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The DMO:

The DMO: . By Whitney Davis 2011 WISE Intern University of Arkansas August 4, 2011. Improving the Quality, Quickness and Quantity of Access to Alzheimer’s Disease Treatments. US Food and Drug Administration. FD&C Act passed in 1938 (safety) Kefauver Harris Amendment in 1962 (efficacy)

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The DMO:

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  1. The DMO: By Whitney Davis 2011 WISE Intern University of Arkansas August 4, 2011 Improving the Quality, Quicknessand Quantity of Access to Alzheimer’sDisease Treatments

  2. US Food and Drug Administration • FD&C Act passed in 1938 (safety) • Kefauver Harris Amendment in 1962 (efficacy) • Only entity legally responsible for approval of: • Medical devices, food, vaccines, veterinary treatments, radiation-emitting products, cosmetics, tobacco products, and drugs for all diseases, conditions, and products

  3. Catheter Wheel- chairs Heart Monitors Imaging Systems Hearing Aids Defibrillator Biologics Xray Systems Infant Formulas Alzheimer’s Disease Dietary Supplements Food Additives MS Breast Implants Vaccines Animal Feed Vet Products Food Blood Products Lou Gehrig’s Drugs HIV Cosmetics FDA Tanning Products Hepatitis Small- pox Tobacco Products Medical Devices Radiation-emitting Products Addison’s Disease Cardiovascular Disease Cancer Arthritis Asthma Fertility Drugs Heart Valves West Nile Virus Lupus Pacemakers SARS Influenza Artificial Hearts

  4. Overview: Alzheimer’s Disease • A progressive, degenerative disorder that attacks the brain's nerve cells, or neurons, resulting in behavioral changes and loss of memory, thinking, and language skills • 6th Leading Cause of Death in US • Average life expectancy after diagnosis is 8 years • Age is greatest risk factor • 5.4 million people live with AD

  5. Economic Impact of AD • Total cost for care: $183 billion • Annual cost of care: $18,500 - $36,000 • Unpaid care in 2010: 14.9 million family & friends provided 17 billion hours = $202.6 billion • Costs US businesses $60 billion a year • Medicare payments are 3x higher • Medicaid payments are 9x higher

  6. Current FDA Challenges Phase IV:Safety & Efficacy Safety Efficacy Safety & Efficacy • To Develop A Drug: • Average Time: 10 years • Average Cost: $1 billion • User Fee: $1 million

  7. Current AD Treatments

  8. Government Reactions • Fast Track • product must concern a serious or life-threatening condition and has to have potential to address an unmet medical need • allows manufacturers to submit sections of their NDA to the FDA as they are ready rather than submitting a complete application at one time • can meet with FDA so that components of clinical study design and presentation can be clearly defined • Accelerated Track • accelerates approval of a drug that provides a “meaningful therapeutic benefit…over existing treatments” • approval based ongoing clinical trials • instead of survival rates or disease progression, a “surrogate endpoint that is reasonably likely…to predict clinical benefit” is used • Priority Review • Intended for products believed to address unmet needs • shortens the approval decision from 10 months to 6 months

  9. Results Manufacturers have requested Fast Track designation for 569 drugs since the Fast Track program was set into law 74.5% of those drug requests were granted Of products with Fast Track designation, 10.6% of the drugs were approved

  10. Current FDA Challenges • Economically Unmanageable Amount of Responsibility • Single Option for Drug Developers • Inefficient In Accurately Perceiving Demand • Can’t specify around a particular disease • Blanket “safety” definition

  11. Needs funds to match human resources & facilities to responsibility Financial resources get spread thin More funds with little production Economically Unmanageable Amount of Responsibility Economically Unmanageable Amount of Responsibility

  12. Single Option • Highly restricted early access except through clinical trials • No personalization • No incentive to improve: • Trials • Cost • Access

  13. Inefficient In Accurately Perceiving Demand • Revenue not directly affected by demand • Revenue always guaranteed

  14. The DMO: Direct Market Option • After submitting an IND, drug developer will have option to pursue DMO parallel to the conventional FDA approval track • Can legally gain approval by free market organization • Only requirement: drug developer must enter into a contract with organization in which the drug developer possesses liability for unknown or unlisted adverse effects • Drug developer can run clinical trials set under different conditions and methods by a free market organization • Organization responsible for: • post-market research • fining the company for false labeling and advertising as seen fit.

  15. Open More Options • More approved drugs • Better specialize • tradeoff of risk vs. benefit • potentially earlier access to drugs • More competition to meet demand • more efficient trials • faster access • cheaper drugs • cheaper user fees

  16. More Accurately Meet Demand • Revenue directly affected by demand • Can specialize & require less resources • Focus funds for better quality

  17. Questions? Whitney Davis IEEE – WISE Intern wxd003@uark.edu

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