Food and Drug Administration, HHS Office of the Inspector General (OIG), U.S. Senate Special Commission on Aging: A number of government agencies try to keep our medical system safe and effective, but
1. The FDA is underfunded to carry out its job. Fifty-percent of funding for drug approval now comes directly from the Big Pharma, clearly a conflict of interest. Jack Mitchell, U.S. Senate Special Commission on Aging
2. The FDA is responsible for overseeing 82,000 industry advertisements/year costing $1 billion. Thomas Abrams RPh, MBA, Director, Office of Prescription Drug Promotion, FDA. With its budget of $4 billion, the FDA is also responsible for food surveillance and safety, antimicrobial resistance monitoring, imported drug monitoring, approval of new drugs and devices and surveillance of all drugs, devices, and medical products already on the market.
3. Since implementation of 510k, "fast track" drug approval, the FDA now approves many medical devices on the basis of being "substantially equivalent" to other devices already on the market, thus avoiding real clinical trials. Jack Mitchell, U.S. Senate Special Commission on Aging
4. When OIG (who oversees Medicare and Medicaid payments) calls a company on the carpet for false statements or fraudulent practices, the company pays a fine, but no CEOs have yet gone to jail for all the harms that they have caused patients. Julie Taitsman, MD, JD, HHS Office of the Inspector General
Suggestions for Improvement:
1. Academia and government regulatory bodies need better data and better data analysis. It is not in the interest of the American people that Big Pharma has better access and use of data than the People. One example for improvement is "registries" to capture data on medical devices. Another example is "academic detailing" that would disseminate scientific truths, rather than commercial marketing.
2. Once there is scientifically validated information available, this information should be transparently disseminated to the medical community. Such information can lead to formularies and guidelines for treatment. Kaiser-Permanente has demonstrated this type of approach to be effective and efficient. Sharon Levine, MD, Kaiser Permanente
3. Public money needs to influence pricing of drugs and devices. Medicare and Medicaid are the biggest consumers of health care, thus representing the largest market share. This gives CMS power to influence prices, just like other countries do.
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