Ethics/Regulatory

FDA’s proposed Expanded Access Navigator points to progress, not panacea

Monday, May 23, 2016

In response to the increasing demand for access to investigational drugs, creation of a clearinghouse to provide information on the request process has been proposed by the Reagan-Udall Foundation for the FDA. Dubbed the Expanded Access (EA) Navigator, the educational tool is the government’s latest effort to increase the efficiency of the complex process of requesting unapproved drugs outside of clinical trials for “compassionate use.”

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IRBs react to new model for registering proposed gene trials

Monday, May 2, 2016

On April 27, the National institutes of Health (NIH) enacted a new administrative model for the review of proposed human gene trials; the new guidelines upend a process that has been in place for more than 40 years. Predictably, reaction throughout the industry is mixed. Larger firms are adjusting quickly to the change and retooling their processes to comply with the new model. At the other end of the spectrum, some IRBs, including IntegReview, declined to comment on the changes, stating that the matter is still under internal review.

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Lack of clinical data overshadows opioid prescribing guidelines

Sunday, May 1, 2016

On March 18, 2016, the Centers for Disease Control (CDC) in Atlanta released its guidelines for prescribing opioids for chronic pain in outpatient settings outside of active cancer treatment, palliative care, and end-of-life care. The results were instantly controversial. While no one argues that opioid addiction has become a health crisis, critics claim that a scarcity of clinical trial data undermine the guidelines and could even lead to patients being harmed.

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Upcoming EU referendum delays UK pharma market changes

Monday, April 18, 2016

Civil servants must observe a period of “purdah” in the weeks before a general election or referendum, which restricts government activity to avoid unfairly influencing public opinion. This has hit two major consultations for the pharma industry—the Accelerated Access Review (AAR) and proposed changes to the medicines pricing system known as the Statutory Scheme. The AAR is the brainchild of life sciences minister George Freeman, who wants it to re-shape the U.K. market and the National Health Service (NHS) around encouraging medical innovation, and remove some of the blocks and bottlenecks which plague the current system.

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Study: U.S. drug spending growth reaches 8.5% in 2015

Monday, April 18, 2016

Total spending on medicines in the U.S. reached $310 billion in 2015 on an estimated net price basis, up 8.5% from the previous year, according to a new report issued by the IMS Institute for Healthcare Informatics. The surge of new medicines remained strong last year and demand for recently launched brands maintained historically high levels. The savings from branded medicines facing generic competition were relatively low in 2015, and the impact of price increases on brands was limited due to higher rebates and price concessions from manufacturers. Specialty dug spending reached $121 billion on a net price basis, up more than 15% from 2014.

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