Why ex-FDA official Joshua Sharfstein supports compounding to combat price hikes
Joshua Sharfstein, associate dean at the Johns Hopkins Bloomberg School of Public Health, wants to deploy the FDA to battle companies like Turing Pharmaceuticals AG that have enraged the public by obtaining sole U.S. distribution rights to medically important generics and exploiting their monopolies to impose astronomical price increases.
Although some precedent exists for FDA taking steps to facilitate access to lower-cost drugs, the concept is highly contentious within the agency and among public health experts who believe FDA should focus exclusively on the medical and scientific aspects of the products it regulates.
Sharfstein, who served as FDA principal deputy commissioner for the first two years of the Obama administration, outlined his proposals in a commentary co-authored by Bloomberg School colleagues Jeremy Greene and Gerard Anderson that was published this month in The Journal of the American Medical Association.
The policy tools Sharfstein and colleagues are proposing - pharmacy compounding and allowing the importation of drugs that haven't been approved by FDA - are at least as controversial as the general principle