Trump met the CEOs of several big pharmaceutical companies Tuesday and promised to reduce FDA regulation, in an effort to make it less difficult to get drugs approved for use. Trump also signed an executive order mandating that agencies cut two additional regulations for each new regulation they pass, without offering any insight how they could do so.
“We’re going to streamline the FDA,” Trump stated.
But Dr. David Kessler, who was the head FDA in the 1990s, stated the agency has already streamlined its drug approval process.
“Every administration for the last 40 years has talked about speeding up drug approval,” said Kessler.
The FDA now has four separate pathways to speed up the approval of drugs:
- Fast track
- Breakthrough therapy
- Accelerated approval
- Priority review
According to the FDA, it requires an average of 10 months for a new drug to get approved.
“The reality is, we have spent the last 3 decades speeding up the drug approval process,” stated Kessler.
In reality, drugs get approved so quickly now that consumer protection groups are complaining. Groups howled last year when the FDA approved a controversial muscular dystrophy drug over the objections of its own advisers.
The 15-year figure is frequently cited by the industry as the time it takes to develop a drug from start to finish —not the FDA approval time, which is normally less than a year.
‘Reform existing laws’
Trump also stated he wanted to bring down drug prices, and stated one particular way to do that would be to bring drug manufacturing back to the United States. On the other hand, drug companies now make a lot of products overseas and get most of their supplies overseas, simply because it’s more affordable to do it that way.
Although it’s more affordable for the drug companies, Americans spend more on drugs than any other developed nation. Most other wealthy nations have government-run health care systems and negotiate for reduced drug costs. That would mean permitting Medicare to negotiate drug costs, but drug companies overwhelmingly oppose that, and Trump has sent mixed messages about whether or not he’d offer his support in letting the federal government negotiate what it pays for drugs.