WASHINGTON — President Trump on Tuesday broadly pledged to encourage more competition to drive down drug prices and vowed to oppose any measure that would make it difficult for smaller drug companies to enter the market.
Trump, speaking from the White House before a meeting with pharmaceutical executives, also said he would streamline and therefore accelerate the drug approval process.
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There are many variables that need to be considered for pharma to bring manufacturing back to US. DJT wish is easier said than done. In addition, FDA and pharma will have kill lot of internal kingdoms to accomplish DJT desire.
Pharma has two components 1) Active Ingredient and 2) their formulations
Both have to come home.
Economies of scale will bring better methods but would they exceed regulatory standards. Would relaxing rules lower drug quality?
Do we have the manpower to build plants that meet the local regulations let’s say in the next five years? That would be asking too much.
We have to remember pharma have increased their revenues by raising prices and introducing very high priced orphan drugs. Not much has been introduced for the masses (5-10 million patients) that are revolutionary compared to existing drugs.
Lot of questions that need to be addressed.
I would take it a step further by getting rid of the Advisory Panel system. It didn’t exist when I started in 1983; but then again the FDA had strong leaders with the cojones to make approval decisions without the advice and consent of outside panels, which include many members whose field of expertise lies outside the drug undr consideration. Next get rid of the ossified second level of entrenched bureaucracy that rules the roost. Finally I would privatize the efficacy reviews to real experts in the field, leaving FDA to review safety and GMP’s only, ensuring that they will continue to make it out of the building by noon on Fridays.
I thank the president for having an interest in the over high price of medications. Working in the field for Part-D and hearing how people can not afford medication is very alarming, greed,greed,greed is the only reason for the high cost, not r&r.
Assuming you mean R&D, I can assure you that both greed and R&D contribute to the costs of pharmaceuticals.
“Trump also said Tuesday that he would soon appoint a commissioner to lead the agency.”
I’m sure this will take some time- after all, he has many hopelessly unqualified political donors to choose from.
Finally a consensus proposal from President Trump. Central negotiation was a Democratic idea, and I am glad the President shows agreement to do this. He will face resistance from Congress, but he will probably sell it as a political point, and getting backing from those who had opposed those costs(insurers, pharmacies, businesses).