goldberg of The Cancer Letter, is fighting back by insisting that the First Amendment shields him from providing the information Amgen is seeking. (Silverman, 6/4)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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