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  • About
    • Why We Matter
    • Our Team
    • Contact Us
  • Tools & Resources
    • AD Core Toolkits >
      • Opioid Safety Toolkit
      • HIV Prevention Toolkit
      • E-Detailing Toolkit
      • Program Building Resources
    • AD Literature Archives
  • Webinars
    • Webinar Series
    • E-Detailing Webinars
    • E-Detailing Roundtables
  • Blog & E-News
    • Best Practices Blog
    • E-Newsletter
  • Community
    • Discussion Forum
    • Partners by Location
    • Detailing Directory
  • EVENTS
    • Training Series
    • CONFERENCE SERIES
    • THE CONFERENCE HUB

The DETAILS BLOG

Capturing Stories from the Field: Reflections, Challenges, & Best Practices

​Is the Nation Making a U-turn on Regulating Drug Promotion?

7/14/2015

 
Jerry Avorn, MD, NaRCAD Co-Director

Tags: Detailing Visits, Health Policy, Jerry Avorn, Medications

For over a century, appropriate medication use in the U.S. has relied heavily on the regulation of what manufacturers can say about their products.  One of the first powers given to the Food and Drug Administration when it was created in 1906 was the ability to require that makers of “patent medicines” state what was actually in their products. (Often, it was a mixture of ineffective ingredients laced with alcohol or opium, but accurate information was a start.) Over time, the agency was granted the authority to regulate claims about efficacy and safety that companies made about prescription drugs.

This has begun to change, with potentially important implications for academic detailing. Currently drug manufacturers promoting their medications to clinicians are limited to discussing indications for which they have obtained approval from FDA, Last year, however, FDA announced its openness to considering policies to make it easier for drug manufacturers to present doctors with their own views about off-label uses of their products that FDA did not consider appropriate. A follow-up “draft guidance” would similarly open the door for manufacturers to provide information about side effects that differs from the determinations of FDA scientists and outside advisers.

Most recently, the agency has revealed plans for a national conference on whether limiting drug-makers’ promotional statements might infringe on these companies’ corporate free speech rights. And a bill that has progressed through Congress, The 21st Century Cures Act, will make it easier for drugs to be approved on the basis of looser standards, including lab tests or other surrogate measures of efficacy rather than actual patient outcomes.

These developments will have important implications for academic detailing. If we are entering a period of lessened government regulation of what pharmaceutical manufacturers are permitted to tell prescribers about off-label uses of their products, or their safety profiles, there will be an even greater need for balanced, evidence-based communication to inform medication use decisions. Just as travelers to developing countries that have polluted water supplies often prefer to drink bottled water, clinicians may increasingly feel the need for access to non-contaminated information sources if they can’t be sure what’s coming out of an increasingly de-regulated informational tap.

All of us concerned with optimal use of medications will need to monitor these developments closely.  If the proposed changes prevent FDA from regulating the promotional claims made by drug manufacturers as closely as in the past, then health care systems and individual practitioners will have increasingly greater need for the more reliable sources of information that academic detailing services can provide. Stay tuned.
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Nora Gurun
10/10/2019 08:34:34 pm

HSV1 & HSV2 Negative.
Saying that, herpes virus is not curable is because you have not seen the right person to help you get rid of the virus. I testify because it's only someone who have experience this virus that konws what it means to be in this situation. After my marriage to Loe my hubby, i noticed one day that I had sudden Cold Sores in my genital part. I went for test and the doctor confirmed me being HSV2 positive.
I felt my life and happiness with my hubby was finished. But to my greatest surprise my husband had contacted this virus and was later confirm HSV1 positive. I started noticing symptoms like cold sores, sore throat, fever blister, weakness of the body, runny nose, cough and finally the was a serious Outbreak. So I started looking for a remedy to our situation because the phamacytical drugs and the pains was too much for I and my hubby. I was looking for remedy online and different website when i saw a testimony about Dr. Akintunde and the herbal medicine that helped Erica to get rid of HSV2, I remembered my doctor told me the is no cure to this virus, I had to contact Dr. Akintunde on his WhatsApp number and told him about us and the virus, he promised to cure this virus with his herbal medicine. And he prepared four bottles of the herbal medicine and send to me through UPS delivery with instructions on how to take it. And only first week of my start, I noticed the outbreak and all the symptoms was off so, I told Dr. Akintunde about it and he said the medicine will eradicate the virus and boots my immune when i complete my medication. After I took the medicine I went back for retest and my doctor was surprised with my new status HSV2 negative my hubby also was cured. Thanks to Dr. Akintunde I am proud to say you safe our life and we remain greatful and we support your mission on humanity Sir, Do you experience such too?
Tell Dr. Akin your health problem and be sure of total cure with his natural roots and herbs. Like Erica did testify to me I also testify for everyone who need help to be free from this inconveniencing virus, and any other health challenges you're having is curable believe me. All the best.
Dr. Akintunde email and WhatsApp number below.
Via email:-
drakintundehomecare@gmail.com

WhatsApp number:. +2347035245593

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Comments are closed.

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