Rise and shine, everyone, another busy day is on the way. We apologize for the late start today, but we are wrapping up yet another road trip and encountered aggravating traffic before we could attempt our usual morning routine. Nonetheless, we are now in gear — thanks, in part, to a pumpkin latte. And so, here are some items of interest. We hope you have a smashing day and please do drop us a line when you run across something fascinating …
Patient advocacy groups have been largely silent in the public debate over pricing, but critics say that by avoiding the debate over cost, they are failing in their patient-advocacy duties, the New York Times reports. The reason for their absence is not surprising: Many of the groups receive millions of dollars a year in donations from companies behind the drugs used by their members. When they prod drug makers, it is generally for better — not cheaper — treatments.
More than half of FDA staffers who reviewed hematology-oncology drugs between 2001 and 2010 later worked for drug makers, raising revolving-door concerns, STAT writes, citing a study in the BMJ. “If you know a major post-employment opportunity is on the other side of the table, you give them the benefit of the doubt,” says study coauthor Vinay Prasad, an assistant professor of medicine at Oregon Health and Science University.
A Right to Try law was signed by California Governor Jerry Brown, giving patients the right to seek experimental treatments that have not yet been approved by the US Food and Drug Administration, the Los Angeles Times tells us. Brown had previously vetoed the legislation. Similar laws now exist in 32 states, and federal legislation is pending in the House and the Senate.
Angry about drug prices? Martin Shkreli, who caused outrage for jacking up the price of a life-saving medicine by 5,000 percent, is offering someone the chance to punch him in the face, USA Today reports. He is attempting to raise money for a friend who left behind a young son who, Shkreli says, recently overcame leukemia. Offers are being accepting on Twitter direct message.
Biosimilar manufacturers and patients may have to wait another year for an FDA draft guidance on so-called interchangeability, Bloomberg News says. In a letter released Sept. 16, the agency writes that the widely anticipated guidance will be released some time before Dec. 31, 2017. Until now, the FDA had suggested the guidance would be released this year.
Shire has returned rights to the two biosimilars it acquired through its recent purchase of Baxalta, retaining its focus on the development of drugs for rare diseases, PharmaTimes writes.