New FDA leadership engages with drug prices

Previously, FDA has generally taken the stance that its role has been to ensure safety and efficacy of medications. Sometimes, the FDA would address issues of availability (e.g. in the case of rare diseases), but it has eschewed drug pricing. The Wall Street Journal reports that the new FDA commissioner is changing tack by proposing policies that will encourage competition. Among the proposals is to accelerate the review of generics. It also sounds like the plan is to make it easier for a manufacturer to prove equivalence, including generic equivalents of Mylan's EpiPen.

These proposals sound promising, but as most other cases, the details matter a lot. It'll be interesting to see if, over time, people are still shocked at high prices of medications that have generic equivalents.