Trump Pledges to Eliminate 75% to 80% of FDA Regulations
During a meeting with the CEOs of leading pharmaceutical companies, President Trump laid out his vision for reducing drug prices and regulatory burdens—vowing to eliminate current FDA regulations by “75% to 80%.”
“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," President Trump said in regards to the current drug approval process.
President Trump noted that for terminal patients, often times drugs are not approved quickly enough to benefit the patient. Currently, the FDA refers to approval for medications for terminal patients as compassionate use or expanded access—the FDA has recently sped up this process. However, in 2016, the FDA approved a record amount of orphan rare disease drugs.
Despite a sped up process, President Trump said in reference to the FDA’s rulemakings, guidance, and other regulations that, “Instead of it being 9,000 pages, it’ll be 100 pages.”
Additionally, for drugs that are manufactured outside of the United States, President Trump said that foreign countries must pay a fair share for drug development costs. Experts have noted, however, that no matter the country where the drug is manufactured, all companies have to follow the regulations set forth by the United States in order for the drug to enter the US market—the biggest market for pharmaceuticals in the world.
President Trump also expressed interest in lowering health care prices, particularly for Medicare and Medicaid. “We have to get prices down for a lot of reasons. We have no choice, for Medicare and Medicaid,” said Mr Trump.
Interestingly, President Trump seems to have reversed his position on allowing Medicare to negotiate drug prices, by speaking out against what he called “price-fixing” in Medicare.
“I'll oppose anything that makes it harder for smaller, younger companies to take the risk of bringing their product to a vibrantly competitive market," Trump said. "That includes price-fixing by the biggest dog in the market, Medicare, which is what's happening. But we can increase competition and bidding wars, big time.”
Currently federal law prohibits the federal government from negotiating directly with drugmakers for drugs purchased through Medicare. Presumably, lifting this ban would make things difficult for “smaller, younger companies” to compete with larger companies for Medicare’s business.
Trump also said “We’re the largest buyer of drugs in the world, and yet we don’t bid properly and we’re going to start bidding and save billions of dollars over a period of time."
President Trump also suggested that drug prices could be lowered through tax cuts for manufacturers that produce drugs in the United States.
The meeting attendees included CEOs from Novartis AG, Merck & Co Inc, Johnson & Johnson, Celgene Corp, Eli Lilly & Co and Amgen Inc as well as the head of the Pharmaceutical Research and Manufacturers of America (PhRMA) lobbying group.
PhRMA CEO Stephen Ubl said the meeting was positive, and said President Trump’s initiatives for taxes, trade, and regulation could create thousands of jobs.
Trump has not yet announced his selection for FDA director.
—Julie Gould (Mazurkiewicz)