Orphan Drugs: The Conundrum
Instructor: Dr Marybeth Regan
Product ID: 500903
Level: Intermediate
Description
The Orphan Drug Act is intended to treat conditions affecting less than 200,000 patients in the US – about 1 in 1500 people. These cases are where there is no reasonable expectation that the developer will recover the costs of drug development and marketing via future sales of the drug in the US.
Instructor: Dr Marybeth Regan
Product ID: 500903
Level: Intermediate
Description
The Orphan Drug Act is intended to treat conditions affecting less than 200,000 patients in the US – about 1 in 1500 people. These cases are where there is no reasonable expectation that the developer will recover the costs of drug development and marketing via future sales of the drug in the US.
The areas covered in this webinar are:
Definition of the Orphan Drug Act
Role of the FDA
Understanding why the Orphan Drug Act has started a conundrum
Why the varying views
Good Intentions, Bad Results
Competing in the Rare Disease Space
Review of drugs passed that are Orphan Drugs
Comparison of Rare Disease Drugs VS other drugs
Benefits of the Orphan Drug Act VS drawbacks
Why Should you Attend:
The Orphan Drug Act was approved in 1983. The question that remains is whether the FDA is encouraging pharmaceutical companies to use its resources in the most efficient manner. According to Clinical Leader Magazine, there are approximately 7,000 different types of rare diseases and disorders affecting an estimated 350 million people worldwide. These diseases are different in many ways and there are the variations in patient treatment and gaps in care. The Rare Disease Impact Report mentions that it takes an average of seven years for a patient with a rare disease in the United States to receive a proper diagnosis. Between diagnosis and treatment, a patient typically visits up to eight different physicians and receives two to three misdiagnoses.
Objectives of the Presentation:
Understanding the objective of the Orphan Drug Act
Understanding why the Orphan Drug Act has started a conundrum
What is the role of the FDA as it pertains to Orphan Drugs?
History of the results of the Orphan Drug Act
What is the likeliest future?
Who can Benefit:
Benefit Managers
Director of Human Resource
Director of Access
Director of Strategy
Pharmacy Benefit Managers
Representatives of Purchasers
Private Employers and Public Purchasers
Consumer Organization Representatives
Federal and State Government Officials
Health Care Regulators and Policy Makers
Health Benefits Consultants
Health Services Researchers and Academics
Chief Innovation Officers
Director of Accountable Care
Directors of Quality Management
Director of Government Programs
Director of Medicare Programs
Director of Medicaid Programs
Director of Network Contracting
Director of Provider Relations
Director of Reimbursement
Pharmaceutical Executives
Pharmaceutical Consultants
Director of Patient Advocacy
Pharmacy Benefit Manager
Electronic Health Record Staff and Venders.