Description
While off-label promotion is illegal, the off-label use of approved drugs and devices is permitted and falls under an individual physician’s responsibility to decide what treatment is best for their patient. (Remember, FDA does not regulate the practice of medicine!). Off-label uses are especially common in oncology and pediatric practice, where the treatments do not have adequate clinical data to support all viable indications, but is approved for use in adults with similar diagnoses. FDA has published its views on the dissemination of information regarding unapproved uses of medical products.
In addition, in December 2012 a supreme court case was decided that adds controversy to this issue (see summary at the link below)
http://www.clm.com/publication.cfm?ID=411
After reviewing the article on off-label promotion, the 2012 Supreme Court Case, FDA’s guidance on Good Reprint Practices and FDA’s Draft Guidances on Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices, and the Draft guidance on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices discuss in your post all the following questions and include references:
- Do you agree with the FDAMA section 401 ‘safe harbor’ provision? Explain why or why not.
- After reviewing all of the following three FDA guidance documents, discuss at least one pro and con for each of the three guidance documents:
- FDA’s guidance on Good Reprint Practices,
- FDA guidance on Distributing Scientific and Medical Publications on Unapproved New Uses and
- FDA guidance on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.
- Do you think the 2012 Supreme Court ruling will lead to widespread promotion of off-label uses by manufacturers? Discuss whether or not the ruling can impact patient safety and risk, while benefiting the drug/device manufacturers.
Explanation & Answer
Attached. Please let me know if you have any questions or need revisions.
Running head: DRUG AND MEDICAL
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DRUG AND MEDICAL
By
[Name of Student]
February 8, 2021
DRUG AND MEDICAL
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1. Section 401 if FADAMA is seeking to create a safe harbour for manufacturers involved
in distributing the articles on unchecked issues. FADAMA's guidance for manufacturers
for medical companies and to stop them write about off-label drugs. It also argues that the
FDA's previous guidance opposed manufacturers' right to share authentic and truthful
information about products. I can't entirely agree with the FADAMA's safe harbour pro
harbour because I think it is manufacturers' rights and limiting them to reveal the nature
of off-label drugs. It prohibits manufacturers from writing and promote off-label drugs
unless the article is written by research or editorial board. And the article should be
published in a recognized source to spread higher information (Advisory, 2012). These
limitations on the promotion and sharing of information show that the government is
protecting the use of drugs for several reasons. Although the FDA does not regulate
medicine, it does restrict the promotion of articles or information using unapproved use
of medical drugs. The FDA has three guidelines that aim to enhance the role of
manufacturers in the medical field. I can't entirely agree with the first and third guidance.
The second guidance that talks about the reliable and authentic use of knowledge are
useful guidance. Manufacturers can ensure users that they are offering healthy choices
along with the detailed prescription. The safe harbour is not all positive and not all
negative because it has different pros and cons.
2. The guidance on three areas can bring success or failure. The effectivity of these three
guidelines depends on the extent to which it would be followed. Some of the pros and
cons are as follows;
i.
The pros of the FDA's guidance on good reprint practices are that sharing of
reprints on certain events or for a certain purpose will avoid the sharing on a large
DRUG AND MEDICAL
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scale and misuse of the information. And the consequence of this guidance is that
because of prohibited promotion, the public will be unaware of the use of drugs
and judge whether the product is good for them.
ii.
The major pros of...
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