> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Cutting FDA Regs, Speeding Approvals ‘Misguided’
- URL: https://www.fdaweb.com/cutting-fda-regs-speeding-approvals-misguided/
- Published: 2017-02-01T12:00:00.000Z
- Updated: 2026-09-14T22:04:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137874

President Trump’s promise to the pharmaceutical industry to [massively gut FDA’s regulations](https://www.fdaweb.com/less-fda-for-lower-prices-trump-to-pharma-ceos/) in exchange for lower drug costs for the American people would “fundamentally destroy the ability of the agency to protect patients and consumers from unsafe or ineffective medications and medical devices, hazardous foods and dietary supplements, and dangerous tobacco products, among other things,” according to [Public Citizen](http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=10142&ref=fdaweb.com). “The end result would be countless preventable deaths, injuries and illnesses across the U.S. Trump’s horrifying proposal reflects utter ignorance about the FDA’s essential role in protecting public health and once again demonstrates his commitment to placing corporate profits above protecting the safety of the American people.”

The group further said that “destroying medication and device approval standards at the FDA will have devastating, life-and-death consequences for hundreds of thousands of Americans. It will also, incidentally, hurt the industry Trump purports to assist by undermining Americans’ faith in the safety of medications and devices and by virtually guaranteeing disasters that subject companies to immense liabilities.”

Calls to make things move even faster reflect a fundamental misunderstanding of what the agency actually does, according to former FDA medical officer **David Gortler**. “Maybe 2% of the people on the whole planet get what we do,” [Gortler told](http://Dr.%20Leonard%20Schleifer,%20the%20billionaire%20CEO%20of%20biotech%20success%20story%20Regeneron%20Pharmaceuticals,%20said%20his%20company%20would%20never%20be%20able%20to%20compete%20with%20the%20Pfizers%20and%20Mercks%20of%20the%20world%20without%20a%20strong%20FDA%20to%20reward%20its%20endeavors.) *Stat News*. Now a consultant at [Former FDA](http://www.formerfda.com/?ref=fdaweb.com), he said: “As a conservative, I’m all for less regulation, but I’m not prepared to let Jane and John Q Public make decisions about pharmacogenomics and pharmacokinetics on their own.”

Some in industry don’t necessarily want FDA to lower its approval bar to rush products to market. Regeneron Pharmaceuticals CEO **Leonard Schleifer** said in December that his company would never be able to compete with the Pfizers and Mercks of the world without a strong FDA to reward its endeavors, *Stat News* noted. “I actually am against making it really easy to get your drug approved,” Schleifer said at [the Forbes Healthcare Summit](http://www.forbes.com/sites/kathryndill/2016/12/05/at-what-cost-parsing-price-at-forbes-healthcare-summit/?ref=fdaweb.com#2daee81770e3). “Having a high bar is a good thing in my opinion, because it allows innovators to compete.”

  
“Streamlining drug approvals sounds good, but the agency has already weakened approval standards and patients are paying the price — hugely expensive drugs that don’t even work,” National Center for Health Research president **Diana Zuckerman** told the [*New York Times*](https://www.nytimes.com/2017/01/31/health/trump-vows-to-ease-rules-for-drug-makers-but-prices-remain-a-focus.html?%5Fr=0&ref=fdaweb.com). She [recently studied](http://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2589085?ref=fdaweb.com) expensive new [cancer](http://health.nytimes.com/health/guides/disease/cancer/overview.html?inline=nyt-classifier&ref=fdaweb.com) drugs and found that many did not help patients feel better or live longer.