Califf On Capitol Hill: Rally Friends, Repair Relationships
New FDA commissioner cautions rare disease advocates about fighting for ineffective treatments and looks to repair communication problems with Senate.
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While not identifying specific situations raising potential questions, the FDA commissioner uses his appearance at agency's annual rare disease event to advise regulatory decisions may be revisited as more data becomes available.
Witnesses call for political pressure on FDA to approve the Duchenne drug; patients and advocates also urge general approval reciprocity with Europe and incentives for pediatric trials; agency was not invited to testify.
At White House summit on precision medicine, President Obama emphasized the need to break down outmoded regulations, and suggested barriers between drug and device oversight need to be loosened; FDA and NIH announced a number of new competitions and projects.