When a cit­i­zen pe­ti­tion works: FDA's re­view of Unit­ed Ther­a­peu­tic­s' PAH drug ex­tend­ed to May

Near­ly every time a bio­phar­ma com­pa­ny or its law firm files a cit­i­zen pe­ti­tion to de­lay a new or gener­ic drug’s ap­proval, the pe­ti­tion is shot down with a quick ex­pla­na­tion from the FDA.

Re­search from 2016 shows more than 90% of these pe­ti­tions are ul­ti­mate­ly re­ject­ed by the FDA, par­tic­u­lar­ly as many are on­ly filed with the in­ten­tion of de­lay­ing an ap­proval.

But in lim­it­ed cas­es, as with Unit­ed Ther­a­peu­tics and MannKind’s re­for­mu­lat­ed pul­monary ar­te­r­i­al hy­per­ten­sion drug Ty­va­so DPI, a cit­i­zen pe­ti­tion can ac­tu­al­ly work to push back the agency’s re­view time­line.

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