REGULATORY AFFAIRS PROFESSIONALS SOCIETYBy Zachary Brennan31 January 2017
In a sign of what’s to come for the US Food and Drug Administration [FDA], President Donald Trump told pharmaceutical company CEOs Tuesday that his administration will be “cutting regulations at a level no one has ever seen before.” The comments, which came before the meeting with CEOs from industry group PhRMA, Merck, Novartis, Johnson & Johnson, Celgene and others, Trump said in terms of the drug approval process: “We’re also going to be streamlining the process, so that from your standpoint, when you have a drug you can actually get it approved, instead of waiting for many, many years."
He also called for significantly lower drug prices and again for better negotiations on drug prices between Medicare and companies. “We’re going to get the approval process much faster,” he repeated, noting that “one thing that’s always disturbed me is that you come up with a new drug for a patient that’s terminal and FDA says you can’t have this drug used on this patient and patient will be dead… we don’t know if drug works or doesn’t work, but the patient’s not going to live for more than 4 weeks.”
The comments on terminal patients seemed to be a reference to what FDA calls compassionate use or expanded access, and as FDA has sped up that process, experts have noted that the difficulty for many of these terminal patients, who have either run out of treatment options or didn’t have any to begin with, is not getting FDA to sign-off on the use of an investigational drug [FDA approves more than 99% of all expanded access requests it receives] but in getting the companies running the clinical trials to allow new patients to enter trials.
“Instead of it being 9,000 pages, it’ll be 100 pages,” Trump said, perhaps in reference to FDA’s rulemakings, guidance and other regulations. He also offered a one-liner about companies not getting their products or their manufacturing plants approved in the US that drew laughter from the group. Between 75% and 80% of all FDA regulations will be eliminated, he added, before commenting on a lack of foreign regulations without any specifics. “It’s very unfair what other countries are doing to us, a lot of that has to do with regulation,” Trump said. “Other countries have no regulation and you go there for that reason.”But as others have noted, no matter where a drug is manufactured, companies have to follow US laws and regulations in order for that drug to enter the US market, which is still the biggest market for pharmaceuticals in the world. As far as his choice for FDA commissioner, Trump said an announcement is coming soon. PhRMA CEO Stephen Ubl called the meeting positive and productive and said Trump’s agenda on taxes, trade and regulation could create 350,000 US jobs over 10 years for the biopharmaceutical industry.