Morning Briefing
Summaries of health policy coverage from major news organizations
Johnson & Johnson To Use Ethicists To Screen Patients' Early Access Requests
Johnson & Johnson has appointed a nationally known bioethicist to create a panel that will make decisions about patients’ requests for lifesaving medicine, responding to an emotional debate over whether companies should allow desperately ill people to have access to the drugs before they are approved. (Thomas, 5/7)
Under increasing pressure to expand access to experimental medicines, Johnson & Johnson has arranged for an independent panel to review requests from seriously ill patients who want to try an unapproved drug even if they aren’t participating in the drug’s testing. The committee of doctors, bioethicists and patient representatives organized by the New York University School of Medicine will consider the hundreds of requests that J&J receives each year from patients who believe an experimental drug can help them. The panel will recommend a course of action to J&J. (Rockoff, 5/7)
Johnson & Johnson will ask an independent panel to recommend who gets a breakthrough drug that’s still under development, a plan that could help the company contend with the phenomenon of desperate patients using social media to campaign for early access to medications. The collaboration between the world’s largest maker of health-care products and the division of medical ethics at New York University Langone Medical Center will start with one medicine. If successful, the company will expand the initiative, said Chief Medical Officer Joanne Waldstreicher. (Cortez, 5/7)
Meanwhile, patient advocates criticize the FDA's review process for biosimilar drugs -
Patient advocacy groups are urging the Food and Drug Administration to reconsider how it reviews copycat biologic therapies, saying the current structure doesn’t provide for adequate expertise in the area. Patients for Biologics and Access, comprised of 20 patient advocacy groups representing chronic and rare illnesses, sent a letter to acting FDA commissioner Stephen Ostroff Wednesday, asking the agency to issue final approval standards for biologic copycats. (Adams, 5/6)
And Reuters looks at developments in new therapies for blood cancers -
New therapies that clinical data show can eliminate blood cancers such as leukemia and lymphoma in 40 percent to 90 percent of patients may have to be genetically modified to include a switch that shields healthy cells from attack. The therapies could generate tens of billions of dollars in annual sales for drugmakers including Kite Pharma and Juno Therapeutics Inc, once they are approved. (Pierson, 5/7)
