Since his inauguration, President Donald Trump has made some questionable decisions but at least one of his cabinet picks appears to be moving in the same direction as the rest of the country. Trump’s newly appointed head of the United States Food and Drug Administration is one of the country’s biggest advocates for lower drug costs and more access to generic versions.
Scott Gottleib is a former FDA deputy commissioner and he contends that streamlining generic approvals, for one, would be among his top priorities. Apparently he is especially focused on improved access to the more complex medications which combine old drugs with new deliver technologies, in addition to those drugs that have long been known to have unusually complicated formulations.
Perhaps more importantly, the administration could make any such changes without the necessity of Congress passing any new laws. This would, effectively, allow for the administration to gain better ground on the currently-failing repeal of [former] President Obama’s Affordable Care Act. Obviously, this was a major selling point of the Trump campaign; but while the move could make it easier to accomplish the mission, it certainly has its opposition.
Big Pharma companies really don’t want to give up their proprietary money-makers in favor of patient/consumer benefit.
Georgetown University Health and Policy Institute professor Jack Hoadley applauds the appointment. He notes, “It is an opportunity for a new administration to make a mark, to do something on an issue where there’s a substantial amount of public interest,” but although the FDA commissioner will have broad perspective, “the proof is in the action. You need to show there’s something real behind it.”
Of course, there is much more to this than just the cost of medicine for consumers. Complex drugs is a loosely-defined category. It can include anything from the EpiPen (Mylan NV) device or asthma inhalers or other injected medicines like Copaxone (Teva Pharmaceuticals Industries Ltd) which are more complicated in structure than simple pills/tablets (et al). “Complex drugs” fall into a proverbial regulatory gray area since you cannot just use the same standard tests to prove efficacy, equivalence, etc.
Indeed, SSR Health analyst Richard Evans comments, that getting complex generic drugs approved “has been a huge battle.” He adds, “It is just not something the agency has been configured to deal with, [though Gottlieb is] as capable as they come in getting the agency to act in a more efficient manner.”