Skip to content
  • About
  • Contact
  • Contribute
  • What Physicians Say
  • My Book
  • Careers
  • Podcast
  • Speaking
KevinMD.com — Social media's leading physician voice
  • All
  • Physician
  • Burnout
  • Practice
  • Policy
  • Finance
  • Conditions
  • .edu
  • Patient
  • Meds
  • Tech
  • Social
  • All
  • Physician
  • Burnout
  • Practice
  • Policy
  • Finance
  • Conditions
  • .edu
  • Patient
  • Meds
  • Tech
  • Social
    • All
    • Physician
    • Burnout
    • Practice
    • Policy
    • Finance
    • Conditions
    • .edu
    • Patient
    • Meds
    • Tech
    • Social
    • About
    • Contact
    • Contribute
    • What Physicians Say
    • My Book
    • Careers
    • Podcast
    • Speaking
KevinMD.com — Social media's leading physician voice
  • All
  • Physician
  • Burnout
  • Practice
  • Policy
  • Finance
  • Conditions
  • .edu
  • Patient
  • Meds
  • Tech
  • Social
    • All
    • Physician
    • Burnout
    • Practice
    • Policy
    • Finance
    • Conditions
    • .edu
    • Patient
    • Meds
    • Tech
    • Social
    • About
    • Contact
    • Contribute
    • What Physicians Say
    • My Book
    • Careers
    • Podcast
    • Speaking
  • About Kevin Pho, MD, Founder of KevinMD
  • Aging and dementia: what physicians say, in their own words
  • Artificial intelligence: what physicians say, in their own words
  • Be heard on social media’s leading physician voice
  • Cancer: what physicians say, in their own words
  • Children’s health: what pediatricians say, in their own words
  • Contact Kevin
  • COVID-19: what physicians wrote as it happened
  • Custom enhanced author page pricing
  • Diabetes and obesity: what physicians say, in their own words
  • Direct primary care: what physicians say, in their own words
  • DMCA Policy
  • End of life: what physicians say, in their own words
  • Establishing, Managing, and Protecting Your Online Reputation: A Social Media Guide for Physicians and Medical Practices
  • GLP-1 drugs: what physicians say about Ozempic and its successors, in their own words
  • Heart disease: what physicians say, in their own words
  • Immigration and medicine: what physicians say about immigrant doctors and immigrant patients, in their own words
  • KevinMD influencer opportunities
  • Medical errors: what physicians say, in their own words
  • Medical ethics: what physicians say, in their own words
  • Medical malpractice: what physicians say, in their own words
  • Medical school: what students and physicians say, in their own words
  • Mental health: what psychiatrists and physicians say, in their own words
  • Nursing: what nurses and physicians say, in their own words
  • Opinion and commentary by KevinMD
  • Opioids: what physicians and pain patients say, in their own words
  • Physician burnout speakers to keynote your conference
  • Physician burnout: what physicians say, in their own words
  • Physician Coaching by KevinMD
  • Physician keynote speaker: Kevin Pho, MD
  • Physician personal finance: what physicians say about their own money, in their own words
  • Physician Speaking by KevinMD: a boutique speakers bureau
  • Physician suicide: what physicians say, in their own words
  • Physicians and administrators: what physicians say about who runs medicine, in their own words
  • Primary care physician in Nashua, NH | Kevin Pho, MD
  • Primary care: what physicians say, in their own words
  • Prior authorization: what physicians say, in their own words
  • Privacy Policy
  • Private equity and corporate medicine: what physicians say, in their own words
  • Race and medicine: what physicians say, in their own words
  • Recommended services by KevinMD
  • Residency: what residents and attendings say, in their own words
  • Scope of practice: what physicians, nurse practitioners, and PAs say, in their own words
  • Subscribe to the KevinMD enhanced author page
  • Subscribe to the newsletter
  • Surgeons and surgery: what surgeons say, in their own words
  • Take-home messages: what physicians say when asked to leave one
  • Terms of Use Agreement
  • Thank you for subscribing to KevinMD
  • Thank you for upgrading to the KevinMD enhanced author page
  • The electronic health record: what physicians say, in their own words
  • Vaccines: what physicians say, in their own words
  • Violence against health care workers: what physicians and nurses say, in their own words
  • What physicians say: the KevinMD records
  • Women in medicine: what women physicians say, in their own words
  • Women’s health: what physicians say, in their own words

Streamlining the process to approve new drugs can save lives

Nathan Fountain, MD
Medications
July 14, 2014
Share
Tweet
Share

My heart sinks each time I see the subject line in this too common email I receive in my medical practice: “Sad news: Matthew was fine when he went to bed last night but his mother found him dead in bed this morning.” Matthew (not his real name) had epilepsy with seizures that persisted despite use of currently available antiseizure medications.

We started Matthew’s evaluation when the latest antiseizure medication had been approved by the U.S. Food and Drug Administration (FDA). But he died while waiting for the Drug Enforcement Administration (DEA) to provide final regulatory approval of the medicine through the scheduling process, as required by the Controlled Substances Act.

I cannot tell you that Matthew would be alive if he had this medicine available. But I can tell you we would have had more treatment options for Matthew if it had been approved more quickly.

That’s why I join with the Epilepsy Foundation and our community in support of the Improving Regulatory Transparency for New Medical Therapies Act (H.R. 4299), which would provide needed clarity and predictability to the DEA review process. It would help ensure innovative treatment options are made available to patients who need them by setting a 45-day deadline for the DEA to schedule new medicines as recommended by the FDA.

But why is this needed?  Although our community is concerned with the urgency of treating epilepsy, this problem applies to all drugs reviewed by the DEA and particularly for conditions that are in urgent need of avoiding unnecessary delays.

Currently there is no time limit on the scheduling process, which is in place to help prevent drugs with the potential for abuse from getting into the wrong hands while ensuring patients who need them have access to them. But the DEA has taken progressively longer to schedule drugs after approval by FDA, from 49 days in the period of 1997-1999 to 237 days in the period 2009-2013 according to a published analysis. This is an average of nearly eight months; and sometimes it takes more than a year.

The FDA conducts a thorough scientific and safety review and makes a recommendation on how a product should be scheduled by the DEA.  The long delay by the DEA is despite the fact that the DEA has always agreed with FDA’s recommendation for scheduling, based on DEA testimony.

The epilepsy community is so sensitive to this because access to new antiseizure medications has been delayed by DEA scheduling in recent years. An antiseizure medication was approved by FDA on October 22, 2012 and scheduled and approved for marketing by DEA on January 2, 2014: an astounding 14 months later, according to FDA News. That means patients, families, parents, and their physicians are waiting for one federal agency to sign off on the work of another when there is no expectation that any changes will be made to the scheduling recommendation. For our community, this is beyond unreasonable; it is a potential danger to life to wait for a bureaucratic rubber stamp.

And this is why Matthew’s story is so frustrating and heartbreaking. He had seizures in his sleep several times per week, which did not bother him much; he was a good student, personable, and had no other medical problems. So, how often do I see such cases? I follow around 2,000 people with epilepsy, and I get this “sad news” email about twice per year. I have encountered 35-50 deaths, mostly due to Sudden Unexpected Death in Epilepsy (SUDEP), in which patients die for no apparent reason: sometimes during a seizure and sometimes out of the blue.

Epilepsy is a medical condition that produces seizures which are often described as an “electrical storm of the brain.” All Americans should know more about epilepsy: in the United States, 1 in 26 people will have epilepsy at some point in their life.  Close to 3 million Americans live with epilepsy at any one time and about one third of them continue to experience seizures despite our best efforts and treatment options.

That’s why we need as many options as possible to treat them. I applaud Reps. Joe Pitts (R-PA) and Frank Pallone (D-NJ) for introducing the Improving Regulatory Transparency for New Medical Therapies Act. It is a simple, common sense solution.

At a time where many of us see gridlock in Congress, the chairman and ranking member of the House subcommittee on health have come together to help solve a problem with a simple solution that all members will hopefully support.  Not only could this legislation streamline federal inefficiencies, but it could also save lives.

Nathan Fountain is a neurologist and chair, Epilepsy Foundation Professional Advisory Board. 

ADVERTISEMENT

Prev

A pediatrician reflects, with deep gratitude to her patients

July 14, 2014 Kevin 0
…
Next

Stop calling nurse practitioners mid-level providers

July 14, 2014 Kevin 256
…

Tagged as: Medications and Prescribing, Neurology

< Previous Post
A pediatrician reflects, with deep gratitude to her patients
Next Post >
Stop calling nurse practitioners mid-level providers

 

ADVERTISEMENT

More in Medications

  • The conflict of interest that discloses as nothing

    Martha Rosenberg
  • Why cannabis use disorder and withdrawal go unnoticed

    Ginger Constantine, MD
  • How fentanyl misinformation turns suspicion into fact

    Lynn R. Webster, MD
  • The nociplastic pain question new pain therapies avoid

    Amir Friedman, MD
  • mRNA hype moves faster than the evidence behind it

    Harry Oken, MD
  • Side effects of osteoporosis drugs the trials never proved

    Michael Duben, MD
  • Most Popular

  • Past Week

    • Retirement isn’t the end of medicine, it’s a second act [PODCAST]

      The Podcast by KevinMD | Podcast
    • The conflict of interest that discloses as nothing

      Martha Rosenberg | Medications
    • Surgical judgment: the skill no one sees from the gallery

      Mustafa Kemal Çalık, MD | Physician
    • Why haven’t ambient AI scribes boosted productivity?

      Karan Kanwar | Health Technology
    • Why exhaustion can make you see things that aren’t there [PODCAST]

      The Podcast by KevinMD | Podcast
    • Physician well-being is not an individual problem

      Heather Buckley | Conditions and Diseases
  • Past 6 Months

    • Why CDC opioid guidelines get the overdose data wrong

      Richard A. Lawhern, PhD | Conditions and Diseases
    • Retirement isn’t the end of medicine, it’s a second act [PODCAST]

      The Podcast by KevinMD | Podcast
    • Sensory processing in autism and the brain’s volume control

      Josette Pelatan, PhD | Conditions and Diseases
    • What maternity care deserts cost a town

      Manisha Kaliaperumal | Health Policy
    • Why medicine needs a national physician license now

      Vaishali Popat, MD, MPH | Physician
    • A cold cost $945. The cost of primary care is broken.

      Susan Newman, MD | Physician
  • Recent Posts

    • Why exhaustion can make you see things that aren’t there [PODCAST]

      The Podcast by KevinMD | Podcast
    • 3 reforms to counter wellness influencers in practice

      Farid Sabet-Sharghi, MD | Physician
    • Shift work and circadian rhythms shape the 24/7 workplace

      Deepak Gupta, MD | Conditions and Diseases
    • Paid for twice

      Physicians paid for G2211 twice. Most never bill it.

      Michael Duben, MD | Physician Finance
    • The next child

      Medicaid managed care and the case for mutual stewardship

      Steven Merahn, MD | Health Policy
    • Choosing a limb lengthening surgeon requires accountability

      Hrayr Basmajian, MD | Physician

Subscribe to KevinMD and never miss a story!

Get free updates delivered free to your inbox.


Find jobs at
Careers by KevinMD.com

Search thousands of physician, PA, NP, and CRNA jobs now.

Learn more

View 1 Comments >

Founded in 2004 by Kevin Pho, MD, KevinMD.com is the web’s leading platform where physicians, advanced practitioners, nurses, medical students, and patients share their insight and tell their stories.

Social

  • Like on Facebook
  • Follow on Twitter
  • Connect on Linkedin
  • Subscribe on Youtube
  • Instagram

ADVERTISEMENT

  • Most Popular

  • Past Week

    • Retirement isn’t the end of medicine, it’s a second act [PODCAST]

      The Podcast by KevinMD | Podcast
    • The conflict of interest that discloses as nothing

      Martha Rosenberg | Medications
    • Surgical judgment: the skill no one sees from the gallery

      Mustafa Kemal Çalık, MD | Physician
    • Why haven’t ambient AI scribes boosted productivity?

      Karan Kanwar | Health Technology
    • Why exhaustion can make you see things that aren’t there [PODCAST]

      The Podcast by KevinMD | Podcast
    • Physician well-being is not an individual problem

      Heather Buckley | Conditions and Diseases
  • Past 6 Months

    • Why CDC opioid guidelines get the overdose data wrong

      Richard A. Lawhern, PhD | Conditions and Diseases
    • Retirement isn’t the end of medicine, it’s a second act [PODCAST]

      The Podcast by KevinMD | Podcast
    • Sensory processing in autism and the brain’s volume control

      Josette Pelatan, PhD | Conditions and Diseases
    • What maternity care deserts cost a town

      Manisha Kaliaperumal | Health Policy
    • Why medicine needs a national physician license now

      Vaishali Popat, MD, MPH | Physician
    • A cold cost $945. The cost of primary care is broken.

      Susan Newman, MD | Physician
  • Recent Posts

    • Why exhaustion can make you see things that aren’t there [PODCAST]

      The Podcast by KevinMD | Podcast
    • 3 reforms to counter wellness influencers in practice

      Farid Sabet-Sharghi, MD | Physician
    • Shift work and circadian rhythms shape the 24/7 workplace

      Deepak Gupta, MD | Conditions and Diseases
    • Paid for twice

      Physicians paid for G2211 twice. Most never bill it.

      Michael Duben, MD | Physician Finance
    • The next child

      Medicaid managed care and the case for mutual stewardship

      Steven Merahn, MD | Health Policy
    • Choosing a limb lengthening surgeon requires accountability

      Hrayr Basmajian, MD | Physician

Copyright © 2026 KevinMD.com | Powered by Astra WordPress Theme

  • Terms of Use Agreement
  • Privacy Policy
  • DMCA Policy
All Content © KevinMD, LLC
Site by Outthink Group

Streamlining the process to approve new drugs can save lives
1 comments

Comments are moderated before they are published. Please read the comment policy.

Loading Comments...