News & Analysis on Clinical Trial Services & Contract Research And Development
Uncertainty with Donald Trump
By Melissa Fassbender
- Last updated on
Many remain uncertain as to what the industry can expect under president-elect Donald Trump – although many have speculated.
Per Mr. Trump’s rhetoric, it seems clear that he will be repealing all or parts of ObamaCare, “but there's a lot of uncertainty for pharma outsourcers because we really don’t know what he plans to do with regard to the FDA,” said Price.
“We know he’s said he would cut back regulations in general but it’s not so simple with FDA; there may be regulations that some people don't like but at the end of the day, it's about saving people's lives,” he added.
“It’s one thing to look for ways to speed up approvals – but if people are adversely effected, that's a real problem.”
One area that Price said does need review is the “ever increasing regulatory scrutiny reviewers at the FDA are giving to new applications for both branded and generic applications.”
He explained that reviews can now be dozens of pages long, “asking questions that might be nice to know, but have little or no actual impact on the quality of the product.”
“The levels of additional investment and the time required to clear up the ‘deficiencies’ can be very significant, and it increases the potential liability for CMOs and sponsors alike.” he explained.
According to Price, the only choice is to raise prices as a hedge against the work necessary to develop an API – which he said would stifle the generics business.
“In turn, that will harm patients who won’t have a choice of lower-cost generic alternative to a more-expensive branded medicine. And the branded version, because it won’t have much competition, will be able to maintain higher prices charged to patients.”