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 A follow-up “draft guidance” would similarly open the door for manufacturers to provide information about side effects that differs from the determinations of FDA scientists and outside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.
1 Comment
Ruth Cholay
1/16/2024 05:14:25 am
I'm here to let everyone know that there is a cure for HERPES1&2. The doctors have succeeded in letting people living with Herpes know that there is no cure for Herpes and they have been enslaved to the antiviral and other supplementary Orthodox medicine just to help suppress the virus and not a cure. I got diagnose of herpes1&2 and i did not believe in my doctor that no cure for herpes rather i went into research online and I was introduce to Dr Osato a herbal healer by a blogger who also narrated Her story online on how she was cured of Herpes after using Dr Osato Herbal Medicine. I got the herbal medicine from Dr Osato and made use of it as I was instructed. I went to the clinic for a checkup after two weeks of using the herbal product. My result came out Negative and I was booked for another appointment after 30days to confirm my result and the test still showed Negative and I was given the green light that I am fully free from herpes. All thanks to God for using this Great herbalist to heal me. You can contact Dr Osato by email: osatoherbalcure@gmail.com or WhatsApp +2347051705853. His website is https://osatoherbalcure.wordpress.com. I have promised to keep sharing my testimony, so people will know that there is a cure for herpes.
Reply
Leave a Reply. |
Highlighting Best PracticesWe highlight what's working in clinical education through interviews, features, event recaps, and guest blogs, offering clinical educators the chance to share successes and lessons learned from around the country & beyond. Search Archives
|