Special Oversight Of Gene Therapies To Be Rolled Back As Treatment Becomes More Commonplace
Experts are wary because while the therapies have provided some miraculous success, there have also been spectacular failures. Health officials, however, say that the FDA can provide enough oversight and extra supervision from the NIH is no longer needed.
The Associated Press:
Officials Remove Special Rules For Gene Therapy Experiments
U.S. health officials are eliminating special regulations for gene therapy experiments, saying that what was once exotic science is quickly becoming an established form of medical care with no extraordinary risks. A special National Institutes of Health oversight panel will no longer review all gene therapy applications and will instead take on a broader advisory role, according to changes proposed Wednesday. The Food and Drug Administration will vet gene therapy experiments and products as it does with other treatments and drugs. (Marchione, 8/15)
In other news —
Express Scripts Staking Out Million Dollar Gene Therapies
Express Scripts Holding Co built a multi-billion enterprise pressuring drug companies to lower their prices for U.S. patients. Now it is quietly building a side business: getting paid to help drug companies dispense a new generation of high-priced drugs. Express Scripts is in talks with biotechnology companies Biomarin Pharmaceutical Inc, Spark Therapeutics Inc and Bluebird Bio Inc to have its specialty pharmaceutical business exclusively distribute their new gene therapies when they are expected to become available in 2019 and 2020, Chief Medical Officer Steve Miller told Reuters in an interview. (Humer and Beasley, 8/15)