By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: How crazy is Ted Cruz’s FDA reform proposal?
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Policy & Law > Health Reform > How crazy is Ted Cruz’s FDA reform proposal?
Health Reform

How crazy is Ted Cruz’s FDA reform proposal?

DavidEWilliams
DavidEWilliams
Share
5 Min Read
SHARE

ID-100355683

I don’t think very highly of Senator and Republican Presidential candidate Ted Cruz, but his proposal to loosen the drug approval process is at least worth discussing. If you haven’t heard, Cruz’s RESULT Act proposal is as follows:

ID-100355683

I don’t think very highly of Senator and Republican Presidential candidate Ted Cruz, but his proposal to loosen the drug approval process is at least worth discussing. If you haven’t heard, Cruz’s RESULT Act proposal is as follows:

More Read

The Stunning Shift Toward Employed Physicians
The ABCs of CCJR
Staying Competitive – Financing Medical Equipment and Technology in the Global Healthcare Market
Sequestration Reduced Your Medicare Pay? You Have Four Options
Does the GOP Have a Health Plan?
  • FDA to grant reciprocal approval of “life-saving” drugs and devices from regulatory agencies in developed countries including EU, Israel, Australia, Canada and Japan. FDA would have only 30 days to review and approve
  • Congress can override FDA decisions with a majority vote

Basically he is trying to make it easier to get drugs and devices on the market. There are a number of problems with this approach, which are pointed out by most of the respectable analysts. Objections include:

  • FDA may just reject the applications anyway since 30 days is not a long enough time to review and they may object to procedures used elsewhere
  • Inserting Congress directly into the process undermines the scientific basis of the decision
  • Trial sponsors may seek the jurisdiction with the lowest standards or fastest review times, imperiling safety for Americans
  • It would hurt US economic development by shifting development resources overseas
  • We would be ceding our sovereignty to foreigners
  • FDA is already pretty fast and responsive and has programs for compassionate use and acceleration of the approval process when warranted

These are all reasonable, and yet I was struck by the fact that almost all the commentators use the Thalidomide debacle as their one and only example.  See for example STAT, The FDA Group Blog, and Harvard Law Blog, which are the top articles that come up under a Google search for “Ted Cruz FDA proposal.”

Thalidomide was approved in Europe as a sleeping pill and for morning sickness but rejected in the US. It caused serious birth defects, with thousands of people affected in Europe, but not the US. Great example but we’re talking 1956. Remember 1956? I don’t. But to give you some perspective it was just two years after food rationing was lifted in the UK and nine years before Medicare was established. I don’t hear people citing 1956 examples about anything else in healthcare.

A more serious discussion could be held on the balance between safety and efficacy in FDA approvals. Cruz’s impulses might be better directed to that debate. Maybe it’s ok for FDA to approve any product that’s safe, and not force sponsors to prove efficacy. Sponsors would still want to demonstrate efficacy, but they’d need to do so for healthcare payers, not the FDA.

That’s not as simple as it sounds either. Here are some of the challenges:

  • The biggest payers are Medicare and Medicaid, so even if you take FDA out of the business of judging efficacy the government is still involved
  • In many situations, safety is relative, not absolute. I might accept a modestly effective cancer drug that kills 1 percent of those who take it, while I wouldn’t accept a cure for toenail fungus with the same death rate. But it’s also important to protect cancer patients from dangerous drugs. A recent NYT article about the death from cancer of the wife of the FDA’s head of oncology included this important and under-appreciated point: “Cancer medicines not only often fail to save patients but can accelerate their deaths and make their last weeks far more painful”
  • Safety and efficacy are individualized. (Cruz seems to recognize this.) Some drugs will be effective for only a small population; similarly safety issues don’t always apply across the board. I would want access to a drug that could cure me even if it could kill someone else, especially if there were a companion diagnostic to sort out who will be helped and hurt

Overall I think the FDA is doing a good job of managing the conflicting pressures it faces. Some parts of FDA (such as the groups with responsibility for HIV and oncology) do a better job than others.

I really would like to see Cruz’s proposal spur a more productive debate and not simply be dismissed out of hand.

Image courtesy of vectorolie at FreeDigitalPhotos.net

—

By healthcare business consultant David E. Williams, president of Health Business Group.

 

 

TAGGED:FDApresidential electionTed Cruz
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

a woman walking on the hallway
6 Easy Healthcare Ways to Sit Less and Move More Every Day
Health
September 9, 2025
Clinical Expertise
Healthcare at a Crossroads: Why Leadership Matters More Than Ever
Global Healthcare
September 9, 2025
travel nurse in north carolina
Balancing Speed and Scope: Choosing the Nursing Degree That Fits Your Goals
Nursing
September 1, 2025
intimacy
How to Keep Intimacy Comfortable as You Age
Relationship and Lifestyle Senior Care
September 1, 2025

You Might also Like

obamacare and you
Health ReformPolicy & LawPublic Health

#ObamaCare and You: Thoughts From Ardis Dee Hoven, M.D., President, AMA

October 24, 2013

Kindred Healthcare Inc. To Pay $125 Million to Settle Allegations of False Claims

February 9, 2016

FDA Approves New Drug for Cystic Fibrosis

February 2, 2012
Data_-_PQRS_Benefits
Health ReformPolicy & LawPublic Health

PQRS and the Benefits of Participating in 2015

December 18, 2014
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?