Off-Label Uses of Medical Products Under FDA Rules: Walking the Fine Line of Promotion Verses Scientific Discussion

Duration: 90 Minutes
FDA has publicly acknowledged that many regulated products have uses beyond what they have been approved for. FDA also recognizes that these unapproved uses may be beneficial to some patients.
21 cfr part 11
Instructor: Mukesh Kumar
Product ID: 500178
The so-called off-label uses may be well-known to the physicians and manufacturers. While there are no restrictions on a physician prescribing off-label uses of a product, manufacturers are prohibited for “actively” promoting an off-label use. However, FDA has recently released some rules under which manufacturers can indeed educate the physicians and, indirectly, even patients about new uses of their products. This seminar will discuss the regulatory perspective on promoting off-label uses for manufacturers.

Why Should you Attend:
Recently the US courts have made some high-profile decisions regarding FDA’s punitive actions to manufacturers accused of off-label promotion. One case, the Caronia case, has been in much discussion since in that case the court sided with the defendant accused of off-label promotion leading to speculation of its impact on FDA’s enforcement of its rules regarding off-label promotion. The legal discussion apart, these cases have raised new regulatory questions about FDA-acceptable practices for promoting off-label uses for approved products. This seminar will discuss the regulatory impact of recent court decisions and strategies for introducing new uses for approved products.

Objectives of the Presentation:
  • Current FDA accepted definition of off-label, in-label, published and anecdotal information
  • FDA guidance documents about off-label promotion
  • Review of case-studies from unsuccessful and successful promotion of off-label uses
  • Practical tips for training of sales and marketing teams in off-label uses of products
  • Regulatory strategies for converting off-label uses to in-label uses
Who can Benefit:
  • Manufacturers of FDA regulated products: Drug, Medical Device and Biotech Companies, Dietary supplement manufacturers
  • Marketing and Advertising Professionals
  • Financial analysts and investors, venture capitalists, insurance professionals
  • Legal experts involved in advising manufacturers of marketed products
  • Senior management for companies developing new products for US market
  • Regulatory affairs professionals, research analysts
$375
Recorded Session for one participant
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Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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