In the largest multistate food-borne E. coli outbreak since 2006, at least 84 people across 19 states have been infected with E. coli from romaine lettuce in the past month. The team at TWTW is counting ourselves lucky that we are unusually big fans of kale. In other news:
One shot cures: A Goldman Sachs issues a report this week about the economic sustainability of one shot therapies. The report questions whether reduced revenue from curative therapies will justify the cost of research and clinical trials, particularly for rare diseases, which typically run at least $1 billion.
►SCOTUS KOs IPR Challenge
The Supreme Court disappointed the pharmaceutical industry this week when it upheld the Constitutionality of Inter Partes Reviews (IPR)—an alternative to litigation for patent challenges. Plaintiffs in the case argued only the judicial branch can review patent legality, and that the political appointees at the US Patent and Trade Office should not have the authority revoke patents through a separate process. The Court disagreed in a 7-2 ruling, but the industry can still work to change the structure of the IPR process through Congress and the administration.
►COPAY Assistance Conundrum
Although drug co-pay assistance organizations were developed help patients shoulder the growing burden of out-of-pocket costs for prescriptions, federal authorities are currently investigating the groups for profiting off of high drug costs. The HHS Inspector General and the U.S. Attorney in Massachusetts have been reviewing insurance copay assistance programs for the past three years, looking for violations of anti-kickback laws that prohibit drug companies from covering copays for Medicare patients and assistance groups from “steering” patients to drugs manufactured by their benefactors. At issue is whether copay assistance programs “mask” the price of drugs, forcing higher costs to insurance companies, which, in turn, pass the costs to consumers and employers. The feature, which ran in USA Today, notes that the funding for these groups comes almost entirely from drug companies.
Until next week.